ISO 9001 13485 and FDA QSR Compare

Correspondence between ISO 9001:2000 and ISO 13485:2003
and the US Quality System Regulation
Prepared by: Ed Kimmelman, Consultant

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Correspondence between ISO 9001:2000 and ISO 13485:2003 and the US Quality System Regulation
ISO/DIS 9001:2000 U.S. Quality System Regulation (21 Comments

ISO 13485:2003 CFR 820)
1 Scope 1 Scope 820.1 Scope The scope sections of each document

1.1 General 1.1 General (a) Applicability. set out their objectives. For the
This International Standard specifies This International Standard specifies (1) Current good manufacturing practice ISO/DIS, the objective is to harmonize
requirements for a quality management requirements for a quality management (CGMP) requirements are set forth in this regulation around the world. As a result
system where an organization system where an organization needs to quality system regulation. The an attempt was made by FDA during
needs to demonstrate its ability to demonstrate its ability to provide medical requirements in this part govern the the revision of the GMPs, while the
consistently provide product that meets devices and related services that methods used in, and the facilities and 1996 version of ISO 13485 was being
customer and applicable regulatory consistently meet customer requirements controls used for, the design, developed, to incorporate the
requirements, and aims to enhance and regulatory requirements applicable to manufacture, packaging,labeling, storage, requirements that were included in that
customer satisfaction through the effective medical devices and related services. installation, and servicing of all finished version of the Standard. While the
application of the system, including devices intended for human use. The agency could not revise the format of
processes for continual improvement of the The primary objective of this International requirements in this part are intended to the regulation to follow that of the
system and the assurance of conformity to Standard is to facilitate harmonized ensure that finished devices will be safe Standard, the requirements were
customer and applicable regulatory medical device regulatory requirements for and effective and otherwise in compliance included.
requirements. quality management systems. As a result, with the Federal Food, Drug, and
it includes some particular requirements Cosmetic Act (the act). This part This section of the regulation contains
NOTE In this International Standard, the for medical devices and excludes some of establishes basic requirements applicable some additional regulatory isssues that
term product applies only to the the requirements of ISO 9001 that are not to manufacturers of finished medical are not appropriate for the Standard.
product intended for, or required by, a appropriate as regulatory requirements. devices.
customer. Because of these exclusions,
organizations whose quality management (c) Authority. Part 820 is established
systems conform to this International and issued under authority of sections
Standard cannot claim conformity to ISO 501, 502, 510, 513, 514, 515, 518, 519,
9001 unless their quality management 520, 522, 701, 704, 801, 803 of the act
systems conform to all the requirements of (21 U.S.C. 351, 352, 360, 360c, 360d,
ISO 9001 (see Annex B) 360e, 360h, 360i, 360j, 360l, 371, 374,
381, 383). The failure to comply with any
applicable provision in this part renders a
device adulterated under section 501(h) of
the act. Such a device, as well as any
person responsible for the failure to
comply, is subject to regulatory action.
(d) Foreign manufacturers. If a

manufacturer who offers devices for
import into the United States refuses to
permit or allow the completion of a Food
and Drug Administration (FDA) inspection
of the foreign facility for the purpose of
determining compliance with this part, it

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ISO 13485:2003 CFR 820)
shall appear for purposes of section

801(a) of the act, that the methods used
in, and the facilities and controls used for,
the design, manufacture, packaging,
labeling, storage, installation, or servicing
of any devices produced at such facility
that are offered for import into the United
States do not conform to the requirements
of section 520(f) of the act and this part
and that the devices manufactured at that
facility are adulterated under section
501(h) of the act.
(e) Exemptions or variances.

(1) Any person who wishes to petition
for an exemption or variance from any
device quality system requirement is
subject to the requirements of section
520(f)(2) of the act.
Petitions for an exemption or variance
shall be submitted according to the
procedures set forth in Sec. 10.30 of this
chapter, the FDA's administrative
procedures. Guidance is available from
the Center for Devices and Radiological
Health, Division of Small Manufacturers
Assistance, (HFZ-220), 1350 Piccard Dr.,
Rockville, MD 20850, U.S.A., telephone 1-
800-638-2041 or 1-301-443-6597, FAX
301-443-8818.
(2) FDA may initiate and grant a variance

from any device quality system
requirement when the agency determines
that such variance is in
the best interest of the public health. Such
variance will remain in effect only so long
as there remains a public health need for
the
device and the device would not likely be
made sufficiently available without the
variance.

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ISO 13485:2003 CFR 820)
1.2 Application 1.2 Application 820.1 Scope Basically, the applicability guidance for
All requirements of this International All requirements of this International (a) Applicability. the two documents is the same in both
Standard are generic and are intended to Standard are specific to organizations (1) Current good manufacturing practice documents. In essence, they allow for
be applicable to all organizations, providing medical devices, regardless of (CGMP) requirements are set forth in this the exclusion from the QMS
regardless of type, size and product the type or size of the organization. quality system regulation. The requirements associated with activities
provided. requirements in this part govern the not performed by the organization. The
Where any requirement(s) of this If regulatory requirements permit methods used in, and the facilities and standard explicitly limits those
International Standard cannot be applied exclusions of design and development controls used for, the design, exclusions to those associated with
due to the nature of an organization and its controls (see 7.3), this can be used as a manufacture, packaging,labeling, storage, product realization.
product, this can be considered for justification for their exclusion from the installation, and servicing of all finished
exclusion. quality management system. These devices intended for human use. The Because of this approach, it will be
Where exclusions are made, claims of regulations can provide alternative requirements in this part are intended to necessary for registrars to explain in
conformity to this International Standard are arrangements that are to be addressed in ensure that finished devices will be safe detail the scope of any certificates of
not acceptable unless these exclusions are the quality management system. It is the and effective and otherwise in compliance compliance with ISO 13485:2003. They
limited to requirements within clause 7, and responsibility of the organization to ensure with the Federal Food, Drug, and will have to spelled out clearly any
such exclusions do not affect the that claims of conformity with this Cosmetic Act (the act). This part exclusions.
organizations ability, or responsibility, to International Standard reflect exclusion of establishes basic requirements applicable
provide product that meets customer and design and development controls [see to manufacturers of finished medical
applicable regulatory requirements. 4.2.2 a) and 7.3]. devices.
If any requirement(s) in Clause 7 of this If a manufacturer engages in only some

International Standard is(are) not operations subject to the requirements in
applicable due to the nature of the medical this part, and not in others, that
device(s) for which the quality manufacturer need only comply with those
management system is applied, the requirements applicable to the operations
organization does not need to include in which it is engaged. With respect to
such a requirement(s) in its quality class I devices, design controls apply only
management system [see 4.2.2 a)]. to those devices listed in Sec.
820.30(a)(2). This regulation does not
The processes required by this apply to manufacturers of components or
International Standard, which are parts of finished devices, but such
applicable to the medical device(s), but manufacturers are encouraged to use
which are not performed by the appropriate provisions of this regulation as
organization, are the responsibility of the guidance. Manufacturers of human blood
organization and are accounted for in the and blood components are not subject to
organizations quality management system this part, but are subject to part 606 of this
[see 4.1 a)]. chapter.
In this International Standard the terms if
appropriate and where appropriate are (2) The provisions of this part shall be
used several times. When a requirement applicable to any finished device as
is qualified by either of these phrases, it is defined in this part, intended for human

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deemed to be appropriate unless the use, that is manufactured, imported, or

organization can document a justification offered for import in any State or Territory
otherwise. A requirement is considered of the United States, the District of
appropriate if it is necessary in order for Columbia, or the Commonwealth of Puerto
. the product to meet specified Rico.
requirements, and/or
. the organization to carry out corrective (3) In this regulation the term ``where
action. appropriate'' is used several times. When
a requirement is qualified by ``where
appropriate,'' it is deemed to be
``appropriate'' unless the manufacturer
can document justification otherwise. A
requirement is ``appropriate'' if
nonimplementation could reasonably be
expected to result in the product not
meeting its specified requirements or the
manufacturer not being able to carry out
any necessary corrective action.
(b) Limitations. The quality system

regulation in this part supplements
regulations in other parts of this chapter
except where explicitly s tated otherwise.
In the event that it is impossible to comply
with all applicable regulations, both in this
part and in other parts of this chapter, the
regulations specifically applicable to the
device in question shall supersede any
other generally applicable requirements.

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2 Normative reference 2 Normative reference

The following normative document contains The following referenced documents are
provisions which, through reference in this indispensable for the application of this
text, constitute provisions of this document. For dated references, only the
International Standard. For dated edition cited applies. For undated
references, subsequent amendments to, or references, the latest edition of the
revisions of, any of these publications do referenced document (including any
not apply. However, parties to agreements amendments) applies .
based on this International Standard are
encouraged to investigate the possibility of ISO 9000:2000, Quality management
applying the most recent edition of the systems Fundamentals and vocabulary
normative document indicated below. For
undated references, the latest edition of the
normative document referred to applies.
Members of ISO and IEC maintain registers
of currently valid International Standards.
ISO 9000:2000, Quality management

systems Fundamentals and vocabulary.
3 Terms and definitions 3 Terms and definitions 820.3 Definitions. The Standard spells out clearly the new
For the purposes of this International For the purposes of this document, the (a) Act means the Federal Food, Drug, meanings of the words supplier and
Standard, the terms and definitions given in terms and definitions given in ISO 9000 and Cosmetic Act, as amended (secs. organization
ISO 9000:2000 apply. apply, together with the following. 201-903, 52 Stat. 1040 et seq., as
The following terms, used in this edition of amended (21 U.S.C. 321-394)). All
ISO 9001 to describe the supply chain, The following terms, used in this edition of definitions in section 201 of the act shall
have been changed to reflect the ISO 13485 to describe the supply chain, apply to the regulations in this part.
vocabulary currently used: have been changed to reflect the
supplier---->organization-------> customer vocabulary currently used:
supplier ---> organization ---> customer
The term "organization" replaces the term
supplier used in ISO 9001:1994, and The term organization replaces the term
refers to the unit to which this International supplier used in ISO 13485:1996, and
Standard applies. Also, the term "supplier" refers to the unit to which this International
now replaces the term "subcontractor". Standard applies. Also, the term supplier
Throughout the text of this International now replaces the term subcontractor.
Standard, wherever the term product
occurs, it can also mean service. Throughout the text of this International
Standard, wherever the term product
occurs, it can also meanservice.
Wherever requirements are specified as

applying to medical devices, the

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requirements apply equally to related

services as supplied by the organization.
The following definitions should be

regarded as generic, as definitions
provided in national regulations can differ
slightly and take precedence.
3.1 I was not able to find the regulatory

active implantable medical device definitions of these items, even though
active medical device which is intended to
Im sure the definitions in the Standard
be totally or partially introduced, surgically
or medically, into the human body or by were taken from a regulatory source.
medical intervention into a natural orifice,
and which is intended to remain after the
procedure
3.2
active medical device
medical device relying for its functioning
on a source of electrical energy or any
source of power other than that directly
generated by the human body or gravity
3.3
advisory notice
notice issued by the organization,
subsequent to delivery of the medical
device, to provide supplementary
information and/or to advise what action
should be taken in
. the use of a medical device,
. the modification of a medical device,
. the return of the medical device to the
organization that supplied it, or
. the destruction of a medical device
NOTE Issue of an advisory notice might

be required to comply with national or
regional regulations.
3.4 (b) Complaint means any written, The regulatory definition is a bit

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customer complaint electronic, or oral communication that broader, as it covers products that have
written, electronic or oral communication alleges deficiencies related to the identity, not, as yet, been placed on the market,
that alleges deficiencies related to the quality, durability,
but have been released for distribution.
identity, quality, durability, reliability, safety reliability, safety, effectiveness, or
or performance of a medical device that performance of a device after it is released This would mean that a lot of product
has been placed on the market for distribution. that has been released for distribution
could be included in the activities
associated with a customer complaint,
even though no part of the lot has not
reached the cus tomer.
3.5 [21CFR 812.3(d) Implant means a device The definition in the Standard includes
implantable medical device that is placed into a surgically or naturally explicitly eye implants. I am not sure
medical device intended formed cavity of the human body if it is
how FDA treats these products.
. to be totally or partially introduced into intended to remain there for a period of 30
the human body or a natural orifice, or days or more. FDA man, in order to protect
. to replace an epithelial surface or the public health, determine that devices placed in
surface of the eye, subjects for shorter periods are also implants
by surgical intervention, and which is for purposes of this part.]
intended to remain after the procedure for
at least 30 days, and which can only be
removed by medical or surgical
intervention
NOTE This definition applies to

implantable medical devices other than
active implantable medical devices.
(c) Component means any raw material,

substance, piece, part, software, firmware,
labeling, or assembly which is intended to
be
included as part of the finished, packaged,
and labeled device.
(d) Control number means any distinctive

symbols, such as a distinctive combination
of letters or numbers, or both, from which
the
history of the manufacturing, packaging,
labeling, and distribution of a unit, lot, or

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batch of finished devices can be

determined.
(e) Design history file (DHF) means a

compilation of records which describes the
design history of a finished device.
3.6 [Federal Food, Drug, and Cosmetics Act, The definition in the regulation is a bit
labelling Section 201: more detailed, but the definition in the
written, printed or graphic matter (m) The term labeling means all labels and
Standard should cover all that is
. affixed to a medical device or any of its other written, printed, or graphic matter (1)
containers or wrappers, or upon any article or any of its containers or covered in the definitions of label and
. accompanying a medical device, wrappers or (2) accompanying such article. labeling in the regulation.
related to identification, technical
description, and use of the medical device, (k) The label means a display of written,
but excluding shipping documents printed, or graphic matter upon the immediate
container of any article; and a requirement
NOTE Some regional and national made by or under authority of this Act that any
regulations refer to labelling as word, statement, or other information appear
information supplied by the on the label shall not be considered to be
manufacturer. complied with unless such word, statement, or
other information also appears on the outside
container or wrapper, if any there be, of the
retail package or such article, or is easity
legible through the outside container or
wrapper.]
[ISO 13485:2003, 7.3.2 Design and (f) Design input means the physical and The definition of design and
development inputs performance requirements of a device that development inputs in the Standard is
Inputs relating to product requirements are used as a basis for device design.
shall be determined and records actually incorporated into the
maintained (see 4.2.4). These inputs shall requirements section. It is also a bit
include more explicit.
a) functional, performance and safety
requirements, according to the intended
use,
b) applicable statutory and regulatory
requirements,
c) where applicable, information derived
from previous similar designs,
d) other requirements essential for design
and development, and

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e) output(s) of risk management (see 7.1).

