BRSM Form 009 Qms MDD Apt

BRSM
Systems: QMSMDD ISO 13485 (2003)

Assessment Report/Checklist
Form 009

CLIENT‐ORGANIZATION (NAME): Alvand Push Teb Co.
PHYSICAL LOCATION(s): No. 222, 32th St., Buali Industrial Zone,
Hamedan, Iran
Stage II Audit Date(s): 26& 27 Feb 2016
Stage I Audit Date(s): 22 Feb 2016
NAICS (or NACE) CODE MD0404
EXCLUSIONS: 7.3, 7.5.1.2.2, 7.5.1.2.3, 7.5.1.3, 7.5.2, 7.5.2.2,
7.5.3.2.2, 7.5.4, 8.2.4.2

Assessment objectives: Verifying the company’s scope and
documentation for the ISO 13485 and GMP
requirements to protect consumers and
communities

ASSESSMENT TEAM INFORMATION
Assessment Team Leader, ATL Marjan Aazad manesh
Assessor 2 shahabadi
Assessor 3

Note: Adjusting the language within this form to the type of activity and nature of the organization is acceptable.
REFERENCE, AS
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Has been
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).
2 Scope of activities Production and sales of non‐sterile disposable medical clothes.
Iranian MOH approval:
Legal status Date: 95.04.08
3 ID: 664/47093
Obligatory applicable standard which UMDNS code: 11904
organization has to follow 
MOH GMP required for Class I MD
4 Quality Management System
GENERAL REQUIREMENTS
Does the organization establish, document, implement,
The organization Does establish, document, implement, maintain and continually
maintain and continually improve a Quality
improve a Quality Management System (QMS) with due consideration given to
Management System (QMS) with due consideration
identification of processes needed for the QMS MDDand their application throughout the
given to identification of processes needed for the
system in process map
QMS and their application throughout the system;
Sequence and interaction of these processes planned in processes map.
determination of sequence and interaction of these
4.1 processes, determination of criteria and methods
required to ensure effective operation and control of
criteria and methods required to ensure effective operation and control of these
processes: 
production and control: rejected from customer, amount of wastes
these processes; availability of resources and
management: result of review meeting
information required to support the operation and
customer relate: compliance/satisfaction
monitoring of processes; measurement, monitoring and
QA and training: effectiveness of training
analysis of the processes; implementation of action to
There is no any outsourced process.
achieve planned results and continual improvement
‐If any, are the outsourced processes are defined?
DOCUMENTATION REQUIREMENTS
Is there a documented quality policy and documented
quality objectives and are they appropriate?
Is there a documented quality manual and are there
documented procedures required by the standards??
4.2
Are required records for planning, acting and controlling
processes efficiently available?
Documentation required for QMS is documented.
Quality manual, quality policy, procedures required in standards is documented. 
Are the documents are created for every type of
medical device including qms requirements and product
specifications? (4.2.3) If these documents are applicable
to manufacturing processes, are montage and service
defined?
QUALITY MANUAL
Does the Quality Manual include, scope of QMS and
details of exclusion? Quality Manual includes scope of QMSMDD and details of exclusion are documented.
4.2.2 Are documented procedures reference to mandatory
procedures;
Exclusions are: 7.3, 7.5.1.2.2, 7.5.1.2.3, 7.5.1.3, 7.5.2, 7.5.2.2, 7.5.3.2.2, 7.5.4, 8.2.4.2
Quality manual info: documented procedures are reference to mandatory procedures.

Is description of interaction of the processes included in
the QMS?
CONTROL OF DOCUMENTS
Are mandatory procedures documented?
Are control conditions pertaining to mandatory
documents proper?
Are review, update and re‐approval situations and
changes and current review situations for documents
Review, update and re‐approval situations and changes and current review situations for
traceable?
documents are traceable.
4.2.3 Are the relevant documents usable, readable and
recognizable at concerned usage points?
E.g.: corrective action procedure.
List of documents is available that include distribution of documents and last version.

