Interpretation of ISO 9001:2008 Requirements: Guardian Independent Certification

Guardian Independent Certification
Chapter 3
Interpretation of ISO 9001:2008 Requirements
©Guardian Independent Certification Pte Ltd Page 1 of 37

Lead Assessor / Assessor Revision: 5 (July 2010)
Chapter 3
Application
An organisation is allowed to exclude requirements based on

the following rules:-
Rule 1:
Exclusion can be from Clause 7 only (Product Realisation)
Rule 2:
Exclusion must not affect the organisation’s ability, or
responsibility to provide products that meet all requirements.

Chapter 3
Exclusion
• Design (7.3)
• Customer Property (7.5.4)
• Control of Monitoring and Measuring
Equipment (7.6)
4. QMS REQUIREMENTS
Quality Management System Requirements (Clause 4.1)
General
Documentation Requirements (Clause 4.2)
General
a) quality policy and quality objectives
b) quality manual
c) documented procedures required by this International
Standard
d) documents required by the organisation to ensure
effective planning, operation and control of its processes
e) Records required by this International Standard

Chapter 3
4.1 General Requirement

- Establish, document, implement and maintain a QMS and
continually improve its effectiveness
New Note
-“Outsourced process” is a process needed by organization’s QMS
but performed by external party
-Responsible to ensure the outsourced processes meet all the
requirements
-Define the type and extent of CONTROL on outsourced processes
(those affect product conformity)
-Determine any potential impacts of the outsourced processes on the
organization’s capability to provide product that conforms to
requirements.
4.2 .1 Documentation Requirements

N
• Quality policy and objectives IO
CT
• Quality manual
RU
• 6 Documented procedures ( 4.2.1 Note 1)

ST
i. Control of Documents
IN
RK
ii. Control of Quality Records

WO
iii. Internal Quality Audit

iv. Control of Non-Conforming Product
v. Corrective and Preventive Action
•Documents needed by company to ensure effective planning, operations
and control of its processes (4.2.1 Note 2)
• Records required by this standard (e.g. minutes of management review;
training records; records of design input; records of results of design
verification & review; calibration records and internal audit results)

Chapter 3
4.2.1 Documentation Requirement

Where the term “documented procedure” whenever appears
within the standard, this means that the procedure is
established, documented, implemented and maintained.
New Note
-Provide flexibility in creation of “documented procedure”
with the stated condition that a single document may address
the requirements for one or more procedures.
-Likewise, a requirement for a “documented procedure” may

be covered by more than one documents
4.2.2 Quality Manual
• Scope of Quality Management System, including details of

and justification for any exclusions
• reference to the documented procedures
• description of interaction between processes of

Quality Management System

Chapter 3
4.2.3 Control of Documents

• review and approval of (new and revised) document
for adequacy
• identify changes & current revision status of documents
• availability of relevant versions of applicable documents

at point of use
• prevent un-intended use of obsolete documents
• documents of external origin are identified and

their distribution controlled
• suitably identify obsolete documents if they are

retained for any purpose
• remain legible and readily identifiable
4.2.3 Control of Documents

4.2.3 (f) to ensure that documents of external origin are
identified and their distribution controlled ….
Clarification
- Determine if the “document of external origin” is necessary for
the planning and operation of the quality management system

Chapter 3
4.2.4 Control of Quality Records

• Records required to demonstrate conformity to requirements and effective
operations of Quality Management System
• Records remain legible, readily identifiable and retrievable
• Documented procedure for identifying, storing, protecting, retrieving,

retaining (retention time) and disposing of records
MANAGEMENT RESPONSIBILITY
Continual Improvement of the Quality Management Systems
Customer Management Customer

Customer
Customer
Responsibility
Measurement
Analysis and Satisfaction
Satisfaction
Resource Improvement
Management
Output
Requirements Product
Realization

Chapter 3
5. MANAGEMENT RESPONSIBILITY
 Management commitment (Clause 5.1)
 Customer focus (Clause 5.2)
 Quality policy (Clause 5.3)
 Planning (Clause 5.4)
>Quality objectives
>Quality management system planning
 Responsibility, authority and communication (Clause 5.5)
>Responsibility and authority
>Management Representative (MR)
>Internal Communication
 Management Review (Clause 5.6)
>General
>Review input
>Review output
5. Management Responsibility
5.1 Management Commitment