These inputs shall be reviewed for
adequacy and approved.
Requirements shall be complete,

unambiguous and not in conflict with each
other.
[ISO 13485:2003, 7.3.3 Design and (g) Design output means the results of a The definition of design and
development outputs design effort at each design phase and at development outputs in the Standard is
The outputs of design and development the end of the total design effort. The
actually incorporated into the
shall be provided in a form that enables finished design output is the basis for the
verification against the design and device master record. The total finished requirements section. It is also a bit
development input and shall be approved design output consists of the device, its more explicit.
prior to release. packaging and labeling, and the device
master record. While the regulation doesnt explicitly
Design and development outputs shall
include examples of design output, it is
a) meet the input requirements for design
and development, clear that FDA considers items like the
b) provide appropriate information for product and component specifications,
purchasing, production and for service manufacturing procedures, engineering
provision, drawings, and logbooks are part of the
c) contain or reference product
design output.
acceptance criteria, and
d) specify the characteristics of the
product that are essential for its safe and
proper use.
Records of the design and development

outputs shall be maintained (see 4.2.4).
NOTE Records of design and

development outputs can include
specifications, manufacturing procedures,
engineering drawings, and engineering or
research logbooks.
3.7 [Federal Food, Drug, and Cosmetics Act, No significant difference.

medical device Section 201:
any instrument, apparatus, implement, (h) The term device () means an
machine, appliance, implant, in vitro instrument, apparatus, implement, machine,
reagent or calibrator, software, material or contrivance, implant, in vitro reagent, or other

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other similar or related article, intended by similar or related article, including any
the manufacturer to be used, alone or in component, part, or accessory, which is
combination, for human beings for one or (1) recognized in the official National
more of the specific purpose(s) of Formulary, or the United States
. diagnosis, prevention, monitoring, Pharmacopeia, or any supplement to
treatment or alleviation of disease, them,
. diagnosis, monitoring, treatment, (2) intended for use in the diagnosis of
alleviation of or compensation for an disease or other conditions, or in the
injury, cure, mitigation, treatment, or prevention
. investigation, replacement, modification, of disease, in man or other animals, or
or support of the anatomy or of a (3) intended to affect the structure or any
physiological process, function of thte body of man or other
. supporting or sustaining life, animals, and which does not achieve its
. control of conception, primary intended purposes through
. disinfection of medical devices, chemical action within or on the body of
man or other animals and which is not
. providing information for medical
dependent upon being metabolized for
purposes by means of in vitro examination
the achievement of its primary intended
of specimens derived fromthe human
body, purposes.]
and which does not achieve its primary
intended action in or on the human body
by pharmacological, immunological or
metabolic means, but which may be
assisted in its function by such means.
NOTE This definition has been developed

by the Global Harmonization Task Force
(GHTF). See bibliographicreference [15].
[ISO 13485:2003, 7.3.4 Design and (h) Design review means a documented, The definition of design and
development review comprehensive, systematic examination of development review in the Standard is
At suitable stages, systematic reviews of a design to evaluate the adequacy of the
actually incorporated into the
design and development shall be design requirements, to evaluate the
performed in accordance with planned capability of the design to meet these requirements section. Otherwise there
arrangements (see 7.3.1) requirements, and to identify problems. is no significant difference.
a) to evaluate the ability of the results of
design and development to meet
requirements, and
b) to identify any problems and propose
necessary actions.
Participants in such reviews shall include

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representatives of functions concerned

with the design and development stage(s)
being reviewed, as well as other specialist
personnel (see 5.5.1 and 6.2.1).
Records of the results of the reviews and

any necessary actions shall be maintained
(see 4.2.4).
3.8
sterile medical device
category of medical device intended to
meet the requirements for sterility
NOTE The requirements for sterility of a

medical device might be subject to
national or regional regulations or
standards
(i) Device history record (DHR) means a

compilation of records containing the
production history of a finished device.
(j) Device master record (DMR) means a

compilation of records containing the
procedures and specifications f or a
finished device.
(k) Establish means define, document (in

writing or electronically), and implement.
(l) Finished device means any device or

accessory to any device that is suitable for
use or capable of functioning, whether or
not it is packaged, labeled, or sterilized.
(m) Lot or batch means one or more

components or finished devices that
consist of a single type, model, class, size,
composition, or software version that are
manufactured under essentially the same
conditions and that are intended to have

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uniform characteristics and quality within

specified limits.
[ISO 9000:2000, 3.2.7 top management (n) Management with executive The intent of both definitions is the
person or group of people who directs responsibility means those senior same.
and controls an organization (3.3.1) at the employees of a manufacturer who have
highest level.] the authority to establish or make changes
to the manufacturer's quality policy and
quality system.
(o) Manufacturer means any person who

designs, manufactures, fabricates,
assembles, or processes a finished
device. Manufacturer
includes but is not limited to those who
perform the functions of contract
sterilization, installation, relabeling,
remanufacturing, repacking, or
specification development, and initial
distributors of foreign entities performing
these functions.
(p) Manufacturing material means any

material or substance used in or used to
facilitate the manufacturing process, a
concomitant
constituent, or a byproduct constituent
produced during the manufacturing
process, which is present in or on the
finished device as a residue or impurity
not by design or intent of the
manufacturer.
[ISO 9000:2000, 3.6.2 nonconformity (q) Nonconformity means the Identical

non-fulfillment of a requirement (3.1.2)] nonfulfillment of a specified requirement.
[ISO 9000:2000, 3.4.2 product the (r) Product means components, The definition in the Standard more
result of a process (3.4.1) manufacturing materials, in- process clearly reflects the process approach of
NOTE 1 There are four generic product devices, finished devices, and returned
categories, as follows: devices. this document.
Services (e.g., transport);
Software (e.g., computer program, The definition in the Standard is a bit

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dictionary); more detailed.

Hardware (e.g., engine mechanical
part);
Processed materials (e.g., lubicant).
Many products comprise elements

belonging to different generic product
categories. Whether the aproduct is then
called service, software, hardware or
processed material depends on the
dominant element. For example, the
offered product automobile consists of
hardware (e.g., tires), processed material
(e.g., fuel, cooling system liquid), software
(e.g., engine control software, drivers
manual), and service (e.g., operating
explanations given by the salesman). ]
[ISO 9000:2000, 3.1.1 quality degree to (s) Quality means the totality of features No significant difference. The definition
which a set of inherent characteristics and characteristics that bear on the ability in the regulation reflects the objective of
(3.5.1) fulfills requirements (3.1.2)] of a device to satisfy fitness-for-use,
including safety and performance. the regulation, that is the assurance of
product safety and effectiveness.
[ISO 90002000, 3.9.1 audit systematic, (t) Quality audit means a systematic, The definition in the regulation imposes
independent and documented process independent examination of a the requirement related to defined
(3.4.1) for obtaining audit evidence (3.9.4) manufacturer's quality system that is
and evaluating it objectively to determine performed at defined intervals and at intervals, and includes activities that
the extent to which audit criteria (3.9.3) sufficient frequency to determine whether occur after the audit is actually
are fulfilled both quality system activities and the performed.
] results of such activities comply with
quality system procedures, that these
procedures are implemented effectively,
and that these procedures are suitable to
achieve quality system objectives.
[ISO 9000:2000, 3.2.4 quality policy (u) Quality policy means the overall No significant difference.
overall intentions and direction of an intentions and direction of an organization
organization (3.3.1) related to quality with respect to quality, as established by
(3.1.1) as formally expressed by top management with executive responsibility.
management ((3.2.7)]
[ISO 9000:2000, 3.2.2 system set of (v) Quality system means the The definition in the regulation is more

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interrelated or interactring elements] organizational structure, responsibilities, instructive, but is consistent with the
procedures, processes, and resources for intent of the Standard.
implementing quality management.
(w) Remanufacturer means any person

who processes, conditions, renovates,
repackages, restores, or does any other
act to a finished
device that significantly changes the
finished device's performance or safety
specifications, or intended use.
[ISO 9000:2000, 3.6.7 rework action (x) Rework means action taken on a No significant difference.
on a nonconforming product (3.4.2) to nonconforming product so that it will fulfill
make it conform to the requirements the specified DMR requirements before it
(3.1.2) is released for distribution.
NOTE Unlike rework, repair (3.6.9) can

affect or change parts of the
nonconforming product.]
[ISO 9000:2000, 3.7.3 specification (y) Specification means any requirement The regulation requires documentation
document (3.7.2) stating requirements with which a product, process, service, or of specifications.
(3.1.2) other activ ity must conform.
NOTE A specification can be related to

activities (e.g., procedure document,
process specification and test
specification), or products (3.4.2) (e.g.,
product specification, performance
specification and drawing)]
[ISO 9000:2000, 3.8.5 validation (z) Validation means confirmation by No significant difference, but neither
confirmation, through the provision of examination and provision of objective definition is very informative.
objective evidence (3.8.1), that the evidence that the particular requirements
requirements (3.1.2) for a specific for a specific intended use can be
intended use or application have been consistently fulfilled. The regulatory definition is more
fulfilled. detailed in that it breaks out and defines
(1) Process validation means establishing process validation and design
NOTE 1 The term validated is used to by objective evidence that a process validation.
designate the corresponding status consistently produces a result or product
meeting its

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NOTE 2 The use conditions for validation predetermined specifications. Normally, validation is performed on the
can be real or simulated] final product or process for
(2) Design validation means establishing
manufacturing, monitoring, testing, and
by objective evidence that device
specifications conform with user needs supporting the product.
and intended use(s).
[ISO 9000:2000, 3.8.4 verification (aa) Verification means confirmation by No significant difference.
confirmation, through the provision of examination and provision of objective
objective evidence (3.8.1) that specified evidence that specified requirements have
requirements (3.1.2) have been fulfilled been fulfilled. The Standard is more detailed.
NOTE 1 The term verified is used to

designate the corrresponding status.
NOTE 2 Confirmation can comprise

activities such as
Performing alternative calculations
Comparing a new design
specification (3.7.3) with a similar
proven design specification,
Undertaking tests (3.8.3) and
demonstrations, and
Reviewing documents prior to issue.]
4 Quality management system 4 Quality management system 820.5 Quality system. No significant differences
4.1 General requirements 4.1 General requirements Each manufacturer shall establish and
The organization shall establish, document, The organization shall establish, maintain a quality system that is
implement and maintain a quality document, implement and maintain a appropriate for the specific medical
management system and continually quality management system and maintain device(s) designed or manufactured, and
improve its effectiveness in accordance with its effectiveness in accordance with the that meets the requirements of this part.
the requirements of this International requirements of this International
Standard. Standard.
The organization shall The organization shall

a) identify the processes needed for the
a) identify the processes needed for the quality management system and their
quality management system and their application throughout the organization
application thoughout the organization (see 1.2),
(see 1.2) b) determine the sequence and interaction
of these processes,
b) determine the sequence and c) determine criteria and methods needed

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ISO 13485:2003 CFR 820)
interaction of these processes to ensure that both the operation and

control of these processes are effective,
c) determine criteria and methods d) ensure the availability of resources and
needed to ensure that both the information necessary to support the
operation and control of these operation and monitoring of these
processes are effective, processes,
e) monitor, measure and analyse these
d) ensure the availability of resources processes, and
and information necessary to support f) implement actions necessary to achieve
the operation and monitoring of these planned results and maintain the
processes, effectiveness of theseprocesses.
e) monitor, measure and analyze these These processes shall be managed by the
processes, and organization in accordance with the
requirements of this International
f) implement actions necessary to Standard.
achieve planned results and continual
improvement of these processes. Where an organization chooses to
outsource any process that affects product
These processes shall be managed by the conformity with requirements, the
organization in accordance with the organization shall ensure control over
requirements of this International Standard. such processes. Control of such
Where an organization chooses to outsourced processes shall be identified
outsource any process that affects product within the quality management system
conformity with requirements, the (see 8.5.1).
organization shall ensure control over such
processes. Control of such outsourced NOTE Processes needed for the quality
processes shall be identified within the management system referred to above
quality management system. should include processes for management
activities, provision of resources, product
NOTE: Processes needed for the quality realization and measurement.
management system referred to above
should include processes for management
activities, provision of resources, product
realization and measurement.
4.2 Documentation requirements 4.2 Documentation requirements The ISO13485 standard lists the
4.2.1 General 4.2.1 General required quality management system
The quality management system The quality management system documentation in this clause, while the
documentation shall include documentation shall include QS Reg indicates the documentation
a) documented statements of a quality requirements in the various sections
a) documented statements of a quality policy and quality objectives, throughout the regulation. There is no

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ISO 13485:2003 CFR 820)
policy and quality objectives, b) a quality manual, significant difference in the

c) documented procedures required by documentation requirements for the two
b) a quality manual, this International Standard, documents, except as indicated below.
d) documents needed by the organization
c) documented procedures required by to ensure the effective planning, operation
this International Standard, and control of its processes,
e) records required by this International
d) documents needed by the organization Standard (see 4.2.4), and
to ensure the effective planning, f) any other documentation specified by
operation and control of its processes, national or regional regulations.
and
Where this International Standard
e) records required by this International specifies that a requirement, procedure,
Standard (see 4.2.4). activity or special arrangement be
documented, it shall, in addition, be
NOTE 1 Where the term documented implemented and maintained.
procedure appears within this International
Standard, this means that the procedure is For each type or model of medical device,
established, documented, implemented and the organization shall establish and
maintained. maintain a file either containing or
identifying documents defining product
NOTE 2 The extent of the quality specifications and quality management The QS Reg implicitly recognizes that
management system documentation can system requirements (see 4.2.3). These the extent of quality management
differ from one organization to another due documents shall define the complete system documentation will reflect the
to manufacturing process and, if applicable, size and complexity of the organization.
a) the size of organization and type of installation and servicing. It also implicitly recognizes that some
activities, documentation may not be needed due
b) the complexity of processes and their NOTE 1 The extent of the quality to the expertise (either through training,
interactions, and management system documentation can education, or experience) of the
c) the competence of personnel. differ from one organization to another personnel.
due to
NOTE 3 The documentation can be in any a) the size of the organization and type of
form or type of medium. activities,
b) the complexity of processes and their
interactions, and
c) the competence of personnel. This text is included in ISO 13485:2003
in order to accommodate the definition
NOTE 2 The documentation can be in any of establish in the QS Reg.
form or type of medium.
4.2.2 Quality manual 4.2.2 Quality manual The QS Reg has no requirement for a
The organization shall establish and The organization shall establish and Quality Manual. Such a manual would

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ISO 13485:2003 CFR 820)
maintain a quality manual that includes maintain a quality manual that includes still be helpful in explaining the nature
a) the scope of the quality management and extent of the quality management
a) the scope of the quality management system, including details of and system to an FDA investigator during
system, including details of and justification for any exclusion and/or non- an inspection. It would also be useful in
justification for any exclusion (see 1.2) application (see 1.2), the training of personnel with regard to
b) the documented procedures the quality management system of the
b) the documented procedures established for the quality management organization and their place within that
established for the quality system, or reference to them, and system.
management system, or reference to c) a description of the interaction between
them, and the processes of the quality management The Quality Manual could be used as
system. the repository of some of the individual
c) a description of the interaction quality management system
between the processes of the quality The quality manual shall outline the documentation required by the QS Reg
management system. structure of the documentation used in the (e.g., the organizational structure and
quality management system. interrelationships, the highest level
procedures in a small organization
dealing with items like document
control, recordskeeping, training)
4.2.3 Control of documents 4.2.3 Control of documents 820.40 Document controls. The requirements are essentially the
Documents required by the quality Documents required by the quality Each manufacturer shall establish and same, except that the QS Reg has the
management system shall be controlled. management system shall be controlled. maintain procedures to control all specific requirement to communicate
Records are a special type of document and Records are a special type of document documents that are required by this part. changes to documents to the affected
shall be controlled according to the and shall be controlled according to the The procedures personnel.
requirements given in 4.2.4. requirements given in 4.2.4. shall provide for the following:
ISO/DIS 13485:2003 requires the
A documented procedure shall be A documented procedure shall be (a) Document approval and distribution. organization to define a retention period
established to define the controls needed established to define the controls needed Each manufacturer shall designate an for obsoleted documents.
a) to review and approve documents for individual(s) to review for adequacy and
a) to approve documents for adequacy prior to issue, approve prior to issuance all documents
adequacy prior to issue, b) to review and update as necessary and established to meet the requirements of
re-approve documents, this part. The approval, including the date
b) to review and update as c) to ensure that changes and the current and signature of the individual(s)
necessary and re-approve revision status of documents are approving the document, shall be
documents, identified, documented. Documents established to
d) to ensure that relevant versions of meet the requirements of this part shall be
c) to ensure that changes and the applicable documents are available at available at all locations for which they are
current revision status of points of use, designated, used, or otherwise necessary,
documents are identified, e) to ensure that documents remain and all obsolete documents shall be
legible and readily identifiable, promptly removed from all points of use or
d) to ensure that relevant versions of f) to ensure that documents of external otherwise prevented from unintended use.
applicable documents are origin are identified and their distribution

