BRSM Form 009 Qms MDD TT

BRSM
Systems:QMS ISO 9001 (2008)‐QMSMDD ISO 13485 (2003)

Assessment Report/Checklist
Form 009

CLIENT‐ORGANIZATION (NAME): TEB TASVIR CO.
PHYSICAL LOCATION(s): No. 4, Behafarin St., Karimkhan Zand Ave.,
Tehran, Iran
Stage II Audit Date(s): 16,17 March 2016
Stage I Audit Date(s): 8,9 March 2016
NAICS (or NACE) CODE MD0202/ MD1201
MD0404/ MD1301/ MD1405/MD101/
MD1402/32.5‐26.60

EXCLUSIONS: 7.5.1.2.2, 7.5.2.2,7.5.1.3

Assessment objectives: ISO9001:2008 & ISO13485:2003

ASSESSMENT TEAM INFORMATION
Assessment Team Leader, ATL Mohammad Reza Khoshgoo
Assessor 2 Marjan Azadmanesh
TE Azimian

Note: Adjusting the language within this form to the type of activity and nature of the organization is acceptable.
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Reference Clause Observations Verified,
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We pursuit to assure that client‐organization adheres to the protection of communities and consumers. This is to
1 follow the intent to the substitution of the word “identify” to the word “determine” as part of the importance to
the processes being capable of achieving desired outputs (including consumer’s well‐being).
Company has three parts:
Part one: Importing
Part two: Manufacturing
Part three: after sale services for above two parts
Mentioned scope in manual is: Sale and after sale services of operating
room equipment including therapeutic and diagnosis medical device and
Design and product of monitoring and diagnosis medical device.
Company has competent engineers and one Doctor in R&D department
which Doctor is part time worker, records of competence was as job
criteria.
2 Scope of activities
Company designs and products:
Spirometry UMDNS 13674
BodyBox UMDNS 13059
Dosimeters UMDNS 16333
Oxygen Monitors UMDNS 128633
And imports and sales 36 Items from 11 Providers as IMED certifications
and quality manual of organizations. Company had certificate from BSI UK
under accreditation of UKAS from three years before and now they switch
to BRSM.
Quality Manual Code is M42200QM01 R03
Legal status Iranian MOH legal requirements.

3
Obligatory applicable standard which ISO13485:2003, ISO 9001:2008, MOH importers

organization has to follow requirements
4 Quality Management System
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 Page 2 of 25
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In stage I, we reviewed documentation requirements as
needed and reported in form 002. There was no NC so
we continued for stage II.
GENERAL REQUIREMENTS The organization Does establish, document, implement,
Does the organization establish, document, implement,
maintain and continually improve a Quality maintain and continually improve a Quality
Management System (QMS) with due consideration Management System (QMS) with due consideration
given to identification of processes needed for the
QMS and their application throughout the system; given to identification of processes needed for the QMS
determination of sequence and interaction of these and their application throughout the system in process
4.1 processes, determination of criteria and methods 
required to ensure effective operation and control of map. According to that, they planned this process:
these processes; availability of resources and
information required to support the operation and
Purchasing, marketing, Sales, after sale services,
monitoring of processes; measurement, monitoring and warehouse and Management.
analysis of the processes; implementation of action to
achieve planned results and continual improvement Sequence and interaction of these processes planned in
‐If any, are the outsourced processes are defined? processes map.
Criteria and methods required ensuring effective
operation and control of these processes is determined.
There is no any outsourced process.
DOCUMENTATION REQUIREMENTS
Is there a documented quality policy and documented Documentation required for QMS is documented.
quality objectives and are they appropriate?
Is there a documented quality manual and are there
Quality manual, quality policy, procedures required in
documented procedures required by the standards?? standards is documented.
Are required records for planning, acting and controlling
4.2 processes efficiently available? In stage I was checked. 
Are the documents are created for every type of Company provided master list of documents and records
medical device including QMS requirements and
product specifications? (4.2.3) If these documents are in one excel file, this document listed technical files and
applicable to manufacturing processes, are montage regulations needed for QMS
and service defined?
Quality Manual includes scope of QMS and details of
QUALITY MANUAL exclusion are documented.
Does the Quality Manual include scope of QMS and
details of exclusion?
Quality manual info documented procedures are
4.2.2 Are documented procedures reference to mandatory reference to mandatory procedures. Issue date: April 
procedures;
Is description of interaction of the processes included in 2012 and last revision is May 2015.
the QMS? It has been distributed such as I observed in R&D and
sales department.
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In stage I, we reviewed documentation requirements as
needed and reported in form 002.
Last documents update was for May 2016, Documents
revised regarding adding manufacturing Spiro meter to
their productions.
CONTROL OF DOCUMENTS
Are mandatory procedures documented? labeling work instruction from IMED has been updated
Are control conditions pertaining to mandatory by Mr. Badrlou, I observed the new work instruction
documents proper?
Are review, update and re‐approval situations and New update of labeling for implants on Jan 2016 has
changes and current review situations for documents been updated by Mr. Badrlou from IMED website.
traceable?
Are the relevant documents usable, readable and The last version of IMED Recall work instruction was
4.2.3 recognizable at concerned usage points?

