BRSM 
  Systems: QMSMDD ISO 13485 (2003) 

 
Assessment Report/Checklist 
Form 009 

 
CLIENT‐ORGANIZATION (NAME):   
Parsian  Teb  Behzad 

PHYSICAL LOCATION(s):  
No.454 , First st. , 1st sanat , high Technology 
Ind. Park , Mashhad , Iran
Phase II Audit Date(s):    16.Dec.2015(1days)

Phase I Audit Date(s):    02.Dec.2015(1days) 

NAICS (or NACE) CODE 32.5/ MD0301&MD0103

EXCLUSIONS:   Clauses :7.3/7.5.1.2.2/7.5.1.2.3/7.5.1.3/7.5.2.2/ 
7.5.3.2.2/7.5.4, 8.2.4.2 
 
Assessment objectives: Attesting requirements of MDD systems have been 
met in client’s management system 
 
 
ASSESSMENT TEAM INFORMATION 
Assessment Team Leader, ATL Mohammad Reza Khoshgoo 
Assessor 2 Farhang Mohajer 
Assessor 3  
Assessor 4
Assessor 5
Technical Expert
 
 
 
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). 
According to quality manual : QM42200QM01
2  Scope of activities  Production of fiberglass cast and splint 

BRSM requires that the organization’s legal obligations and

regulatory are met. Who are the main responsible for executing
Legal status  and monitoring of these regulations  
3  MoH License: has not yet received
Obligatory applicable standard which  MOH requirements about class A,B products
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  Interaction between processes is specified in F41000QM01
QMS and their application throughout the system;  and.
determination of sequence and interaction of these 
Processes are: management , sale , production , risk
4.1  processes, determination of criteria and methods 
required to ensure effective operation and control of  management , purchasing , quality control , training , 
these processes; availability of resources and  warehousing , preventive maintenance .
information required to support the operation and 
monitoring of processes; measurement, monitoring and 
No processes has outsourced.
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? 
Is there a documented quality manual and are there  The Quality Manual (QM) was observed. All required
documented procedures required by the standards??  standards clauses have been mentioned.
4.2 
Are required records for planning, acting and controlling 
processes efficiently available?  They have developed quality policy (QP) . 
Are the documents are created for every type of  Technical file for production is documented and approved by
medical device including qms requirements and product  MOH.
specifications? (4.2.3) If these documents are applicable 
to manufacturing processes, are montage and service 
defined? 
QUALITY MANUAL 
Does the Quality Manual include, scope of QMS and  According to quality manual: QM42200QM01 , all applied
details of exclusion? 
standard requirements and exclusions are defined. Are required
4.2.2  Are documented procedures reference to mandatory 
procedures;  procedures are addressed in this. 
Is description of interaction of the processes included in 
the QMS? 
CONTROL OF DOCUMENTS 
Are mandatory procedures documented? 
Are control conditions pertaining to mandatory 
Control of documents procedure is specified in P42300QM01.
documents proper?  Distribution of copies between units was done and before that
Are review, update and re‐approval situations and  approved by authorities. List of documents and method of
P42300QM01

changes and current review situations for documents 
traceable? 
distribution observed in F42300QM01
Control of records procedure: P42400QM01 Records are kept
4.2.3  Are the relevant documents usable, readable and 
recognizable at concerned usage points?  in related archives. AR
Are outsourced documents defined? 
Are distribution of documents controlled, outdated 
In one case the traceability form of for reporting to IMED was
documents prevented from being used and appropriate  not updated. They use the version number 2, While the third
definition method applied in case of being stored for  version is published by the IMED 2 month ago.
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 16 
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 CONTROL OF RECORDS 
Are documents readable, easily recognizable and stored 
in available manner? 
Has a documented procedure been established and 
4.2.4  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 
should be understood by all personnel? 
Quality policy is available and management review is
5.1  Is a quality policy available? 
Are quality objectives available?  established. 
Is management review established? 
Does  the  management  provide  required  sources  for 
QMS? 

CUSTOMER FOCUS 

5.2 
Does  top  management  have  methodologies  to  ensure 
that  customer  needs  and  expectations  are  determined  System for gathering of costumer feedback is stablished. 
and met for increasing customer satisfaction? 

