BRSM 

Systems: QMSMDD ISO 13485 (2003) 

Assessment Report/Checklist 
Form 009 

 
CLIENT‐ORGANIZATION (NAME):   
ElectroMed Persian Toos

PHYSICAL LOCATION(s):  
Khorasan Science and Technology Park, 12end
km Mashad-Ghoochan Road, Iran
Stage II Audit Date(s):   
2&3 May 2016
Stage I Audit Date(s):   
23 April 2016

NAICS (or NACE) CODE
MD0106
 

EXCLUSIONS:    7.3, 7.5.4, 7.5.3.2.2, 7.5.1.2.2, 7.5.1.2.3

 
 
Assessment objectives: Verifying the company’s scope and
documentation for the requested regulators and
ISO13485:2003 & IMED requirements to protect
consumers and communities 
 
 
ASSESSMENT TEAM INFORMATION 
Assessment Team Leader, ATL Farhang Mohajer
Assessor 2 Milad Pourhasan
TE  
 
 
 
 
 
 
 
 
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). 

2  Scope of activities  Manufacture of Cardiac Tissue Stabilizer 

ISIRI certificate: Not Applicable

Legal status  Ministry of Industrial and mines certificate: 315918  
3  IMED Certificate: 664/319440
Obligatory applicable standard which  Technical supervisor certificate: 9003208-1130049
organization has to follow    
Applicable ISIRIs: not developed 
4  Quality Management System 
GENERAL REQUIREMENTS 
Does the organization establish, document, implement, 
maintain and continually improve a Quality 
Management System (QMS) with due consideration  In audit stage I, the lead auditor checked the developed
given to  identification of processes needed for the 
QMS and their application throughout the system; 
documentation, legal requirement & GMP regulation
determination of sequence and interaction of these  coverage method; all major documents have been
4.1  processes, determination of criteria and methods 
required to ensure effective operation and control of 
mentioned in audit stage I report (002); 
these processes; availability of resources and  For each process there is a specific Process profile
information required to support the operation and 
monitoring of processes; measurement, monitoring and 
(FQM07) such as production process with criteria of the
analysis of the processes; implementation of action to  rate of deviation from the production plan; Process Map
achieve  planned results and continual improvement 
‐If any, are the outsourced processes are defined? 
(FQM04) was observed. This map indicates the
DOCUMENTATION REQUIREMENTS   interaction between processes.
Is there a documented quality policy and documented  Quality policy (FMD04) & Quality objective (FMD05)
quality objectives and are they appropriate? 
Is there a documented quality manual and are there  has been developed which are discussed in related clause.
documented procedures required by the standards?? 

4.2 
Are required records for planning, acting and controlling 
processes efficiently available?  
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 (MMD01-R00) was checked; it has been
developed based on ISO13485:2003. ISO14971:2007 and
QUALITY MANUAL  IMED regulations; the clauses 7. 7.3, 7.5.4, 7.5.3.2.2,
Does the Quality Manual include, scope of QMS and 
details of exclusion?  7.5.1.2.2, 7.5.1.2.3 are excluded and clause 8.2.4.2 is not
4.2.2  Are documented procedures reference to mandatory 
procedures; 
applicable. The exclusion justification is about the 
Is description of interaction of the processes included in  product nature.
the QMS?  All applicable clauses are discussed and explained in
their related sections.

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 2 of 18 
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CONTROL OF DOCUMENTS 
Are mandatory procedures documented? 
Are control conditions pertaining to mandatory 
documents proper?  Document procedure (PQM01) & records control
Are review, update and re‐approval situations and  procedure (PQM02) were observed. Master list (FQM01)
changes and current review situations for documents 
traceable?  including determination of document distribution method
4.2.3  Are the relevant documents usable, readable and 
recognizable at concerned usage points? 
was checked. Because of the organization context and 
Are outsourced documents defined?  size and processes complexity and established processes,
Are distribution of documents controlled, outdated  all documents are distributed paper-based; In each
documents prevented from being used and appropriate 
definition method applied in case of being stored for 
department the related documents are maintained for
any purpose?  example the document distribution in storage &
Are these subjects clear in the relevant procedure?  Purchasing departments were checked.
 CONTROL OF RECORDS  Retention period for all records are defined in related
Are documents readable, easily recognizable and stored 
in available manner?  form (FQM02), for example the records of purchasing
activities are maintained for 3 years. 
4.2.4 
Has a documented procedure been established and 
applied for determination of required controls for 
 