Are outsourced documents defined?
downloaded from IMED.ir web site.
Are distributions of documents controlled, outdated Quality Manual has been distributed such as I observed
documents prevented from being used and appropriate
definition method applied in case of being stored for in marketing and Warehouse.
any purpose?
PM procedure with code of P63000PM01 R01 was
Are these subjects clear in the relevant procedure?
observed. They have developed backup plan:
1‐ Sales: daily, weekly, every 6 month, annually
2‐ After services: daily, annually
3‐ R&D, end of design project, and in case of
update of any D&D documents.
Documents readable, easily recognizable and stored in
are available manner in two format, softcopy and
hardcopy.
According to type of products, some records need to
archive 2 years and records of identification and
traceability of product shall remain 10 years (warranty
years) products needs to archive to always. That’s
CONTROL OF RECORDS
Are documents readable, easily recognizable and stored planned in the procedure.
in available manner?
Has a documented procedure been established and Master list F42300QM01 R01 is in Microsoft excel
4.2.4 applied for determination of required controls for format contains several columns covering QMS needs, 
storage, retrieval, retention time and disposition of
records? such as retention time, Documents Distributing Map,
Has the archiving defined for at least 2 years?
and which QMS clause the documented information
covers such as:
72300, F72300SA01 R01
Which 72300 means 7.2.3.
It department is responsible backing up documented
information. Records of backing up from financial
department on 10 January 2016 has been observed.
5 Management responsibility
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MANAGEMENT COMMITTMENT
Mr. yazdani, top management has ensured that
Has the top management ensured that requirement for requirement for meeting customer conditions and legal
meeting customer conditions and legal conditions
should be understood by all personnel?
conditions should be understood by all personnel. As
5.1 Is a quality policy available?
Are quality objectives available?
quality policy statement preparation and signed by him. 
Is management review established? He had 33 years of work experience in this company.
Does the management provide required sources for Quality policy available and management review
QMS?
established. Such as quality policy on R&D department.
Top management have methodologies to ensure that
customer needs and expectations are determined and
CUSTOMER FOCUS
met for increasing customer satisfaction by determine
5.2
Does top management have methodologies to ensure
that customer needs and expectations are determined procedure. 
and met for increasing customer satisfaction?
Such as management review or customer feedback
monitoring
Top management has established a Quality Policy in
accordance with the objective of the organization.
QUALITY POLICY Quality policy: F53100QM01 R0, issue date: October
Has top management established a Quality Policy in
accordance with the objective of the organization? 2012 last revised on May 2015.
Does the Quality Policy include a statement of
5.3 commitment to meeting requirements and continual
improvement of the QMS?
The Quality Policy has been revised for communication, 
Has the Quality Policy been revised for communication,
understanding and continuous compliance within the
understanding and continuous compliance within the body of the Organization.
body of the Organization?
There are 4 long term policies mentioned such as:
Objective No. 3, increase in sale.
Objective No. 3, increase in sale. (10 %)
Anticipating sales in 1395
QUALITY OBJECTIVES
Are quality objectives established by top management
Adding 15% to all products (concerning price raise)
at relevant functions and levels within the organization?
Are the objectives measurable and consistent with the Gathering tools and plans
Quality Policy
5.4 5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING Sorting all tools and plans 
Has the QMS been planned by Top Management in
order to meet the conditions and quality objectives Selecting most efficient ways
detailed in Section 4.1?
When changes are initiated, is the integrity of the QMS Planning and reviewing every month.
maintained during the change process?
This objective has been revised in management review
and company specified tools and operational planning to
reach objective.
5.5 Responsibility, Authority and Communication
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Responsibility and authority determined according the
top chart.
Responsibility and authority Sales and marketing, MD
observed:
1. Providing domestic and international manufacturers
of raw materials and keeping up to date
2. Knowledge of rules and regulations to adapt and
investigating business importing and exporting
documents with them.
RESPONSIBILITY AND AUTHORITY
Has top management identified responsibility and
3. Track on the basis of the order.
5.5.1 authority and been communicated within the
organization?
4. Follow‐up and Coordination for the purchase of 
businesses.

5. Check the internal and external purchase inquiries and
coordinating with management to select the most
appropriate.
6. Follow‐up get legal permits import and export
commodities. (Ministry of Culture, Ministry of Industry,
Ministry of Health)
Required Education, Bachelor's usually needed; master's
preferred by some employers
Other Requirements, Computer skills
In formal announcement Mr. Badrlou is Mr. from 2013.
Mr. Badrlou (QA manager) is management
MANAGEMENT REPRESENTATIVE representative.
Has top management appointed a member as Responsibility and authority of management
Management Representative with responsibility and
representative observed. Such as:
5.5.2
authority to ensure that the processes of the QMS are
established, implemented and maintained; report to
Established, implemented and maintained; report to top

top management on the performance of the QMS,
including needs for improvement and promote management on the performance of the QMS, including
awareness of customer requirements?
needs for improvement and promote awareness of
customer requirements are in his Responsibility.
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Face2face, Emails, phone and periodic meeting are ways
to make internal communication.
Also, they have a manager’s relation procedure.
Such as letter of appointing Mr. in customer show room
has been observed.
Or letter from Mr. Bdrlou to Mr. for reporting first half
INTERNAL COMMUNICATION
of Shamsi year’s report for processes performance
Has the top management ensured establishment of Mr. Amiri, R&D manager is responsible to check IMED
5.5.3
appropriate communication processes within the
organization? Has the top management ensured regulations. He is Technical supervisor too. 
realization of communication considering the processes On 7/5/1394 july 2015 aftersales services send a letter
of the QMS and their effectiveness?
to IT department and cc to MD as below:
“as all devices has identity, there is no need for login
window, removing login window help speeding up
procedures”
On 19/5/1394 (12 days later) software department send
a letter to aftersales services and cc o MD as below:
“login window removed, firmware updated.”
5.6 Management review
TOP MANAGEMENT REVIEW
Does top management review the QMS to ensure its
continuing suitability, adequacy and effectiveness at This meeting planned annually.
5.6.1
regular and planned intervals?
Do reviews include assessing opportunities for Last meeting date is Dec 2016. 
improvement including the need for changes to the All staff manager has been in this meeting.
QMS, quality policy, and quality objectives?
Are management review records kept?
REVIEW INPUT
Does review input include current performance and
Review input include current performance and
improvement opportunities related to: improvement opportunities dose related to ISO13485.
a) results of audits;
b) customer feedback; Such as:
5.6.2 c) process performance and product conformance;
d) status of corrective and preventive actions;
5) follow‐up outputs of previous management reviews, 
e) follow‐up action from earlier management reviews; 6) changes that could affect the quality management
f) changes that could affect the QMS,
g) recommendations for improvement system, such as regulation changes
h) New or revised regulatory rules? 7) opportunities for improvement
Outputs were as requirements such as:
Buying another calibration syringe
REVIEW OUTPUT
Does output from management review include actions Connecting after sale services ERP to website.
5.6.3
related to improvement of the QMS and its processes,
improvement of product related to customer Updating website 
requirements, actions and decisions relate to resource
needs?
Preparing new training courses
Registering on IRANMED fair on April