QUALITY POLICY  Quality policy , F53100QM01 is approved by top management

Has top management established a Quality Policy in 
accordance with the objective of the organization? 
and communicated is to factory.
Does the Quality Policy include a statement of  Enhancement of customer satisfactions with identifing and
5.3  commitment to meeting requirements and continual 
improvement of the QMS? 
accountability of that and compliance with legal requirements 
Has the Quality Policy been revised for communication, 
– enhancement of services level provided and increasing
understanding and continuous compliance within the  awareness of staff
body of the Organization?  Quality policy are reviewed annually.
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 
Organization objectives are : production license from MOH ,
Quality Policy  increase the variety of products (production of medical plaster
5.4  5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING 
Has the QMS been planned by Top Management in 
bandages) , increasing the number of manufacturing , improve 
order to meet the conditions and quality objectives 
production infrastructure (construction equipped lab.).
detailed in Section 4.1?  Objectives are approved by top management.
When changes are initiated, is the integrity of the QMS 
maintained during the change process? 

5.5  Responsibility, Authority and Communication
In job specification determined job qualification required. for
RESPONSIBILITY AND AUTHORITY  example : production operator is responsible for production
Has top management identified responsibility and  quantitative and qualitative control during manufacturing and
5.5.1 
authority and been communicated within the 
organization?  control of machines , provision of production report and 
Has top management defined responsibilities and  cleaning of environment and machines .
authorizations for CE marking?  This job specification communicated to personnel, such as Mr.
haghi
MANAGEMENT REPRESENTATIVE  Management representative is trading manager. In a letter
Has  top  management  appointed  a  member  as 
Management  Representative  with  responsibility  and  No.1233.44 MD puts Mr Moghadam az MR.
5.5.2 
authority to ensure that the processes of the QMS are 
established,  implemented  and  maintained;  report  to  
top  management  on  the  performance  of  the  QMS, 
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 16 
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internal phone and official letter & information board are the
INTERNAL COMMUNICATION 
Has the top management ensured establishment of  main methods for internal communication. Also the interaction
between job positions for making communication are
5.5.3 
appropriate communication processes within the 
organization? Has the top management ensured  determined in procedures, work instructions and organization 
realization of communication considering the processes 
of the QMS and their effectiveness?  chart. Such as the letter No.1233.44 that MD puts Mr
Moghadam az MR.
5.6  Management review
TOP MANAGEMENT REVIEW 
Does top management review the QMS to ensure its 
continuing suitability, adequacy and effectiveness at 
regular and planned intervals? 
5.6.1  Do reviews include assessing opportunities for 
improvement including the need for changes to the 
QMS, quality policy, and quality objectives? 
Are management review records kept? 
 REVIEW INPUT  Management review commission was established on 94.09.23
Does review input include current performance and  (December 2015).
improvement opportunities related to:  All required inputs has handled. For example : risk
a) results of audits; 
b) customer feedback;  management requirements , results of internal audit , …
5.6.2  c) process performance and product conformance;  Outputs of commission are: provision of sale program until end 
d) status of corrective and preventive actions;  of this year , running production line for plaster bandage and
e) follow‐up action from earlier management reviews; 
f) changes that could affect the QMS,   equipped laboratory for this production , correction of fiber
g) recommendations for improvement  glass production packaging to prevention of air infiltration into
h)  New or revised regulatory rules? 
the product and running production line for fiber glass clothes .
REVIEW OUTPUT 
Does output from management review include actions 
related to improvement of the QMS and its processes, 
5.6.3  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 
6.1  provide resources needed to implement and improve 
the processes of the QMS and address customer 
Resource needed to implement of processes are determined.  
satisfaction by meeting requirements? 
6.2  Human Resources 
Are personnel assigned with responsibilities that affect 
product quality competent on the basis of applicable 
6.2.1  education, training, skills, and experience? 
Are  trainings  performed  for  achievement  of  Required  Required qualifications for production operator are: diploma
Competence? 
with 1 year experience , training in GMP and production
COMPETENCE, AWARENESS, AND TRAINING 
Has the organization identified the experience,  method and also for quality control head are : bachler of sience
qualifications, competencies and skills of the personnel  in medical enginnering and awareness of GMP and quality
performing activities affecting safety and efficiency of 
control methods.
medical devices particularly being manufactured and 
provided to customer?   One of production operator has approved by production 
6.2.2 
Is training provided by the organization to satisfy the  manager after training cource about mashine and tools.