--- To the development and implementation of an effective
QMS
--- Management Review, Policy, objectives
--- The importance of meeting customer,

statutory and regulatory requirements
.
5.2 Customer Focus
Ensure that customer requirements are determined and are met

with the aim of enhancing customer satisfaction

Chapter 3
5.3 Quality Policy

Top Management shall ensure that:
--- Appropriate to the purpose of organization

--- Commitment to comply with requirements and
continually improve effectiveness of QMS
--- Framework to establish and review Quality
Objectives
--- Communicated & understood within company
--- Reviewed for continuing suitability
5.4.1 Quality Objectives
Establish Quality objectives at relevant functions
and levels within organization
Consider requirement related to the product
Consistent with Quality Policy and measurable
5.4.2 QMS Planning
Top Management shall ensure that:
--- Planning of QMS meet the general requirement

and Quality Objectives
--- Integrity of QMS is maintained when changes to

QMS are planned & implemented
--- Improve effectiveness of QMS via use of Quality

policy, Quality objectives, audit results, corrective
/ preventive action & management review

Chapter 3
5.5.1 Responsibility and Authority
Top management shall ensure that the Responsibility

and Authority are defined and communicated
5.5.2 Management Representative
Top management shall appoint a member of

management who, irrespective of other
responsibilities, shall have responsibility and
authority that includes ……
Clarification
- Member of Management must be a member of the

organization’s management team, and not an external
member of management

Chapter 3
5.5.3 Internal Communication
Top management shall ensure:

• communication processes are established within company
Communication takes place regarding effectiveness of QMS
Communicate:
• Quality policy
• Promote awareness of customer
requirements within company
• Responsibilities and authorities
• Aware of relevance & importance
of their activities & how they
contribute to achievement
of Quality Objectives
5.6 Management Review

Top Management:
Review QMS at planned interval to ensure its continuing suitability,
adequacy and effectiveness
Review Input
(1) Follow-up actions from previous management reviews
(2) Results of audits ( Internal + External )
(3) Customer Feedback ( Survey/Complaint / Compliment )
(4) Process Performance & Product Conformity
(5) Status of Corrective/Preventive Actions
(6) Change that could affect the QMS
(7) Recommendations for Improvement
(8) Review Quality Policy & Objectives
(9) Review Supplier Performance

Chapter 3
5.6 Management Review
Review Output
(1) Improvement of the effectiveness of the QMS
(2) Improvement of the Product
(3) Resource Needs
RESOURCE MANAGEMENT

Customer
Customer
Responsibility
Measurement
Satisfaction
Management
Output
Realization

Chapter 3
6. RESOURCE MANAGEMENT
Provision of resources (Clause 6.1)

Human resources (Clause 6.2)
Infrastructure (Clause 6.3)
Work environment (Clause 6.4)
6. Resources Management
6.1 Provision of Resources

Determine and provide resources needed
--- to implement and maintain QMS and continually
improve its effectiveness
--- to enhance customer satisfaction by meeting customer
requirements

Chapter 3
6.2.1 Human Resources ( General )

Personnel performing work affecting product quality shall be
competent on the basis of appropriate education, training,
skills and experience
New Note
“conformity to product requirement” ( replaced “product
quality” above ) can be affected either directly or indirectly by
personnel performing any task within the quality management
system )
6.2.2 Competence, Awareness & Training

Determine competency of staff performing work affecting product quality
Provide training or take other actions to satisfy these needs
Evaluate effectiveness of action taken
Ensure personnel are aware of relevance and
importance of their activities & how they contribute
to achieving Quality Objectives
Maintain records of education training, skills and
experience

Chapter 3
6.3 Infrastructure
Determine, provide and maintain infrastructure needed to
achieve conformity to product requirements.
Such as building, workspace, utilities, equipment, supporting
services ( such as transport and communication)
Clarification
“Information systems” can
also be an example of the
support services
6.4 Work Environment