storage, retrieval, retention time and disposition of 
records? 
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  Managing director by developing quality policy,
should be understood by all personnel? 
assigning management representative, required resources
5.1  Is a quality policy available? 
Are quality objectives available?  for establishing & maintaining the quality management 
Is management review established?  system has presented his commitment.
Does  the  management  provide  required  sources  for 
QMS? 
Customer satisfaction approach has been mentioned in
quality policy; Customer feedback procedure (PCF01)
CUSTOMER FOCUS  has been developed; also by conducting management
5.2 
Does  top  management  have  methodologies  to  ensure 
that  customer  needs  and  expectations  are  determined 
review & internal audit top management monitors the 
and met for increasing customer satisfaction?  customer satisfaction and organization performance in
customer focus approach.
  
QUALITY POLICY 
Has top management established a Quality Policy in 
accordance with the objective of the organization? 
Quality policy (FMD04) has been developed in Oct-15,
Does the Quality Policy include a statement of  the main targets in quality policy are as follows:
5.3  commitment to meeting requirements and continual 
improvement of the QMS? 
1- Increasing staff awareness & knowledge 
Has the Quality Policy been revised for communication,  2- Continual improvement in processes & products
understanding and continuous compliance within the 
body of the Organization? 
3- Increasing market share
QUALITY OBJECTIVES  Organization has developed 3 Quality objectives
Are quality objectives established by top management  (FMD05) which as follows:
at relevant functions and levels within the organization? 
Are the objectives measurable and consistent with the  1- Increasing training man/hrs to 30
Quality Policy  2- Increasing product diversity to 2 new products
5.4  5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING 
Has the QMS been planned by Top Management in  3- Increasing number of customers 
order to meet the conditions and quality objectives  All developed objectives are planned with sub-
detailed in Section 4.1? 
When changes are initiated, is the integrity of the QMS  actions(FMD06), responsible and related time table.
maintained during the change process? 

5.5  Responsibility, Authority and Communication

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 3 of 18 
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Organization chart (FMD01) was observed. All identified

RESPONSIBILITY AND AUTHORITY  job positions with indicating interaction between them
Has top management identified responsibility and  were checked. Organization chart has been developed in
5.5.1 
authority and been communicated within the 
organization?  May-2015. 
Has top management defined responsibilities and  They have developed Job description (FTR01) for all job
authorizations for CE marking? 
positions were checked such as production operator &
storage responsible.
MANAGEMENT REPRESENTATIVE 
Has  top  management  appointed  a  member  as 
Management  Representative  with  responsibility  and  Top management has assigned Mrs. Zinati (QC manager)
5.5.2 
authority to ensure that the processes of the QMS are 
established,  implemented  and  maintained;  report  to  as management representative with an official letter in 
top  management  on  the  performance  of  the  QMS,  May-15 with letter number of 94/K/80.
including  needs  for  improvement  and  promote 
awareness of customer requirements? 

Based on the Organization chart (FMD01) and Quality

INTERNAL COMMUNICATION 
Has the top management ensured establishment of 
manual (MMD01-R00) and conducted site visit, internal
communication is handling by phone, official letter and
5.5.3 
appropriate communication processes within the 
organization? Has the top management ensured 
information boards. For example the official letter on

realization of communication considering the processes 
of the QMS and their effectiveness?  storage board about internal communication with QC
department in Aug-15 was observed.
5.6  Management review
TOP MANAGEMENT REVIEW 
Does top management review the QMS to ensure its 
continuing suitability, adequacy and effectiveness at 