6 Resource Management
PROVISION OF RESOURCES
Does the organization have methods to determine and The organizations determine and provide resources
6.1 provide resources needed to implement and improve needed to implement and improve the processes of the 
the processes of the QMS and address customer
satisfaction by meeting requirements? QMS.
6.2 Human Resources
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Personnel assigned with responsibilities that affect
product quality competent on the basis of applicable
education, training, skills, and experience.
Are personnel assigned with responsibilities that affect
product quality competent on the basis of applicable
Refer to 5.5.1, for sales manager:
6.2.1 education, training, skills, and experience?
Are trainings performed for achievement of Required
Required Education, Bachelor's usually needed; master's 
Competence? preferred by some employers
Other Requirements, Computer skills
and experience 2 years in sales department of a medical
device company
Training procedure was observed. The job description
has been developed according to the job positions
mentioned in organization chart.
The staff profiles have been developed such as Mr.
Badrlou profile.
Training needs being evaluated based on P62200TR01
R01 every year before manaegent review sessions.
COMPETENCE, AWARENESS, AND TRAINING 1395 ha been observed such as:
Has the organization identified the experience,
qualifications, competencies and skills of the personnel Course about IMED technical supervisors, for Badrlou
performing activities affecting safety and efficiency of has been checked on July-August 2015, course was
medical devices particularly being manufactured and
provided to customer? effective and grade of Mr. Badrlou in this course is 95
6.2.2
Is training provided by the organization to satisfy the
competency needs?
from 100, He have a certificate from IMED for this 
Does the organization ensure that its employees are course.
aware of the relevance and importance of their
activities and how they contribute to the achievement Certificate of Internal audit course for Mr. Badrlou, Ms.
of quality objectives? Zehtab and Ms. Asghari has been observed.
Are records of education, experience, training and
qualifications maintained? Also the record of conducted course “effective
communication” in July-08 was observed. Participants
were sales and after sales personnel by Mr. Hazeri, PhD
of university of Tehran, from Mahan MBA training
institute. Assessment of this provider is done based on
P74100PU01 R01; grade of Mahan institute is 85.
For PhD Hossein Tomiri, certificate of participation in
course “inpirator devices ventilator systems for Evans
Medical Ltd. Has been observed.
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PM procedure: P63000PM01 R01was observed.

INFRASTRUCTURE
Has manufacturing equipment been designed, Pc’s control checklist with code of F63000PM03 R01 has
constructed, properly established and placed for proper
operation, maintenance, adjustment and cleaning? been observed with prepared records was checked such
In case of applicability, has the organization ensured as the records of Jan 2016.
documentation of natural limits or permissible
tolerances in manufacturing process and measuring and Network maintenance checklist with code of
test equipment and availability of the same for
operators? P63000PM01 R01was observed, the records of
6.3 Are documented processes available for maintenance, 
cleaning and control of all equipment used in
completed checklist in Jan 2016 were observed such for
manufacturing process and control of work server room.
environment?
Are required adjustments and maintenance intervals Calibrator Syringe has been ordered for safety stock of
identified?
Is maintenance plan placed normally on or near the organization.
equipment and easily reachable?
Is maintenance realized based on the relevant plan? The checklist of controlling the storage temperature in
form of P63000PM01 R01 for Feb‐2016 was observed.
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WORK ENVIRONMENT
Does the organization identify and manage required
work environment needed to achieve conformity of
product?
Are the following factors which could affect product
quality in the work environment identified?
‐ Process equipment,
‐ Work environment,
‐ Personnel in this work environment
Are qualified and quantified limit values of the work
environment identified for a desired quality of the work
environment?
Are pollution levels of microbial and solid particles
controlled during product manufacturing where sterile
product or pollution of solid particle which is stipulated
to be sterilized or could live or not live during its
manufacture or utilization is important? Work environment is clan and tidy, organization is in
Has exclusion been applied during all manufacturing
processes for a controlled environment? As valid
three divisions
ground of exclusion, is pollution reduced to known, 1‐ Administrative, warehouse and sales
consistent and controlled level by an approved cleaning
method and packaging kept at this level through control 2‐ after sales services
process? 3‐ R&D and manufacturing site
Have indicators been identified for a controlled
environment which covers valid cleaning and packaging All three are in same building, all clean and tidy
processes including the organizations holding a valid Manufacturing site floor is covered by antibacterial
6.4 cleaning process?
(Temperature, Humidity, Air Current, Filtration of Air, epoxy (license No.28937463‫)ب‬
Ionization of Air, Pressure differences, Lighting (along
with its spectral content and severity), Sound, Vibration,
There are four doors before manufacturing site two of
cleaning of Working surfaces and processes, Water them are interlock.
quality, number of persons in the work environment)
Have dressing conditions, cleaning conditions and There are local lamps for tables.
health conditions for any person being in contact with Users have anti electicricity clothes.
the product or the work environment including those
persons who enter the area sterilized prior to use or Checklist of inspection of work environment has been
temporarily or for a short period in terms of importance observed for first week of Jan 2016.
microbiologic cleaning holds been identified?
Are personnel to work in special work conditions or a
controlled environment provided with special training
and/or supervision? In the event that any personnel
including temporary and trained personnel for
performance of special tasks in a controlled
environment are assigned for performance of the works
such as production, maintenance, cleaning or repair, are
such personnel supervised by an appropriately trained
person? Have the procedures for product introduction,
product polluted or being likely to be polluted, manual
working for working surfaces or personnel, cleaning or
removal of contamination in order to prevent cross
pollution of product, work environment or personnel?
Are the records indicating appropriateness for all
conditions kept?
7 Product Realization
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The organization prepared a procedure containing all
processes of product realization for risk management
activities.
Risk Management Plan observed.
Risk team and its Responsibilities: R&D, technical
supervisor and top manager.
Definition of hazards, Evaluation of Risks: hazards
identified. Such as risk analysis for Dosimeter:
1‐
Weakness of board because of crack
Maybe lead to decrease in life of device
RPN=36
PLANNING OF PRODUCT REALIZATION
Electric board performance test and increasing thickness
Has the organization considered the scope of its own of crack from 0.1 to 0.3
quality management system in planning of product
realization?
Post RPN= 12
Has the organization prepared required records for a 2‐
proof indicating that quality objectives and product
rules, processes established, documents and product‐ Separating flat cable from board
specific necessary resources, verification, validation, LCD not working
tracking, measuring, inspection and product‐specific
test activities , realization processes and the product RPN=36
meet the rules?
In the event that inspection and test are conducted by
Final product qc
manufacturing personnel, do inspection and test Connector with lock
results, processes, organization’s procedures ensure
impartiality of inspection and test results?
Post RPN= 12
7.1 Risk management 3‐ 
Has the organization prepared a procedure containing
all processes of product realization for risk management Contamination
activities and realized the following? Infection
Keeping the records
Preparation of Risk Management Plan RPN=24
Determination of Risk team and its Responsibilities
Determination of Intended Use of Device and Safety
Disinfection work instruction, work environment
Characteristics of Device cleaning
Definition of hazards
Risk Estimation for Hazards
Post RPN=12
Evaluation of Risks 4‐
Risk Control Measures
Definition of Residual Risks High input pressure
Risk/Benefit Analysis Patient injury
Preparation of Risk Management Report
RPN=48
Putting safety valve regulator
And LCD warning and board intelligence alarm for
pressure less than 1.9 and above 2.1
Post RPN=10
Technical files had been reviewed in SI
Aero Xpert, Intended use 20 min‐ 5 Hours