The organization shall determine and manage the work
environment needed to achieve conformity to product
requirements.
New Note
The term “work environment” relates to those conditions,
under which work is performed, including physical,
environments and other factors ( such as noise, temperature,
humidity, lighting or weather )

Chapter 3
PRODUCT REALIZATION

Customer
Customer
Responsibility
Measurement
Satisfaction
Management
Output
Realization
7. PRODUCT REALIZATION
 Planning of realization (Clause 7.1)
 Customer-related processes (Clause 7.2)
>Determination of requirements related to the product
>Review of requirements related to the product
>Customer communication
 Design and development (Clause 7.3)
 Purchasing (Clause 7.4)
>Purchasing process
>Purchasing information
>Verification of purchased product
 Production and service provision (Clause 7.5)
>Control
>Validation of processes
>Identification and traceability
>Customer property
>Preservation of product
 Control of monitoring and measuring devices (Clause 7.6)

Chapter 3
7. Product Realization
7.1 Planning of Product Realization

Plan and develop the processes needed for product
realization
Determine the following :

--- quality objectives, requirements for the product
--- the need to establish processes, documents, resources
--- verification, validation, monitoring, inspection and test

activities specific to the product
--- records needed to provide evidence that realization

processes and resulting product meet requirements
7.2.1 Determination of Requirements related to

product
(a) Requirements specified by the customer, including the
requirements for delivery and post-delivery activities
New Note
“Post-delivery activities” include actions under warranty

provision, contractual
Obligations (such as maintenance services ) and
supplementary services ( such as recycling or final disposal
).

Chapter 3
7.2.2 Review requirements related to product
Review conducted prior to commitment to supply

… ensure requirements are defined
… order requirements and those previously expressed
are not different
… company has ability to meet requirements
… where product requirements are changed, ensure
relevant documents are amended and affected personnel
are informed
7.2.3 Customer Communication

Determine & implement effective arrangements for communicating with
customers in relation to:
• Product Information
• Enquiries, contracts or order handling
• Customer feedback and complaints

Chapter 3
7.3.1 Design and Development Planning
The organization shall manage the interfaces between

different groups involved in design and
development to ensure effective communication
and clear assignment of responsibility …..
New Note
Design and Development review, verification and

validation have distinct purposes. They can be
conducted and recorded separately or in any
combination, as suitable for the product and the
organization
7.3.2 Design and Development Inputs
7.3.3 Design and Development Outputs

Design and development outputs shall
(b) Provide appropriate information for purchasing, production and
for service provision …..
New Note
Information for “production and service provision” can include
details for the product of preservation.
7.3.4 Design and Development Review
• evaluate the ability of the results of the design and

development to meet requirements
• identify problems and propose necessary actions

Chapter 3
7.3.5 Design and Development Verification
Ensure that design & development outputs have met design & development
input requirements
7.3.6 Design and Development Validation
Ensure that resulting product is capable of meeting the requirements for the
specified application or intended use, where known
7.3.7 Control of Design and Development Changes
Changes shall be reviewed, verified and validated, as appropriate, and

approved before implementation
7.4 Purchasing
7.4.1 Purchasing Process
• Ensure purchased product conforms to specified requirements
• Evaluate and select suppliers based on their ability to supply product (service) in
accordance with company’s requirements
• Criteria for selection, evaluation and re-evaluation shall be established
7.4.2 Purchasing Information

• Describe the product to be purchased
• Ensure adequacy of the specified purchase requirements prior to communication
to the supplier
7.4.3 Verification of Purchased Product

• Inspection to ensure that purchased product meets specified purchase
requirements.
• When performing verification at supplier’s premises, verification
arrangement and method of product release shall be stated in purchasing
information

Chapter 3
7.5 Production and Service Provision

7.5.1 Control of Production and Service Provision
Plan and carry out production and service provision under
controlled condition that may include following applicable
items:
• availability of works instructions
• availability of information that describes
characteristics of product
• the availability and use of monitoring and
measuring devices
• implementation of monitoring and
measurement
• use of suitable equipment
7.5.2 Validation of Processes for Production and Service