5.6.1 
regular and planned intervals? 
Do reviews include assessing opportunities for  
improvement including the need for changes to the 
QMS, quality policy, and quality objectives?  Management review procedure (PMD01) was checked;
Are management review records kept? 
 REVIEW INPUT 
the first meeting was conducted in 28-Jan-16. All
Does review input include current performance and  determined inputs have been discussed and decided
improvement opportunities related to:  outputs in were about:
a) results of audits; 
b) customer feedback;  - Changing clean room control plan
5.6.2  c) process performance and product conformance; 
d) status of corrective and preventive actions;  - Gathering all test report from the suppliers 
e) follow‐up action from earlier management reviews;  - Calibration of the thermometer and humidity
f) changes that could affect the QMS,  
g) recommendations for improvement  meter
h)  New or revised regulatory rules? 
All aforementioned outputs have responsible and
REVIEW OUTPUT  timetable.
Does output from management review include actions 
5.6.3 
related to improvement of the QMS and its processes, 
improvement of product related to customer  
requirements, actions and decisions relate to resource 
needs? 

6  Resource Management
PROVISION OF RESOURCES 
Does the organization have methods to determine and 
Organization has developed specific procedure for each
6.1  provide resources needed to implement and improve 
the processes of the QMS and address customer 
type of resources management; by conducting site visit, 
satisfaction by meeting requirements? 
preparations of required resources are appropriate.  
6.2  Human Resources 
Are personnel assigned with responsibilities that affect 
product quality competent on the basis of applicable  Training procedure (PTR01) was checked;
6.2.1  education, training, skills, and experience? 
Are  trainings  performed  for  achievement  of  Required 
Staff profile (FTR03) for Mr. Kaviani & Mr. Najmabad 
Competence?  were observed.

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 4 of 18 
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Training need evaluation (FTR002) records in June-15

COMPETENCE, AWARENESS, AND TRAINING 
Has the organization identified the experience,  for all department & Training schedule (FTR005) with
qualifications, competencies and skills of the personnel  determination of 9 courses such as “clean room
performing activities affecting safety and efficiency of 
medical devices particularly being manufactured and  maintaining” was observed.
provided to customer?   Training course record for “clean room maintaining”
6.2.2 
Is training provided by the organization to satisfy the 
competency needs?  Dec-15 with evaluation of training effectiveness 
Does the organization ensure that its employees are  (FTR009) of them were observed:
aware of the relevance and importance of their 
activities and how they contribute to the achievement  Mr. Kaviani with grade of 74% Mr. abrizgan with grade
of quality objectives?  81%
Are  records  of  education,  experience,  training  and 
qualifications maintained? 
And for the “FMEA principles” course in Aug-15:
Mr. abrizgan with grade of 71%
INFRASTRUCTURE 
Has manufacturing equipment been designed, 
PM procedure (PPM01) has been developed.
constructed, properly established and placed for proper  Equipment list (FPM01) with identifying 21 equipment
operation, maintenance, adjustment and cleaning?  
In case of applicability, has the organization ensured 
was checked. Each equipment has a specific profile
documentation of natural limits or permissible  (FMP02) such as air handling unit, air compressor,
tolerances in manufacturing process and measuring and 
test equipment and availability of the same for 
ultrasound, cable tensile machine; annual maintenance
schedule (FMP03) for air handling unit including the
6.3 
operators? 
Are documented processes available for maintenance,  records of changing heap & bag filters were observed.   
cleaning and control of all equipment used in 
manufacturing process and control of work  Repairing request form (FMP04) for ultrasound in Nov-
environment?  15 and record of repairing with code of (FMP05) was
Are required adjustments and maintenance intervals 
identified?   checked.
Is maintenance plan placed normally on or near the  Washing & disinfecting Work Instruction (WQM04) and
equipment and easily reachable? 
Is maintenance realized based on the relevant plan?  related control record in developed checklist in Sep- 15

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 5 of 18 
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WORK ENVIRONMENT  were observed.