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ISO 13485:2003 CFR 820)
available at points of use, controlled, and (b) Document changes. Changes to

g) to prevent the unintended use of documents shall be reviewed and
e) to ensure that documents remain obsolete documents, and to apply suitable approved by an individual(s) in the same
legible and readily identifiable, identification to them if they are retained function or organization that performed the
for any purpose. original review and approval, unless
f) to ensure that documents of specifically designated otherwise.
external origin are identified and The organization shall ensure that Approved changes shall be communicated
their distribution controlled, and changes to documents are reviewed and to the appropriate personnel in a timely
approved either by the original approving manner. Each manufacturer shall maintain
g) to prevent the unintended use of function or another designated function records of changes to documents. Change
obsolete documents, and to apply which has access to pertinent background records shall include a description of the
suitable identification to them if information upon which to base i ts change, identification of the affected
they are retained for any purpose. decisions. documents, the signature of the approving
individual(s), the approval date, and when
The organization shall define the period the change becomes effective.
for which at least one copy of obsolete
controlled documents shall be retained.
This period shall ensure that documents to
which medical devices have been
manufactured and tested are available for
at least the lifetime of the medical device
as defined by the organization, but not
less than the retention period of any
resulting record (see 4.2.4), or as
specified by relevant regulatory
requirements.
4.2.4 Control of records 4.2.4 Control of records 820.180 General requirements. No significant differences in the general
Records shall be established and Records shall be established and All records required by this part shall be requirements associated with control of
maintained to provide evidence of maintained to provide evidence of maintained at the manufacturing records, except that the QS Reg
conformity to requirements and of the conformity to requirements and of the establishment or other location that is contains requirements for
effective operation of the quality effective operation of the quality reasonably communications with FDA.
management system. Records shall remain management system. Records shall accessible to responsible officials of the
legible, readily identifiable and retrievable. A remain legible, readily identifiable and manufacturer and to employees of FDA
documented procedure shall be established retrievable. A documented procedure shall designated to perform inspections. Such
to define the controls needed for the be established to define the controls records,
identification, storage, protection, retrieval, needed for the identification, storage, including those not stored at the inspected
retention time and disposition of records. protection, retrieval, retention time and establishment, shall be made readily
disposition of records. available for review and copying by FDA
employee(s). Such
The organization shall retain the records records shall be legible and shall be
for a period of time at least equivalent to stored to minimize deterioration and to

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the lifetime of the medical device as prevent loss. Those records stored in
defined by the organization, but not less automated data processing systems shall
than two years from the date of product be backed up.
release by the organization or as specified
by relevant regulatory requirements. (a) Confidentiality. Records deemed
confidential by the manufacturer may be
marked to aid FDA in determining whether
information may be disclosed under the
public information regulation in part 20 of
this chapter.
(b) Record retention period. All records

required by this part shall be retained for a
period of time equivalent to the design and
expected life of the device, but in no case
less than 2 years from the
date of release for commercial distribution
by the manufacturer.
(c) Exceptions. This section does not

apply to the reports required by Sec.
820.20(c) Management review, Sec.
820.22 Quality audits, and
supplier audit reports used to meet the
requirements of Sec. 820.50(a) Evaluation
of suppliers, contractors, and consultants,
but does apply to procedures established
under these provisions. Upon request of a
designated employee of FDA, an
employee in management with executive
responsibility shall certify in writing that the
management reviews and quality audits
required under this part, and supplier
audits where applicable, have been
performed and documented, the dates on
which they were performed, and that any
required corrective action has been
undertaken.
820.181 Device master record. The QS Reg requires the establishment

Each manufacturer shall maintain device of a Device Master Record (DMR). The
master records (DMR's). Each DMR may be a separate file of

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manufacturer shall ensure that each DMR documents and records, or it may be
is prepared and approved document containing references to the
in accordance with Sec. 820.40. The DMR various elements of the DMR. ISO/DIS
for each type of device shall include, or 13485:2003 has no requirement for
refer to the location of, the following such a file even though it requires the
information: individual documents and records that
would be contained within that file.
(a) Device specifications including
appropriate drawings, composition,
formulation, component specifications,
and software specifications;
(b) Production process specifications

including the appropriate equipment
specifications, production methods,
production procedures, and production
environment specifications;
(c) Quality assurance procedures and

specifications including acceptance criteria
and the quality assurance equipment to be
used;
(d) Packaging and labeling specifications,

including methods and processes used;
and
(e) Installation, maintenance, and

servicing procedures and methods.
820.184 Device history record. The QS Reg requires the establishment

Each manufacturer shall maintain device of a Device History Record (DHR) for
history records (DHR's). Each each lot of devices or unit
manufacturer shall establish and maintain manufactured. The DHR may be a
procedures to ensure separate file containing the records, or
that DHR's for eac h batch, lot, or unit are may be document that references the
maintained to demonstrate that the device location of these records. ISO/DIS
is manufactured in accordance with the 13485:2003 does not require the
DMR and the requirements of this part. establishment of such a file, even
The DHR shall include, or refer to the though it requires the individual records
location of, the following information: that would be contained with that file.

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ISO 13485:2003 CFR 820)
(a) The dates of manufacture;
(b) The quantity manufactured;
(c) The quantity released for distribution;
(d) The acceptance records which

demonstrate the device is manufactured in
accordance with the DMR;
(e) The primary identification label and

labeling used for each production unit; and
(f) Any device identification(s) and control

number(s) used.
820.186 Quality system record. The QS Reg requires the establishment

Each manufacturer shall maintain a quality of a Quality System Record, which may
system record (QSR). The QSR shall be a separate file containing the
include, or refer to the location of, required documents or a document
procedures and the referencing the required contents.
documentation of activities required by this ISO/DIS 13485:2003 does not require
part that are not specific to a particular the establishment of suc h a file, even
type of device(s), including, but not limited though it does requirement the
to, the establishment of the various documents
records required by Sec. 820.20. Each that would be included in that file.
manufacturer shall ensure that the QSR is
prepared and approved in accordance
with Sec. 820.40.

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ISO 13485:2003 CFR 820)
5 Management responsibility 5 Management responsibility 820.20 Management responsibility. No significant differences in

5.1 Management commitment 5.1 Management commitment (a) Quality policy. Management with management responsibilities; the QS
Top management shall provide evidence of Top management shall provide evidence executive responsibility shall establish its Reg spells some of them out in
its commitment to the development and of its commitment to the development and policy and objectives for, and commitment subsequent sections of the regulation.
implementation of the quality management implementation of the quality management to, quality.
system and continually improving its system and maintaining its effectiveness Management with executive responsibility
effectiveness by by shall ensure that the quality policy is
a) communicating to the organization the understood, implemented, and maintained
a) communicating to the organization the importance of meeting customer as well at all levels of the organization.
importance of meeting customer as as statutory and regulatory requirements,
well as statutory and regulatory b) establishing the quality policy,
requirements, c) ensuring that quality objectives are
established,
b) establishing the quality policy, d) conducting management reviews, and
e) ensuring the availability of resources.
c) ensuring that quality objectives are
established, NOTE For the purposes of this
International Standard, statutory
d) conducting management reviews, and requirements are limited to the safety and
performance of the medical device only.
e) ensuring the availability of resources.
5.2 Customer focus 5.2 Customer focus ISO/DIS 13485:2003 has a distinct
Top management shall ensure that Top management shall ensure that focus on meeting customer
customer requirements are determined and customer requirements are determined requirements in addition to meeting
are met with the aim of enhancing customer and are met (see 7.2.1 and 8.2.1). regulatory requirements. The QS Reg
satisfaction (see 7.2.1 and 8.2.1). is entirely focused on meeting those
requirements that have as their
objective the design, manufacture,
distribution, and support of safe and
effective medical devices.
ISO/DIS 13485:2003 will include

requirements for determining customer
requirements during the entire product
realization process, while the QS Reg
will include requirements that identify
product and process requirements that
are focused on ensuring safe and
effective medical devices.
5.3 Quality policy 5.3 Quality policy 820.20 Management responsibility. No significant differences
Top management shall ensure that the Top management shall ensure that the (a) Quality policy. Management with

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quality policy quality policy executive responsibility shall establish its

a) is appropriate to the purpose of the policy and objectives for, and commitment
a) is appropriate to the purpose of the organization, to, quality.
organization, b) includes a commitment to comply with Management with executive responsibility
requirements and to maintain the shall ensure that the quality policy is
b) includes a commitment to comply with effectiveness of the quality understood, implemented, and maintained
requirements and continually improve management system, at all levels of the organization.
the effectiveness of the quality c) provides a framework for establishing
management system, and reviewing quality objectives,
d) is communicated and understood within
c) provides a framework for establishing the organization, and
and reviewing quality objectives, e) is reviewed for continuing suitability.
d) is communicated and understood

within the organization, and
e) is reviewed for continuing suitability.
5.4 Planning 5.4 Planning 820.20 Management responsibility. No significant differences

5.4.1 Quality objectives 5.4.1 Quality objectives (a) Quality policy. Management with
Top management shall ensure that quality Top management shall ensure that quality executive responsibility shall establish its
objectives, including those needed to meet objectives, including those needed to policy and objectives for, and commitment
requirements for product [see 7.1 a)], are meet requirements for product [see 7.1 to, quality.
established at relevant functions and levels a)], are established at relevant functions Management with executive responsibility
within the organization. The quality and levels within the organization. The shall ensure that the quality policy is
objectives shall be measurable and quality objectives shall be measurable and understood, implemented, and maintained
consistent with the quality policy. consistent with the quality policy. at all levels of the organization.
5.4.2 Quality management system 5.4.2 Quality management system 820.5 Quality system. The QS Reg contains the proscriptive
planning planning Each manufacturer shall establish and requirements for a quality plan and
Top management shall ensure that Top management shall ensure that maintain a quality system that is quality system procedures.
a) the planning of the quality management appropriate for the specific medical
system is carried out in order to meet the device(s) designed or manufactured, and
a) the planning of the quality requirements given in 4.1, as well as the that meets the requirements of this part.
management system is carried out in quality objectives, and
order to meet the requirements given b) the integrity of the quality management (d) Quality planning. Each manufacturer It is not clear what the FDA is looking
in 4.1, as well as the quality objectives, system is maintained when changes to the shall establish a quality plan which defines for when they ask for a quality plan. It
quality management system are planned the quality practices, resources, and seems to be combination of a high level
and and implemented. activities relevant to devices that are quality planning document, containing
designed and manufactured. The policy and key objectives, with a
b) the integrity of the quality management manufacturer shall establish how the mandate to drive those objectives down
requirements for quality will be met. into the organization, and a set of high
system is maintained when changes to

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ISO 13485:2003 CFR 820)
the quality management level procedures that illustrate how that

plan will be met.
(e) Quality system procedures. Each Both the QS Reg and ISO/DIS
manufacturer shall establish quality 13485:2003 require the establishment
system procedures and instructions. An of these kinds of procedures; only the
outline of the structure of the QS Reg gives them special standing as
documentation used in the quality system quality system procedures.
shall be established where appropriate.
5.5 Responsibility, authority and 5.5 Responsibility, authority and 820.20 Management responsibility No significant differences
communication communication (b) Organization. Each manufacturer
5.5.1 Responsibility and authority 5.5.1 Responsibility and authority shall establish and maintain an adequate
Top management shall ensure that Top management shall ensure that organizational structure to ensure that
responsibilities and authorities are defined, responsibilities and authorities are devices are designed and produced in
documented and communicated within the defined, documented and accordance with the requirements of this
organization. communicated within the organization. part.
Top management shall establish the (1) Responsibility and authority. Each
interrelation of all personnel who manage, manufacturer shall establish the
perform and verify work affecting quality, appropriate responsibility, authority, and
and shall ensure the independence and interrelation of all
authority necessary to perform these personnel who manage, perform, and
tasks. assess work affecting quality, and provide
the independence and authority necessary
NOTE National or regional regulations to perform these tasks.
might require the nomination of specific
persons as responsible for activities
related to monitoring experience from the
post-production stage and reporting
adverse events (see 8.2.1 and 8.5.1).
5.5.2 Management representative 5.5.2 Management representative 820.20 Management responsibility No significant differences, except the
Top management shall appoint a member Top management shall appoint a member (b) Organization requirements in ISO/DIS 13485:2003
of management who, irrespective of other of management who, irrespective of other (3) Management representative. reflect the focus on meeting customer
responsibilities, shall have responsibility responsibilities, shall have responsibility Management with executive responsibility requirements.
and authority that includes: and authority that includes shall appoint, and document such
a) ensuring that processes needed for the appointment of, a
a) ensuring that processes needed for quality management system are member of management who, irrespective
the quality management system are established, implemented and maintained, of other responsibilities, shall have

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established, implemented and b) reporting to top management on the established authority over and
maintained; performance of the quality management responsibility for:
system and any need for improvement
b) reporting to top management on the (see 8.5), and (i) Ensuring that quality system
performance of the quality c) ensuring the promotion of awareness of requirements are effectively established
management system and any need for regulatory and customer requirements and effectively maintained in accordance
improvement; and throughout the with this part; and
organization.
c) ensuring the promotion of awareness (ii) Reporting on the performance of the
of customer requirements throughout NOTE The responsibility of a management quality system to management with
the organization. representative can include liaison with executive responsibility for review.
external parties on matters relating to the
NOTE The responsibility of a management quality management system.
representative can include liaison with
external parties on matters relating to the
quality management system.
5.5.3 Internal communication 5.5.3 Internal communication 820.20 Management responsibility No significant differences; the QS Reg
Top management shall ensure that Top management shall ensure that (b) Organization. Each manufacturer implicitly requires the necessary
appropriate communication processes are appropriate communication processes are shall establish and maintain an adequate communication processes that make for
established within the organization and that established within the organization and organizational structure to ensure that successful interrelationships
communication takes place regarding the that communication takes place regarding devices are designed and produced in
effectiveness of the quality management the effectiveness of the quality accordance with the requirements of this
system. management system. part.
(1) Responsibility and authority. Each

manufacturer shall establish the
appropriate responsibility, authority, and
interrelation of all
personnel who manage, perform, and
assess work affecting quality, and provide
the independence and authority necessary
to perform these tasks.
5.6 Management review 5.6 Management review 820.20 Management responsibility No significant differences.
5.6.1 General 5.6.1 General (c) Management review.
Top management shall review the Top management shall review the Management with executive responsibility
organizations quality management system, organizations quality management shall review the suitability and
at planned intervals, to ensure its continuing system, at planned intervals, to ensure its effectiveness of the quality system at
suitability, adequacy and effectiveness. This continuing suitability, adequacy and defined intervals and with sufficient
review shall include assessing opportunities effectiveness. This review shall include frequency according to established
for improvement and the need for changes assessing opportunities for improvement procedures to ensure that the quality

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to the quality management system, and the need for changes to the quality system satisfies the requirements of this
including the quality policy and quality management system, including the quality part and the manufacturer's established
objectives. policy and quality objectives. quality policy and objectives. The dates
and results of quality system reviews shall
Records from management reviews shall be Records from management reviews shall be documented.
maintained (see 4.2.4). be maintained (see 4.2.4).
5.6.2 Review input 5.6.2 Review input The requirements for review input that
The input to management review shall The input to management review shall are spelled out in ISO/DIS 13485:2003
include information on include information on are logical and would be expected by
a) results of audits, an FDA investigator during an
a) results of audits,
b) customer feedback, inspection that focused on management
c) process performance and product responsibilities.
b) customer feedback, conformity,
d) status of preventive and corrective
actions,
c) process performance and product
e) follow -up actions from previous
conformity, management reviews,
f) changes that could affect the quality
d) status of preventive and corrective management system,
g) recommendations for improvement, and
actions, h) new or revised regulatory requirements
e) follow -up actions from previous

management reviews,
f) changes that could affect the quality

management system, and
g) recommendations for improvement.
5.6.3 Review output 5.6.3 Review output The requirements for review output that
The output from the management review The output from the management review are spelled out in ISO/DIS 13485:2003
shall include any decisions and actions shall include any decisions and actions are logical and would be expected by
related to related to an FDA investigator during an
a) improvements needed to maintain the inspection that focused on management
a) the effectiveness of the quality effectiveness of the quality management responsibilities.
management system and its system and its processes,
processes b) improvement of product related to
customer requirements, and

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ISO 13485:2003 CFR 820)
b) improvement of product related to c) resource needs.

customer requirements, and
c) resource needs.
6 Resource management 6 Resource management 820.20 Management respons ibility No significant differences, especially
6.1 Provision of resources 6.1 Provision of resources (b) Organization since ISO/DIS 13485:2003 includes the
The organization shall determine and The organization shall determine and (2) Resources. Each manufacturer shall requirement to meeting regulatory
provide the resources needed provide the resources needed provide adequate resources, including the requirements.
a) to implement the quality management assignment of trained personnel, for
a) to implement and maintain the quality system and to maintain its effectiveness, management, performance of work, and
management system and continually and assessment activities, including internal
improve its effectiveness, and b) to meet regulatory and customer quality audits, to meet the requirements of
requirements this part.
b) to enhance customer satisfaction by
meeting customer requirements.
6.2 Human resources 6.2 Human resources 820.20 Management responsibility No significant differences.
6.2.1 General 6.2.1 General (b) Organization
Personnel performing work affecting Personnel performing work affecting (2) Resources. Each manufacturer shall
product quality shall be competent on the product quality shall be competent on the provide adequate resources, including the
basis of appropriate education, training, basis of appropriate education, training, assignment of trained personnel, for
skills and experience. skills and experience. management, performance of work, and
assessment activities, including internal
quality audits, to meet the requirements of
this part.
820.25 Personnel.
(a) General. Each manufacturer shall
have sufficient personnel with the
necessary education, background,
training, and experience to assure that all
activities required by this part are c orrectly
performed.
(b) Training. Each manufacturer shall

establish procedures for identifying
training needs and ensure that all
personnel are trained to
adequately perform their assigned
responsibilities. Training shall be
documented.