Provision
Validate any processes for production and service provision where resulting
output can’t be verified by subsequent monitoring or measured.
 Define criteria for review and approval of processes

 Approval of equipment and qualification of personnel
 Re-validation (e.g. periodic evaluation on
the skill of operator)
 Use of specific methods and procedures

Chapter 3
7.5.3 Identification and Traceability

The organization shall identify the product status
with respect to monitoring and measurement
requirement.
Where traceability is a requirement, the
organization shall control and record the unique
identification of the product.
Clarification
Identification of Product status is to be applied
throughout product realization.
Records for traceability ( when it is a requirement )
shall be maintained
7.5.4 Customer Property

 Identify, verify, protect and safeguard customer property
 Report to customer when it is lost, damaged or unsuitable for use
Clarification
Beside intellectual property, customer property can also be personal
data
7.5.5 Preservation of Product

Preserve conformity of product during internal processing and delivery
It shall include identification, handling, packaging, storage and protection

Chapter 3
7.6 Control of Monitoring and Measuring Equipment

When used in the monitoring and measurement of specified
requirements, the ability of computer software to satisfy the
intended application shall be confirmed. This shall be
undertaken prior to initial use and re-confirmed as necessary
New Note
Confirmation of the ability of computer software to satisfy the
intended application would typically include its verification and
configuration management to maintain its suitability for use
Devices renamed as “equipment”
MEASUREMENT, ANALYSIS AND IMPROVEMENT

Customer
Customer
Responsibility
Measurement
Satisfaction
Management
Output
Realization

Chapter 3
8. MEASUREMENT, ANALYSIS AND IMPROVEMENT
General (Clause 8.1)

Monitoring and measurement (Clause 8.2)
>Customer satisfaction
>Internal audit
>Monitoring and measurement of processes
>Monitoring and measurement of product
Control of nonconforming product (Clause 8.3)
Analysis of data (Clause 8.4)
Improvement (Clause 8.5)
>Continual improvement
>Corrective action
>Preventive action
8.1 Plan and Implement Monitoring, Measurement,

Analysis and Improvement Processes
• to demonstrate conformity of product

• to ensure conformity of QMS
• to continually improve the effectiveness of QMS

Chapter 3
8.2.1 Customer Satisfaction

As one of the measurements of the performance of the quality
management system, the organization shall monitor information
relating to customer perception as to whether the organization has
met customer requirements. The methods for obtaining and using this
information shall be determines.
New Note
Monitoring customer perception can include obtaining input from
sources, such as:
- customer Satisfaction Surveys
- customer Data ( on delivered product quality )
- user opinion surveys
- lost business analysis Customer
- dealer’s reports survey
- compliments
-warranty claims
8.2.2 Internal Audit
Conduct Internal Audit at planned intervals
Consider the status and importance of the processes and areas

to be audited, as well as results of the previous audits
Audit criteria, scope, frequency and methods shall be defined
Auditors shall not audit their own work
Management responsible for the area shall ensure actions are

taken, promptly
Follow up activities shall include verification of actions taken

and reporting verification results

Chapter 3
8.2.2 Internal Audit

The responsibilities and requirements for
planning and conducting audits, and for
reporting results and maintaining records
shall be defined in a documented procedure.
Clarification
Records of the audit and their results shall
be maintained
8.2.3 Monitoring and Measurement of

Processes
The organization shall apply suitable methods for monitoring and
where applicable, measurement of the quality management system
processes. These methods shall demonstrate the ability of the
processes to achieve planned results. When planned results are not
achieved, correction and corrective action shall be taken, as
appropriate, to ensure conformity of the product
New Note
When determining “suitable methods”, it is advisable that the
organization consider the type and extent of monitoring or
measurement appropriate to each of its processes in relation to their
impact on the conformity to product requirements, and on the
effectiveness of the quality management system

Chapter 3
8.2.4 Monitoring and Measurement of Product
Product release and service delivery shall not proceed until the
planned arrangement have been satisfactorily completed,
unless otherwise approved by relevant authority and, where
applicable, the customer.
Clarification
The release of product and delivery of service ( to the customer
) shall not proceed ……
8.3 Control of Non-