Are outsourced documents defined?
Outsourced documents are defined including standards.
Are distribution of documents controlled, outdated
documents prevented from being used and appropriate
definition method applied in case of being stored for
any purpose?
Are these subjects clear in the relevant procedure?
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 Page 2 of 15
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CONTROL OF RECORDS
Are documents readable, easily recognizable and stored
Documents readable, easily recognizable and stored in are available manner.
in available manner?
4.2.4
Has a documented procedure been established and
applied for determination of required controls for
The products shelf life is 3 years and the time of archive records according to this legal
requirement is 3 years. 
storage, retrieval, retention time and disposition of
records? E.g.: QC control reports
Has the archiving defined for at least 2 years?
5 Management responsibility
MANAGEMENT COMMITTMENT
Has the top management ensured that requirement for
meeting customer conditions and legal conditions
should be understood by all personnel? The top management has ensured that requirement for meeting customer conditions
5.1 Is a quality policy available?
Are quality objectives available?
and legal conditions should be understood by all personnel.
Quality policy available and management review established.

Is management review established?
Does the management provide required sources for
QMS?
CUSTOMER FOCUS
Does top management have methodologies to ensure top management have methodologies to ensure that customer needs and expectations
5.2 that customer needs and expectations are determined are determined and met for increasing customer satisfaction by determine procedure.
and met for increasing customer satisfaction?
Top management has established a Quality Policy in accordance with the objective of the
QUALITY POLICY organization. Quality policy: issue date: Jun 2015
Has top management established a Quality Policy in
accordance with the objective of the organization? The Quality Policy has been revised for communication, understanding and continuous
Does the Quality Policy include a statement of compliance within the body of the Organization.
5.3 commitment to meeting requirements and continual
improvement of the QMS?
There are 3 policy in this document: 
Has the Quality Policy been revised for communication, 1‐ increasing the customer satisfaction
understanding and continuous compliance within the 2‐ determine safety work environment according to product required
body of the Organization?
3‐ Increasing product type.
QUALITY OBJECTIVES
Are quality objectives established by top management
at relevant functions and levels within the organization?
Are the objectives measurable and consistent with the the objectives measurable and consistent with the Quality Policy:
Quality Policy ‐ improvement product delivery from 14 to 8 days
5.4 5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING
Has the QMS been planned by Top Management in ‐ installing the sterile line for new type of products

order to meet the conditions and quality objectives All objective targets dates is end of 1395(2016) year.
detailed in Section 4.1?
When changes are initiated, is the integrity of the QMS
maintained during the change process?
5.5 Responsibility, Authority and Communication
RESPONSIBILITY AND AUTHORITY
Has top management identified responsibility and
Responsibility and authority determined according the top chart.
5.5.1
authority and been communicated within the
organization? Responsibility and authority technical supervisor, product supervisor.

Has top management defined responsibilities and
authorizations for CE marking?
MANAGEMENT REPRESENTATIVE
Has top management appointed a member as Mrs. Shiri (technical supervisor) is management representative.
Management Representative with responsibility and Responsibility and authority of management representative observed.
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 management on the 
top management on the performance of the QMS, performance of the QMS, including needs for improvement and promote awareness of
including needs for improvement and promote customer requirements are in his Responsibility.
awareness of customer requirements?
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INTERNAL COMMUNICATION
Has the top management ensured establishment of
Board, phone and periodic meeting are ways to make internal communication.
5.5.3
appropriate communication processes within the
organization? Has the top management ensured
Also, technical supervisor responsible to make communication way with MOH by IMED.ir
or distribution of official announcement.

realization of communication considering the processes
of the QMS and their effectiveness?
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 for 6 months.
5.6.1
regular and planned intervals?
Do reviews include assessing opportunities for
Last meeting date is Feb 2016.
All staff manager has been in this meeting, (MD, MR, Sales, production)

improvement including the need for changes to the
QMS, quality policy, and quality objectives?
Are management review records kept?
REVIEW INPUT
Does review input include current performance and
improvement opportunities related to:
a) results of audits; All inputs were considered
b) customer feedback;
5.6.2 c) process performance and product conformance;
d) status of corrective and preventive actions;
Note:Review input include current performance and improvement opportunities dose
related to ISO13485. 
e) follow‐up action from earlier management reviews; There is a complete report from MR and other managers to
f) changes that could affect the QMS,
g) recommendations for improvement
h) New or revised regulatory rules?
REVIEW OUTPUT
Does output from management review include actions
e.g. for outputs:
5.6.3
related to improvement of the QMS and its processes,
improvement of product related to customer According to new objective, meeting output is planning to providing a new products line.

