BRSM 
  QMSMDD ISO 13485 (2003) 

 
Assessment Report/Checklist 
Form 009 

 
CLIENT‐ORGANIZATION (NAME):    Teb Tajhiz Gharn 

PHYSICAL LOCATION(s):   No. 449 ,  Floor 3 ,  Tower  Bahar Street , sourth 
Bahar , Enghelab Ave. , Tehran , Iran. 

Stage II Audit Date(s):    16 & 17 Apr.2016   

Stage I Audit Date(s):    28 Feb 2016 

NAICS (or NACE) CODE MD0105, MD0204 

EXCLUSIONS:    7.3 /7.5.1.2.1/7.5.1.2.2/7.5.1.2.3/7.5.2/7.5.4/7.6

 
Assessment objectives: Attesting requirements of QMS MDD systems 
have been met in client’s management system 
 
 
ASSESSMENT TEAM INFORMATION 
Assessment Team Leader, ATL Mojtaba Ramezani 
Assessor 2 Marjan Azadmanesh 
TE  Fatemeh Montajebi 
Assessor 4
Assessor 5
Assessor 6
 
 
 
Note: Adjusting the language within this form to the type of activity and nature of the organization is acceptable.
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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). 
OBL of lenses includes : Foldable Hydrophilic ,Foldable Hydrophilic A+,
2  Scope of activities  Foldable Hydrophobic , Foldable Hydrophobic A+ , PMMA AC and PC ,
IRIS Retractors , Capsular tension Ring , injector & Cartridge
MOH requirements about OBL products and technical
Legal status  supervisor are responsible for meet and monitoring of  
3  these legal.
Obligatory applicable standard which 
IMED regulations     
organization has to follow 

4  Quality Management System 
GENERAL REQUIREMENTS 
Does the organization establish, document, implement, 
maintain and continually improve a Quality 
Management System (QMS) with due consideration 
given to  identification of processes needed for the 
QMS and their application throughout the system; 
Processes are: storage, purchasing, packing, control of
determination of sequence and interaction of these  non -conform product , training , contract review ,
4.1  processes, determination of criteria and methods 
required to ensure effective operation and control of 
corrective and preventive action. 
these processes; availability of resources and  Acceptance criteria are defined in M-3-01-00.
information required to support the operation and 
monitoring of processes; measurement, monitoring and 
analysis of the processes; implementation of action to 
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?  The Quality Manual (QM) was observed. All required
Is there a documented quality manual and are there 
documented procedures required by the standards??  standards clauses have been mentioned.
Are required records for planning, acting and controlling  They have developed quality policy (QP) by determining main
4.2  processes efficiently available?  targets
Are the documents are created for every type of 
medical device including qms requirements and product  Quality Objectives (QO) have been determined according to
specifications? (4.2.3) If these documents are applicable  the main targets of quality policy.
to manufacturing processes, are montage and service 
defined? 
QUALITY MANUAL 
Does the Quality Manual include, scope of QMS and 
details of exclusion?  Quality manual: M-0-01.
4.2.2  Are documented procedures 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  Control of documents and records: A-1-03-00.
traceable?  Responsibilities for approve and issued is determined in
Are the relevant documents usable, readable and 
4.2.3  recognizable at concerned usage points?  this procedure. Method for control of approved and non
Are outsourced documents defined?  approved and reviewed documents is determined in this
Are distribution of documents controlled, outdated 
documents prevented from being used and appropriate 
procedure 
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  According to records control procedure, records are kept