Non-conforming Product
Identify and control to prevent un-intended use or delivery of non

conforming product.
Dealing with non-conformity include:

• Take correction
• Grant concession
• Determine alternative use
Record nature of non-conformity and

action taken (if any)
- subject corrected product to re-verification

Chapter 3
8.4 Analysis of Data

Determine, collect and analyze appropriate data to evaluate:
• suitability and effectiveness of QMS
• continual improvement of effectiveness of QMS
Analysis of Data shall provide information relating to:

• Customer satisfaction
• Conformity to Product Requirements
• Characteristics and trends of processes and products
• Suppliers
8.5 Improvement
8.5.1 Continual Improvement

Continually improve the effectiveness of QMS through the use of quality
policy, objectives, audit results, analysis of data, Corrective and preventive
actions and management review.
8.5.2 Corrective Action

(f) Reviewing corrective action taken
Clarification
Reviewing the “effectiveness” of the corrective action taken
8.5.3 Preventive Action

(f) Reviewing preventive action taken
Clarification
Reviewing the ”effectiveness” of the preventive action taken

Chapter 3
NOTES
SUMMARY OF ISO 9001:2008
ISO 9001:2008 has been produced in nine sections as follow:
Clause 0 This deals with the introduction of the standard refers to compatibility with ISO
14001:2004 and other related documents. It also refers to ‘the process approach’,
defines it in general terms and refers the reader to figure 1 which is the model of ISO
9001:2008.
Clause 1 This deals with General (1.1) and defines the use of the standard where an
organisation needs to demonstrate its ability to consistently provide product meeting
customers and regulatory requirements and where it aims to enhance customer
satisfaction.
Reference to Application (1.2), an organisation is allowed to exclude requirements which

are not applicable with the following caveats: -
a) The exclusion can be from Clause 7 only (Product Realization)
b) The exclusion must not affect the organisation’s ability, or responsibility to
provide products that meet all requirements.
Examples of such exclusions are: -

i). ‘Design’ (7.3) which may not be applicable to some organisation, where it may
have already been established by somebody else.
ii). ‘Customer Property’ (7.5.4) which may not always be used by many organisation.
iii). Control of Monitoring and Measuring Devices’ (7.6) which may not be applicable
to training organisation.
Clause 2 This deals with Normative references and refers the reader to ISO 9000:2008.
Clause 3 This deals with specific terms and definitions such as ‘organisation’, ‘suppliers’
and ‘customers’. Reference is also made to ISO 9000:2008.

Chapter 3
Clause 4-8 inclusively deal with the specific requirements.
Clause 4 is entitled ‘Quality Management System’ and contains the following sub
clauses: -
4.1 General requirements

4.2 Documentation requirements
4.2.1 General
4.2.2 Quality manual
4.2.3 Control of documents
4.2.4 Control of records
4.1 requires a documented system in line with the ISO 9001:2008. 4.1 (b) requires the
‘sequence and interaction’ of these processes that make up the system to be identified.
4.2.1 requires document(s) to include quality policy, objectives and manual, procedures,
other documents as required and records.
4.2.2 requires a quality manual including or referring to procedures and a description of

the interaction between the processes of the QMS.
4.2.3 requires QMS documents to be controlled and a list of requirements provided.
4.2.4 requires QMS records to be controlled and a list of requirements provided.

Chapter 3
Clause 5 is management responsibility and contain the following sub clauses: -
5.1 Management commitment

5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.4.1 Quality objectives
5.4.2 Quality management system planning
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
5.5.2 Management representative
5.5.3 Internal communication
5.6 Management review
5.6.1 General
5.6.2 Review input
5.6.3 Review output
5.1 requires top management to provide evidence of commitment to system and

improvement by communication of customer and regulatory requirements, policy and
objectives’ establishment, conducting management reviews and ensuring resources are
available.
Auditors may request top managers to illustrate commitment by example, involvement

and participation, leading specific discussions and initiatives in the organisation, leading
quality improvement teams etc.
5.2 requires a constant effort to improve the way the customer perceives the
organisation’s services.
5.3 requires top management to ensure that the policy is appropriate, includes
commitments to compliance and improvement, provides a framework for reviewing
quality objectives, is communicated and understood at all levels and is reviewed.