Does the organization identify and manage required 
work environment needed to achieve conformity of 
product?  Particle control Work Instruction (WQM05), Clean room
Are the following factors which could affect product 
quality in the work environment identified?   washing and disinfection plan and record of controlling
‐ Process equipment,   the clean room cleanliness in Nov-15 was checked.
‐ Work environment,  
‐ Personnel in this work environment   the record of clean room particle measuring by ‘Kian
Are qualified and quantified limit values of the work  gostaresh salamat asia” in Jan-16 according to the ISO
environment identified for a desired quality of the work 
environment?  14644-1 & BS5295; clean room class is determined
Are pollution levels of microbial and solid particles  100000:
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 
method and packaging kept at this level through control 
process? 
Have indicators been identified for a controlled 
environment which covers valid cleaning and packaging 
processes including the organizations holding a valid 
6.4  cleaning process? 
(Temperature, Humidity, Air Current, Filtration of Air, 
  
Ionization of Air, Pressure differences, Lighting (along 
with its spectral content and severity), Sound, Vibration, 
cleaning of Working surfaces and processes, Water  Staff Health Work Instruction (WQM02), Personal health
quality, number of persons in the work environment) 
 Have dressing conditions, cleaning conditions and  monitoring checklist records in Jan-16 was checked. The
health conditions for any person being in contact with  report of clinical test for Mr. abrizgan in Dec-15
the product or the work environment including those 
persons who enter the area sterilized prior to use or  generated by Health and safe work environment center of
temporarily or for a short period in terms of importance  Mashad was observed.
microbiologic cleaning holds been identified?  
Are personnel to work in special work conditions or a 
controlled environment provided with special training  5S Work Instruction (WQM01) has been developed and
and/or supervision? In the event that any personnel 
including temporary and trained personnel for  observed.
performance of special tasks in a controlled 
environment are assigned for performance of the works 
such as production, maintenance, cleaning or repair, are 
such personnel supervised by an appropriately trained 
person? Have the procedures for product introduction, 
product polluted or being likely to be polluted, manual 
working for working surfaces or personnel, cleaning or 
removal of contamination in order to prevent cross 
pollution of product, work environment or personnel? 
Are  the  records  indicating  appropriateness  for  all 
conditions kept? 

7  Product Realization 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 6 of 18 
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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  Risk management procedures (PQM08), FMEA for risk
rules, processes established, documents and product‐
specific necessary resources, verification, validation, 
assessment work instruction (WQM03) were observed.
tracking, measuring, inspection and product‐specific  . Essential requirement checklist, risk occurrence table
test activities , realization processes and the product 
meet the rules? 
(FQM23 ), risk assessment table (FQM24) was checked
In the event that inspection and test are conducted by  for example:
manufacturing personnel, do inspection and test 
results, processes, organization’s procedures ensure 
- Hazard type: sharp edges because of the problem
impartiality of inspection and test results?  in designing the product PQ
7.1  Risk management  
Has the organization prepared a procedure containing 
- Failure effect: inappropriate performance and AR  M08
all processes of product realization for risk management  causing infection ‐R00 
activities and realized the following? 
Keeping the records 
- Severity (4), occurrence(5), detection (3), RPN =
Preparation of Risk Management Plan  60
Determination of Risk team and its Responsibilities  - Required action: design modification
Determination of Intended Use of Device and Safety 
Characteristics of Device  And
Definition of hazards 
Risk Estimation for Hazards 
Evaluation of Risks  - Hazard type: pieces breaking because of the
Risk Control Measures  problem in raw material quality
Definition of Residual Risks  
Risk/Benefit Analysis  - Failure effect: inappropriate performance
Preparation of Risk Management Report  - Severity (3), occurrence(3), detection (4), RPN =
DETERMINATION OF REQUIREMENTS RELATED TO THE 
PRODUCT/SERVICE  36
Has the organization defined the requirements of  - Required action: 100% QC of the raw material
customer including the requirements for the activities 
on delivery and after delivery?  - In one Case RPN risk was not Appropriate,)(for
Do these requirements include the following?:  risk of wrong labeling)
‐ regulatory and legal requirements related to the 
countries and territories where the product is supplied 
to the market  -
‐ anticipated utilization, 
‐ Performance expectations,  
QC procedure (PQC01) has been developed. Product
‐ Design factors  OPC in form of (FPR01) was checked. The product
7.2.1  ‐ Delivery plans   

 
‐Unclear customer expectations  BOM (FPR04) was observed. Technical file was
 Does the organization record customer’s expectations 
related to product/service in order to revise the same?  observed. All main processes including risk assessment
In the event of any change in order or offer or both for  result and methodology were mentioned.
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 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 7 of 18 
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Sales & Contract review procedure (PSA01) was