Are documents readable, easily recognizable and stored  properly, table of records was observed. Records are kept
in available manner? 
Has a documented procedure been established and  at least 2 years. Except for implants products which shall
4.2.4  applied for determination of required controls for  be recorded 99 years.
storage, retrieval, retention time and disposition of 
records?  Duration of keeping qc records is 2 years after packing of
Has the archiving defined for at least 2 years? 
products. 
5  Management responsibility 
MANAGEMENT COMMITTMENT 
Has the top management ensured that requirement for 
Top management communicated requirement for meeting
meeting customer conditions and legal conditions  customer conditions and legal conditions to personal by
should be understood by all personnel? 
weekly commission s. quality policy is available in
5.1  Is a quality policy available? 
Are quality objectives available?  production line and office. Management reviews has 
Is management review established? 
Does  the  management  provide  required  sources  for 
established and hold annually. Equipments for production
QMS?  processes provided.
CUSTOMER FOCUS  Methodology to customer relation has determined such as
5.2 
Does  top  management  have  methodologies  to  ensure 
that  customer  needs  and  expectations  are  determined  : customer survey form and customer complaints records 
and met for increasing customer satisfaction?  form. 
QUALITY POLICY 
Has top management established a Quality Policy in 
accordance with the objective of the organization? 
Quality policy M-0-03: improvement of sales,
Does the Quality Policy include a statement of  enhancement of personal awareness and customer
5.3  commitment to meeting requirements and continual 
improvement of the QMS? 
satisfaction. 
Has the Quality Policy been revised for communication, 
understanding and continuous compliance within the 
 
body of the Organization? 
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  Objectives of organization according to M-3-02-00 are:
Quality Policy 
increase of sale up to 30% , increase of customer
5.4  5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING 
Has the QMS been planned by Top Management in  satisfaction up to 5 %, improvement of awareness by 4

order to meet the conditions and quality objectives 
detailed in Section 4.1? 
hours training. Before September 2016 
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 
Responsibilities of packing and labeling department
observed on F-3-1-00 such as: control of sterility, control
5.5.1 
authority and been communicated within the 
organization? 
of primary packing, control of product cleaning and

Has top management defined responsibilities and 
authorizations for CE marking?  packing, control of warehouse bout correct situation , ….
MANAGEMENT REPRESENTATIVE 
Has  top  management  appointed  a  member  as 
Management  Representative  with  responsibility  and  Head of trading dept. is management representative. He
5.5.2 
authority to ensure that the processes of the QMS are 
established,  implemented  and  maintained;  report  to  is aware about his responsibilities. He approved by MD 
top  management  on  the  performance  of  the  QMS,  through Official letter 6 month ago.
including  needs  for  improvement  and  promote 
awareness of customer requirements? 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 3 of 15 
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INTERNAL COMMUNICATION  Organization chart: M-6-01-00 observed. Packing and

Has the top management ensured establishment of 
labeling department determined in that.
5.5.3 
appropriate communication processes within the 
organization? Has the top management ensured  
realization of communication considering the processes  Internal Communication is done facetoface, phone and
of the QMS and their effectiveness?  email.
5.6  Management review
TOP MANAGEMENT REVIEW 
Does top management review the QMS to ensure its 
continuing suitability, adequacy and effectiveness at 
Management review is planning every 6 mounts and has
5.6.1 
regular and planned intervals? 
Do reviews include assessing opportunities for  held on Feb 2016.  
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; 
b) customer feedback; 
All inputs has reviewed .such as: internal audit result,
5.6.2  c) process performance and product conformance; 
d) status of corrective and preventive actions;  customer feedback … 

e) follow‐up action from earlier management reviews; 
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  Review output are as equired such as:
5.6.3 
related to improvement of the QMS and its processes, 
improvement of product related to customer  training course about sales department 
requirements, actions and decisions relate to resource 
needs?  action for license from MOH for OBL products.  

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 
satisfaction by meeting requirements? 
6.2  Human Resources 
Are personnel assigned with responsibilities that affect 
product quality competent on the basis of applicable 
Human resources, infrastructure provided for support of
6.2.1  education, training, skills, and experience? 
Are  trainings  performed  for  achievement  of  Required  processes.