For Oxygen Monitor:
1‐
Sensor remain unchanged
Patient injury

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RPN=48
Service time
Post RPN=14
2‐
Adaptor failure
Patient injury
RPN=48
Supplier evaluation/ incoming material verification
Post RPN=10
3‐
lack of Design input
Bad performance/patient injury
RPN=48
Using competent D&D team
Design as procedure
Performance test
Post RPN=12
DETERMINATION OF REQUIREMENTS RELATED TO THE
PRODUCT/SERVICE
Has the organization defined the requirements of All customer requirements has been determined in the
customer including the requirements for the activities
on delivery and after delivery? mutual contract or Performa.
Do these requirements include the following?:
‐ regulatory and legal requirements related to the Performa of 15 full set of stent for Imam Khomeini
countries and territories where the product is supplied Hospital has been observed with serial 9423, delivery
to the market
‐ anticipated utilization, deadline is 20/2/2016 and delivery date has been signed
‐ Performance expectations,
‐ Design factors
by Mr. Khavari on 20/2/2016
7.2.1 ‐ Delivery plans
Performa for Milad Hospital has been observed for three 
‐Unclear customer expectations
Does the organization record customer’s expectations adult ventilator on 20/1/1394 which has been delivered
related to product/service in order to revise the same?
In the event of any change in order or offer or both for in 20 days, stamp of Milad Hospital has been observed
any reason whatsoever, are changes revised and an on Performa 94774
agreement is reached on the changes as it is in original
order or offer? Performa for Spirometry order from ministry of labor
In the event that changes are accepted, are all
personnel being affected by the changes within the has been observed, quantity is 24, which have been
organization informed?
Are relevant documents affected by these changes
delivered on 2016.
amended?
7.2 Customer‐Related Processes
REVIEW OF REQUIREMENTS RELATED TO THE
PRODUCT/SERVICE
Does the organization review the requirements related The reviewing of requirements of the customer is
to the product? finalized by signing the contract by mutual parties; in
Are review records kept?
Has this review been realized prior to commitment of case of any changes in the requirements, there will be a
the organization for provision of the product to amendment for the contract which is mentioned in
7.2.2 customer? 
Has the organization ensured settlement of contract or quality manual and sale procedure; since the
order requirements which are different from previously
defined?
implementation of the quality management system in
Does the organization have the ability to meet defined organization, there is no any changes in customer
requirements?
Are the results of review and subsequent follow‐up requirement since installing QMS.
actions recorded?
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They have developed a procedure for handling
communication with customers including evaluating
CUSTOMER COMMUNICATION
Are arrangements for communication identified and
their satisfaction & handling their complaints; also the
implemented relating to product information, demands, frame and process of communication with customers
7.2.3
applications, contracts or realization of order including
amendments? has been mentioned in quality manual. 
Are required arrangements identified and implemented All communication records with customers are retained
for customer feedback and communication with
customers including customer complaints? in the related contract profile for example the
communication records with “Milad” hospital in Tehran
for invoice no.: 94186 in Nov‐15 was checked.
7.3 Design and Development
DESIGN AND DEVELOPMENT PLANNING
Have the stages of design and/or development been D&D records are for two years ago such as
identified? Spirometry, Project ID is 9102 defined on April 2013.
Have review, verification and validation activities
appropriate to each design and/or development stage, Project defined in MSP format in 48 tasks such as:
7.3.1 responsibilities and authorities been identified in design 
and development planning?
8‐ Completing inputs
Are design and development planning updated when 17‐ Reverse engineering
planning output is appropriate and in the progress of
design and development?
40‐ validation
DESIGN AND DEVELOPMENT INPUTS For Spirometry device
Are inputs related to product requirements identified
and relevant records maintained? Record of validation from “BEHDARI KOL NAJA” has
Do these inputs include functional and performance been observed on 93/10/24
7.3.2 requirements, applicable regulatory and legal 
requirements, applicable information derived from Record of Validation from “Dr. Mostafa Ghaneie,
previous and similar designs a any other requirements
essential for design?
MOH code 29368” has been observed on medical
Have the inputs been reviewed in terms of adequacy? device technical file
DESIGN AND DEVELOPMENT OUTPUTS
Are design and/or development outputs approved
before prior to release and in a manner that enables
verification against the design and/or development All required outputs has been achieved on 8/9/1393
inputs?
Do the design and/or development outputs meet the (Dec 2013) such as:
7.3.3 design input requirements and 
‐provide appropriate information for purchasing,
software validation for Spirometry software has
manufacture and service performance, been observed on sv‐svv75100pr50 r01
‐ contain or reference product acceptance criteria
‐ define the characteristics of the product that are
essential to its safe and proper use?
DESIGN AND DEVELOPMENT REVIEW
Does the organization identify suitable stages for
systematic reviews of design and/or development?
Record of weekly reviewed has been observed such
7.3.4 Are the results of review and subsequent follow‐up as review record on 12/8/1393 (November 2013) 
actions recorded in order to evaluate the ability to
fulfill requirements and identify problems and about case design completion in time
propose corrective actions?
For Spirometry device
Record of validation from “BEHDARI KOL NAJA” has
DESIGN AND DEVELOPMENT VERIFICATION
been observed on 93/10/24
7.3.5 Does the organization in planned arrangements ensure 
that design output meets input criteria Record of Validation from “Dr. Mostafa Ghaneie,
MOH code 29368” has been observed on medical
device technical file
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DESIGN AND DEVELOPMENT VALIDATION For Spirometry device
Is the design and/or development validation performed
in accordance with planned arrangements to confirm
Record of validation from “BEHDARI KOL NAJA” has
that final product is capable of meeting the been observed on 93/7/24
requirements of intended use or application
7.3.6 requirements defined? Record of Validation from “Dr. Mostafa Ghaneie, 
Is verification completed (if applicable) prior to delivery MOH code 29368” has been observed on medical
or implementation of product? Ara relevant records
maintained? device technical file
Are results of review and required actions recorded?
CONTROL OF DESIGN AND DEVELOPMENT CHANGES
Have design and development changes been identified
and recorded? Email: Padyab to Barahmani
Have design and development changes been reviewed, Change: Spirometi add export patient info on excel
verified, validated and approved prior to
implementation? file
7.3.7 Does the review of design and development changes 
include evaluation of the effect of changes on
@ 19/5/1394 July 2015
previously delivered product and the parts constituting CC: Mr. Karimian, Mr. Keyvani
the product?
Are the results of review of changes and subsequent