competency needs? 
Does the organization ensure that its employees are 
Training records of technical supervisor checked and are meet
aware of the relevance and importance of their  to legal requirements . training cource planing for him
activities and how they contribute to the achievement  observed and includes ISO 13485:2003.
of quality objectives? 
Are  records  of  education,  experience,  training  and 
qualifications maintained? 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 4 of 16 
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INFRASTRUCTURE 
Has manufacturing equipment been designed, 
constructed, properly established and placed for proper 
operation, maintenance, adjustment and cleaning?  
In case of applicability, has the organization ensured 
documentation of natural limits or permissible 
Preventive maintenance planning for manufacturing machines
tolerances in manufacturing process and measuring and  observed. For example : heat sewing machine and production
test equipment and availability of the same for  line of fiber glass splint . planning includes : cleaning after
6.3 
operators? 
Are documented processes available for maintenance,  production , control of heater temperature , checking and    
cleaning and control of all equipment used in  lubricating of rolling .this operations are planned daily and
manufacturing process and control of work  observed records.
environment? 
Are required adjustments and maintenance intervals 
identified?  
Is maintenance plan placed normally on or near the 
equipment and easily reachable? 
Is maintenance realized based on the relevant plan? 
WORK ENVIRONMENT 
Does the organization identify and manage required 
work environment needed to achieve conformity of 
product? 
Are the following factors which could affect product 
quality in the work environment identified?  
‐ Process equipment,  
‐ Work environment,  
‐ Personnel in this work environment  
Are qualified and quantified limit values of the work 
environment identified for a desired quality of the work 
environment? 
Are pollution levels of microbial and solid particles 
controlled during product manufacturing where sterile 
product or pollution of solid particle which is stipulated 
to be sterilized or could live or not live during its 
manufacture or utilization is important?  
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?  After every production planning , must be removed residual
Have indicators been identified for a controlled  resin from tank and rollers and then cleaned by thinner .also
environment which covers valid cleaning and packaging  floor production hall and warehouse observed clean and
processes including the organizations holding a valid 
6.4  cleaning process?  ordered.  
(Temperature, Humidity, Air Current, Filtration of Air,  Records of temperature and humidity control in manufacturing
Ionization of Air, Pressure differences, Lighting (along 
with its spectral content and severity), Sound, Vibration,  line and lab. Was observed for December 2015
cleaning of Working surfaces and processes, Water 
quality, number of persons in the work environment) 
 Have dressing conditions, cleaning conditions and 
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 16 
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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? 
Operational process chart and provided control plan documented
In the event that inspection and test are conducted by 
manufacturing personnel, do inspection and test  for productions .
results, processes, organization’s procedures ensure  Production hazards are determined in risk analysis based on
impartiality of inspection and test results? 
ISO14971 guideline. For example: hardening of the product due
7.1  Risk management    
Has the organization prepared a procedure containing  to open package and insuitable storage temperature . control
all processes of product realization for risk management  method of this hazards has defined.
activities and realized the following? 
Keeping the records 
Control of packing healthy and storage temperature is logging
Preparation of Risk Management Plan  daily which I mentioned in 6.4 of this report.
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  Products of organization has not yet received license of product
‐ anticipated utilization, 
‐ Performance expectations,  
from MOH and therefore can not sales them. to determine
‐ Design factors  customer needs and orders , documented sale and contract review
7.2.1  ‐ Delivery plans  : P72300SA01. No national standard issued for production    
‐Unclear customer expectations 
 Does the organization record customer’s expectations 
organization . identifying legal requirements is done by technical
related to product/service in order to revise the same?  supervisor.
In the event of any change in order or offer or both for  No records of customer order observed .
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 6 of 16 
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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  All production requirements determined in technical files . also
the  organization  for  provision  of  the  product  to 
feasibility of the order of customers is done based of sale and
7.2.2  customer? 
Has the organization ensured settlement of contract or  contract review : P72300SA01.    
order requirements which are different from previously 
defined? 
Does the organization have the ability to meet defined 
requirements? 
Are the results of review and subsequent follow‐up 
actions recorded? 