Competence? 
Needed qualifications for packing and labeling personal
are: awareness of products, statistic and packing process,
COMPETENCE, AWARENESS, AND TRAINING  requirements of ISO 9001, ISO 13485.
Has the organization identified the experience, 
qualifications, competencies and skills of the personnel  Mr. Asghari’s training schedule is based on training
performing activities affecting safety and efficiency of 
medical devices particularly being manufactured and 
needs which has been prepared by Management
provided to customer?   representative such as:
6.2.2 
Is training provided by the organization to satisfy the 
competency needs?  Course teamwork on end September 2015, effectiveness 
Does the organization ensure that its employees are  of course has been measured, it was 50, corrective action
aware of the relevance and importance of their 
activities and how they contribute to the achievement  has been observed, and root cause was the instructor, so
of quality objectives?  he has been considered as black list.
Are  records  of  education,  experience,  training  and 
qualifications maintained?  Course has been re-held on November 2015 and record
of effectiveness of course for Mr. Ashghari has been
observed on December 2015. His grade is 90 from 100. 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 4 of 15 
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INFRASTRUCTURE 
Has manufacturing equipment been designed, 
Equipment for labeling of product provided, labeling
constructed, properly established and placed for proper  section was clean, labeling rail’s disinfecting repot on
operation, maintenance, adjustment and cleaning?  
In case of applicability, has the organization ensured 
Dec 2015 has been observed.
documentation of natural limits or permissible  Activity for maintenance of this equipment has
tolerances in manufacturing process and measuring and 
test equipment and availability of the same for  determined.
6.3 
operators? 
Are documented processes available for maintenance, 
Labeling personnel shall have cap and gloves, GMP    
cleaning and control of all equipment used in  requirement has been done which accepted by IMED too.
manufacturing process and control of work 
environment?  Mr. Asghari, packaging operator has been observed he
Are required adjustments and maintenance intervals  had gloves and cap.
identified?  
Is maintenance plan placed normally on or near the  His health card has been observed which is valid before
equipment and easily reachable? 
Is maintenance realized based on the relevant plan? 
August 2016. 
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?  
Has exclusion been applied during all manufacturing 
processes for a controlled environment? As valid 
ground of exclusion, is pollution reduced to known, 
consistent and controlled level by an approved cleaning  For labeling of finished products, no need special
method and packaging kept at this level through control 
process? 
environmental requirements. Labeling is doing in general
Have indicators been identified for a controlled  situations and storage of products must be done in
environment which covers valid cleaning and packaging  accordance with requirements on label. Control of
processes including the organizations holding a valid 
6.4  cleaning process?  warehouse environment situations is doing by head of    
(Temperature, Humidity, Air Current, Filtration of Air,  warehouse by thermometer and humidity meter in
Ionization of Air, Pressure differences, Lighting (along 
with its spectral content and severity), Sound, Vibration,  warehouse. The records show temperature between 18c
cleaning of Working surfaces and processes, Water  to 25 c.
quality, number of persons in the work environment) 
 Have dressing conditions, cleaning conditions and  Records kept in this dept. 
health conditions for any person being in contact with 
the product or the work environment including those 
persons who enter the area sterilized prior to use or 
temporarily or for a short period in terms of importance 
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? 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 5 of 15 
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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, 
tracking, measuring, inspection and product‐specific 
test activities , realization processes and the product 
meet the rules? 
In the event that inspection and test are conducted by 
Risk analysis instruction observed: B-3-01.
manufacturing personnel, do inspection and test  Record of risk analysis form observed: B-3-10.
results, processes, organization’s procedures ensure 
impartiality of inspection and test results?  Hazard about labeling and packing identified
7.1  Risk management   completely such as: no label of product specification  