requirements, actions and decisions relate to resource
needs?
6 Resource Management
PROVISION OF RESOURCES
Does the organization have methods to determine and
6.1 provide resources needed to implement and improve
the processes of the QMS and address customer
The organization determines and provides resources needed to implement and
improve the processes of the QMS. 
satisfaction by meeting requirements?
6.2 Human Resources
Are personnel assigned with responsibilities that affect Personnel assigned with responsibilities that affect product quality competent on the
product quality competent on the basis of applicable basis of applicable education, training, skills, and experience.
6.2.1 education, training, skills, and experience?
Are trainings performed for achievement of Required
e.g.: 
Technical supervisor: chemistry college degree, 2 years experience, MOH training
Competence?
approval and training organization working system.
COMPETENCE, AWARENESS, AND TRAINING
Has the organization identified the experience,
qualifications, competencies and skills of the personnel Training plan observed:
performing activities affecting safety and efficiency of These is a technical curse about making cloths; “how to work with sewing Machin” is
medical devices particularly being manufactured and planned in 94.6.5
provided to customer?
And effectiveness date is 94.6.28
6.2.2
Is training provided by the organization to satisfy the
competency needs? Mrs. Rahmani effectiveness record info: 
Does the organization ensure that its employees are Date of curse: 94.7.1 sep 2015
aware of the relevance and importance of their
Date of evaluation: 94.7.25 , 24 days later
activities and how they contribute to the achievement
of quality objectives? Rate of evaluation: 16.6/20 and its Ok.
Are records of education, experience, training and
qualifications maintained?
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INFRASTRUCTURE
Has manufacturing equipment been designed,
constructed, properly established and placed for proper
operation, maintenance, adjustment and cleaning?
In case of applicability, has the organization ensured
documentation of natural limits or permissible
tolerances in manufacturing process and measuring and Manufacture facility is suitable for product requirements
test equipment and availability of the same for
There are 23 sewing machines in product line and we can see a PM method for each one.
6.3
operators?
Are documented processes available for maintenance, In those documents Personnel/machine safety requirements is planned. 
cleaning and control of all equipment used in There is a record of repair for machine No. B20
manufacturing process and control of work
environment?
Are required adjustments and maintenance intervals
identified?
Is maintenance plan placed normally on or near the
equipment and easily reachable?
Is maintenance realized based on the relevant plan?
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? The organization dose identifies and manage required work environment needed to
Has exclusion been applied during all manufacturing achieve conformity of product.
processes for a controlled environment? As valid There is no any sterile product in manufacture.
ground of exclusion, is pollution reduced to known,
Exclusion Has been applied during all manufacturing processes for a controlled
consistent and controlled level by an approved cleaning
environment but that is a class I work environment.
method and packaging kept at this level through control
process? No need to indicators for a controlled environment such as Temperature, Humidity, …
Have indicators been identified for a controlled Last environmental audit was 94.11.17
environment which covers valid cleaning and packaging There are many weekly records for cleanliness assessment.
processes including the organizations holding a valid
6.4 cleaning process?
(Temperature, Humidity, Air Current, Filtration of Air,
We checked 94.6.7 and 94.11.15 records
It has some cleanliness information about personnel and infrastructure, according to

Ionization of Air, Pressure differences, Lighting (along conformity of products.
with its spectral content and severity), Sound, Vibration, Stuff entry has air washing and place for change cloths and their shows.
cleaning of Working surfaces and processes, Water
quality, number of persons in the work environment) WC place is out of product hall
Have dressing conditions, cleaning conditions and AC system is activated and air filtering is complete with HEPA filters.
health conditions for any person being in contact with The layout of row material and middle products place is on the pallets.
the product or the work environment including those
Personnel cleaning requirement is good
persons who enter the area sterilized prior to use or
temporarily or for a short period in terms of importance Overall; for this product classification, the GMP is enough.
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?
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7 Product Realization
PLANNING OF PRODUCT REALIZATION
Has the organization considered the scope of its own
quality management system in planning of product
realization?
Has the organization prepared required records for a
proof indicating that quality objectives and product
rules, processes established, documents and product‐
specific necessary resources, verification, validation,
The organization considered the scope of its own quality management system in planning
tracking, measuring, inspection and product‐specific
of product realization.
test activities , realization processes and the product
In the technical file, for a proof indicating that quality objectives and product rules,
meet the rules?
processes established, documents and product‐specific necessary resources, verification,
In the event that inspection and test are conducted by
validation, tracking, measuring, inspection and product‐specific test activities, realization
manufacturing personnel, do inspection and test
WP-MA001
processes and the product meet the rules with quality control plan.
results, processes, organization’s procedures ensure
UMDNS code is: 11904
impartiality of inspection and test results?
Classification is: A or I
7.1 Risk management
Intended use of product is patient cloths (Non‐woven) RA
Has the organization prepared a procedure containing
Shelf life of product is 3 years
all processes of product realization for risk management
Labeling: according to EN980
activities and realized the following?
Risk management method is FMEA with RPN<= 50 are acceptable.
Keeping the records
These is no any residual risks
Preparation of Risk Management Plan
OPC and models of each part of products observed.
Determination of Risk team and its Responsibilities
Clinical evaluation report does not exist.
Determination of Intended Use of Device and Safety