REVIEW  OF  REQUIREMENTS  RELATED  TO  THE 
PRODUCT/SERVICE 
observed.
Does the organization review the requirements related  All customer orders are recorded in order registry form
to the product? 
Are review records kept? 
(FSA01) for “Javad alaemeh hospital” in Mashad city in
Has  this  review  been  realized  prior  to  commitment  of  Aug-15 for 60 pcs was observed. The organization has
the  organization  for  provision  of  the  product  to 
not reached to mass production level. So this is the only
7.2.2  customer? 
Has the organization ensured settlement of contract or  real order and sale record, the previous delivery of the   
order requirements which are different from previously  products was only for the purpose of gathering data of
defined? 
Does the organization have the ability to meet defined  product performance from the users.
requirements?  According to the developed procedure, all required items
Are the results of review and subsequent follow‐up 
actions recorded?  from the customer are recorder in registry form and any
changes will be amended to the mentioned form.
CUSTOMER COMMUNICATION 
Are arrangements for communication identified and  Customer communication is done through telephone
implemented relating to product information, demands,  lines, email, official letter and fax; this has been
7.2.3 
applications, contracts or realization of order including 
amendments?  explained in quality manual. The communication record   
Are required arrangements identified and implemented  with “Javad alaemeh hospital” in Mashad city for
for customer feedback and communication with 
customers including customer complaints?  finalizing the devlivery date in Aug-15 was observed.
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 
 
7.3.1 
appropriate to each design and/or development stage, 
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 

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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 
7.3.7 
implementation? 
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?  Purchasing & Supplier evaluation procedure (PPU01)
Does the organization have the proofs indicating that  Was observed.
supplier monitoring activities, outsourced processes are 
controlled and the products or services conform to the 
The records of purchasing order (FPU03) for loosening
grease in Dec-15was checked.
7.4.1 
rules of the organization containing customer demands 
and regulatory rules? 
Supplier list (FPU05) with determination of 14 suppliers
  
Have the requirements of purchasing information 
(containing the rules related to supplier records)  observed.
including outsourced processes been identified to 
ensure product and service quality? 
Supplier evaluation checklist (FPU06) for testa lab with
Does the organization have the methodology to  grade of 70%, shahab kian arman with grade of 75%, was
communicate these requirements to the supplier? 
Are purchasing contracts available? 
checked. Also the record of periodic evaluation of
Do the type and content of the control on supplier and  supplier in (FPU07) for fara fan toos with grade of 85%
purchased product depend on the next product  was observed.
realization of purchased product or final product? 
Are purchasing records retained? 
PURCHASING INFORMATION  Verification of purchased product is executed according
Does purchasing information define the product to be 
purchased?  to the developed QC procedure (PQC01) for example the
Where appropriate, does purchasing information  record of QC for packaging nylon in Jan-16 in form of
include product approval, procedures, requirements for 
(FQC02) was observed.
7.4.2 
process and equipment, Personnel qualification and the 
requirements of Quality Management System?    
How does organization ensure the adequacy of 
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?  
Do the processes include the provisions in order to 
verify that incoming product is provided along with 

7.4.3 
support documentation (e.g. conformity certificates, 
acceptance test reports)?  
Has data been provided related to analysis of previous 
acceptance inspection data, rejection history in the 
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  Production procedure (PPR01)
manner that enables process and product specifications 
to be obtained? 
was observed.
Have  the  documents  for  using  appropriate  equipment  The record of production planning (FPR01) in Aug 15
been established? 
Has  it  been  verified  that  new  and/or  significantly 
was checked; it had been planned to produce 200 pcs.
modified  equipment  meets  purchasing/design  Production report (FPR02) for Aug-15 which was about
specifications  and  posses  the  ability  to  operate  within 
210 pcs was observed.
7.5.1  the limits defined and process operating limits?  
Have control devices been identified?  The organization has not reached to mass production
  
Has  a  document  been  prepared  for  using  control 
devices? 
level. So this is the only real order and sale record, the
Have  implementation  and  control  requirements  for  previous delivery of the products was only for the
labeling and packaging been identified?  purpose of gathering data of product performance from
Are the records obtained during manufacturing process 
of  any  product  lot  and  facilitating  traceability  and  the users.
review of the manufacture of this lot retained?   OPC in form of (FPR01) was checked. The product
Do the records include the following information? 
‐  When  applicable,  quantity  of  raw  materials,  BOM (FPR04) was observed.  
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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Washing & disinfecting Work Instruction (WQM04) and

related control record in developed checklist in Sep- 15
were observed.