follow‐up actions documented?
7.4 Purchasing
Order due to Invoice 93432
ICU ventilator for Adults
Purchasing Process; Has the organization prepared
documented process to ensure that purchased product Sn# 20145i21831
conforms to purchasing requirements?
Are criteria for selection of suppliers defined? SN# 20145i21835
Are evaluation and reevaluation of suppliers have been
defined? As letter 90471495301 @ 31/2/1394 (May 2015) has
Has the organization defined tracking frequency of
supplier’s performance? been passed from customer in 35 days
Does the organization have the proofs indicating that
supplier monitoring activities, outsourced processes are Order due to Invoice 201541280
controlled and the products or services conform to the
rules of the organization containing customer demands Safety Pack set bestehed and antibacterial safety filter in
7.4.1 and regulatory rules? 
Have the requirements of purchasing information
same Invoice
(containing the rules related to supplier records)
including outsourced processes been identified to As letter 90483545211 @ 20/7/1394 (Septemebr 2015)
ensure product and service quality? has been passed from customer in 20 days.
Does the organization have the methodology to
communicate these requirements to the supplier? Criteria for selection of suppliers are defined and
Are purchasing contracts available?
Do the type and content of the control on supplier and evaluation and reevaluation of suppliers have been
purchased product depend on the next product
realization of purchased product or final product?
defined.
Are purchasing records retained?
Suppliers evaluated per 6 months according list of
correct suppliers. Supplier with grade will be evaluated
every year.
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

Purchasing information defined in Procedure and
PURCHASING INFORMATION
catalogs. If any changes happen for purchasing
Does purchasing information define the product to be information, company shall be accepted by IMED
purchased?
Where appropriate, does purchasing information Importing Department.
include product approval, procedures, requirements for They have special ID code to identifying products.
process and equipment, Personnel qualification and the
7.4.2 requirements of Quality Management System? Such as: 
How does organization ensure the adequacy of
specified requirements in the purchasing information Order due to Invoice 93432
prior to their release to the supplier?
Are records for the information related to purchased ICU ventilator for Adults
product available?
Sn# 20145i21831

Warehouse man responsible to verification of product
whit packing list.
The packing list relate to invoice 93432 information and
VERIFICATION OF PURCHASED PRODUCT who checked:
Has the organization identified a method in order to Batch No., Exp. Date and Qty. performance sheet,
ensure that the product received conforms to the
specifications, is finished, holds appropriate identity serial 9423 for stent on Invoice No: 93206 has been
and is free from any damage?
Do the processes include the provisions in order to
observed.
verify that incoming product is provided along with Nebulizer 3way part
support documentation (Such as conformity certificates,
7.4.3 acceptance test reports)? Incoming date 1/7/1394 (septemebr 2015) Company 
Has data been provided related to analysis of previous LEMON lot: 01695847567
acceptance inspection data, rejection history in the
plant or customer complaints, required inspection Qc records has been observed such as
quantity and necessity of reevaluation of supplier? Quantity
Has the organization identified the authorized person
for conformity approval of incoming material? Expiration date
Are verification records retained?
Appearance
Papers
serial
plump
7.5 Production and Service Provision
REFERENCE, AS
This Clause
APPLICABLE1
Has been
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CONTROL OF PRODUCTION AND SERVICE PROVISION
7.5.1.1 General rules
Has the organization identified control requirements for
production and service process?
Is control quantity and control detail level
proportionate to criticality level of its process?
Has the characteristic qualities of product been
identified? When required, have documented
procedures, documented rules, work instructions and
reference materials reference materials and reference Company provides control plans for all products as
measuring processes been made available?
Has appropriate equipment been selected in the
below:
manner that enables process and product specifications Spirometry product quality plan F71000QM03 R01‐1
to be obtained?
Have the documents for using appropriate equipment
been established? Areo Xpert product quality plan F71000QM03 R01‐2
Has it been verified that new and/or significantly
modified equipment meets purchasing/design
specifications and possess the ability to operate within
Product quality plan oxy Xpert F71000QM03 R01‐3
7.5.1 the limits defined and process operating limits? 
Have control devices been identified?
Has a document been prepared for using control
devices?
Product quality plan body box design F71000QM03 R01‐4
Have implementation and control requirements for
labeling and packaging been identified?
Are the records obtained during manufacturing process
Ambi Xpert product quality plan F71000QM03 R01‐5
of any product lot and facilitating traceability and
review of the manufacture of this lot retained?
Do the records include the following information? Based on procedure P75100QC01 R01 company does qc
‐ When applicable, quantity of raw materials, for ongoing and final products.
components and intermediate products and lot
numbers of those materials,
‐ When applicable, start and completion dates of
different stages of manufacture including sterilization
records,
‐ Quantity of manufactured product,
‐ Signed results of all inspections and tests,
‐ Representation of production line used,
‐ Any deviation from manufacturing specifications.
7.5.1.2 Control of production and service‐Special rules
Control of product cleanliness and contamination
Has the organization identified product cleanliness
rules?
Have the materials and substances used during Cleaning checklist P64000CL01 R01 for date 22/11/1394
manufacturing process been adequately defined and
labeled in order to prevent complexity and process
has been observed (Jan 2016).
7.5.1.2.1 faults? Based on procedure P75100QC01 R01 company does 
Have certain medical devices been cleaned and/or
cleared of contamination so as to prevent employees cleaning and disinfection for final product and after sale
and other product from being exposed to any services.
contamination
Have cleaning and implementation requirements been
documented?
Assembly activities
Have assembly activities and responsibility for medical
device been identified?
In the event that any medical device should be
assembled and mounted in the location where the user
is present, have guiding instructions been prepared by
7.5.1.2.2 the organization for accurate assembly, montage, tests NA
and/or calibrations?
Has the organization provided the instructions which
allow assembler to confirm proper operation of the
device?
Are the results of assembly or commissioning tests
recorded?
REFERENCE, AS
This Clause
APPLICABLE1
Has been
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Code: 3063
Service activities Karaj Bahonar Hospital
In the event that functionality of products needs service
or maintenance for proper utilization of products, have
Evant Inspiring Device
documented requirements been established for service Installation date: 2009/01/16
activity?
Has the organization identified service responsibilities
Device has been observed in site: report of detection of
between distributors and users? error has been installed on it on paper of customer
Have service activities carried out by the organization or
a separate agency been planned? property.
Have the design and functionality of equipment or Work done reported such as:
devices with special purpose related to manual
operation and service after assembly been validated? Compressor service, backing up of log, updating
7.5.1.2.3 Are measuring and test equipment used for site service firmware, retesting 
and tests controlled?
Have instructions related to the lists of spare parts or
parts and for use in product service been prepared?
Has the infrastructure covering technical consultancy
Code:3061
and technical support, customer training and spare On 1/12/1394 (march 2016)
parts or provision of parts been established?
Are service personnel trained? Service is done on customers site
Are specialized service personnel available? Error: low battery
Has the organization formed a system for receiving
customer demands so as to determine whether Service done : three hours
customer complaints and rules are handled?
Are service records retained?
Service report: changing battery, updating firmware
Service done 31 hours after first call