 
Has the organization prepared a procedure containing 
all processes of product realization for risk management  in pack, un correct expiry date (more than 3 years) ,
activities and realized the following? 
Keeping the records 
… and effects and causes of these failures
Preparation of Risk Management Plan  determined completely.
Determination of Risk team and its Responsibilities 
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  Orders from customer received and then must be
‐ anticipated utilization, 
‐ Performance expectations,   record in order form. Because of no license product
‐ Design factors  from MOH , organization cannot sale and no
7.2.1  ‐ Delivery plans     
‐Unclear customer expectations  records of sale observed.
 Does the organization record customer’s expectations 
related to product/service in order to revise the same?  As a Sample order form which was contain Delivery
In the event of any change in order or offer or both for 
any reason whatsoever, are changes revised and an  time, amount, product Code was observed. 
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 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 6 of 15 
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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  Contract review is done by check of time delivery
7.2.2 
the  organization  for  provision  of  the  product  to 
customer? 
and warehouse inventory when order received. If    
Has the organization ensured settlement of contract or  inventory is sufficient, order delivered on time. Else
order requirements which are different from previously 
defined?  time delivery set by production planning. 
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,  Communication with customers be done by:
7.2.3 
applications, contracts or realization of order including 
amendments?  provision of user manual, catalogue And website   
Are required arrangements identified and implemented 
for customer feedback and communication with 
through phone, email,fax or facetoface 
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  excluded     
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  Excluded     
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  Excluded     
‐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  Excluded     
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  Excluded     
that design output meets input criteria 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 7 of 15 
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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?  Excluded     
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  Excluded     
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 
Supplier’s evaluation checklist: B-3-02 observed.
controlled and the products or services conform to the  Supplier (producer of lenses) evaluated about :
7.4.1 
rules of the organization containing customer demands 
and regulatory rules?  credit of supplier , on-time delivery , quality of   
Have the requirements of purchasing information 
(containing the rules related to supplier records) 
product , … score was : 88 and was acceptable
including outsourced processes been identified to  score. (Acceptable range is more than 70).
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  For purchasing of finished products from main
7.4.2 
process and equipment, Personnel qualification and the 
requirements of Quality Management System?  producer, name and code of product announces to   
How does organization ensure the adequacy of 
specified requirements in the purchasing information 
main producer.
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?  
After purchasing of finished product from main
Do the processes include the provisions in order to  producer, these products verified according to
verify that incoming product is provided along with 
packing instruction.  Such as: serial 15322 qc record 
7.4.3 
support documentation (e.g. conformity certificates, 
acceptance test reports)?  has been observed regarding document review and  
Has data been provided related to analysis of previous 
acceptance inspection data, rejection history in the  quantity on12/6/1394 August 2015. 
plant or customer complaints, required inspection 
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? 
Has  appropriate  equipment  been  selected  in  the 
manner that enables process and product specifications 
to be obtained?  Packing of product instruction documented:
Have  the  documents  for  using  appropriate  equipment 
been established? 
labeling, insert of catalog and specification, packing.
Has  it  been  verified  that  new  and/or  significantly  Controls of products packed primary has defined
modified  equipment  meets  purchasing/design 
specifications  and  posses  the  ability  to  operate  within  according to risk analysis, such as : control of hazard
7.5.1  the limits defined and process operating limits?   about un correct exp. Date of products and also 

 
Have control devices been identified? 
Has  a  document  been  prepared  for  using  control  information with packing for every product are
devices? 
Have  implementation  and  control  requirements  for 
different from others . This controls during packing
labeling and packaging been identified?  has defined completely in packing instruction Q-6-
Are the records obtained during manufacturing process 
of  any  product  lot  and  facilitating  traceability  and  01.  
review of the manufacture of this lot retained?  
Do the records include the following information? 
‐  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 
Control of product cleanliness and contamination  
Has the organization identified product cleanliness 
rules?  Cleaning includes: sterilization of product be done
Have the materials and substances used during 
manufacturing process been adequately defined and  by main producer and this clause excluded.
labeled in order to prevent complexity and process  Record of cleanness monitoring for 15/6/1394 has
7.5.1.2.1  faults? 
Have certain medical devices been cleaned and/or  been observed signed by Technical supervisor,
  
cleared of contamination so as to prevent employees 
and other product from being exposed to any  report of cleaning for same week has been observed
contamination  with signed by manufacturing manager. 
Have cleaning and implementation requirements been 
documented? 