Particle control Work Instruction (WQM05), Clean room

washing and disinfection plan and record of controlling
the clean room cleanliness in Nov-15 was checked.
the record of clean room particle measuring by ‘Kian
gostaresh salamat asia” in Jan-16 according to the ISO
Control of product cleanliness and contamination   14644-1 & BS5295; clean room class is determined
Has the organization identified product cleanliness 
rules? 
100000:
Have the materials and substances used during 
manufacturing process been adequately defined and 
labeled in order to prevent complexity and process 
7.5.1.2.1  faults? 
Have certain medical devices been cleaned and/or 
  
cleared of contamination so as to prevent employees 
and other product from being exposed to any 
contamination 
Have cleaning and implementation requirements been 
documented? 

5S Work Instruction (WQM01) has been developed and

observed.

 
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 
and/or calibrations? 
excluded   ---  
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? 

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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 
and tests controlled? 
excluded   ---  
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? 
Sterile procedure (PQC03) was observed. The
sterilization has been outsourced. Each lot number which
Special rules for sterile devices  delivered to the sterilization supplier is recorded in
Does the organization record process parameters  related form (PRF21-2).there is serial number of
7.5.1.3 
related to sterilization process and used for each 
sterilization lot?  sterilization for each sterile lot number. For example the   
Are sterilization records tracked for each production lot  record of sterilization of :
related to medical devices? 
- Lot No.; TS13941005,
- Sterilization serial number: 94-10-05
Was checked.
7.5.2  VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION 

Because of the nature of the product; the sterilization

process has been identified as specific process.
General rules  The organization has outsourced the sterilization process.
a)defined criteria for review and approval of the 
process 
They have developed Sterile procedure (PQC03);
b)approval of equipment and qualification of staff  Sterilization validation report by “ecrodit lab” accredited
involved 
in Feb-16 by testing lot No.: TS13941008 was checked:
7.5.2.1  c) use of specific methods and procedures 
d)records requirements 
  
e)revalidation  - Sample code:B-743
documented procedure for validation of 
software/computer applications, and records of  - Micro-organism less than 10
validation  - Coliform bacteria less than 10
- Mold and yeast less than 10

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 
process been identified and implemented? 
excluded   ---  
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 
7.5.3.1  realization? 
How has the organization identified product situations  Traceability & identification procedure (PPR01) has been   
in accordance with tracing and measuring  developed; there was a production tracking form
requirements? 
TRACEABILITY  (FPPR03). A sample for effectiveness of the traceability
75.3.2.1  General  method for lot number of TS13941008 for Feb-16 was
How is the product traced? 
checked.
7.5.3.2  Has any method been documented for traceability? 
Does the organization ensure traceability of the medical 
  
device  during  typically  production  and  storage  process 
up to expiration of ownership? 
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 
raw materials, changes in the works performed through 
excluded   ---  
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? 
According to the Traceability & identification procedure
Status Identification 
(PPR01), organization uses lot no, to identify status.
7.5.3.3  Organization  has  identified  status  of  product  with 
respect to measurement and monitoring requirements  They use grey colored metal label for approved products   
and red colored metal label for non conforming products.
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 

7.5.4 
while it is under the organization’s control or being 
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? 
Storage procedure (PST01) was observed. The records of
storage temporary receipt (FST01), storage receipt for
packaging nylon in Jul-15 was checked.
PRESERVATION OF PRODUCT 
Are methods and controls established to preserve 
The cardex of packaging nylon (FST02) were checked;
conformity of product during internal processing and  according to the developed procedure, the cardex shall be
until delivery to intended destination? 
Has the organization established documented processes 
updated once in a week which it was checked and
or documented work instructions for control of the  approved.
product with limited shelf life or which requires special 
Form of layout in storage (FST05) was observed and
7.5.5  storage?  
 