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ISO 13485:2003 CFR 820)
(1) As part of their training, personnel shall

be made aware of device defects which
may occur from the improper performance
of their specific jobs.
(2) Personnel who perform verification and
validation activities shall be made aware
of defects and errors that may be
encountered as
part of their job functions.
6.2.2 Competence, awareness and 6.2.2 Competence, awareness and 820.20 Management responsibility No significant differences.
training training (b) Organization
The organization shall The organization shall (2) Resources. Each manufacturer shall
a) determine the necessary competence provide adequate resources, including the
a) determine the necessary competence for personnel performing work affecting assignment of trained personnel, for
for personnel performing work product quality, management, performance of work, and
affecting product quality, b) provide training or take other actions to assessment activities, including internal
satisfy these needs, quality audits, to meet the requirements of
c) evaluate the effectiveness of the actions this part.
b) provide training or take other actions to taken,
satisfy these needs, d) ensure that its personnel are aware of 820.25 Personnel.
the relevance and importance of their (a) General. Each manufacturer shall
activities and how they contribute to the have sufficient personnel with the
c) evaluate the effectiveness of the
achievement of the quality objectives, and necessary education, background,
actions taken, e) maintain appropriate records of training, and experience to assure that all
education, training, skills and experience activities required by this part are correctly
d) ensure that its personnel are aware of (see 4.2.4). performed.
the relevance and importance of their NOTE National or regional regulations (b) Training. Each manufacturer shall
activities and how they contribute to might require the organization to establish establish procedures for identifying
the achievement of the quality documented procedures for identifying training needs and ensure that all
objectives, and training needs. personnel are trained to
adequately perform their assigned
responsibilities. Training shall be
e) maintain appropriate records of documented.
education, training, skills and (1) As part of their training, personnel shall
experience (see 4.2.4). be made aware of device defects which
may occur from the improper performance
of their specific jobs.
(2) Personnel who perform verification and
validation activities shall be made aware
of defects and errors that may be

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encountered as
part of their job functions.
6.3 Infrastructure 6.3 Infrastructure 820.70 Production and process The intent of the two documents is
The organization shall determine, provide The organization shall determine, provide control consistent; the QS Reg contains a
and maintain the infrastructure needed to and maintain the infrastructure needed to (d) Personnel. Each manufacturer shall number of specific requirements related
achieve conformity to product requirements. achieve conformity to product establish and maintain requirements for to the creation of maintenance
Infrastructure includes, as applicable requirements. Infrastructure includes, as the health, cleanliness, personal practices, schedules, inspections and adjustment
applicable and clothing of personnel if contact of equipment, and manufacturing
a) buildings, workspace and associated a) buildings, workspace and associated between such personnel and product or materials.
utilities, environment could reasonably be
utilities, b) process equipment (both hardware and expected to have an adverse effect on
software), and product quality. The manufacturer shall
b) process equipment (both hardware c) supporting services (such as transport ensure that maintenance and other
or communication). personnel who are required to work
and software), and
temporarily under special environmental
The organization shall establish conditions are appropriately trained or
c) supporting services (such as transport documented requirements for supervised by a trained individual.
or communication). maintenance activities, including their
frequency, when such activities or lack (f) Buildings. Buildings shall be of
thereof can affect product quality. suitable design and contain sufficient
space to perform necessary operations,
Records of such maintenance shall be prevent mixups, and assure orderly
maintained (see 4.2.4).. handling.
(g) Equipment. Each manufacturer shall

ensure that all equipment used in the
manufacturing process meets specified
requirements and is appropriately
designed, constructed, placed, and
installed to facilitate maintenance,
adjustment, cleaning, and use.
(1) Maintenance schedule. Each

manufacturer shall establish and maintain
schedules for the adjustment, cleaning,
and other maintenance of equipment to
ensure that manufacturing specifications
are met. Maintenance activities, including
the date and individual(s) performing the
maintenance activities, shall be
documented.

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(2) Inspection. Each manufacturer shall

conduct periodic inspections in
accordance with established procedures
to ensure adherence to applicable
equipment maintenance schedules. The
inspections, including the date and
individual(s) conducting the inspections,
shall be documented.
(3) Adjustment. Each manufacturer shall

ensure that any inherent limitations or
allowable tolerances are visibly posted on
or near
equipment requiring periodic adjustments
or are readily available to personnel
performing these adjustments.
(h) Manufacturing material. Where a

manufacturing material could reasonably
be expected to have an adverse effect on
product quality, the manufacturer shall
establish and maintain procedures for the
use and removal of such manufacturing
material to ensure that it is removed or
limited to an amount that does not
adversely affect the device's quality. The
removal or reduction of such
manufacturing material shall be
documented.
6.4 Work environment 6.4 Work environment 820.70 Production and process The intent of both documents is
The organization shall determine and The organization shall determine and controls consistent; ISO/DIS 13485 specifically
manage the work environment needed to manage the work environment needed to (c) Environmental control. Where calls for control of used product to
achieve conformity to product requirements. achieve conformity to product environmental conditions could reasonably prevent contamination of other product,
requirements. be expected to have an adverse effect on the manufacturing environment or
product quality, the manufacturer shall personnel.
The following requirements shall apply. establish and maintain procedures to
a) The organization shall establish adequately control these environmental
documented requirements for health, conditions. Environmental control
cleanliness and clothing of personnel if system(s) shall be periodically inspected
contact between such personnel and the to verify that the system, including

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product or work environment could necessary equipment, is adequate and

adversely affect the quality of the product functioning properly. These activities shall
(see 7.5.1.2.1). be documented and reviewed
b) If work environment conditions can
have an adverse effect on product quality, (d) Personnel. Each manufacturer shall
the organization shall establish establish and maintain requirements for
documented requirements for the work the health, cleanliness, personal practices,
environment conditions and documented and clothing of personnel if contact
procedures or work instructions to monitor between such personnel and product or
and control these work environment environment could reasonably be
conditions (see 7.5.1.2.1). expected to have an adverse effect on
c) The organization shall ensure that all product quality. The manufacturer shall
personnel who are required to work ensure that maintenance and other
temporarily under special environmental personnel who are required to work
conditions within the work environment are temporarily under special environmental
appropriately trained or supervised by a conditions are appropriately trained or
trained person [see 6.2.2 b)]. supervised by a trained individual.
d) If appropriate, special arrangements
shall be established and documented for (e) Contamination control. Each
the control of contaminated or potentially manufacturer shall establish and maintain
contaminated product in order to prevent procedures to prevent contamination of
contamination of other product, the work equipment or product by substances that
environment or personnel (see 7.5.3.1). could reasonably be expected to have an
adverse effect on product quality.
7 Product realization 7 Product realization 820.5 Quality system. The QS Reg doesnt specifically
7.1 Planning of product realization 7.1 Planning of product realization Each manufacturer shall establish and recognize the concept of product
The organization shall plan and develop the The organization shall plan and develop maintain a quality system that is realization, even though it includes
processes needed for product realization. the processes needed for product appropriate for the specific medical requirements related to essentially all of
Planning of product realization shall be realization. Planning of product realization device(s) designed or manufactured, and the processes associated with product
consistent with the requirements of the shall be consistent with the requirements that meets the requirements of this part. realization. The QS Reg also requires,
other processes of the quality management of the other processes of the quality either implicitly or explicitly, in various
system (see 4.1). management system (see 4.1). sections planning associated with these
requirements.
In planning product realization, the In planning product realization, the
organization shall determine the following, organization shall determine the following,
as appropriate: as appropriate:
a) quality objectives and requirements for
a) quality objectives and requirements for the product;
the product; b) the need to establish processes,
documents, and provide resources
b) the need to establish processes, specific to the product;

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documents, and provide resources c) required verification, validation,

specific to the product; monitoring, inspection and test activities
specific to the product and the criteria for
c) required verification, validation, product acceptance;
monitoring, inspection and test d) records needed to provide evidence
activities specific to the product and that the realization processes and
the criteria for product acceptance; resulting product meet
requirements (see 4.2.4).
d) records needed to provide evidence
that the realization processes and The output of this planning shall be in a
resulting product meet requirements form suitable for the organizations method
(see 4.2.4). of operations.
The output of this planning shall be in a The organization shall establish

form suitable for the organizations method documented requirements for risk
of operations. management throughout product
realization. Records arising from risk
NOTE 1 A document specifying the management shall be maintained (see
processes of the quality management 4.2.4).
system (including the product realization
processes) and the resources to be applied NOTE 1 A document specifying the
to a specific product, project or contract, processes of the quality management
can be referred to as a quality plan. system (including the product realization
NOTE 2 The organization may also apply processes) and the resources to be
the requirements given in 7.3 to the applied to a specific product, project or
development of product realization contract, can be referred to as a quality
processes. plan.
NOTE 2 The organization may also apply

the requirements given in 7.3 to the
development of product realization
processes.
ISO/DIS 13485:2003 recognizes the
NOTE 3 See ISO 14971 for guidance fact that risk management is a process
related to risk management. that shall be conducted throughout the
product realization process, while the
QS Reg refers to risk management only
in the section related to design
validation. FDA, however, recognizes
the wisdom of the ISO/DIS 13485:2003
risk management requirementswill seek
records associated with risk

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management consistent with the

requirements set out in ISO/DIS
13485:2003.
7.2 Customer-related processes 7.2 Customer-related processes The closest the QS Reg gets to
7.2.1 Determination of requirements 7.2.1 Determination of requirements determining customer requirements
related to the product related to the product in in 820.30(c)
related to the product The organization shall determine design inputs. The customer
The organization shall determine a) requirements specified by the customer, requirements referred to in clause 7.2 of
including the requirements for delivery and ISO/DIS 13485:2003 refer to those
a) requirements specified by the post-delivery activities, requirements associated with getting
customer, including the requirements b) requirements not stated by the the product to the customer. This
for delivery and post-delivery activities, customer but necessary for specified or includes items associated with order
intended use, where known, handling and what were referred to in
c) statutory and regulatory requirements early versions of ISO 9001 as contract
b) requirements not stated by the related to the product, and review. These are not focuses of the
customer but necessary for specified d) any additional requirements determined QS Reg.
or intended use, where known by the organization.
c) statutory and regulatory requirements

related to the product, and
d) any additional requirements

determined by the organization.
7.2.2 Review of requirements related to 7.2.2 Review of requirements related to

the product the product
The organization shall review the The organization shall review the
requirements related to the product. This requirements related to the product. This
review shall be conducted prior to the review shall be conducted prior to the
organization's commitment to supply a organization's commitment to supply a
product to the customer (e.g. submission of product to the customer (e.g. submission
tenders, acceptance of contracts or orders, of tenders, acceptance of contracts or
acceptance of changes to contracts or orders, acceptance of changes to
orders) and shall ensure that contracts or orders) and shall ensure that
a) product requirements are defined and
a) product requirements are defined, documented,
b) contract or order requirements differing
b) contract or order requirements differing from those previously expressed are
from those previously expressed are resolved, and

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ISO 13485:2003 CFR 820)
resolved, and c) the organization has the ability to meet

the defined requirements.
c) the organization has the ability to meet
the defined requirements. Records of the results of the review and
actions arising from the review shall be
Records of the results of the review and maintained (see 4.2.4).
actions arising from the review shall be
maintained (see 4.2.4). Where the customer provides no
documented statement of requirement, the
Where the customer provides no customer requirements shall be confirmed
documented statement of requirement, the by the organization before acceptance.
customer requirements shall be confirmed
by the organization before acceptance. Where product requirements are changed,
the organization shall ensure that relevant
Where product requirements are changed, documents are amended and that relevant
the organization shall ensure that relevant personnel are made aware of the changed
documents are amended and that relevant requirements.
personnel are made aware of the changed
requirements. NOTE In some situations, such as internet
sales, a formal review is impractical for
NOTE In some situations, such as internet each order. Instead the review can cover
sales, a formal review is impractical for relevant product information such as
each order. Instead the review can cover catalogues or advertising material.
relevant product information such as
catalogues or advertising material.
7.2.3 Customer communication 7.2.3 Customer communication
The organization shall determine and The organization shall determine and
implement effective arrangements for implement effective arrangements for
communicating with customers in relation to communicating with customers in relation
to
a) product information, a) product information,
b) enquiries, contracts or order handling,
b) enquiries, contracts or order handling, including amendments,
including amendments, c) customer feedback, including customer
complaints (see 8.2.1), and
c) customer feedback, including d) advisory notices (see 8.5.1).
customer complaints.
7.3 Design and development 7.3 Design and development 820.30 Design controls The overall objectives of the two
7.3.1 Design and development planning 7.3.1 Design and development (a) General. (1) Each manufacturer of documents related to design control
The organization shall plan and control the planning any class III or class II device, and the planning are consistent. The QS Reg
design and development of product. The organization shall establish class I devices listed in paragraph (a)(2) of limits the applicability of design controls

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documented procedures for design and this section, shall establish and maintain to more high risk medical devices, while
During the design and development development. procedures to control the design ISO/DIS 13485:2003 applies them to all
planning, the organization shall determine of the device in order to ensure that medical devices.
The organization shall plan and control the specified design requirements are met.
a) the design and development stages, design and development of product. (2) The following class I devices are
subject to design controls:
b) the review, verification and validation During the design and development (i) Devices automated with computer
that are appropriate to each design planning, the organization shall determine software; and
and development stage, and a) the design and development stages, (ii) The devices listed in the follow ing
b) the review, verification, validation and chart.
c) the responsibilities and authorities for design transfer activities (see Note) that
design and development. are appropriate at each design and --------------------------------------------------------
development stage, and Section Device
The organization shall manage the c) the responsibilities and authorities for --------------------------------------------------------
interfaces between different groups involved design and development. 868.6810......Catheter, Tracheobronchial
in design and development to ensure Suction.
effective communication and clear The organization shall manage the 878.4460......Glove, Surgeon's.
assignment of responsibility. interfaces between different groups 880.6760......Restraint, Protective.
involved in design and development to 892.5650......System, Applicator,
Planning output shall be updated as ensure effective communication and clear Radionuclide,
appropriate, as the design and development assignment of responsibility. Manual.
progresses (see 4.2.3). 892.5740.......Source, Radionuclide
Planning output shall be documented, and Teletherapy.
updated as appropriate, as the design and --------------------------------------------------------
development progresses (see 4.2.3).
(b) Design and development planning.
NOTE Design transfer activities during the Each manufacturer shall establish and
design and development process ensure maintain plans that describe or reference
that design and development outputs are the design and
verified as suitable for manufacturing development activities and define
before becoming final production responsibility for implementation.
specifications.
The plans shall identify and describe the
interfaces with different groups or activities
that provide, or result in, input to the
design and development process. The
plans shall be reviewed, updated, and
approved as design and development
evolves.
(j) Design history file. Each