CUSTOMER COMMUNICATION 
On packaging of fiber glass bandage observed information
Are arrangements for communication identified and  about : instruction for use , color of production , production
implemented relating to product information, demands,  date and expiration date , production lot no., production size:
7.2.3 
applications, contracts or realization of order including 
amendments?  length and width .   
Are required arrangements identified and implemented  On packaging of fiber glass splint observed : temperature
for customer feedback and communication with  storage(15-30ºc) , signing for single-use.
customers including customer complaints? 

7.3  Design and Development 
DESIGN AND DEVELOPMENT PLANNING  excluded
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     
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  Excluded
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     
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  Excluded
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     
‐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  Excluded
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     
actions recorded in order to evaluate the ability to 
fulfill requirements and identify problems and 
propose corrective actions? 
DESIGN AND DEVELOPMENT VERIFICATION  Excluded
7.3.5  Does the organization in planned arrangements ensure     
that design output meets input criteria 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 7 of 16 
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DESIGN AND DEVELOPMENT VALIDATION  Excluded
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?     
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?  Record of Supplier of row fiber glass bandage evaluation
Does the organization have the proofs indicating that  observed. This supplier approved by MOH . avaluation criteria
supplier monitoring activities, outsourced processes are 
controlled and the products or services conform to the 
are: to meet production with demand company , provision of
information . score of this supplier was 40 and acceptance
7.4.1 
rules of the organization containing customer demands 


 
and regulatory rules?  score is 55. But because of exclusivity of this product , with let
Have the requirements of purchasing information 
(containing the rules related to supplier records) 
leniency of management representative ,it is working with
including outsourced processes been identified to  supplier.
ensure product and service quality? 
Does the organization have the methodology to  Purchasing data is specified in F74200PU01 .
communicate these requirements to the supplier? 
Are purchasing contracts available?  As organization control plan, purchased Items shall be kept in
Do the type and content of the control on supplier and  temporary warehouse and after verification by technical
purchased product depend on the next product 
realization of purchased product or final product? 
supervisor of QC manager, Items can be stored in warehouse.
Are purchasing records retained?  There is no direct delivery.
PURCHASING INFORMATION 
Does purchasing information define the product to be 
Resin with consumer issue : 2501940201 observed in
purchased?  warehouse and this material verified base of no polution by
Where appropriate, does purchasing information  head of quality control also for fiber glass bandage , weight of
include product approval, procedures, requirements for 
1 inch in 1 meter must be 15 gr. And verified by him.
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 
support documentation (e.g. conformity certificates, 
7.4.3  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 
manner that enables process and product specifications 
to be obtained? 
Have  the  documents  for  using  appropriate  equipment  Stages of splint production control with LOT NO.: 240907
been established?  observed , includes : start and end of preparation , humidity of
Has  it  been  verified  that  new  and/or  significantly 
modified  equipment  meets  purchasing/design 
machine was 4.8% and accepted humidity is : up to 5% .
specifications  and  posses  the  ability  to  operate  within  temperature of machine was 48ºc and accepted temperature is
7.5.1  the limits defined and process operating limits?  
Have control devices been identified? 
30-50ºc . length and width of splint were in acceptance level .   
Has  a  document  been  prepared  for  using  control 
percent of components (resin and catalyst ) was according to
devices?  production instruction .rotational speed roll , machine
Have  implementation  and  control  requirements  for  temperature and resin was determined in production
labeling and packaging been identified? 
Are the records obtained during manufacturing process 
instruction.
of  any  product  lot  and  facilitating  traceability  and 
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? 
Have the materials and substances used during 
manufacturing process been adequately defined and  Productions produced non-sterilized and therefore
labeled in order to prevent complexity and process 
organization established GMP includes : cleaning of
7.5.1.2.1  faults? 
Have certain medical devices been cleaned and/or  production machine special surfaces that are in direct contact   
cleared of contamination so as to prevent employees  with the product.
and other product from being exposed to any 
contamination 
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 
related to sterilization process and used for each 
7.5.1.3  Excluded

 
sterilization lot? 
Are sterilization records tracked for each production lot 
related to medical devices? 