Special rules for sterile devices
Does the organization record process parameters
related to sterilization process and used for each
7.5.1.3 sterilization lot? NA
Are sterilization records tracked for each production lot
related to medical devices?
7.5.2 VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION
General rules
a)defined criteria for review and approval of the
process
b)approval of equipment and qualification of staff
involved For Spirometry: software validation for Spirometry
7.5.2.1 c) use of specific methods and procedures 
d)records requirements software has been observed on sv‐svv75100pr50 r01
e)revalidation
documented procedure for validation of
software/computer applications, and records of
validation
Special rules for sterile medical devices
Have sterilization processes been validated prior to
use?
7.5.2.2 Have the standards used for validation of sterilization NA
process been identified and implemented?
Have the requirements in the Article no. 7.5.2.1 been
met?
7.5.3 Identification and Traceability
Identification
Has the organization identified and documented the The organization has developed a procedure for
product through appropriate methods during product
7.5.3.1 realization? Identification and Traceability; based on the 
How has the organization identified product situations manufacturer regulation, all product crucial data are
in accordance with tracing and measuring
requirements? recorded in all presented document to the customer &
TRACEABILITY
75.3.2.1 General
patient such as invoice, hospital receipt; the record of
How is the product traced? delivered, I took two sample on 7.2.1, both them could
7.5.3.2 Has any method been documented for traceability?
be traced (Performa 9423 and 94774) 

Does the organization ensure traceability of the medical
device during typically production and storage process
up to expiration of ownership? Also in the storage the expired products, non
REFERENCE, AS
This Clause
APPLICABLE1
Has been
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Special rules related to active implantable medical

devices and implantable medical devices
applicable products are separated in from the other
Does the organization ensure traceability in inspection items and products; and their related data are recorded
and stock records for the changes of the personnel
performing a work traceability of which belongs to an
in storage software and labeled with red colored tag.
introductory (Such asserial number, data code, lot code, P7
Stent with serial No. 84273640972 is on Mrs. Aziz’s
party number) special to operation source, changes in 53
raw materials, changes in the works performed through heart, operation is done on July 2016 on Milad 00
tools, new or different machine devices, changes of AR
process methods? Hospital. W
H0
When applicable, are special personnel assigned to act Sensor’s serial on oxygen monitor is not written on 1
during processing medical device or each stage of
delivery traced? product file
Status Identification
7.5.3.3 Organization has identified status of product with
respect to measurement and monitoring requirements
The customer property is determined as the intellectual
property of the patient specially their clinical data, all
customers are assigned a identification code and after
CUSTOMER PROPERTY finalizing the sales process the related records will be
Does the organization ensure identification, verification,
protection and safety of customer property provided retained with limited accessibility level.
for product or in the manner that it creates product Code: 3063
7.5.4
while it is under the organization’s control or being
used? Karaj Bahonar Hospital 
Does the process ensure that occurrence of any
customer property that is lost, damaged or otherwise
Evant Inspiring Device
found to be unsuitable for use are recorded and Installation date: 2009/01/16
reported to the customer?
Device has been observed in site: report of detection of
error has been installed on it on paper of customer
property.

REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

Storage is very clean and tidy, every row and column
has number for ease of access.
Lay outing is based on colored printed layout.
Storage is managed with software; the layout of items
have been determined and installed on information
board. All records of entering and exiting the items
are recorded such as:
‐ Filters, layout code disposasbles Column code
11, #2015747273 Inventory 4, order point 3,
PRESERVATION OF PRODUCT
Are methods and controls established to preserve Inventory On Mrs. Mohamadi warehouse
conformity of product during internal processing and
until delivery to intended destination?
software was 4 too.
Has the organization established documented processes
or documented work instructions for control of the
product with limited shelf life or which requires special
‐ Stent, layout code: freezers, size 3.5 inventory
7.5.5 storage? 35, order point 20, recordered inventory is 35 