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a DHF for each type of device. The DHF

shall contain or reference the records While ISO/DIS 13485:2003 requires the
necessary to demonstrate that the design creation of design control
was developed in accordance with the documentation and records, the QS
approved design plan and the Reg requires the establishment of a
requirements of this part. Design History File which either
contains or refers to all the documents
and records associated with the
application of the design control
processes to a particular product.
7.3.2 Design and development 7.3.2 Design and development inputs 820.30 Design controls No significant differences.
inputs Inputs relating to product requirements (c) Design input. Each manufacturer
Inputs relating to product requirements shall shall be determined and records shall establish and maintain procedures to
be determined and records maintained (see maintained (see 4.2.4). These inputs shall ensure that the design requirements
4.2.4). These inputs shall include include relating to a device are appropriate and
a) functional, performance and safety address the intended use of the device,
a) functional and performance requirements, according to the intended including the needs of the user and
requirements, use, patient. The procedures shall include a
b) applicable statutory and regulatory mechanism for addressing incomplete,
b) applicable statutory and regulatory requirements, ambiguous, or conflicting requirements.
requirements, c) where applicable, information derived The design input requirements shall be
from previous similar designs, documented and shall be reviewed and
c) where applicable, information derived d) other requirements essential for design approved by a designated individual(s).
from previous similar designs, and and development, and The approval, including the date and
e) output(s) of risk management (see 7.1). signature of the individual(s) approving the
d) other requirements essential for design These inputs shall be reviewed for requirements, shall be documented.
and development. adequacy and approved.
These inputs shall be reviewed for Requirements shall be complete,

adequacy. Requirements shall be complete, unambiguous and not in conflict with each
unambiguous and not in conflict with each other.
other.
7.3.3 Design and development outputs 7.3.3 Design and development outputs 820.30 Design controls The intent of the two documents is
The outputs of design and development The outputs of design and development (d) Design output. Each manufacturer consistent, with the QS Reg containing
shall be provided in a form that enables shall be provided in a form that enables shall establish and maintain procedures specific requirements associated with
verification against the design and verification against the design and for defining and documenting design the approval and release of design
development input and shall be approved development input and shall be approved output in terms that allow an adequate outputs.
prior to release. prior to release. evaluation of conformance to design input
requirements. Design output procedures
Design and development outputs shall Design and development outputs shall shall contain or make reference to
a) meet the input requirements for design acceptance criteria and shall ensure that

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a) meet the input requirements for design and development, those design outputs that are essential for
and development, b) provide appropriate information for the proper functioning of the device are
purchasing, production and for service identified.
b) provide appropriate information for provision, Design output shall be documented,
purchasing, production and for service c) contain or reference product reviewed, and approved before release.
provision, acceptance criteria, and The approval, including the date and
d) specify the characteristics of the signature of the individual(s) approving the
c) contain or reference product product that are essential for its safe and output, shall be documented.
acceptance criteria, and proper use.
d) specify the characteristics of the Records of the design and development

product that are essential for its safe outputs shall be maintained (see 4.2.4).
and proper use.
NOTE Records of design and
development outputs can include
specifications, manufacturing procedures,
engineering drawings, and engineering or
research logbooks.
7.3.3 Design and development 7.3.4 Design and development review 820.30 Design controls The intent of the two documents is
review At suitable stages, systematic reviews of (e) Design review. Each manufacturer consistent, with ISO/DIS 13485:2003
At suitable stages, systematic reviews of design and development shall be shall establish and maintain procedures to illustrating in more detail the objectives
design and development shall be performed performed in accordance with planned ensure that formal documented reviews of of the design review and the QS Reg
in accordance with planned arrangements arrangements (see 7.3.1) the design results are planned and jincluding proscriptive design review
(see 7.3.1) a) to evaluate the ability of the results of conducted at appropriate stages of the process requirements not contained in
design and development to meet device's design development. The the standard.
requirements, and procedures shall ensure that participants
a) to evaluate the ability of the results of b) to identify any problems and propose at each design review include
design and development to meet necessary actions. representatives of all functions concerned
requirements, and with the design stage being reviewed and
Participants in such reviews shall include an individual(s) who does not have direct
representatives of functions concerned responsibility for the design stage being
b) to identify any problems and propose with the design and development stage(s) reviewed, as well as any specialists
necessary actions. being reviewed, as well as other specialist needed. The results of a design review,
personnel (see 5.5.1 and 6.2.1). including
Participants in such reviews shall include identification of the design, the date, and
Records of the results of the reviews and the individual(s) performing the review,
representatives of functions concerned w ith any necessary actions shall be maintained shall be documented in the design history
the design and development stage(s) being (see 4.2.4). file (the DHF).
reviewed. Records of the results of the
reviews and any necessary actions shall be
maintained (see 4.2.4).

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7.3.5 Design and development 7.3.5 Design and development 820.30 Design controls The intent of the two documents is
verification verification (f) Design verification. Each consistent, with the QS Reg including
Verification shall be performed in Verification shall be performed in manufacturer shall establish and maintain proscriptive design verification process
accordance with planned arrangements accordance with planned arrangements procedures for verifying the device design. requirements not contained in the
(see 7.3.1) to ensure that the design and (see 7.3.1) to ensure that the design and Design verification shall confirm that the standard.
development outputs have met the design development outputs have met the design design output meets the design input
and development input requirements. and development input requirements. requirements. The results of the design
Records of the results of the verification and Records of the results of the verification verification, including identification of the
any necessary actions shall be maintained and any necessary actions shall be design, method(s), the date, and the
(see 4.2.4). maintained (see 4.2.4). individual(s) performing the verification,
shall be documented in the DHF.
7.3.6 Design and development validation 7.3.6 Design and development 820.30 Design controls The intent of the two documents is
Design and development validation shall be validation (g) Design validation. Each consistent. The QS Reg seems to
performed in accordance with planned Design and development validation shall manufacturer shall establish and maintain indicate that risk analysis is a design
arrangements (7.3.1) to ensure that the be performed in accordance with planned procedures for validating the device validation process. This is not
resulting product is capable of meeting the arrangements (see 7.3.1) to ensure that design. Design validation shall be consistent with the teachings of ISO
requirements for the specified application or the resulting product is capable of meeting performed under defined operating 14971:2000 which calls for risk
intended use, where known. Wherever the requirements for the specified conditions on initial production units, lots, management activities thoughout the
practicable, validation shall be completed application or intended use. Validation or batches, or their equivalents. Design product realization process.
prior to the delivery or implementation of the shall be completed prior to the delivery or validation shall ensure that devices
product. Records of the results of validation implementation of the product (see Note conform to defined user needs and ISO/DIS 13485:3002 addresses a
and any necessary actions shall be 1). intended uses and shall include testing of scenario not addressed by the QS Reg
maintained (see 4.2.4) production units under actual or simulated (e.g., where final assembly of the
Records of the results of validation and use conditions. Design validation shall medical device is accomplished on
any necessary actions shall be maintained include delivery to the customer)
(see 4.2.4). software validation and risk analysis,
where appropriate. The results of the The QS Reg contains a number of
As part of design and development design validation, including identification of design validation process requirements
validation, the organization shall perform the design, method(s), the date, and the not included in the standard.
clinical evaluations and/or evaluation of individual(s) performing the validation,
performance of the medical device, as shall be documented in the DHF.
required b y national or regional
regulations (see Note 2).
NOTE 1 If a medical device can only be

validated following assembly and
installation at point of use, delivery is not
considered to be complete until the
product has been formally transferred to
the customer.

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NOTE 2 Provision of the medical device

for purposes of clinical evaluations and/or
evaluation of performance is not
considered to be delivery.
7.3.7 Control of design and development 7.3.7 Control of design and 820.30 Design controls ISO/DIS 13485:2003 contains
changes development changes (i) Design changes. Each manufacturer requirements related to the effect of
Design and development changes shall be Design and development changes shall be shall establish and maintain procedures design changes on product already
identified and records maintained. The identified and records maintained. The for the identification, documentation, delivered and records of design
changes shall be reviewed, verified and changes shall be reviewed, verified and validation or where appropriate changes that do not appear in the QS
validated, as appropriate, and approved validated, as appropriate, and approved verification, review, and approval of design Reg.
before implementation. The review of before implementation. The review of changes before their implementation.
design and development changes shall design and development changes shall
include evaluation of the effect of the include evaluation of the effect of the
changes on constituent parts and product changes on constituent parts and product
already delivered. already delivered.
Records of the results of the review of

Records of the results of the review of
changes and any necessary actions shall
changes and any necessary actions shall be maintained (see 4.2.4).
be maintained (see 4.2.4).
7.4 Purchasing 7.4 Purchasing 820.50 Purchasing controls. No significant differences.

7.4.1Purchasing process 7.4.1 Purchasing process Each manufacturer shall establish and
The organization shall ensure that The organization shall establish maintain procedures to ensure that all
purchased product conforms to specified documented procedures to ensure that purchased or otherw ise received product
purchase requirements. The type and purchased product conforms to specified and services conform to specified
extent of control applied to the supplier and purchase requirements. requirements.
the purchased product shall be dependent
upon the effect of the purchased product on The type and extent of control applied to (a) Evaluation of suppliers, contractors,
subsequent product realization or the final the supplier and the purchased product and consultants. Each manufacturer
product. shall be dependent upon the effect of the shall establish and maintain the
The organization shall evaluate and select purchased product on subsequent product requirements, including
suppliers based on their ability to supply realization or the final product. quality requirements, that must be met by
product in accordance with the suppliers, contractors, and consultants.
organizations requirements. Criteria for The organization shall evaluate and select Each manufacturer shall:
selection, evaluation and re-evaluation shall suppliers based on their ability to supply
be established. Records of the results of product in accordance with the (1) Evaluate and select potential suppliers,
evaluations and any necessary actions organizations requirements. Criteria for contractors, and consultants on the basis
arising from the evaluation shall be selection, evaluation and re-evaluation of their ability to meet specified
maintained (see 4.2.4). shall be established. requirements, including quality

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requirements. The evaluation shall be

Records of the results of evaluations and documented.
any necessary actions arising from the
evaluation shall be maintained (see 4.2.4). (2) Define the type and extent of control to
be exercised over the product, services,
suppliers, contractors, and consultants,
based on the evaluation results.
(3) Establish and maintain records of

acceptable suppliers, contractors, and
consultants.
7.4.2 Purchasing information 7.4.2 Purchasing information 820.50 Purchasing controls The intent of both documents is
Purchasing information shall describe the Purchasing information shall describe the (b) Purchasing data. Each manufacturer consistent.
product to be purchased, including where product to be purchased, including where shall establish and maintain data that
appropriate appropriate clearly describe or reference the specified ISO/DIS 13485:2003 contains a
a) requirements for approval of product, requirements, including quality requirement associated with the
a) requirements for approval of product, procedures, processes and equipment, requirements, for purchased or otherwise organization ensuring the adequacy of
procedures, processes, and b) requirements for qualification of received product and services. Purchasing purchasing requirements prior to
equipment, personnel, and documents shall include, where possible, communicating them to the supplier.
c) quality management system an agreement that the suppliers,
b) requirements for qualification of requirements. contractors, and consultants agree to The QS Reg contains a requirement
personnel, and notify the manufacturer of changes in the that the organization obtain, where
The organization shall ensure the product or service so that manufacturers possible the agreement of the supplier
c) quality management system adequacy of specified purchase may determine whether the changes may to notify the organization of changes to
requirements. requirements prior to their affect the quality of a finished device. the product or service so that the
communicationto the supplier. Purchasing data shall be approved in organization can assess the potential
The organization shall ensure the adequacy accordance with Sec. 820.40. effect on the quality of the medical
of specified purchase requirements prior to To the extent required for traceability device.
their communication to the supplier. given in 7.5.3.2, the organization shall
maintain relevant purchasing information,
i.e. documents (see 4.2.3) and records
(see 4.2.4).
7.4.3 Verification of purchased product 7.4.3 Verification of purchased product 820.80 Receiving, in-process, and ISO/DIS 13485:2003 contains
The organization shall establish and The organization shall establish and finished device acceptance requirements related to the scenario
implement the inspection or other activities implement the inspection or other activities (b) Receiving acceptance activities. where the organization seeks to verify
necessary for ensuring that purchased necessary for ensuring that purchased Each manufacturer shall establish and purchased product at the suppliers
product meets specified purchase product meets specified purchase maintain procedures for acceptance of location.
requirements. requirements. incoming product.
Incoming product shall be inspected,
Where the organization or its customer Where the organization or its customer tested, or otherwise verified as conforming

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intends to perform verification at the intends to perform verification at the to specified requirements. Acceptance or
suppliers premises, the organization shall suppliers premises, the organization shall rejection shall be documented.
state the intended verification arrangements state the intended verification
and method of product release in the arrangements and method of product
purchas ing information. release in the purchasing information.
Records of the verification shall be

7.5 Production and service provision 7.5 Production and service provision 820.70 Production and process The intent of both documents is
7.5.1 Control of production and service 7.5.1 Control of production and service controls. consistent with each of the documents
provision provision (a) General. Each manufacturer shall providing details of control or the types
The organization shall plan and carry out 7.5.1.1 General requirements develop, conduct, control, and monitor of processes that must be controlled in
production and service provision under The organization shall plan and carry out production processes to ensure that a a way that supplements each other.
controlled conditions. Controlled conditions production and service provision under device conforms to its specifications.
shall include, as applicable controlled conditions. Where deviations from device It is suggested that the sections be read
Controlled conditions shall include, as specifications could occur as a result of together in order to get a complete list
a) the availability of information that applicable the manufacturing process, the of processes and process controls that
describes the characteristics of the a) the availability of information that manufacturer shall establish and maintain are to be included in the quality
product, describes the characteristics of the process control procedures that describe management system
product, any process controls necessary to ensure
b) the availability of work instructions,as b) the availability of documented conformance to specifications.
necessary, procedures, documented requirements ,
work instructions, and reference materials Where process controls are needed they
c) the use of suitable equipment, and reference measurement procedures shall include:
as necessary,
d) the availability and use of monitoring c) the use of suitable equipment, 1) Documented instructions, standard
and measuring devices, d) the availability and use of monitoring operating procedures (SOP's), and
and measuring devices, methods that define and control the
e) the implementation of monitoring and e) the implementation of monitoring and manner of production;
measurement, and measurement,
f) the implementation of release, delivery (2) Monitoring and control of process
f) the implementation of release, delivery and post-delivery activities, and parameters and component and device
and post-delivery activities. g) the implementation of defined characteristics during production;
operations for labelling and packaging.
The organization shall establish and (3) Compliance w ith specified reference
maintain a record (see 4.2.4) for each standards or codes;
batch of medical devices that provides
traceability to the extent specified in 7.5.3 (4) The approval of processes and
and identifies the amount manufactured process equipment; and
and amount approved for distribution. The
batch record shall be verified and (5) Criteria for workmanship which shall be

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approved. expressed in documented standards or by

means of identified and approved
NOTE A batch can be a single medical representative
device. samples.
7.5.1.2 Control of production and (b) Production and process changes.

service provision Specific Each manufacturer shall establish and
requirements maintain procedures for changes to a
7.5.1.2.1 Cleanliness of product and specification, method, process, or
contamination control procedure. Such changes shall be verified
The organization shall establish or where appropriate validated according
documented requirements for cleanliness to Sec. 820.75, before implementation and
of product if these activities shall be documented.
a) product is cleaned by the organization Changes shall be approved in accordance
prior to sterilization and/or its use, or with Sec. 820.40.
b) product is supplied non-sterile to be
subjected to a cleaning process prior to (c) Environmental control. Where
sterilization and/or its use, or environmental conditions could reasonably
c) product is supplied to be used non- be expected to have an adverse effect on
sterile and its cleanliness is of significance product quality, the manufacturer shall
in use, or establish and maintain procedures to
d) process agents are to be removed from adequately control these environmental
product during manufacture. conditions. Environmental control
system(s) shall be periodically inspected
If product is cleaned in accordance with a) to verify that the system, including
or b) above, the requirements contained in necessary equipment, is adequate and
6.4 a) and 6.4 b) do not apply prior to the functioning properly. These activities shall
cleaning process. be documented and reviewed.
7.5.1.2.2 Installation activities (d) Personnel. Each manufacturer shall

If appropriate, the organization shall establish and maintain requirements for
establish documented requirements which the health, cleanliness, personal practices,
contain acceptance criteria for installing and
and verifying the installation of the medical clothing of personnel if contact between
device. such personnel and product or
If the agreed customer requirements allow environment could reasonably be
installation to be performed other than by expected to have an adverse effect on
the organization or its authorized agent, product quality. The manufacturer shall
the organization shall provide documented ensure that maintenance and other
requirements for installation and personnel who are required to work
verification. temporarily under special environmental
conditions are appropriately trained or

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Records of installation and verification supervised by a trained individual.

performed by the organization or its
authorized agent shall be maintained (see (e) Contamination control. Each
4.2.4). manufacturer shall establish and maintain
procedures to prevent contamination of
7.5.1.2.3 Servicing activities equipment or product by substances that
If servicing is a specified requirement, the could reasonably be expected to have an
organization shall establish documented adverse effect on product quality.
procedures, work instructions and
reference materials and reference (f) Buildings. Buildings shall be of
measurement procedures, as necessary, suitable design and contain sufficient
for performing servicing activities and space to perform necessary operations,
verifying that they meet the specified prevent mixups, and assure orderly
requirements. handling.
Records of servicing activities carried out
by the organization shall be maintained (g) Equipment. Each manufacturer shall
(see 4.2.4). ensure that all equipment used in the
manufacturing process meets specified
NOTE Servicing can include, for example, requirements and is appropriately
repair and maintenance. designed, constructed, placed, and
installed to facilitate maintenance,
7.5.1.3 Particular requirements for adjustment, cleaning, and use.
sterile medical devices
The organization shall maintain records of (1) Maintenance schedule. Each
the process parameters for the sterilization manufacturer shall establish and maintain
process which was used for each schedules for the adjustment, cleaning,
sterilization batch (see 4.2.4). Sterilization and other maintenance of equipment to
records shall be traceable to each ensure that manufacturing specifications
production batch of medical devices (see are met.
7.5.1.1). Maintenance activities, including the date
and individual(s) performing the
maintenance activities, shall be
documented.
(2) Inspection. Each manufacturer shall

conduct periodic inspections in
accordance with established procedures
to ensure adherence to applicable
equipment maintenance schedules. The
inspections, including the date and
individual(s) conducting the inspections,
shall be documented.