7.5.2  VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION 
General rules 
a)defined criteria for review and approval of the 
process  For validation of product , organization has established
b)approval of equipment and qualification of staff  instruction for preparation of resin W7100PR01 , instruction
involved 
for production of splint and bandage. According to these
7.5.2.1  c) use of specific methods and procedures 
d)records requirements  instructions , parameters controls duration production such as: 
e)revalidation  temperature and humidity of machine .for every LO NO.
documented procedure for validation of 
software/computer applications, and records of 
recorded parameters of these processes
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  Traceability duration production for fiber glass bandage with

Has the organization identified and documented the 
product through appropriate methods during product  LOT NO.: 140908 recorded in form. By using this form ,
7.5.3.1  realization?  obtained information about : number and the amount of row  
How has the organization identified product situations  material , amount of resin and solvent , color and temperature
in accordance with tracing and measuring 
requirements?  and humidity of production machine. Also quality control
result such as: preparation stage , length and weight of bandage
TRACEABILITY  recorded. 
75.3.2.1  General  Traceability duration production for splint with LOT NO.:
How is the product traced?  240826 checked and it was traceable to number of polyester
7.5.3.2  Has any method been documented for traceability?   
Does the organization ensure traceability of the medical  and glue.
device  during  typically  production  and  storage  process  In sales invoice for bandages, recorded LOT NO. Of sold
up to expiration of ownership?  production and is traceable to customer.

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  Excluded  
raw materials, changes in the works performed through 
tools,  new  or  different  machine  devices,  changes  of 
process methods? 
When applicable, are special personnel assigned to act 
during  processing  medical  device  or  each  stage  of 
delivery traced? 
Some packaged splint observed in warehouse and QC manager
Status Identification  told these products have damaged packaged and are non-
7.5.3.3  Organization  has  identified  status  of  product  with 
respect to measurement and monitoring requirements 
consumer. These products are out of warehouse sale. Products   
in warehouse sale have complete labeling involves : production
and expiration date , lot no.
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 
or documented work instructions for control of the 
Periodic visits recorded in related checklist. Items are : lack of
product with limited shelf life or which requires special  moisture in floor , walls and ceiling- completely labeling in
7.5.5  storage? 
Are such special storage requirements controlled and 
warehouse – observance of FIFO in warehouse and …this   
recorded? 
checking must be done every 3 mounts and in last checking
Does this preservation include definition, transport,  was good.
packaging, storage and protection of the product and 
the parts constituting the product? 
Is there a logo on product? Is it proper to its 
instructions? 

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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?  Balance that used for weighing final product after cutting,
a) Be calibrated or verified at specified intervals, or 
prior to use, against measurement standards traceable 
calibrated according to calibration time schedule and has no
to international or national measurement standards;  error in working range.
7.6  where no such standards exist, the basis used for 
calibration or verification s hall be recorded;  
Output of dryer (temperature and humidity) checked by   
b) Be adjusted or re‐adjusted as necessary;  
monitor of production machine. Thermometer of machine
c) Be identified to enable the calibration status to be  recently installed and have calibration time schedule.
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 
Analysis of data procedure is documented with code:
8.1 
processes required for conformity of the product and 
QMS and improvement of its efficiency?  84000QM01.    
Are measurement, analysis and improvement 
processes are carried out through statistical 
techniques and applicable methods? 

8.2  Monitoring and Measuring 
8.2.1 CUSTOMER SATISFACTION  Two clinical feedbacks received from doctors who used
Does the organization monitor the information related 
to customer perception in order to understand whether  fiberglass bandage and splint about quality and efficiency.
8.2.1  customer requirements are met or not? 
Has the organization determined methodologies for 
Both of them were satisfied.   
obtaining and using information on customer 
satisfaction and/or dissatisfaction? 
INTERNAL AUDIT  Internal audit planned every 6 mounts. The first has done on
Has a documented procedure been established that 
includes responsibilities and requirements,  94.08.20 (November 2915) . Processes audited were:
requirements for planning and conducting the audit,  production-quality control-warehouse-preventive maintenance-
reporting the results, maintaining the records?  purchasing-sale and management. Observations have recorded
Are audits planned in the form of an audit program? 
in checklist. Checklist has designed according to process
8.2.2 
Does audit programme take importance and status of 