Characteristics of Device
Definition of hazards
Risk Estimation for Hazards
Evaluation of Risks
Risk Control Measures
Definition of Residual Risks
Risk/Benefit Analysis
Preparation of Risk Management Report
DETERMINATION OF REQUIREMENTS RELATED TO THE
PRODUCT/SERVICE
Has the organization defined the requirements of
customer including the requirements for the activities
on delivery and after delivery?
Do these requirements include the following?:
‐ regulatory and legal requirements related to the
countries and territories where the product is supplied
to the market The organization has defined the requirements of customer including the requirements
‐ anticipated utilization, for the activities on delivery and after delivery.
‐ Performance expectations, Customer order was recorded in sale forms:
‐ Design factors Invoice ID: 315
7.2.1 ‐ Delivery plans
‐Unclear customer expectations
Date of delivered: 94.12.13
Qty: 102 box

Does the organization record customer’s expectations Customer name: EHYA DARMAN Co.
related to product/service in order to revise the same? Order information ID form: 28
In the event of any change in order or offer or both for Date record: 94.12.8
any reason whatsoever, are changes revised and an
agreement is reached on the changes as it is in original
order or offer?
In the event that changes are accepted, are all
personnel being affected by the changes within the
organization informed?
Are relevant documents affected by these changes
amended?
7.2 Customer‐Related Processes
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REVIEW OF REQUIREMENTS RELATED TO THE

PRODUCT/SERVICE
Does the organization review the requirements related
to the product?
Are review records kept?
Has this review been realized prior to commitment of
the organization for provision of the product to There is no any record but the sale software can record all order change.
7.2.2 customer?
Has the organization ensured settlement of contract or The consent after review is verbal

order requirements which are different from previously
defined?
Does the organization have the ability to meet defined
requirements?
Are the results of review and subsequent follow‐up
actions recorded?
CUSTOMER COMMUNICATION
Are arrangements for communication identified and
implemented relating to product information, demands,
Purchase requests and follow‐up telephone communication measured by unit sales and
7.2.3
applications, contracts or realization of order including
amendments? after‐sales customer comments. Such as letter from Qods hospital about quality of 
Are required arrangements identified and implemented products.
for customer feedback and communication with
customers including customer complaints?
7.3 Design and Development
DESIGN AND DEVELOPMENT PLANNING
Have the stages of design and/or development been
identified?
Have review, verification and validation activities
appropriate to each design and/or development stage,
7.3.1 responsibilities and authorities been identified in design NA
and development planning?
Are design and development planning updated when
planning output is appropriate and in the progress of
design and development?
DESIGN AND DEVELOPMENT INPUTS
Are inputs related to product requirements identified
and relevant records maintained?
Do these inputs include functional and performance
7.3.2 requirements, applicable regulatory and legal NA
requirements, applicable information derived from
previous and similar designs a any other requirements
essential for design?
Have the inputs been reviewed in terms of adequacy?
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
inputs?
Do the design and/or development outputs meet the
7.3.3 design input requirements and NA
‐provide appropriate information for purchasing,
manufacture and service performance,
‐ 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?
7.3.4 Are the results of review and subsequent follow‐up NA
actions recorded in order to evaluate the ability to
fulfill requirements and identify problems and
propose corrective actions?
DESIGN AND DEVELOPMENT VERIFICATION
7.3.5 Does the organization in planned arrangements ensure NA
that design output meets input criteria
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DESIGN AND DEVELOPMENT VALIDATION
Is the design and/or development validation performed
in accordance with planned arrangements to confirm
that final product is capable of meeting the
requirements of intended use or application
7.3.6 requirements defined? NA
Is verification completed (if applicable) prior to delivery
or implementation of product? Ara relevant records
maintained?
Are results of review and required actions recorded?
CONTROL OF DESIGN AND DEVELOPMENT CHANGES
Have design and development changes been identified
and recorded?
Have design and development changes been reviewed,
verified, validated and approved prior to
implementation?
7.3.7 Does the review of design and development changes NA
include evaluation of the effect of changes on
previously delivered product and the parts constituting
the product?
Are the results of review of changes and subsequent
follow‐up actions documented?
7.4 Purchasing
Purchasing Process; Has the organization prepared
documented process to ensure that purchased product
conforms to purchasing requirements?
Are criteria for selection of suppliers defined?
Are evaluation and reevaluation of suppliers have been
defined?
Has the organization defined tracking frequency of
supplier’s performance?
Does the organization have the proofs indicating that
supplier monitoring activities, outsourced processes are Criteria for selection of suppliers are defined and evaluation and reevaluation of
controlled and the products or services conform to the suppliers have been defined.
7.4.1
rules of the organization containing customer demands
and regulatory rules?
There is a list of current supply. E.g.: row material non‐woven tissue supply BAFTINEH Co.