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(3) Adjustment. Each manufacturer shall

ensure that any inherent limitations or
allowable tolerances are visibly posted on
or near
equipment requiring periodic adjustments
or are readily available to personnel
performing these adjustments.
(h) Manufacturing material. Where a

manufacturing material could reasonably
be expected to have an adverse effect on
product quality, the manufacturer shall
establish and maintain procedures for the
use and removal of such manufacturing
material to ensure that it is removed or
limited to an amount that does not
adversely affect the device's quality. The
removal or reduction of such
manufacturing material shall be
documented.
(i) Automated processes. When

computers or automated data processing
systems are used as part of production or
the quality system, the manufacturer shall
validate computer software for its intended
use according to an established protocol.
All software changes shall be validated
before approval and issuance. These
validation activities and results shall be
documented.
820.170 Installation.
(a) Each manufacturer of a device
requiring installation shall establish and
maintain adequate installation and
inspection instructions, and where
appropriate test procedures. Instructions
and procedures shall include directions for
ensuring proper installation so that the
device will perform as intended after

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ISO 13485:2003 CFR 820)
installation. The
manufacturer shall distribute the
instructions and procedures with the
device or otherwise make them available
to the person(s) installing the
device.
(b) The person installing the device shall

ensure that the installation, inspection,
and any required testing are performed in
accordance with the manufacturer's
instructions and procedures and
shall document the inspection and any test
results to demonstrate proper installation.
820.200 Servicing.
(a) Where servicing is a specified
requirement, each manufacturer shall
establish and maintain instructions and
procedures for performing
and verifying that the servicing meets the
specified requirements.
(b) Each manufacturer shall analyze

service reports with appropriate statistical
methodology in accordance with Sec.
820.100.
(c) Each manufacturer who receives a

service report that represents an ev ent
which must be reported to FDA under part
803 or 804 of this
chapter shall automatically consider the
report a complaint and shall process it in
accordance with the requirements of Sec.
820.198.
(d) Service reports shall be documented

and shall include:
(1) The name of the device serviced;
(2) Any device identification(s) and control

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number(s) used;
(3) The date of service;
(4) The individual(s) servicing the device;
(5) The service performed; and
(6) The test and inspec tion data.
820.30 Design controls

(h) Design transfer.
Each manufacturer shall establish and here is no specific reference to design
maintain procedures to ensure that the transfer in ISO/DIS 13485:2003.
device design is correctly translated into
production specifications.
7.5.1 Validation of processes for 7.5.2 Validation of processes for 820.75 Process validation. No significant differences. The QS Reg
production and service production and service provision (a) Where the results of a process cannot contains a number of prosciptive
provision 7.5.2.1 General requirements be fully verified by subsequent inspection requirements associated with
The organization shall validate any The organization shall validate any and test, the process shall be validated documentation of validation activities.
processes for production and service processes for production and service with a high degree of assurance and
provision where the resulting output cannot provision where the resulting output approved according to established
be verified by subsequent monitoring or cannot be verified by subsequent procedures. The validation activities and
measurement . This includes any processes monitoring or measurement. This includes results, including the date and signature of
where deficiencies become apparent only any processes where deficiencies become the individual(s) approving the validation
after the product is in use or the service has apparent only after the product is in use or and where appropriate the major
been delivered. the service has been delivered. equipment validated, shall be
documented.
Validation shall demonstrate the ability of Validation shall demonstrate the ability of
these processes to achieve planned results. these processes to achieve planned (b) Each manufacturer shall establish and
results. maintain procedures for monitoring and
The organization shall establish control of process parameters for
arrangements for these processes The organization shall establish validated processes to ensure that the
including, as applicable arrangements for these processes specified requirements continue to be met.
including, as applicable
a) defined criteria for review and approval a) defined criteria for review and approval (1) Each manufacturer shall ensure that
of the processes, validated processes are performed by
of the processes,
b) approval of equipment and qualification qualified individual(s).
of personnel,
b) approval of equipment and c) use of s pecific methods and (2) For validated processes, the
procedures, monitoring and control methods and data,

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ISO 13485:2003 CFR 820)
qualification of personnel, d) requirements for records (see 4.2.4), the date performed, and, where
and appropriate, the individual(s)
e) revalidation. performing the process or the major
c) use of specific methods and equipment used shall be documented.
procedures , The organization shall establish
documented procedures for the validation (c) When changes or process deviations
of the application of computer software occur, the manufacturer shall review and
d) requirements for records (see 4.2.4), (and changes to such software and/or its evaluate the process and perform
and application) for production and service revalidation where appropriate. These
provision that affect the ability of the activities shall be documented.
e) revalidation. product to conform to specified
requirements. Such software applications
shall be validated prior to initial use.
Records of validation shall be maintained

(see 4.2.4)
There are no specific requirements
7.5.2.2 Particular requirements for related to process validation of
sterile medical devices sterilization processes in the QS Reg.
The organization shall establish
documented procedures for the validation
of sterilization processes.
Sterilization processes shall be validated

prior to initial use.
Records of validation of each sterilization

process shall be maintained (see 4.2.4).
7.5.3 Identification and traceability 7.5.3 Identification and traceability 820.60 Identification.
Where appropriate, the organization shall 7.5.3.1 Identification Each manufacturer shall establish and
identify the product by suitable means The organization shall identify the product maintain procedures for identifying product
throughout product realization. by suitable means throughout product during all stages of receipt, production,
realization, and shall establish distribution, and installation to prevent
The organization shall identify the product documented procedures for such product mixups.
status with respect to monitoring and identification.
measurement requirements.
Where traceability is a requirement, the documented procedures to ensure that ISO/DIS13485:2003 addresses the
organization shall control and record the medical devices returned to the identification and traceability of product
unique identification of the product (see organization are identified and returned to the organization in order to
4.2.4). distinguished from conforming product ensure it is distinguished from normal

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[see 6.4 d)]. product.

NOTE In some industry sectors,
configuration management is a means by 7.5.3.2 Traceability 820.65 Traceability.
which identification and traceability are 7.5.3.2.1 General
maintained. The organization shall establish Each manufacturer of a device that is ISO/DIS 13485:2003 includes some
documented procedures for traceability. intended for surgical implant into the body general requirements associated with
Such procedures shall define the extent of or to support or sustain life and whose traceability not found in the QS Reg.
product traceability and the records failure to perform when properly used in
required (see 4.2.4, 8.3 and 8.5). accordance with instructions for use
provided in the labeling can be reasonably
Where traceability is a requirement, the expected to result in a significant injury to
organization shall control and record the the user shall establish and maintain
unique identification of the product (see procedures for identifying with a control
4.2.4). number each unit, lot, or batch of finished
devices and where appropriate
NOTE Configuration management is a components. The procedures shall
means by which identification and facilitate corrective action. Such
traceability can be maintained. identification shall be documented in the
DHR.
7.5.3.2.2 Particular requirements for
active implantable medical devices and
implantable medical devices
In defining the records required for The requirements for implantable and
traceability, the organization shall include active implantable devices found in both
records of all components, materials and documents are supplementary and all
work environment conditions, if these be incorporated into the quality
could cause the medical device not to management system of an organization
satisfy its specified requirements. supplying such medical devices.
The organization shall require that its

agents or distributors maintain records of
the distribution of medical devices to allow
traceability and that such records are
available for inspection.
Records of the name and address of the
shipping package consignee shall be
7.5.3.3 Status identification
The organization shall identify the product
status with respect to monitoring and
measurement requirements.

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The identification of product status shall 820.80 Receiving, in-process, and

be maintained throughout production, finished device acceptance
storage, installation and servicing of the (e) Acceptance records. Each
product to ensure that only product that manufacturer shall document acceptance
has passed the required inspections and activities required by this part. These
tests (or released under an authorized records shall include: (1) The acceptance
concession) is dispatched, used or activities performed; (2) the dates
installed. acceptance activities are performed; (3)
the results; (4) the signature of the
individual(s) conducting the acceptanc e
activities; and (5) where appropriate the
equipment used. These records shall be
part of the DHR.
820.86 Acceptance status.

Each manufacturer shall identify by
suitable means the acceptance status of
product, to indicate the conformance or The QS Reg contains a number of
nonconformance of proscriptive requirements associated
product with acceptance criteria. The with the records of acceptance status.
identification of acceptance status shall be
maintained throughout manufacturing,
packaging, labeling, installation, and
servicing of the product to ensure that only
product which has passed the required
acceptance activities is distributed, used,
or installed.
7.5.4 Customer property 7.5.4 Customer property Aside from the general controls to be
The organization shall exercise care with The organization shall exercise care with exerted by the organization over
customer property while it is under the customer property while it is under the purchased product, the QS Reg does
organizations control or being used by the organizations control or being used by the not specifically address the issue of
organization. The organization shall identify, organization. The organization shall care to exercised over customer
verify, protect and safeguard customer identify, verify, protect and safeguard property when it is being held or
property provided for use or incorporation customer property provided for use or processed by the organization.
into the product. If any customer property is incorporation into the product. If any
lost, damaged or otherwise found to be customer property is lost, damaged or
unsuitable for use, this shall be reported to otherwise found to be unsuitable for use,
the customer and records maintained (see this shall be reported to the customer and
4.2.4). records maintained (see 4.2.4).
NOTE Customer property can include NOTE Customer property can include

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ISO 13485:2003 CFR 820)
intellectual property. intellectual property or confidential health

information.
7.5.5 Preservation of property 7.5.5 Preservation of product 820.120 Device labeling. While the intent of the two documents is
The organization shall preserve the The organization shall establish Each manufacturer shall establish and consistent, the QS Reg contains many
conformity of product during internal documented procedures or documented maintain procedures to control labeling proscriptive requirements related to
processing and delivery to the intended work instructions for preserving the activities. label control and the handling, storage,
destination. This preservation shall include conformity of product during internal packaging, preservation, and
identification, handling, packaging, storage processing and delivery to the intended (a) Label integrity. Labels shall be distribution of product not specifically
and protection. Preservation shall also destination. printed and applied so as to remain legible called out in ISO/DIS 13485:2003.
apply to the constituent parts of a product. and affixed during the customary
This preservation shall include conditions of processing, storage,
identification, handling, packaging, handling, distribution, and where
storage and protection. Preservation shall appropriate use.
also apply to the constituent parts of a
product. (b) Labeling inspection. Labeling shall
not be released for storage or use until a
The organization shall establish designated individual(s) has examined the
documented procedures or documented labeling for accuracy including, where
work instructions for the control of product applicable, the correct expiration date,
with a limited shelf-life or requiring special control number, storage instructions,
storage conditions. Such special storage handling instructions, and any additional
conditions shall be controlled and processing instructions. The release,
recorded (see 4.2.4). including the date and signature of the
individual(s) performing the examination,
shall be
documented in the DHR.
(c) Labeling storage. Each

manufacturer shall store labeling in a
manner that provides proper identification
and is designed to prevent mixups.
(d) Labeling operations. Each

manufacturer shall control labeling and
packaging operations to prevent labeling
mixups. The label and
labeling used for each production unit, lot,
or batch shall be documented in the DHR.
e) Control number. Where a control

number is required by Sec. 820.65, that

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control number shall be on or shall

accompany the device through
distribution.
820.150 Storage.
(a) Each manufacturer shall establish and
maintain procedures for the control of
storage areas and stock rooms for product
to prevent
mixups, damage, deterioration,
contamination, or other adverse effects
pending use or distribution and to ensure
that no obsolete, rejected, or deteriorated
product is used or distributed. When the
quality of product deteriorates over time, it
shall be stored in a manner to facilitate
proper stock rotation, and its condition
shall be assessed as appropriate.
(c) Each manufacturer shall establish and

maintain procedures that describe the
methods for authorizing receipt from and
dispatch to storage areas and stock
rooms.
820.130 Device packaging.

Each manufacturer shall ensure that
device packaging and shipping containers
are designed and constructed to protect
the device from
alteration or damage during the customary
conditions of processing, storage,
handling, and distribution.
820.140 Handling.
Each manufacturer shall establish and
maintain procedures to ensure that
mixups, damage, deterioration,
contamination, or other adverse
effects to product do not occur during
handling.