Are such special storage requirements controlled and
recorded? too
Does this preservation include definition, transport,
packaging, storage and protection of the product and
the parts constituting the product? In the storage the expired products, non applicable
Is there a logo on product? Is it proper to its
instructions?
products are separated in from the other items and
products in red section; and their related data are
recorded in storage software and labeled with red
colored tag.
Storage log of humidity and temperature has been
observed for October and December, log of Humidity
and temperature for first week of February was not
observed. As Mrs. mohamadi, storage responsible says,
he prepared it, but he possibly, lost it, so I referred it to
control of records not warehouse.
CONTROL OF MONITORING AND MEASURING DEVICES
No. 6923
Has the organization identified the measurements to be Ambient Pressure meter code 958.82 0% error,
made and the measuring and monitoring devices
required to ensure conformity of product to specified verification for accuracy of instruments, is valid before
requirement? may 2015
a) Be calibrated or verified at specified intervals, or
prior to use, against measurement standards traceable No. 6929
to international or national measurement standards; Syringe calibration cylinder code 888.29 error 0%
7.6 where no such standards exist, the basis used for
calibration or verification s hall be recorded; calibration certification code 84735472/d/15 valid

b) Be adjusted or re‐adjusted as necessary;
c) Be identified to enable the calibration status to be
before June 2016.
determined; Digital multimeter calibration certification:
d) Be safeguarded from adjustments that would
invalidate the measurement result; 9400711‐01
e) Be protected from damage and deterioration during Electrical safety analyzer calibration certification
handling, maintenance and storage.
B12060444 error 0 volt
8 Measurement, Analysis and Improvement
REFERENCE, AS
This Clause
APPLICABLE1
Has been
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The organization dose plan to implement the

General
Does the organization plan to implement the
monitoring, measurement, analysis, and improvement
monitoring, measurement, analysis, and improvement processes required for conformity of the product and
processes required for conformity of the product and
8.1 QMS and improvement of its efficiency? QMS and improvement of its efficiency and 
Are measurement, analysis and improvement measurement, analysis and improvement processes are
processes are carried out through statistical
techniques and applicable methods? carried out through statistical techniques and
applicable methods by Analysis procedures.
8.2 Monitoring and Measuring
The organization monitor the information related to
customer perception in order to understand whether
customer requirements and determined methodologies
for obtaining and using information on customer
8.2.1 CUSTOMER SATISFACTION satisfaction and/or dissatisfaction by
Does the organization monitor the information related
to customer perception in order to understand whether
corrective/preventive action procedure.
8.2.1 customer requirements are met or not?
Has the organization determined methodologies for
There is no any record for customer compliance and 
obtaining and using information on customer recall. There is no complaint recorded recent two
satisfaction and/or dissatisfaction? years.
After sales services average of customer satisfaction is
98.61194 %
Sales average of customer satisfaction 9.38 from 10
There is no complaint recorded recent two years
The audits planned in the form of audit program on
INTERNAL AUDIT second month of each year (April 2015 in the case) and
Has a documented procedure been established that
includes responsibilities and requirements,
audit program has taken importance and status of the
requirements for planning and conducting the audit, fields and processes to be audited as procedure
reporting the results, maintaining the records?
Are audits planned in the form of an audit program?
implies.
8.2.2
Does audit programme take importance and status of There are 2 internal auditors (Technical supervisor and 
the fields and processes to be audited including the
results of previous audits? MR) from two different departments for impartiality.
Do selection of auditors and implementation of audit The last audit date is Jan 2016 and 12 NCRs detective in
ensure objectivity and impartiality of the process?
Do auditors audit their works? this audit.
Do follow‐up actions cover verification of the measures
taken and reporting of verification results?
Action plan for resolved observed.
It was assumed as management review input too.

REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

Data analysis & process monitoring has been

conducted and the prepared record was observed:
‐ Sales process, criteria increase in sale (15% and
acceptable 10%), situation is 14% before march
MONITORING AND MEASUREMENT OF PROCESSES
2016
Does the organization implement appropriate methods ‐ Training process, criteria 90% of effective
8.2.3
for monitoring QMS processes and where applicable,
for measurement such WMS processes? training courses, situation is 90.33% 
When planned results are not achieved, is corrective Customer satisfaction, criteria 90%, situation is After
action taken for product conformity?
sales services average of customer satisfaction is
98.61194 % and Sales average of customer satisfaction
9.38 from 10
‐ Objective achievement, criteria 90%, situation
is 100%
8.2.4 MONITORING AND MEASUREMENT OF PRODUCT
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
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Final product qc for Aero Expert has been checked
Serial:
94‐a01‐00‐0104
Appearance factors? OK
Reading inputs? error 0
Reading outputs? Error 0.2 (in range)
Verification for 3 bar test? passed
Reading of pressure sensor pressure air 2 bars? error 0
Adaptor? 7‐30 V
Serial No? OK
Drug nebulizing from chamber? Passed
General rules

Does the organization establish appropriate stages to final product qc
measure and monitor product characteristics?
Have verification methods been documented?
Oxygen monitor94‐001‐00‐0101 @ 25/8/1394
Is this verification process realized in accordance with Using current 300‐400 ma? Passed ± 5%
the arrangements planned during appropriate stages of
8.2.4.1 product realization process? 
Are conformity evidences along with acceptance criteria Final product Qc records for Spirometry:
maintained?
Are the records approved by the authorized Spirometry 94‐02001‐39 @5/12/1394
person/persons in the process of product release? Felowmeter control? Passed
Are product release and distribution of service, planned
regulations (Article 7.1) completed satisfactorily? Verification of humiditry ±1%? Passed
Verification of tempreture ± 25? Passed
Ambient pressure control n 880 Kpa? Passed
Linear loging control as report svs140158
Fellow sensor? Error In 0.3 Ex 0.4 passed

Final product qc:
Body box 94‐002‐00‐2100 @12/5/1394
Pressure sensor of box 2.5? passed
Pressure sensor of mouth 200? passed
Pressure sensor of flow 12.5? passed

There is a list of key person who has responsible to QC
Special rules related to active implantable medical
of products in each part of process
8.2.4.2
devices and implantable medical devices
Does the organization record the identity of the
Such as: prothes, QC MR. .dabib has response to check

personnel carrying out any inspection or test?
and has authorized to rejact.
REFERENCE, AS
This Clause
APPLICABLE1
Has been
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CONTROL OF NON‐CONFORMING PRODUCT
Does the organization have methodologies to ensure
that product that does not conform to requirements is
identified and controlled to prevent unintended use or
delivery?
Is there a documented procedure related to non‐
conforming product?
Does the organization take measures to remove non‐
conformity related to product?
When applicable, do the processes identify the methods
8.3
authorizing the non‐conformity’s use, release or
acceptance in agreement with customer? There is no any record non‐conforming product yet. 
Are required measures taken to preclude the product’s
original intended use or application?
Are records related to the nature of nonconformities
and the measures taken later maintained?
Is corrected nonconforming product subject to re‐
verification to demonstrate conformity to the
requirements?
Do the processes ensure that appropriate corrective
action is initiated when non‐conforming product is
detected after delivery or use has started?
DATA ANALYSIS
Data analysis & process monitoring has been
Does the organization collect, identify and analyze conducted and the prepared record was observed:
appropriate data to demonstrate efficiency and
appropriateness of QMS and the fields where QMS’s ‐ Sales process, criteria 10% deviation for the
efficiency can be continuously improved? sales plan, situation is 91.77%
Has a documented procedure been prepared for these
‐ Training process, criteria 75% of effective
8.4
analyses?