 
the fields and processes to be audited including the  requirements. 10 nonconformities recorded. Corrective action
results of previous audits?  for them issued.
Do selection of auditors and implementation of audit 
ensure objectivity and impartiality of the process? 
Do auditors audit their works? 
Do follow‐up actions cover verification of the measures 
taken and reporting of verification results? 
MONITORING AND MEASUREMENT OF PROCESSES 
Does the organization implement appropriate methods  For purchasing process, determined acceptance criteria. This is
conformity of purchasing to planning and result was 100% .
8.2.3 
for monitoring QMS processes and where applicable, 
for measurement such WMS processes?  For production, an acceptance criterion is the amount of waste   
When planned results are not achieved, is corrective 
action taken for product conformity?  up to 10% and result was 8.9%.
8.2.4  MONITORING AND MEASUREMENT OF PRODUCT 
General rules 
Does the organization establish appropriate stages to 
measure and monitor product characteristics? 
Have verification methods been documented? 
Is this verification process realized in accordance with 
Result of final quality control of production recorded on
the arrangements planned during appropriate stages of  traceability duration production form. For example: production
8.2.4.1  product realization process? 
Are conformity evidences along with acceptance criteria 
with LOT NO.: 240907. Parameters of control are: weight, size   
maintained? 
and color of product according to production planning. This
Are the records approved by the authorized  form signed by QC manager.
person/persons in the process of product release? 
Are product release and distribution of service, planned 
regulations (Article 7.1) completed satisfactorily? 

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Special  rules  related  to  active  implantable  medical 

devices and implantable medical devices 
8.2.4.2  Does the organization record the identity of the  N/A  
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?  Some of splints observed in polyester cutting hall. QC manager
When applicable, do the processes identify the methods  told these are nonconformity products. Because they have
8.3 
authorizing the non‐conformity’s use, release or 
acceptance in agreement with customer?  unsuitable and opened packaging and have dried and are   
Are required measures taken to preclude the product’s  useless. With recommendation of him , these products must be
original intended use or application?  removed from organization as waste.
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? 
Has a documented procedure been prepared for these  Performance of suppliers also result of monitoring of processes
analyzed. Such as supplier of packages has a progress from
8.4 
analyses? 


 
Do the characteristics and tendencies of the processes  first season of year, (5 % progress) Their situation is ok and
and products including data analysis, customer 
satisfaction, conformance to product requirements,  has not defined corrective and preventive actions.
opportunities for corrective actions provide information 
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?: 
‐  whether the organization fails to comply with its own 
specifications or not,  Corrective and preventive action procedure documented. For
8.5.1  ‐ whether the organization has caused problems to 
occur despite the fact that it has complied with its own 
root causes of some production problems , defined corrective   
specifications 
action.
In the event that the activities outside the organization 
are identified through examination of the contribution 
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 
8.5.2  reviewing non‐conformities (including customer 
complaints), determining the causes of non‐conformity, 
evaluating the actions needed to ensure that 
nonconformities do not recur, determining and 
One problem seen in production line and was related to delay
implementing the corrective action needed, and review  of splint machine. Root cause has identified and corrective
of the results of the action initiated? 
Is adequacy of corrective‐preventive actions identified? 
action defined for that and was using glue instead of sewing 
PREVENTIVE ACTION 
thread. Effectiveness of this action reviewed by management
Has  the  organization  established  a  documented  representative and was effective.
procedure  for  preventive  action  with  defined 
requirements for identifying potential non‐conformities 
and  their  causes;  evaluating  the  need  for  action  to 
8.5.3  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 14 of 16 
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

Good awareness about management system No cases seen 
 

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:N/A

In one case the traceability form for reporting to IMED was not updated. they use the version number 2, While the third 
version is published by the IMED 2 month ago. 

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

ATL: Mohammad Reza khoshgoo DATE: 16.Dec.2015

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

 
 REFERENCE, AS
This Clause

APPLICABLE1 
Has been
  Reference Clause  Observations  Verified,
please Tick
mark √ 
 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 16 of 16