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820.160 Distribution.
(a) Each manufacturer shall establish and
maintain procedures for control and
distribution of finished devices to ensure
that only those devices approved for
release are distributed and that purchase
orders are reviewed to ensure that
ambiguities and errors are resolved before
devices are released for distribution.
Where a device's fitness for use or quality
deteriorates over time, the procedures
shall ensure that expired devices or
devices deteriorated beyond acceptable
fitness for use are not distributed.
(b) Each manufacturer shall maintain

distribution records which include or refer
to the location of:
(1) The name and address of the initial

consignee;
(2) The identification and quantity of

devices shipped;
(3) The date shipped; and
(4) Any control number(s) used.
7.6 Control of monitoring and 7.6 Control of monitoring and 820.72 Inspection, measuring, and test The intent of the two documents is
measuring devices measuring devices equipment. consistent, with ISO/DIS 13485:2003
The organization shall determine the The organization shall determine the (a) Control of inspection, measuring, giving generalized guidance as to the
monitoring and measurement to be monitoring and measurement to be and test equipment. Each manufacturer control of monitoring and measuring
undertaken and the monitoring and undertaken and the monitoring and shall ensure that all inspection, measuring, devices and the QS Reg focusing more
measuring devices needed to provide measuring devices needed to provide and test specifically on the process of calibration
evidence of conformity of product to evidence of conformity of product to equipment, including mechanical, of such equipment.
determined requirements (see 7.2.1). determined requirements (see 7.2.1). automated, or electronic inspection and
test equipment, is suitable for its intended
The organization shall establish processes The organization shall establish purposes and is
to ensure that monitoring and measurement documented procedures to ensure that capable of producing valid results. Each
can be carried out and are carried out in a monitoring and measurement can be manufacturer shall establish and maintain
manner that is consistent with the carried out and are carried out in a procedures to ensure that equipment is

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ISO 13485:2003 CFR 820)
monitoring and measurement requirements. manner that is consistent with the routinely
monitoring and measurement calibrated, inspected, checked, and
Where necessary to ensure valid results, requirements. maintained. The procedures shall include
measuring equipment shall: provisions for handling, preservation, and
Where necessary to ensure valid results, storage of
a) be calibrated or verified at specified measuring equipment shall equipment, so that its accuracy and fitness
intervals, or prior to use, against a) be calibrated or verified at specified for use are maintained.
measurement standards traceable to intervals, or prior to use, against
international or national measurement measurement standards traceable to These activities shall be documented.
standards; where no such standards international or national measurement
exist, the basis used for calibration or standards; where no such standards exist, (b) Calibration. Calibration procedures
verification shall be recorded; the basis used for calibration or shall include specific directions and limits
verification shall be recorded; for accuracy and precision. When
b) be adjusted or re-adjusted as b) be adjusted or re-adjusted as accuracy and precision limits are not met,
necessary; necessary; there shall be provisions for remedial
c) be identified to enable the calibration action to reestablish the limits and to
c) be identified to enable the calibration status to be determined; evaluate whether there was any adverse
status to be determined; d) be safeguarded from adjustments that effect on the device's quality. These
would invalidate the measurement result; activities shall be
d) be safeguarded from adjustments that e) be protected from damage and documented.
would invalidate the measurement deterioration during handling,
result; maintenance and storage. (1) Calibration standards. Calibration
standards used for inspection, measuring,
e) be protected from damage and In addition, the organization shall assess and test equipment shall be traceable to
deterioration during handling, and record the validity of the previous national or international standards. If
maintenance and storage. measuring results when the equipment is national or international standards are not
found not to conform to requirements. The practical or available, the manufacturer
In addition, the organization shall assess organization shall take appropriate action shall use an independent reproducible
and record the validity of the previous on the equipment and any product standard. If no applicable standard exists,
measuring results when the equipment is affected. Records of the results of the manufacturer shall establish and
found not to conform to requirements. The calibration and verification shall be maintain an in-house standard.
organization shall take appropriate action maintained (see 4.2.4).
on the equipment and any product affected. (2) Calibration records. The equipment
Records of the results of calibration and When used in the monitoring and identification, calibration dates, the
verification shall be maintained (see 4.2.4). measurement of specified requirements, individual performing each calibration, and
the ability of computer software to satisfy the next calibration date shall be
When used in the monitoring and the intended application shall be documented. These records shall be
measurement of specified requirements, the confirmed. This shall be undertaken prior displayed on or near each piece of
ability of computer software to satisfy the to initial use and reconfirmed as equipment or shall be readily available to
intended application shall be confirmed. necessary. the personnel using such equipment and
This shall be undertaken prior to initial use to the individuals responsible for
and reconfirmed as necessary (see 7.5.2). NOTE See ISO 10012 for guidance calibrating the equipment.

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related to measurement management

NOTE See ISO 10012-1 and ISO 10012-2 systems.
for guidance.
8 Measurement, analysis and 8 Measurement, analysis and There is no one section of the QS Reg
improvement improvement that corresponds to this clause of
8.1 General 8.1 General ISO/DIS 13485:2003. It is clear from a
The organization shall plan and implement The organization shall plan and implement reading of the overall QS Reg that the
the monitoring, measurement, analysis and the monitoring, measurement, analysis objectives of this clause of ISO/DIS
improvement processes needed and improvement processes needed 13485:2003 and the QS Reg are
a) to demonstrate conformity of the consistent.
a) to demonstrate conformity of the product,
product, b) to ensure conformity of the quality
management system, and
b) to ensure conformity of the quality c) to maintain the effectiveness of the
management system, and quality management system.
This shall include determination of
c) to continually improve the applicable methods, including statistical 820.250 Statistical techniques.
effectiveness of the quality techniques, and the extent of their use. (a) Where appropriate, each manufacturer
management system. shall establish and maintain procedures
NOTE National or regional regulations for identifying valid statistical techniques
This shall include determination of might require documented procedures for required for establishing, controlling, and
applicable methods, including statistical implementation and control of the verifying the acceptability of process
techniques, and the extent of their use. application of statistical techniques. capability and product characteristics.
(b) Sampling plans, when used, shall be

written and based on a valid statistical
rationale. Each manufacturer shall
establish and maintain procedures to
ensure that sampling methods are
adequate for their intended use and to
ensure that when changes occur the
sampling plans are reviewed. These
activities shall be documented.
8.2 Monitoring and measurement 8.2 Monitoring and measurement 820.198 Complaint files. The QS Reg contains proscriptive
8.2.1 Customer satisfaction 8.2.1 Feedback (a) Each manufacturer shall maintain requirements regarding the handling of
As one of the measurements of the As one of the measurements of the complaint files. Each manufacturer shall complaints and other user input that
performance of the quality management performance of the quality management establish and maintain procedures for would be useful in conducting corrective
system, the organization shall monitor system, the organization shall monitor receiving, reviewing, and evaluating or preventive action. These
information relating to customer perception information relating to whether the complaints by a formally designated unit. requirements are not spelled out in
as to whether the organization has met organization has met customer detail in ISO/DIS 13485:2003, but

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customer requirements. The methods for requirements. Such procedures shall ensure that: compliance with the requirements set
obtaining and using this information shall be (1) All complaints are processed in a out in the QS Reg would satisfy the
determined. The methods for obtaining and using this uniform and timely manner; requirements of ISO/DIS 13485:2003.
information shall be determined.
(2) Oral complaints are documented upon
The organization shall establish a receipt; and
documented procedure for a feedback
system [see 7.2.3 c)] to provide early (3) Complaints are evaluated to determine
warning of quality problems and for input whether the complaint represents an event
into the corrective and preventive action which is required to be reported to FDA
processes (see 8.5.2 and 8.5.3). under part 803 or 804 of this chapter,
Medical Device Reporting.
If national or regional regulations require
the organization to gain experience from (b) Each manufacturer shall review and
the post-production phase, the review of evaluate all complaints to determine
this experience shall form part of the whether an investigation is necessary.
feedback system (see 8.5.1). When no investigation
is made, the manufacturer shall maintain a
record that includes the reason no
investigation was made and the name of
the individual
responsible for the decision not to
investigate.
(c) Any complaint involving the possible

failure of a device, labeling, or packaging
to meet any of its specifications shall be
reviewed, evaluated, and investigated,
unless such investigation has
already been performed for a similar
complaint and another investigation is not
necessary.
(d) Any complaint that represents an event

803 or 804 of this chapter shall be
promptly reviewed, evaluated, and
investigated by a designated individual(s)
and shall be maintained in a separate
portion of the complaint files or
otherwise clearly identified. In addition to
the information required by Sec.

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820.198(e), records of investigation under

this paragraph shall
include a determination of:
(1) Whether the device failed to meet

specifications;
(2) Whether the device was being used for

treatment or diagnosis; and
(3) The relationship, if any, of the device to

the reported incident or adverse event.
(e) When an investigation is made under

this section, a record of the investigation
shall be maintained by the formally
designated unit
identified in paragraph (a) of this section.
The record of investigation shall include:
(1) The name of the device;
(2) The date the complaint was received;

number(s) used;
(4) The name, address, and phone

number of the complainant;
(5) The nature and details of the

complaint;
(6) The dates and results of the

investigation;
(7) Any corrective action taken; and
(8) Any reply to the complainant.
(f) When the manufacturer's formally

designated complaint unit is located at a

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ISO 13485:2003 CFR 820)
site separate from the manufacturing

establishment, the investigated
complaint(s) and the record(s) of
investigation shall be reasonably
accessible to the manufacturing
establishment.
(g) If a manufacturer's formally designated

complaint unit is located outside of the
United States, records required by this
section
shall be reasonably accessible in the
United States at either:
(1) A location in the United States where

the manufacturer's
records are regularly kept; or
(2) The location of the initial distributor.
8.2.2 Internal audit 8.2.2 Internal audit 820.22 Quality audit. No significant differences.
The organization shall conduct internal The organization shall conduct internal Each manufacturer shall establish
audits at planned intervals to determine audits at planned intervals to determine procedures for quality audits and conduct
whether the quality management system whether the quality management system such audits to assure that the quality
a) conforms to the planned arrangements system is in compliance with the
(see 7.1), to the requirements of this established quality system requirements
a) conforms to the planned arrangements
International Standard and to the quality and to determine the effectiveness of the
(see 7.1), to the requirements of this management system requirements quality system. Quality audits shall be
International Standard and to the established by the organization, and conducted by individuals who do not have
quality management system b) is effectively implemented and direct responsibility for the matters being
requirements established by the maintained. audited. Corrective action(s), including a
reaudit of deficient matters, shall be taken
organization, and An audit programme shall be planned, when necessary. A report of the results of
taking into consideration the status and each quality audit, and reaudit(s) where
b) is effectively implemented and importance of the processes and areas to taken, shall be made and such reports
be audited, as well as the results of shall be reviewed by management having
maintained.
previous audits. The audit criteria, scope, responsibility for the matters audited. The
frequency and methods shall be defined. dates and results of quality audits and
An audit programme shall be planned, Selection of auditors and conduct of audits reaudits shall be documented.
taking into consideration the status and shall ensure objectivity and impartiality of
importance of the processes and areas to the audit process. Auditors shall not audit
be audited, as well as the results of their own work.
previous audits. The audit criteria, scope,

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ISO 13485:2003 CFR 820)
frequency and methods shall be defined. The responsibilities and requirements for
Selection of auditors and conduct of audits planning and conducting audits, and for
shall ensure objectivity and impartiality of reporting results and maintaining records
the audit process. Auditors shall not audit (see 4.2.4) shall be defined in a
their own work. documented procedure.
The management responsible for the area
The responsibilities and requirements for being audited shall ensure that actions are
planning and conducting audits, and for taken without undue delay to eliminate
reporting results and maintaining records detected nonconformities and their
(see 4.2.4) shall be defined in a causes. Follow -up activities shall include
documented procedure. the verification of the actions taken and
the reporting of verification results (see
The management responsible for the area 8.5.2).
being audited shall ensure that actions are
taken without undue delay to eliminate NOTE See ISO 19011 for guidance
detected nonconformities and their causes. related to quality auditing.
Follow-up activities shall include the
verification of the actions taken and the
reporting of verification results (see 8.5.2).
NOTE See ISO 19011
8.2.3 Monitoring and measurement of 8.2.3 Monitoring and measurement of 820.70 Production and process The intent of the two documents is
processes processes controls. consistent, even though the QS Reg is
The organization shall apply suitable The organization shall apply suitable (a) General. Each manufacturer shall far more detailed and has a product
methods for monitoring and, where methods for monitoring and, where develop, conduct, control, and monitor focus.
applicable, measurement of the quality applicable, measurement of the quality production processes to ensure that a
management system processes. These management system processes. These device conforms to its specifications.
methods shall demonstrate the ability of the methods shall demonstrate the ability of Where deviations from device
processes to achieve planned results. the processes to achieve planned results. specifications could occur as a result of
When planned results are not achieved, When planned results are not achieved, the manufacturing process, the
correction and corrective action shall be correction and corrective action shall be manufacturer shall establish and maintain
taken, as appropriate, to ens ure conformity taken, as appropriate, to ensure process control procedures that describe
of the product. conformity of the product. any process controls necessary to ensure
conformance to specifications.
Where process controls are needed they

shall include:
1) Documented instructions, standard

operating procedures (SOP's), and
methods that define and control the

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ISO 13485:2003 CFR 820)
manner of production;
(2) Monitoring and control of process

parameters and component and device
characteristics during production;
(3) Compliance with specified reference

standards or codes;
(4) The approval of processes and

process equipment; and
(5) Criteria for workmanship which shall be

expressed in documented standards or by
means of identified and approved
representative
samples.
820.250 Statistical techniques.

(a) Where appropriate, each manufacturer
shall establish and maintain procedures
for identifying valid statistical techniques
required for establishing, controlling, and
verifying the acceptability of process
capability and product characteristics.

8.2.4 Monitoring and measurement of 8.2.4 Monitoring and measurement of 820.80 Receiving, in-process, and The intent of the two documents is
product product finished device acceptance consistent, even though the QS Reg is
The organization shall monitor and measure 8.2.4.1 General requirements (a) General. Each manufacturer shall far more detailed and proscriptive.
the characteristics of the product to verify The organization shall monitor and establish and maintain procedures for
that product requirements have been met. measure the characteristics of the product acceptance activities. Acceptance
This shall be carried out at appropriate to verify that product requirements have activities include

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ISO 13485:2003 CFR 820)
stages of the product realization process in been met. This shall be carried out at inspections, tests, or other verification
accordance with the planned arrangements appropriate stages of the product activities.
(see 7.1). realization process in accordance with the
planned arrangements (see 7.1) and (b) Receiving acceptance activities.
Evidence of conformity with the acceptance documented procedures (see 7.5.1.1). Each manufacturer shall establish and
criteria shall be maintained. Records shall maintain procedures for acceptance of
indicate the person(s) authorizing release of Evidence of conformity with the incoming product.
product (see 4.2.4). acceptance criteria shall be maintained. Incoming product shall be inspected,
Records shall indicate the person(s) tested, or otherwise verified as conforming
Product release and service delivery shall authorizing release of product (see 4.2.4). to specified requirements. Acceptance or
not proceed until the planned arrangements rejection shall be documented.
(see 7.1) have been satisfactorily Product release and service delivery shall
completed, unless otherwise approved by a not proceed until the planned (c) In-process acceptance activities.
relevant authority and, where applicable, by arrangements (see 7.1) have been Each manufacturer shall establish and
the customer. satisfactorily completed. maintain acceptance procedures, where
appropriate, to
8.2.4.2 Particular requirement for active ensure that specified requirements for in-
implantable medical devices and process product are met. Such procedures
implantable medicaldevices shall ensure that in-process product is
The organization shall record (see 4.2.4) controlled until the required inspection and
the identity of personnel performing any tests or other verification activities have
inspection or testing been completed, or necessary approvals
are received, and are documented.
(d) Final acceptance activities. Each

procedures for finished device acceptance
to ensure that each production run, lot, or
batch of finished devices meets
acceptance criteria. Finished devices shall
be held in quarantine or otherwise
adequately controlled until released.
Finished devices shall not be released for
distribution until:
(1) The activities required in the DMR are

completed;
(2) the associated data and

documentation is reviewed;
(3) the release is authorized by the

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ISO 13485:2003 CFR 820)
signature of a designated individual(s);

and
(4) the authorization is dated.
(e) Acceptance records. Each The acceptance records requirements

manufacturer shall document acceptance of the QS Reg would appear to satsify
activities required by this part. These the implantable and active implantable
records shall include: (1) The acceptance requirements of ISO/DIS 13485:2003.
activities performed; (2) the dates
acceptance activities are performed; (3)
the results; (4) the signature of the
individual(s) conducting the acceptance
activities; and (5) where appropriate the
equipment used. These records shall be
part of the DHR.
820.250 Statistical techniques.

(a) Where appropriate, each manufacturer
shall establish and maintain procedures
for identifying valid statistical techniques
required for establishing, controlling, and
verifying the acceptability of process
capability and product characteristics.