Chapter 3
5.4.1 requires that top management establish objectives at relevant levels; that they are
measurable and consistent with policy, contain continual improvement and product
requirements.
Auditors may ask on how these are established, measured and acted upon i.e. reviewed
and updated.
5.4.2 requires top management to plan to meet 4.1 and quality objectives; also ensure
that any changes to the system do not affect its ability to meet requirements.
5.5.1 requires that the responsibility, authority and interrelation are defined and
communicated. Typically, this would be in role or job descriptions, flow charts,
organisational charts etc.
5.5.2 requires top management to appoint a member or members of management to

ensure for QMS is maintained, report to top management on the performance of the
QMS and needs for improvement and ensure that customer awareness is promoted
throughout the organisation.
5.5.3 requires top management to ensure that processes for internal communication are
established. These may take the form of regular meetings, briefings, staff surveys,
availability of formal systems e.g. e-mail, written memos, minutes of meetings etc.
Auditors can ask how this occurs and for evidence.
5.6.1 requires top management reviews the QMS at planned intervals. 5.6.2 lists the
required inputs and 5.6.3 lists the required outputs.

Chapter 3
Clause 6 is Resource management and has sub clauses as follow:

6.1 Provision of resources
6.2 Human resources
6.2.1 General
6.2.2 Competence, awareness and training
6.3 Infrastructure
6.4 Work environment
6.1 requires resources to maintain the QMS, improve its effectiveness and enhance
customer satisfaction.
6.2.1 requires organisations to have competent and qualified people. ISO 9004 focuses
more on people involvement than basic competence but does provide numerous
examples of ways by which competence may be enhanced.
6.2.2 requires organisation to determine competence needs, provide training where

necessary, evaluate its effectiveness, ensure that people are aware of how they affect
objectives and maintain records for employees’ education, training, skills and
experience.
6.3 requires infrastructure to be in place e.g. buildings, workspace, associated utilities,

process equipment, hardware and software and supporting services.
6.4 requires work conditions to achieve product conformity. ISO 9004 provide examples
of both human and physical factors.

Chapter 3
Clause 7 is Product realization and has sub clauses as follows:

7.1 Planning of product realization
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
7.2.2 Review of requirements related to the product
7.2.3 Customer communication
7.3 Design and development
7.3.1 Design and development planning
7.3.2 Design and development inputs
7.3.3 Design and development outputs
7.3.4 Design and development review
7.3.5 Design and development verification
7.3.6 Design and development validation
7.3.7 Design and development changes
7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 Verification of purchased product
7.5 Production and service provision
7.5.1 Control of production and service provision
7.5.2 Validation of processes for production and service provision
7.5.3 Identification and traceability
7.5.4 Customer property
7.5.5 Preservation of product
7.6 Control of monitoring devices
7.1 requires planning of ‘product realization’.
Control of process is effected, as is well established, by controlling all the inputs i.e.
competence of people, capability of the equipment, compliance of materials used,
approval of the processes and procedures and restrictions on the environment.

Chapter 3
7.2.1 requires that all product requirements are defined.
7.2.2 requires that the product requirements are reviewed as to whether the organisation
can comply.
7.2.3 requires a mechanism for ensuring customers can be kept advised and in touch.
7.3.1 to 7.3.7 cover the processes of design/development.
7.4.1 requires evaluation and selection of suppliers against defined criteria with
evaluation records.
7.4.2 requires information to be on purchasing documents like process control principles

and QMS requirements.
7.4.3 requires verification of what is purchased.
7.5.1 requires that production and service are controlled by information being provided
about instructions and/or the product, suitable equipment being available, suitable
measuring devices being available etc.
7.5.2 requires that any ‘special processes’ are validated i.e. controlled to the extent that
they will produce good output.
7.5.3 requires identification of product to the extent necessary; also that the status of
product regarding inspection/test is know at any time.
7.5.4 requires that ‘customer property’ is protected and looked after and if damaged or
lost is reported to the customer. The emphasis here is not on specific material to be
incorporated into the final product but customer property generally.
7.5.5 requires protection of materials and product throughout the production processes.