Do the characteristics and tendencies of the processes
and products including data analysis, customer
training courses, situation is 80.16%
satisfaction, conformance to product requirements, ‐ Customer satisfaction, criteria 70%, situation is
opportunities for corrective actions provide information
related to suppliers?
75%
Have data types for data analysis been defined? Business plan achievement, criteria 70%, situation is
Are data analyses recorded?
79%
8.5 Improvement
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

The organization established written procedures in

order that advisory warnings can be published and
CONTINUAL IMPROVEMENT
Has the organization identified required changes by implemented but the organization used that outputs
using quality policy, quality objectives, audit results, onto IFU and user manual.
analyses of data, corrective and preventive actions and
management review in order to ensure and sustain According to 8‐2‐1 there is no any customer compliant.
ongoing conformity and efficiency of quality
management system and does the organization
So the organization identified required changes by using
implement such changes? quality policy, quality objectives, audit results, analyses
Has the organization established written procedures in
order that advisory warnings can be published and of data, corrective and preventive actions and
implemented? management review in order to ensure and sustain
Are the records of all examinations related to customer
complaint maintained? ongoing conformity and efficiency of quality
Have the complaints been evaluated within the scope of management system and does the organization
8.5.1 the following points?:
‐ whether the organization fails to comply with its own implement such changes according to clause 5‐4

specifications or not,
‐ whether the organization has caused problems to
On 7/5/1394 july 2015 aftersales services send a letter
occur despite the fact that it has complied with its own to IT department and cc to MD as below:
specifications
In the event that the activities outside the organization “as all devices has identity, there is no need for login
are identified through examination of the contribution window, removing login window help speeding up
of such activities to customer complaint, has the
relevant information been shared among responsible procedures”
organizations? On 19/5/1394 (12 days later) software department send
In the event that any customer complaint is not
followed up through a corrective and/or preventive a letter to aftersales services and cc o MD as below:
action, has the reason of this failure been confirmed
and recorded?
“login window removed, firmware updated.”
Advisory notice for Aero Xpert:
Contraindications: asthma, COPD
Corrective actions:
8.5.2. CORRECTIVE ACTION #9423 @1/6/1394 audgust 2016
Is there a documented procedure for Corrective and There are five aftersales services that users did not put the device in the place for
Preventive Action? charging but they thought it is not charging.
Are corrective actions taken to eliminate causes of Root cause:
nonconformities effective in preventing recurrences? In all cases, new users bought the device re‐used
Does this procedure include the requirements of Correction: putting this case on call center guidelines
8.5.2 reviewing non‐conformities (including customer
complaints), determining the causes of non‐conformity,
#9432 internal audit 20/11/1394 Jan 2016
Aftersales services had a repair case more than 80 hours without any corrective action

evaluating the actions needed to ensure that and root cause analysis
nonconformities do not recur, determining and Root cause: after sales manager asked for human power three month ago due to
implementing the corrective action needed, and review increase of customers, but because Mr. Yazdani was at business trip, they did not hired
of the results of the action initiated? human power in time.
Is adequacy of corrective‐preventive actions identified? Correction: recording the case on format

PREVENTIVE ACTION
Has the organization established a documented
procedure for preventive action with defined
requirements for identifying potential non‐conformities
8.5.3
and their causes; evaluating the need for action to
prevent occurrence; determining and implementing
There is no any record about preventive action 
preventive action needed; recording results of action
taken; reviewing preventive action taken.
What are the methods for identifying the adequacy of
corrective‐preventive actions?

By exception, we indicate the specific Strengths and weakness of the organization in light of the management system, as we perceive and seen through
processes in reference to requirements of the criteria being ascribed as these apply and relate to the assessment plan and planning of the assessment.
This aspect relates to Accreditation Body as it does to the protection of consumers in the client-organization’s role within their respective supply – chain.
Disclaimers: (1) herein, we reiterate that any suggestion or opinion that the assessment team expresses does not construe to be a contractual
requirement. (2) The degree of certainty in conclusions increases by the competence of the assessment team as well as the attestation within the
assessment protocol, values, mission and vision under which we operate for the protection of consumers, still remains a certain level of uncertainty.
Strength Weakness
R&D Process analysis
Team Work ‐

action Request Type I Form-008 – as we indicate and that each of the RA addresses the basic four (4) questions
as seen in Form-008:N/A
action Request Type II Form-008 – as we indicate and that each of the AR addresses the basic four (4) questions
as seen in Form-008:
TT‐01‐2016: Sensor on oxygen monitor is not written on product file
Observation Form-018 – with uniquely specific identification:N/A
ATL: Mohammad Reza Khoshgoo DATE: 17 March 2016
END of REPORT
FORM-014 – Opening Meeting Checklist FORM-009 – MS Reporting,

FORM-017 – Closing Meeting Checklist FORM-008 – RA / AR, as requires
FORM-005 – Participants of opening & closing meetings FORM-018 – OBS, as requires
FORM-004 – Assessment Plan FORM-010 – As requires, recommendation for CoR
FORM-007 – Planning onto -004, as process determined FORM-026 – Assessment documents check-sheet, optional

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Legal status Iranian MOH legal requirements.

PM procedure: P63000PM01 R01was observed.

Special rules related to active implantable medical

The organization dose plan to implement the

Data analysis & process monitoring has been

The organization established written procedures in

Observation Form-018 – with uniquely specific identification:N/A

ATL: Mohammad Reza Khoshgoo DATE: 17 March 2016

FORM-014 – Opening Meeting Checklist FORM-009 – MS Reporting,

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