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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  excluded   
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  Excluded   
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  Organization received sterilization records tracked
related to sterilization process and used for each 
7.5.1.3  sterilization lot?  for each production lot from producer .records of  
Are sterilization records tracked for each production lot 
related to medical devices? 
Dec 2015 were observed. 
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 
7.5.2.1  c) use of specific methods and procedures  excluded   
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  excluded   
process been identified and implemented? 
Have the requirements in the Article no.  7.5.2.1 been 
met? 
7.5.3  Identification and Traceability 

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Identification 
Has the organization identified and documented the 
product through appropriate methods during product  Identifying and traceability procedure: P-1-02-00
7.5.3.1  realization? 
How has the organization identified product situations  documented.
  
in accordance with tracing and measuring 
requirements? 
In P-1-02-00, method of identifying and traceability
TRACEABILITY  are Compatible to real lot no. batch No. on pack of
75.3.2.1  General 
How is the product traced? 
product. Such as: in pack of hydrophilic, lot no. has
7.5.3.2  Has any method been documented for traceability? 
Does the organization ensure traceability of the medical 
checked. Identifying of lot No. and batch No. done   
device  during  typically  production  and  storage  process  by main producer and this organization do not
up to expiration of ownership? 
change these specifications. Such as: batch 012549
which has been bought for Mrs. Amiri Hospital toos.
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  For all lenses has determined patient card for record
performing  a  work  traceability  of  which  belongs  to  an 
7.5.3.2.2  introductory  (e.g.  serial  number,  data  code,  lot  code, 
of patient and surgeon name. On pack of these
 
party  number)  special  to  operation  source,  changes  in 
raw materials, changes in the works performed through 
products recorded barcode for trace of product to   
tools,  new  or  different  machine  devices,  changes  of  customer. Such as code 012549 which has been
process methods? 
When applicable, are special personnel assigned to act 
bought for Mrs. Amiri left eye in toos Hospital.
during  processing  medical  device  or  each  stage  of 
delivery traced? 
Status Identification  In warehouse observed products ready to sale and all
7.5.3.3  Organization  has  identified  status  of  product  with 
respect to measurement and monitoring requirements  of them have complete labeling.
  
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?  Excluded  
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? 
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 
Storage , handling and keeping of product procedure has
or documented work instructions for control of the  documented : F-1-03. Storage temperature has
product with limited shelf life or which requires special 
determined : 18-25◦c. up to 5 pack must be put in shelf
7.5.5  storage? 
Are such special storage requirements controlled and  of warehouse. Size of packing for lenses determined in   
recorded? 
Does this preservation include definition, transport, 
this procedure. Storage situation checked and all
packaging, storage and protection of the product and  requirements has meet. Such as : storage temperature.
the parts constituting the product? 
Is there a logo on product? Is it proper to its 
instructions? 

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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 
to international or national measurement standards; 
7.6  where no such standards exist, the basis used for  excluded  
calibration or verification s hall be recorded;  
b) Be adjusted or re‐adjusted as necessary;  
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 
monitoring, measurement, analysis, and improvement 
measurement, analysis and improvement processes are
processes required for conformity of the product and  carried out through statistical techniques and
8.1     
QMS and improvement of its efficiency? 
Are measurement, analysis and improvement 
applicable methods according to Statistic analysis
processes are carried out through statistical  procedure 
techniques and applicable methods? 

8.2  Monitoring and Measuring 
Customer satisfaction is handling by procedure: B-2-02.
Every 6 mounts.
8.2.1 CUSTOMER SATISFACTION  Customer survey is done based on: function, safety,
Does the organization monitor the information related 
to customer perception in order to understand whether  reliability, quality, packing …
8.2.1  customer requirements are met or not? 
Has the organization determined methodologies for 
Because of no license product from MOH, organization   
obtaining and using information on customer  cannot sale and no customer survey collected. But
satisfaction and/or dissatisfaction?  procedure is as requirement.
For sample and mock a form has been completed.
 