Have the requirements of purchasing information To evaluation and selection of supply for each year, there is a method.
(containing the rules related to supplier records) So according to that method, Baftineh co. has a good rate (87 from 100).
including outsourced processes been identified to
ensure product and service quality?
Does the organization have the methodology to
communicate these requirements to the supplier?
Are purchasing contracts available?
Do the type and content of the control on supplier and
purchased product depend on the next product
realization of purchased product or final product?
Are purchasing records retained?
PURCHASING INFORMATION
Does purchasing information define the product to be
purchased?
Where appropriate, does purchasing information
include product approval, procedures, requirements for Non‐woven tissues have an internal standard, but that supplier need to MOH approval
7.4.2
process and equipment, Personnel qualification and the
requirements of Quality Management System?
and they have.
Whatever, purchasing information’s are in purchase orders. 
How does organization ensure the adequacy of Packing property in purchase order no. 309 in 94.8.19 including size and QTY.
specified requirements in the purchasing information
prior to their release to the supplier?
Are records for the information related to purchased
product available?
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VERIFICATION OF PURCHASED PRODUCT
Has the organization identified a method in order to
ensure that the product received conforms to the
specifications, is finished, holds appropriate identity
and is free from any damage? In purchase verification, they con linked row material LOT. To verification report to trace.
Do the processes include the provisions in order to Verification report of non‐woven tissue in 94.5.10 observed that is according to MOH
verify that incoming product is provided along with required.
7.4.3
support documentation (e.g. conformity certificates,
acceptance test reports)?
LOT.: 94000348
Color: pink 
Has data been provided related to analysis of previous Qty.: 3 roll
acceptance inspection data, rejection history in the Density: 45
plant or customer complaints, required inspection Supplier: BAFTINEH Co.
quantity and necessity of reevaluation of supplier?
Has the organization identified the authorized person
for conformity approval of incoming material?
Are verification records retained?
7.5 Production and Service Provision
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
measuring processes been made available? The organization has identified control requirements for production and service process
Has appropriate equipment been selected in the and control quantity and control detail level proportionate to criticality level of its
manner that enables process and product specifications process. Appropriate equipment has been selected in the manner that enables process
to be obtained? and product specifications to be obtained. An implementation and control requirement
Have the documents for using appropriate equipment for labeling and packaging has been identified.
been established? Production plan started by sale order.
Has it been verified that new and/or significantly Date of last order is Dec 2015
modified equipment meets purchasing/design There are some record for control in process:
specifications and posses the ability to operate within Id: 94‐09
7.5.1 the limits defined and process operating limits?
Have control devices been identified?
For 120 Qty. products
According to OPC, the product realization is going to complete:

Has a document been prepared for using control Cutting,
devices? Sewing,
Have implementation and control requirements for Iron press,
labeling and packaging been identified? Packaging and
Are the records obtained during manufacturing process Warehousing
of any product lot and facilitating traceability and That information recorded in products forms.
review of the manufacture of this lot retained? Record of row material flow recorded in production records.
Do the records include the following information? Qc planned according to OPC and recorded into that forms.
‐ When applicable, quantity of raw materials,
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
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The organization dose identifies and manage required work environment needed to
achieve conformity of product.
There is no any sterile product in manufacture.
Exclusion Has been applied during all manufacturing processes for a controlled
Control of product cleanliness and contamination
environment but that is a class I work environment.
Has the organization identified product cleanliness
rules? No need to indicators for a controlled environment such as Temperature, Humidity, …
Have the materials and substances used during Last environmental audit was 94.11.17
manufacturing process been adequately defined and
There are many weekly records for cleanliness assessment.
labeled in order to prevent complexity and process
7.5.1.2.1 faults?
Have certain medical devices been cleaned and/or
We checked 94.6.7 and 94.11.15 records

It has some cleanliness information about personnel and infrastructure, according to
cleared of contamination so as to prevent employees conformity of products.
and other product from being exposed to any
Staff entry has air washing and place for change cloths and their shows.
contamination
Have cleaning and implementation requirements been WC place is out of product hall
documented? AC system is activated and air filtering is complete with HEPA filters.
The layout of row material and middle products place is on the pallets.
Personnel cleaning requirement is good
Overall; for this product classification, the GMP is enough.
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?
Service activities
In the event that functionality of products needs service
or maintenance for proper utilization of products, have
documented requirements been established for service
activity?
Has the organization identified service responsibilities
between distributors and users?
Have service activities carried out by the organization or
a separate agency been planned?
Have the design and functionality of equipment or
devices with special purpose related to manual
operation and service after assembly been validated?
7.5.1.2.3 Are measuring and test equipment used for site service NA
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
and technical support, customer training and spare
parts or provision of parts been established?
Are service personnel trained?
Are specialized service personnel available?
Has the organization formed a system for receiving
customer demands so as to determine whether
customer complaints and rules are handled?
Are service records retained?
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
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General rules
a)defined criteria for review and approval of the
process
b)approval of equipment and qualification of staff
involved
7.5.2.1 c) use of specific methods and procedures NA
d)records requirements
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
product through appropriate methods during product
7.5.3.1 realization?
How has the organization identified product situations
The organization has identified and documented the product by using some baskets.
And each basket has information label about QC situation. 
in accordance with tracing and measuring
requirements?
Each part of products has a LOT. Number. E.g.: B 941212 A 12
To explain that LOT:
TRACEABILITY Part 1: number of sewing machine
75.3.2.1 General Part 2: date of product
How is the product traced? Part 3: AM/PM
7.5.3.2 Has any method been documented for traceability?
Does the organization ensure traceability of the medical
Part 4: time of day of product
Production is by customer order and each order has a special LOT and that LOT is linked

device during typically production and storage process with all production steps and row material.
up to expiration of ownership? For above LOT., row material is 1064
So, for traceability, each fault in process can detect by Lot. Number and each flute in row
material can detect by material LOT. That use in form F02‐P04.
Special rules related to active implantable medical
devices and implantable medical devices
Does the organization ensure traceability in inspection
and stock records for the changes of the personnel
performing a work traceability of which belongs to an
7.5.3.2.2 introductory (e.g. serial number, data code, lot code,

party number) special to operation source, changes in NA
raw materials, changes in the works performed through
tools, new or different machine devices, changes of
process methods?
When applicable, are special personnel assigned to act
during processing medical device or each stage of
delivery traced?
Status Identification
7.5.3.3 Organization has identified status of product with According to 7.5.3.1
respect to measurement and monitoring requirements
CUSTOMER PROPERTY
Does the organization ensure identification, verification,
protection and safety of customer property provided
for product or in the manner that it creates product
while it is under the organization’s control or being
7.5.4 used? NA
Does the process ensure that occurrence of any
customer property that is lost, damaged or otherwise
found to be unsuitable for use are recorded and
reported to the customer?
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

PRESERVATION OF PRODUCT
Are methods and controls established to preserve
conformity of product during internal processing and
until delivery to intended destination?
Has the organization established documented processes Methods and controls are established to preserve conformity of product during
or documented work instructions for control of the processing.
product with limited shelf life or which requires special That product has limited shelf life and they established FIFO system to delivery products.
7.5.5 storage?
Are such special storage requirements controlled and
This preservation includes definition, packaging, storage and protection of the product
and the parts constituting the product. The warehouse manager has full control for