Chapter 3
7.6 requires that measurements of products are defined and made with equipment
whose accuracy compared to (inter)national standards is known; also that records are
kept; reference is made to ISO 10012.
Clause 8 is Measurement, analysis and improvement and has sub clauses as follows:
8.1 General
8.2 Monitoring and measurement
8.2.1 Customer satisfaction
8.2.2 Internal audit
8.2.3 Monitoring and measurement or processes
8.2.4 Monitoring and measurement of product
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
8.5.1 Continual improvement
8.5.2 Corrective action
8.5.3 Prevention action
8.1 requires the organisation to think about the kinds of checking of product, system and
effectiveness of the QMS required.
8.2.1 requires measurements of customers’ perceptions of whether the organisation has

fulfilled requirements.
8.2.2 requires internal audits at planned intervals, frequency dependent on status and
importance and previous audit results. Auditors shall not audit their own work. A
documented procedure is required with responsibilities and reporting methods.
8.2.3 requires monitoring of processes. The standard doesn’t say which processes, just
those of the QMS. This requires objectives (outputs) to be specified for any process in
the QMS and measurement (and records) of that.

Chapter 3
8.2.4 requires that the appropriate checks of product i.e. inspection and test are carried
out as planned and be recorded.
8.3 requires that any product which does not conform is identified to prevent use or
delivery. Options for dealing with such material are given. A documented procedure is
requires.
8.4 requires that appropriate data are identified, collected and analysed to evaluate
where continual improvement can be made.
8.5.1 requires continual improvement of the QMS to occur through policy, objectives,
audits, analysis of data, corrective and preventive action and management reviews.
8.5.2 requires that when something is found not to conform it is corrected by applying a
disciplined and comprehensive problem solving process. A documented procedure is
required.
8.5.3 requires a documented procedure to eliminate the causes of potential

nonconformities. A good initial procedure should of course prevent nonconformities
along with analysis of real data on objectives, trends, measurements of critical and non-
critical processes etc.

Chapter 3

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An organisation is allowed to exclude requirements based on

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4.1 General Requirement

4.2 .1 Documentation Requirements

• 6 Documented procedures ( 4.2.1 Note 1)

ii. Control of Quality Records

iii. Internal Quality Audit

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4.2.1 Documentation Requirement

-Likewise, a requirement for a “documented procedure” may

4.2.2 Quality Manual

• Scope of Quality Management System, including details of

• reference to the documented procedures

• description of interaction between processes of

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4.2.3 Control of Documents

• identify changes & current revision status of documents

• availability of relevant versions of applicable documents

• prevent un-intended use of obsolete documents

• documents of external origin are identified and

• suitably identify obsolete documents if they are

• remain legible and readily identifiable

4.2.3 Control of Documents

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4.2.4 Control of Quality Records

• Records remain legible, readily identifiable and retrievable

• Documented procedure for identifying, storing, protecting, retrieving,

Continual Improvement of the Quality Management Systems

Customer Management Customer

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5.1 Management Commitment

--- Management Review, Policy, objectives

--- The importance of meeting customer,

Ensure that customer requirements are determined and are met

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5.3 Quality Policy

--- Appropriate to the purpose of organization

Consider requirement related to the product

Consistent with Quality Policy and measurable

5.4.2 QMS Planning

Top Management shall ensure that:

--- Planning of QMS meet the general requirement

--- Integrity of QMS is maintained when changes to

--- Improve effectiveness of QMS via use of Quality

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5.5.1 Responsibility and Authority

Top management shall ensure that the Responsibility

5.5.2 Management Representative

Top management shall appoint a member of

- Member of Management must be a member of the

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5.5.3 Internal Communication

Top management shall ensure:

Communication takes place regarding effectiveness of QMS

5.6 Management Review

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5.6 Management Review

Continual Improvement of the Quality Management Systems

Customer Management Customer