Are such special storage requirements controlled and  according to the traceability & identification procedure
recorded?  (PPR01) , raw material identification (FST04) was
Does this preservation include definition, transport, 
packaging, storage and protection of the product and  observed.
the parts constituting the product?  Raw material request form (FST07) in Nov-15 for
Is there a logo on product? Is it proper to its 
instructions?  working cloth for 3 sets was observed.
The record of product delivery to Javad alaemeh
hospital” in Mashad city in Aug-15 for 60 pcs was
checked.

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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  Measuring device control procedure (PCA01) was
requirement? 
a) Be calibrated or verified at specified intervals, or 
observed.
prior to use, against measurement standards traceable  List of measuring devices (FCA01) with determination of
to international or national measurement standards; 
9 devices, calibration annual schedule (FCA02),
7.6  where no such standards exist, the basis used for 
calibration or verification s hall be recorded;   calibration record (FCA03) for pressure gauge with   
b) Be adjusted or re‐adjusted as necessary;   certification number of 3995/P & calipper with
c) Be identified to enable the calibration status to be 
determined;   certification number of 3994/D from “testa lab” in Oct-
d) Be safeguarded from adjustments that would  15 were checked.
invalidate the measurement result;  
e) Be protected from damage and deterioration during 
handling, maintenance and storage.  

8  Measurement, Analysis and Improvement 
By developing:
- Customer feedback procedure (PCF01)
- Internal audit procedure (PQM10)
General 
Does the organization plan to implement the  - Nonconforming product control procedure
monitoring, measurement, analysis, and improvement  (PQM09)
8.1 
processes required for conformity of the product and 
QMS and improvement of its efficiency?  - Data analysis work instruction (PQM11)   
Are measurement, analysis and improvement  - Corrective & preventive actions procedure
processes are carried out through statistical 
techniques and applicable methods? 
(PQM08)
Organization has established a system to monitor their
effectiveness.
 
8.2  Monitoring and Measuring 
8.2.1 CUSTOMER SATISFACTION 
Customer feedback procedure (PCF01) was observed.
Does the organization monitor the information related  Customer satisfaction (FCF01) for the feedback records:
to customer perception in order to understand whether 
- Javad alaemeh hospital, 84%
8.2.1  customer requirements are met or not? 
Has the organization determined methodologies for  - Mashahd oloom pezeshki hospital, 72%   
obtaining and using information on customer  the average is 79% as the criteria determined 70%.
satisfaction and/or dissatisfaction? 
There is no customer complaints
INTERNAL AUDIT 
Has a documented procedure been established that 
includes responsibilities and requirements, 
Internal audit procedure (PQM10) was checked; it has
requirements for planning and conducting the audit,  been conducted in 14-Dec-15; internal audit annual
reporting the results, maintaining the records? 
Are audits planned in the form of an audit program? 
schedule (FQM01), checklist (FQM02), report (FQM03)
were observed, they have issued 4 NCR’s and related
8.2.2 
Does audit programme take importance and status of 
the fields and processes to be audited including the  corrective action (FQM11).   
results of previous audits? 
Do selection of auditors and implementation of audit  All determined corrective actions have been closed and
ensure objectivity and impartiality of the process?  their effectiveness have been evaluated by the
Do auditors audit their works? 
Do follow‐up actions cover verification of the measures  management representative. 
taken and reporting of verification results? 

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Data analysis procedure (PQM11) was observed. The

report of data analysis (PQM16) in 08-Dec-15 including
bar charts & pie charts were checked:
- Customer satisfaction criteria 79%, the result
MONITORING AND MEASUREMENT OF PROCESSES 
Does the organization implement appropriate methods 
70%
- production process with criteria of the rate of
8.2.3 
for monitoring QMS processes and where applicable, 


 
for measurement such WMS processes?  deviation from the production plan 4% and the
When planned results are not achieved, is corrective 
action taken for product conformity?  result is 0.07%
- rejected product rate criteria less than 5% in 3
months and the result is 0.
- Equipment wreckage rate is 100 minutes in 6
months and result is 45 minutes
8.2.4  MONITORING AND MEASUREMENT OF PRODUCT 

QC procedure (PQC01) & Technical file were observed.