recorded? entries and exit and record that.
Does this preservation include definition, transport, E.g.: id form for exit row material for order number 284 in 94.10.01 for 1 roll blue tissue.
packaging, storage and protection of the product and
the parts constituting the product?
Is there a logo on product? Is it proper to its
instructions?
CONTROL OF MONITORING AND MEASURING DEVICES
Has the organization identified the measurements to be
made and the measuring and monitoring devices
required to ensure conformity of product to specified
requirement?
a) Be calibrated or verified at specified intervals, or
prior to use, against measurement standards traceable The organization has identified the measurements to be made and the measuring and
to international or national measurement standards; monitoring devices required to ensure conformity of product to specified requirement.
7.6 where no such standards exist, the basis used for
calibration or verification s hall be recorded;
So, there is very simple equipment to M&M in qc line.
Ruler for dimensional parameters and weighting‐machine for density.

b) Be adjusted or re‐adjusted as necessary; Calibration plan is annually and that’s calibrated by SEKA Co. in 94.9
c) Be identified to enable the calibration status to be
determined;
d) Be safeguarded from adjustments that would
invalidate the measurement result;
e) Be protected from damage and deterioration during
handling, maintenance and storage.
8 Measurement, Analysis and Improvement
General
Does the organization plan to implement the
The organization dose plan to implement the monitoring, measurement, analysis,
monitoring, measurement, analysis, and improvement
and improvement processes required for conformity of the product and QMS and
8.1
processes required for conformity of the product and
QMS and improvement of its efficiency?
improvement of its efficiency and measurement, analysis and improvement
processes are carried out through statistical techniques and applicable methods by

Are measurement, analysis and improvement
Analysis procedures.
processes are carried out through statistical
techniques and applicable methods?
8.2 Monitoring and Measuring
The organization monitor the information related to customer perception in order to
8.2.1 CUSTOMER SATISFACTION
understand whether customer requirements and determined methodologies for
Does the organization monitor the information related
obtaining and using information on customer satisfaction and/or dissatisfaction by
to customer perception in order to understand whether
8.2.1 customer requirements are met or not?
Has the organization determined methodologies for
corrective/preventive action procedure.
There is no any record for customer compliance and recall. 
Satisfaction of Motahari hospital observed.
obtaining and using information on customer
Level of satisfaction is good (80/100).
satisfaction and/or dissatisfaction?
They analysis that information in the management review meeting each 6 months.
INTERNAL AUDIT
Has a documented procedure been established that
includes responsibilities and requirements, The audits planned in the form of an audit program in 12 months by qualified person and
requirements for planning and conducting the audit, audit programe has taken importance and status of the fields and processes to be
reporting the results, maintaining the records? audited.
Are audits planned in the form of an audit program? There are 2 internal auditors (MD and technical supervisor) from two different
8.2.2
Does audit programme take importance and status of
the fields and processes to be audited including the
departments.
The last audit date is Jan 2016 and 8 NCRs detective in this audit.

results of previous audits? Action plan for resolved observed.
Do selection of auditors and implementation of audit It was effectiveness.
ensure objectivity and impartiality of the process?
Do auditors audit their works?
Do follow‐up actions cover verification of the measures
taken and reporting of verification results?
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

The organization implements appropriate methods for monitoring/ measurement QMS
MONITORING AND MEASUREMENT OF PROCESSES
processes according to a documented procedure.
Does the organization implement appropriate methods
e.g.:
8.2.3
for monitoring QMS processes and where applicable,
for measurement such WMS processes?
sales: increasing up to 20%
production: increasing customer up to 20%

When planned results are not achieved, is corrective
All indicators in progress until end of 1395 and MR make a progress report to make a
action taken for product conformity?
decision for not achieved targets.
8.2.4 MONITORING AND MEASUREMENT OF PRODUCT
General rules
Does the organization establish appropriate stages to
measure and monitor product characteristics? The organization establishes appropriate stages to measure and monitor product
Have verification methods been documented? characteristics by QC Plan documents.
Is this verification process realized in accordance with E.g.:
the arrangements planned during appropriate stages of There are some record for control in process:
8.2.4.1 product realization process?
Are conformity evidences along with acceptance criteria
For customer order no. 209 in 94.10:
Cutting: 94.12.9 time: 2 PM