INTERNAL AUDIT 
Has a documented procedure been established that 
includes responsibilities and requirements, 
Internal audit procedure: A-1-04-00.needed qualification
requirements for planning and conducting the audit,  for audit team is determined in this procedure. Intervals
reporting the results, maintaining the records? 
Are audits planned in the form of an audit program? 
for internal audit are every 6 mounts. first internal audit
has held on Feb.2016. Planning of internal audit : A-3-
8.2.2 
Does audit programme take importance and status of 
the fields and processes to be audited including the  09-00 observed. all processes has audited. Questions and   
results of previous audits? 
Do selection of auditors and implementation of audit  evidence of audit recorded in audit checklist A-3-06-00.
ensure objectivity and impartiality of the process? 
Do auditors audit their works? 
One non conformity observed in internal audit(about
Do follow‐up actions cover verification of the measures  training effectiveness)  
taken and reporting of verification results? 

MONITORING AND MEASUREMENT OF PROCESSES 
Processes has measured based on acceptance
Does the organization implement appropriate methods  criteria. result of measuring observed according to
8.2.3 
for monitoring QMS processes and where applicable, 
for measurement such WMS processes?  analysis of data procedure .sample :purchasing   
When planned results are not achieved, is corrective 
action taken for product conformity? 
process that measured based on time purchasing and
result was 100%
8.2.4  MONITORING AND MEASUREMENT OF PRODUCT 

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General rules 
Does the organization establish appropriate stages to 
measure and monitor product characteristics? 
Test and investigation procedure: Q-1-01-00.
Have verification methods been documented?  Controls before and during of packing according to
Is this verification process realized in accordance with 
the arrangements planned during appropriate stages of  risk analysis such as: exp. Date , specification on
8.2.4.1  product realization process? 
Are conformity evidences along with acceptance criteria 
label and supplier qc report shall be done.   
maintained?  For lot: 012638s 20150056 , batch no.: 012638 .
Are the records approved by the authorized 
person/persons in the process of product release? 
Items must be controlled records observed on record
Are product release and distribution of service, planned  Q-3-01-00.
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  excluded  
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  Procedure for control of non conforming products
8.3 
authorizing the non‐conformity’s use, release or 
acceptance in agreement with customer?  has documented but no records observed.   
Are required measures taken to preclude the product’s 
original intended use or application? 
Responsibilities have determined.
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 
appropriateness of QMS and the fields where QMS’s 
efficiency can be continuously improved? 
Analysis of data for result of processes measuring
Has a documented procedure been prepared for these  observed. Results were in acceptable range and no
8.4 
analyses? 
corrective and preventive action defined. Also 

 
Do the characteristics and tendencies of the processes 
and products including data analysis, customer  analysis of supplier performance (main producer)
satisfaction, conformance to product requirements, 
opportunities for corrective actions provide information  observed and results were acceptable. 
related to suppliers? 
Have data types for data analysis been defined? 
Are data analyses recorded? 

8.5  Improvement 

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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? 
Have the complaints been evaluated within the scope of 
the following points?:  Instruction for customer complaints management
‐  whether the organization fails to comply with its own 
specifications or not, 
observed: B-2-03-00.
8.5.1  ‐ whether the organization has caused problems to 
occur despite the fact that it has complied with its own 
Recall procedure has documented.   
specifications  Corrective and preventive and improvement
In the event that the activities outside the organization 
are identified through examination of the contribution 
procedure: A-1-05-00. 
of such activities to customer complaint, has the 
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 
nonconformities effective in preventing recurrences? 
Does this procedure include the requirements of  Records of corrective action observed. The effectiveness
8.5.2  reviewing non‐conformities (including customer 
complaints), determining the causes of non‐conformity, 
was checked.(records of internal Audit non-conformity,   
evaluating the actions needed to ensure that  related to training effectiveness were checked). 
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  No records of preventive action observed.   
preventive  action  needed;  recording  results  of  action 
taken; reviewing preventive action taken. 
What are the methods for identifying the adequacy of 
corrective‐preventive actions? 
 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 14 of 15 
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

Management commitment Inventory control 
 

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:

TTG‐08‐2016: No customer feedback observed, as Iran’s regulation, company can not sale before IMED certificate, so customer 
feedback analysis is not possible 

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

ATL: Mojtaba Ramezani DATE: 17 Apr 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