General rules  All output & result of risk assessment has been
Does the organization establish appropriate stages to 
measure and monitor product characteristics?  considered in QC methods.
Have verification methods been documented?  The product BOM (FPR04), OPC in (FPR01) were
Is this verification process realized in accordance with 
the arrangements planned during appropriate stages of  observed.
 
8.2.4.1  product realization process? 
Are conformity evidences along with acceptance criteria 
The records of raw material QC in (FQC04) for 
maintained?  packaging nylon in Oct-15
Are the records approved by the authorized  records of semi-final product steps in (FQC05) in nov-
person/persons in the process of product release? 
Are product release and distribution of service, planned  15; records of final product QC in (FQC06) in Nov-15
regulations (Article 7.1) completed satisfactorily?  was observed.
The quality plan in (FQC07) was checked.
Special  rules  related  to  active  implantable  medical 
8.2.4.2 
devices and implantable medical devices 
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 
Nonconforming product control procedure (PQM09) was
observed. Since the implementation of the quality
8.3 
authorizing the non‐conformity’s use, release or 
acceptance in agreement with customer?  management system in the organization, it has not issued   
Are required measures taken to preclude the product’s 
original intended use or application?  any nonconforming product or services.
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? 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 15 of 18 
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Data analysis procedure (PQM11) was observed. The

DATA ANALYSIS  report of data analysis (PQM16) in 08-Dec-15 including
Does the organization collect, identify and analyze 
appropriate data to demonstrate efficiency and 
bar charts & pie charts were checked:
appropriateness of QMS and the fields where QMS’s  - Customer satisfaction criteria 79%, the result
efficiency can be continuously improved? 
Has a documented procedure been prepared for these 
70%
- production process with criteria of the rate of
8.4 
analyses? 


 
Do the characteristics and tendencies of the processes  deviation from the production plan 4% and the
and products including data analysis, customer 
satisfaction, conformance to product requirements,  result is 0.07%
opportunities for corrective actions provide information  - rejected product rate criteria less than 5% in 3
related to suppliers? 
Have data types for data analysis been defined?  months and the result is 0.
Are data analyses recorded?  - Equipment wreckage rate is 100 minutes in 6
months and result is 45 minutes
8.5  Improvement 
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  Because of the few months of the implementation of
implement such changes? 
Has the organization established written procedures in 
management system in organization, continual
order that advisory warnings can be published and  improvement can be assessed in surveillance audit. At the
implemented? 
Are the records of all examinations related to customer 
moment organization by developing:
complaint maintained?  - Customer feedback procedure (PCF01)
Have the complaints been evaluated within the scope of 
the following points?: 
- Internal audit procedure (PQM10)
‐  whether the organization fails to comply with its own  - Nonconforming product control procedure
specifications or not,  (PQM09)
8.5.1  ‐ whether the organization has caused problems to 
occur despite the fact that it has complied with its own  - Data analysis work instruction (PQM11)   
specifications  - Corrective & preventive actions procedure
In the event that the activities outside the organization 
are identified through examination of the contribution  (PQM08)
of such activities to customer complaint, has the  Organization has established a system to monitor their
relevant information been shared among responsible 
organizations?  effectiveness & its movement through the continual
In the event that any customer complaint is not  improvement.
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  Corrective & preventive actions procedure (PQM08) was
Preventive Action? 
Are corrective actions taken to eliminate causes of 
observed. They have issued 4 corrective actions which
nonconformities effective in preventing recurrences?  were about internal audit result.
Does this procedure include the requirements of 
All corrective actions (FQM11) have been closed and
8.5.2  reviewing non‐conformities (including customer 
complaints), determining the causes of non‐conformity,  their effectiveness has been evaluated by the   
evaluating the actions needed to ensure that  management representative.
nonconformities do not recur, determining and 
implementing the corrective action needed, and review  Since the implementation of the quality management
of the results of the action initiated?  system in organization, they have not issued preventive
Is adequacy of corrective‐preventive actions identified? 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 16 of 18 
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PREVENTIVE ACTION  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    
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 17 of 18 
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

Work environment cleanliness ‐‐‐ 
 

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: ‐ In one Case RPN risk was not Appropriate (for example : wrong labeling risk).

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

ATL: Farhang Mohajer DATE: 3 May 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