maintained? Sewing: 94.12.12 time: 12 AM
Are the records approved by the authorized Packaging: 94.12.13 time: 8 AM
person/persons in the process of product release? Approved by QC manager
Are product release and distribution of service, planned
regulations (Article 7.1) completed satisfactorily?
Special rules related to active implantable medical
devices and implantable medical devices
8.2.4.2 Does the organization record the identity of the NA
personnel carrying out any inspection or test?
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 The organization dose has methodologies to ensure that product that does not conform
8.3
authorizing the non‐conformity’s use, release or
acceptance in agreement with customer?
to requirements is identified and controlled to prevent unintended use or delivery.
The organization dose takes measures to remove non‐conformity related to product, but 
Are required measures taken to preclude the product’s There is no any non‐conforming product.
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
Does the organization collect, identify and analyze
appropriate data to demonstrate efficiency and
The organization collect, identify and analyze appropriate data to demonstrate efficiency
appropriateness of QMS and the fields where QMS’s
and appropriateness of QMS and the fields where QMS’s efficiency can be continuously
efficiency can be continuously improved?
improved. The analysis is including:
Has a documented procedure been prepared for these
‐ Feedback, according to 8‐2‐1 is ok.
8.4
analyses?
‐ Product requirements, according to 8‐2‐4 and 8‐3 is ok and there is not any non‐ 

Do the characteristics and tendencies of the processes
conformity in products.
and products including data analysis, customer
‐ Opportunities for corrective actions, according to 8‐5‐3 there is no any situation
satisfaction, conformance to product requirements,
and record.
opportunities for corrective actions provide information
‐ Suppliers, according to 7‐4‐1 the supply grade are correct for organization.
related to suppliers?
Have data types for data analysis been defined?
Are data analyses recorded?
8.5 Improvement
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

CONTINUAL IMPROVEMENT
Has the organization identified required changes by
using quality policy, quality objectives, audit results,
analyses of data, corrective and preventive actions and
management review in order to ensure and sustain
ongoing conformity and efficiency of quality
management system and does the organization
implement such changes?
Has the organization established written procedures in
order that advisory warnings can be published and
implemented?
Are the records of all examinations related to customer
complaint maintained? The organization established written procedures in order that advisory warnings can be
Have the complaints been evaluated within the scope of published and implemented but the organization used that outputs onto IFU and user
the following points?: manual.
‐ whether the organization fails to comply with its own According to 8‐2‐1 there is no any customer compliance.
specifications or not, So the organization identified required changes by using quality policy, quality objectives,
8.5.1 ‐ whether the organization has caused problems to
occur despite the fact that it has complied with its own
audit results, analyses of data, corrective and preventive actions and management
review in order to ensure and sustain ongoing conformity and efficiency of quality

specifications management system and does the organization implement such changes according to
In the event that the activities outside the organization clause 5‐4
are identified through examination of the contribution According to organization objective there is an improvement project, that about new
of such activities to customer complaint, has the sterile products.
relevant information been shared among responsible
organizations?
In the event that any customer complaint is not
followed up through a corrective and/or preventive
action, has the reason of this failure been confirmed
and recorded?
Has the organization established a documented
procedure for notifying adverse events and alertness
within the scope of after‐sale supervision activities?
Does the process comply with international guides?
(MEDDEV 2.12.1 – MEDDEV 2.12.2)
Are the notices for adverse events recorded
8.5.2. CORRECTIVE ACTION
Is there a documented procedure for Corrective and
Preventive Action?
Are corrective actions taken to eliminate causes of
There is a documented procedure for Corrective and Preventive Action and corrective
nonconformities effective in preventing recurrences?
actions are taken to eliminate causes of nonconformities effective in preventing
Does this procedure include the requirements of
8.5.2 reviewing non‐conformities (including customer
complaints), determining the causes of non‐conformity,
recurrences. The organization uses this procedure about any product/process non‐
conformity according to product/customer needs. 
e.g.: internal audit non‐conformity reports.
evaluating the actions needed to ensure that
In warehouse need to use non‐wooden pallet.
nonconformities do not recur, determining and
implementing the corrective action needed, and review
of the results of the action initiated?
Is adequacy of corrective‐preventive actions identified?
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 one record for preventive action:
To delivery on time in last month of 1394, they increasing work time per shift. 
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
GMP Marketing

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:
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:
Clinical evaluation report does not exist
Observation Form-018 – with uniquely specific identification:
ATL:Marjan Azadmanesh DATE: 28 Feb 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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REVIEW OF REQUIREMENTS RELATED TO THE

Observation Form-018 – with uniquely specific identification:

ATL:Marjan Azadmanesh DATE: 28 Feb 2016

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

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