8.3 Control of nonconforming product 8.3 Control of nonconforming product 820.90 Nonconforming product. The intent of the two documents is
The organization shall ensure that product The organization shall ensure that product (a) Control of nonconforming product. consistent.
which does not conform to product which does not conform to product Each manufacturer shall establish and
requirements is identified and controlled to requirements is identified and controlled to maintain procedures to control product The QS Reg provides more detail as to
prevent its unintended use or delivery. The prevent its unintended use or delivery. The that does not the items to be recorded in a
controls and related responsibilities and controls and related responsibilities and conform to specified requirements. The nonconforming product situation. It
authorities f or dealing with nonconforming authorities for dealing with nonconforming procedures shall address the explicitly addresses the subject of the

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ISO 13485:2003 CFR 820)
product shall be defined in a documented product shall be defined in a documented identification, documentation, evaluation, need for an investigation in such a
procedure. procedure. segregation, and disposition of situation.
nonconforming product. The evaluation of
The organization shall deal with The organization shall deal with nonconformance shall include a
nonconforming product by one or more of nonconforming product by one or more of determination of the need for an
the following ways: the following ways: investigation and notification of the
a) by taking action to eliminate the persons or organizations responsible for
a) by taking action to eliminate the detected nonconformity; the nonconformance. The evaluation and
detected nonconformity; b) by authorizing its use, release or any investigation shall be documented.
acceptance under concession;
b) by authorizing its use, release or c) by taking action to preclude its original (b) Nonconformity review and
acceptance under concession by a intended use or application. disposition.
relevant authority and, where (1) Each manufacturer shall establish and
applicable, by the customer; The organization shall ensure that maintain procedures that define the
nonconforming product is accepted by responsibility for review and the authority
c) by taking action to preclude its original concession only if regulatoryrequirements for the disposition of nonconforming
intended use or application. are met. Records of the identity of the product. The procedures shall set forth the
person(s) authorizing the concession shall review and disposition process.
Records of the nature of nonconformities be maintained (see 4.2.4). Disposition of nonconforming product shall
and any subsequent actions taken, be documented. Documentation shall
including concessions obtained, shall be Records of the nature of nonconformities include the justification for use of
maintained (see 4.2.4). and any subsequent actions taken, nonconforming product and the signature
including concessions obtained, shall be of the individual(s) authorizing the use.
When nonconforming product is corrected it maintained (see 4.2.4).
shall be subject to re-verification to (2) Each manufacturer shall establish and
demonstrate conformity to the When nonconforming product is corrected maintain procedures for rework, to include
requirements. it shall be subject to re-verification to retesting and reevaluation of the
demonstrate conformity to the nonconforming
When nonconforming product is detected requirements. product after rework, to ensure that the
after delivery or use has started, the product meets its current approved
organization shall take action appropriate to When nonconforming product is detected specifications. Rework and reevaluation
the effects, or potential effects, of the after delivery or use has started, the activities, including
nonconformity. organization shall take action appropriate a determination of any adverse effect from
to the effects, or potential effects, of the the rework upon the product, shall be
nonconformity. documented in the DHR. ISO/DIS 13485:2003 addresses the
handling of already released product
If product needs to be reworked (one or that is subject to a finding of
more times), the organization shall nonconformity.
document the rework process in a work
instruction that has undergone the same
authorization and approval procedure as ISO/DIS 13485:2003 provides
the original work instruction. Prior to requirements related to rework of non-

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ISO 13485:2003 CFR 820)
authorization and approval of the work conforming product.

instruction, a determination of any adverse
effect of the rework upon product shall be
made and documented (see 4.2.3 and
7.5.1).
8.4 Analysis of data 8.4 Analysis of data 820.250 Statistical techniques. There is no one section of the QS Reg
The organization shall determine, collect The organization shall establish (a) Where appropriate, each manufacturer that corresponds directly with subclause
and analyse appropriate data to documented procedures to determine, shall establish and maintain procedures 8.4 of ISO/DIS 13485:2003.
demonstrate the suitability and collect and analyse appropriate data to for identifying valid statistical techniques Requirements for analysis of data
effectiveness of the quality management demonstrate the suitability and required for establishing, controlling, and related to various elements of the
system and to evaluate where continual effectiveness of the quality management verifying the acceptability of process quality management systems is
improvement of the effectiveness of the system and to evaluate if improvement of capability and product characteristics. contained in a number of QS Reg
quality management system can be made. the effectiveness of the quality sections. The intent of the two
This shall include data generated as a result management system can be made. (b) Sampling plans, when used, shall be documents as it relates to analysis of
of monitoring and measurement and from written and based on a valid statistical data is consistent.
other relevant sources. This shall include data generated as a rationale. Each manufacturer shall
result of monitoring and measurement and establish and maintain procedures to
The analysis of data shall provide from other relevant sources. ensure that sampling methods are
information relating to adequate for their intended use and to
The analysis of data shall provide ensure that when changes occur the
a) customer satisfaction (see 8.2.1), information relating to sampling plans are reviewed. These
a) feedback (see 8.2.1), activities shall be documented.
b) conformity to product requirements b) conformity to product requirements (see
(see 7.2.1), 7.2.1),
c) characteristics and trends of processes
c) characteristics and trends of and products including opportunities for
processes and products including preventive action, and
opportunities for preventive action, and d) suppliers.
d) suppliers. Records of the results of the analysis of

data shall be maintained (see 4.2.4).
8.5 Improvement 8.5 Improvement 820.20 Management responsibilities There is no one section of the QS Reg
8.5.1 Continual improvement 8.5.1 General (c) Management review. Management that corresponds directly with subclause
The organization shall continually improve The organization shall identify and with executive responsibility shall review 8.5.1 of ISO/DIS 13485:2003. The
the effectiveness of the quality management implement any changes necessary to the suitability and effectiveness of the intent of the two documents as it relates
system through the use of the quality policy, ensure and maintain the continued quality system at defined intervals and to improvement of the quality
quality objectives, audit results, analysis of suitability and effectiveness of the quality with sufficient frequency according to management system through the use of
data, corrective and preventive actions and management system through the use of established procedures to ensure that the corrective and preventive action is
management review . the quality policy, quality objectives, audit quality system satisfies the requirements consistent.
resul ts, analysis of data, corrective and of this part and the manufacturer's

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ISO 13485:2003 CFR 820)
preventive actions and management established quality policy and objectives.

review. The dates and results of quality system
reviews shall be documented.
documented procedures for the issue and 820.198 Complaint files. The requirements of the QS Reg are
implementation of advisory notices. (a) Each manufacturer shall maintain significantly more proscriptive related to
complaint files. Each manufacturer shall the handling and documentation of
These procedures shall be capable of establish and maintain procedures for complaints.
being implemented at any time. receiving, reviewing, and evaluating
Records of all customer complaint complaints by a formally designated unit.
investigations shall be maintained (see
4.2.4). If investigation determines that the Such procedures shall ensure that:
activities outside the organization (1) All complaints are processed in a
contributed to the customer complaint, uniform and timely manner;
relevant information shall be exchanged
between the organizations involved (see (2) Oral complaints are documented upon
4.1). receipt; and
If any customer complaint is not followed (3) Complaints are evaluated to determine
by corrective and/or preventive action, the whether the complaint represents an event
reason shall beauthorized (see 5.5.1) and which is required to be reported to FDA
recorded (see 4.2.4). under part 803 or 804 of this chapter,
Medical Device Reporting.
If national or regional regulations require
notification of adverse events that meet (b) Each manufacturer shall review and
specified reporting criteria, the evaluate all complaints to determine
organization shall establish documented whether an investigation is necessary.
procedures to such notification to When no investigation
regulatory authorities. is made, the manufacturer shall maintain a
record that includes the reason no
investigation was made and the name of
the individual
responsible for the decision not to
investigate.
(c) Any complaint involving the possible

failure of a device, labeling, or packaging
to meet any of its specifications shall be
reviewed, evaluated, and investigated,
unless such investigation has
already been performed for a similar
complaint and another investigation is not

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ISO 13485:2003 CFR 820)
necessary.
(d) Any complaint that represents an event

803 or 804 of this chapter shall be
promptly reviewed, evaluated, and
investigated by a designated individual(s)
and shall be maintained in a separate
portion of the complaint files or
otherwise clearly identified. In addition to
the information required by Sec.
820.198(e), records of investigation under
this paragraph shall
include a determination of:
(1) Whether the device failed to meet

specifications;
(2) Whether the device was being used for

treatment or diagnosis; and
(3) The relationship, if any, of the device to

the reported incident or adverse event.
(e) When an investigation is made under

this section, a record of the investigation
shall be maintained by the formally
designated unit
identified in paragraph (a) of this section.
The record of investigation shall include:
(1) The name of the device;
(2) The date the complaint was received;

number(s) used;
(4) The name, address, and phone

number of the complainant;
(5) The nature and details of the

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ISO 13485:2003 CFR 820)
complaint;
(6) The dates and results of the

investigation;
(7) Any corrective action taken; and
(8) Any reply to the complainant.
(f) When the manufacturer's formally

designated complaint unit is located at a
site separate from the manufacturing
establishment, the investigated
complaint(s) and the record(s) of
investigation shall be reasonably
accessible to the manufacturing
establishment.
(g) If a manufacturer's formally designated

complaint unit is located outside of the
United States, records required by this
section
shall be reasonably accessible in the
United States at either:
(1) A location in the United States where

the manufacturer's
records are regularly kept; or
(2) The location of the initial distributor.
8.5.2 Corrective action 8.5.2 Corrective action 820.100 Corrective and preventive The intent of the two documents is
The organization shall take action to The organization shall take action to action. consistent.
eliminate the cause of nonconformities in eliminate the cause of nonconformities in (a) Each manufacturer shall establish and
order to prevent recurrence. Corrective order to prevent recurrence. maintain procedures for implementing The requirements as set out by the QS
actions shall be appropriate to the effects of corrective and preventive action. The Reg are more proscriptive.
the nonconformities encountered. Corrective actions shall be appropriate to procedures shall include requirements for:
the effects of the nonconformities
A documented procedure shall be encountered. (1) Analyzing processes, work operations,
established to define requirements for concessions, quality audit reports, quality
A documented procedure shall be records, service records, complaints,
a) reviewing nonconformities (including established to define requirements for returned product, and other sources of

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ISO 13485:2003 CFR 820)
customer complaints), a) reviewing nonconformities (including quality data to identify existing and
customer complaints), potential causes of nonconforming
b) determining the causes of b) determining the causes of product, or other quality problems.
nonconformities, nonconformities, Appropriate statistical methodology shall
c) evaluating the need for action to ensure be employed where necessary to detect
c) evaluating the need for action to that nonconformities do not recur, recurring quality problems;
ensure that nonconformities do not d) determining and implementing action
recur, needed, including, if appropriate, updating (2) Investigating the cause of
documentation (see 4.2), nonconformities relating to product,
d) determining and implementing action e) recording of the results of any processes, and the quality system;
needed, investigation and of action taken (see
4.2.4), and (3) Identifying the action(s) needed to
e) records of the results of action taken f) reviewing the corrective action taken correct and prevent recurrence of
(see 4.2.4), and and its effectiveness. nonconforming product and other quality
problems;
f) reviewing corrective action taken.
(4) Verifying or validating the corrective
and preventive action to ensure that such
action is effective and does not adversely
affect the
finished device;
(5) Implementing and recording changes

in methods and procedures needed to
correct and prevent identified quality
problems;
(6) Ensuring that information related to

quality problems or nonconforming
product is disseminated to those directly
responsible for
assuring the quality of such product or the
prevention of such problems; and
(7) Submitting relevant information on

identified quality problems, as well as
corrective and preventive actions, for
management review.
(b) All activities required under this

section, and their results, shall be
documented.

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ISO 13485:2003 CFR 820)
8.5.3 Preventive action 8.5.3 Preventive action 820.100 Corrective and preventive The intent of the two documents is
The organization shall determine action to The organization shall determine action to action. consistent.
eliminate the causes of potential eliminate the causes of potential (a) Each manufacturer shall establish and
nonconformities in order to prevent their nonconformities in order to prevent their maintain procedures for implementing The requirements as set out by the QS
occurrence. Preventive actions shall be occurrence. Preventive actions shall be corrective and preventive action. The Reg are more proscriptive.
appropriate to the effects of the potential appropriate to the effects of the potential procedures shall include requirements for:
problems. problems.
(1) Analyzing processes, work operations,
A documented procedure shall be A documented procedure shall be concessions, quality audit reports, quality
established to define requirements for established to define requirements for records, service records, complaints,
a) determining potential nonconformities returned product, and other sources of
a) determining potential nonconformities and their causes, quality data to identify existing and
and their causes, b) evaluating the need for action to potential causes of nonconforming
prevent occurrence of nonconformities, product, or other quality problems.
b) evaluating the need for action to c) determining and implementing action Appropriate statistical methodology shall
prevent occurrence of nonconformities, needed, be employed where necessary to detect
d) recording of the results of any recurring quality problems;
c) determining and implementing action investigations and of action taken (see
needed, 4.2.4), and (2) Investigating the cause of
e) reviewing preventive action taken and nonconformities relating to product,
d) records of the results of action taken its effectiveness processes, and the quality system;
(see 4.2.4), and
(3) Identifying the action(s) needed to
e) reviewing preventive action taken. correct and prevent recurrence of
nonconforming product and other quality
problems;
(4) Verifying or validating the corrective

and preventive action to ensure that such
action is effective and does not adversely
affect the
finished device;
(5) Implementing and recording changes

in methods and procedures needed to
correct and prevent identified quality
problems;
(6) Ensuring that information related to

quality problems or nonconforming
product is disseminated to those directly

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ISO 13485:2003 CFR 820)
responsible for
assuring the quality of such product or the
prevention of such problems; and
(7) Submitting relevant information on

identified quality problems, as well as
corrective and preventive actions, for
management review.
(b) All activities required under this

section, and their results, shall be
documented.

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Correspondence between ISO 9001:2000 and ISO 13485:2003

and the US Quality System Regulation

Prepared by: Ed Kimmelman, Consultant

ISO/DIS 9001:2000 U.S. Quality System Regulation (21 Comments

1 Scope 1 Scope 820.1 Scope The scope sections of each document

(d) Foreign manufacturers. If a

Prepared by: Ed Kimmelman, Consultant

ISO/DIS 9001:2000 U.S. Quality System Regulation (21 Comments

shall appear for purposes of section

(e) Exemptions or variances.

(2) FDA may initiate and grant a variance

Prepared by: Ed Kimmelman, Consultant

ISO/DIS 9001:2000 U.S. Quality System Regulation (21 Comments

If any requirement(s) in Clause 7 of this If a manufacturer engages in only some

Prepared by: Ed Kimmelman, Consultant

ISO/DIS 9001:2000 U.S. Quality System Regulation (21 Comments

deemed to be appropriate unless the use, that is manufactured, imported, or

(b) Limitations. The quality system

Prepared by: Ed Kimmelman, Consultant

ISO/DIS 9001:2000 U.S. Quality System Regulation (21 Comments

2 Normative reference 2 Normative reference

ISO 9000:2000, Quality management

Wherever requirements are specified as

Prepared by: Ed Kimmelman, Consultant

ISO/DIS 9001:2000 U.S. Quality System Regulation (21 Comments

requirements apply equally to related

The following definitions should be

3.1 I was not able to find the regulatory

NOTE Issue of an advisory notice might

Prepared by: Ed Kimmelman, Consultant

ISO/DIS 9001:2000 U.S. Quality System Regulation (21 Comments

NOTE This definition applies to

(c) Component means any raw material,

(d) Control number means any distinctive

Prepared by: Ed Kimmelman, Consultant

ISO/DIS 9001:2000 U.S. Quality System Regulation (21 Comments

batch of finished devices can be

(e) Design history file (DHF) means a

Prepared by: Ed Kimmelman, Consultant

ISO/DIS 9001:2000 U.S. Quality System Regulation (21 Comments

e) output(s) of risk management (see 7.1).

Requirements shall be complete,

Records of the design and development

NOTE Records of design and

3.7 [Federal Food, Drug, and Cosmetics Act, No significant difference.

Prepared by: Ed Kimmelman, Consultant

ISO/DIS 9001:2000 U.S. Quality System Regulation (21 Comments

NOTE This definition has been developed

Participants in such reviews shall include

Prepared by: Ed Kimmelman, Consultant

ISO/DIS 9001:2000 U.S. Quality System Regulation (21 Comments

representatives of functions concerned

Records of the results of the reviews and

NOTE The requirements for sterility of a

(i) Device history record (DHR) means a

(j) Device master record (DMR) means a

(k) Establish means define, document (in

(l) Finished device means any device or

(m) Lot or batch means one or more

Prepared by: Ed Kimmelman, Consultant

ISO/DIS 9001:2000 U.S. Quality System Regulation (21 Comments

uniform characteristics and quality within

(o) Manufacturer means any person who

(p) Manufacturing material means any