BRSM 
  Systems: ISO 9001:2008 QMSMDD ISO 13485 (2003)-OHSAS 18001:2007‐ISO 14001:2004 

 
Assessment Report/Checklist 
Form 009 

 
CLIENT‐ORGANIZATION (NAME):    Mehran Teb Med

PHYSICAL LOCATION(s):   No 107, 8th Eastern St, Farvardin BLVD, Safa Dasht, 
Industrial Zone, Shahriyar, Iran 
 
Stage II Audit Date(s):    26 to 28 Jan 2016

Stage I Audit Date(s):    3 Jan 2016

NAICS (or NACE) CODE 32.5/ Non‐active medical devices other than specified 
above (MD0404), Active devices for patient 
positioning and transport (MD1109) 
 

EXCLUSIONS:    No Exclusion ( for EMS & OHSAS 18001) 

For ISO13485:2003:  Clauses 
:7.5.1.3/7.5.1.2.2/7.5.2.2/7.5.3.2.2/7.5.4 
 
Assessment objectives: Attesting requirements of ISO9001:2008, 
ISO13485:2003, EMS ISO 14001:2004 and 
OHSAS18001:2007 systems have been met in client’s 
management system
 
 
ASSESSMENT TEAM INFORMATION 
Assessment Team Leader, ATL Ms. Azadmanesh 
Assessor 2 Mr. Pourhassan 
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 Q/M/02:
Design, Manufacturing, Sales and after Sale Services in the field of Hospital
Furniture including Beds, Stretchers, over bed tables, Trolleys, Cabinets was
observed.
2  Scope of activities 
Outsourced processes are : Calibration, sewing of mattress cover , produce of
dresser from ABS material , framework of trolley, over bed table and
dresser/cabinet
Excluded clauses are : 7.5.1.3/7.5.1.2.2/7.5.2.2/7.5.3.2.2/7.5.4
MOH (IMED) requirements for production of class A,B
Legal status 
products  
3  BS 1694:1990, ISIRI 10339 , BS 5402:1976 , BS 2838-1:1988
Obligatory applicable standard 
which organization has to follow 
, BS 2838-2:1991 , BS 2881:1989 , IEC60601-2-38,    
IEC60601-1-2
4  Quality Management System 
Process of organization observed in: F/Q/24 and are:
Production-preventive and maintenance-quality control-sale-
GENERAL REQUIREMENTS 
after sales service-warehouse-health and safety-training-
Does the organization establish, document,  management-quality assurance-design-purchasing.
implement, maintain and continually improve a 
Quality Management System (QMS) with due 
Interaction between processes defined in F/W/06.
consideration given to  identification of  HR,
processes needed for the QMS and their 
application throughout the system; 
Index : average of personnel staying at company
determination of sequence and interaction of  Responsible: MD
4.1 
these processes, determination of criteria and 
methods required to ensure effective operation 
Inputs: information, human resource, feedback 
and control of these processes; availability of  Output: motivation, penalty, encouragement
resources and information required to support 
the operation and monitoring of processes; 
Control of documents and records had defined in FTS-WP-
measurement, monitoring and analysis of the  005
processes; implementation of action to achieve  
planned results and continual improvement  Technical files for productions documented and observed.
‐If any, are the outsourced processes are  They are according to MOH requirements.
defined? 
the organization has established, documented, implemented
and maintains and continually improves EMS and OHSAS
systems

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 2 of 23 
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Documented quality manual (Q/M/02 ) observed.

Documented procedures required by the standards, such as :
control of documents and records , design , corrective and
preventive production
Top management established an integrated Policy about
Environmental and Oh&S in accordance with the objective of
the organization.
The Policy is appropriate to the nature, scale and
environmental impact of its activities, products and services,
Environmental/ Oh&S Policy  
DOCUMENTATION REQUIREMENTS  
included commitment to continual improvement, comply with
Is there a documented quality policy and  applicable legal requirements and with other requirements to
documented quality objectives and are they 
appropriate? 
which the organization subscribes which relate to its
Is there a documented quality manual and are  environmental aspects.
there documented procedures required by the 
4.2  standards?? 
Are required records for planning, acting and 
That revision no. is “0” and year of issued is 1393. 
controlling processes efficiently available? 
e.g:
Are the documents are created for every type of  Health maintenance personnel
medical device including GMP  requirements 
and product specifications? (4.2.3) If these  Reducing the risks
documents are applicable to manufacturing 
processes, are montage and service defined?  Prevention of pollution
The organization documentation included
policy, objectives and targets, description of the scope and aria
of the systems, description of the main elements of the
environmental/Oh&S management system and their
interaction, and reference to related documents, including
records, required by this International Standard, that
determined by the organization to be necessary to ensure the
effective planning, operation and control of processes that
relate to its risk and significant environmental aspects.
QUALITY MANUAL 
Does the Quality Manual include, scope of QMS  Quality Manual Q/M/02 observed. Scope of QMS and details
and details of exclusion? 
of exclusion identified in that. Documented procedures are
4.2.2  Are documented procedures reference to 
mandatory procedures;  reference mandatory procedures by code of that. description of

Is description of interaction of the processes 
included in the QMS? 
interaction of the processes included in the QMS
CONTROL OF DOCUMENTS 
Are?  Mandatory procedures have documented. Control conditions
Are control conditions pertaining to mandatory  pertaining to mandatory documents are proper and they have
documents proper? 
Are review, update and re‐approval situations  kept in separate archives. review, update and re-approval
and changes and current review situations for  situations and changes and current review situations for
documents traceable? 
Are the relevant documents usable, readable  documents traceable in list of documents and data. the relevant
4.2.3  and recognizable at concerned usage points? 
Are outsourced documents defined? 
documents are usable, readable and recognizable at concerned 
Are distribution of documents controlled, 
usage points .all documents has been typed. Outsourced
outdated documents prevented from being  documents such as standards have defined.
used and appropriate definition method applied 
in case of being stored for any purpose? 
Distributions of documents are controlled and production line
Are these subjects clear in the relevant 
personal have related documents.
procedure?  Work instruction for montage of over bed table has been

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 3 of 23 
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observed on 20/5/1394 (July 2015) on f05-p01

Documents are readable, easily recognizable and stored in
available manner. Control of records procedure documented
and storage, retrieval, retention time and disposition of records
has defined in that.
The organization established and maintained records as
necessary to demonstrate conformity to the requirements of its
OH&S/Environmental management system and the results
achieved.
The organization established, implemented and maintained a
procedure for the identification, storage, protection, retrieval,
retention and disposal of records.
 CONTROL OF RECORDS 
Are documents readable, easily recognizable  Documents Approve by adequacy prior to issue (HSE expert)
and stored in available manner?  and Review and update as necessary and re-approve
Has a documented procedure been established 
4.2.4  and applied for determination of required  documents.
controls for storage, retrieval, retention time  The changes and the current revision status of documents are
and disposition of records? 
Has the archiving defined for at least 2 years?  identified and
Those documents remain legible and readily identifiable by
PC.
The external documents origin determined by the organization
to be necessary for the planning and operation of the system
are identified and their distribution controlled (e.g: legal
requirements); and
We can check the master list of documents and distribute.
All documents have 3 signatures; preparation, conform and
approve.
Records remain legible, identifiable and traceable.
For example training record, measuring record and Evaluation
and Compliance for this and last year.
4.3  Environmental/ OH&S planning

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 4 of 23 
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The organization established a procedure for risk/aspect evaluation: 
Risk and environmental aspects is identify in each activities and work 
units including: 
Warehouse, production (cutting, welding, coating, assembling, 
packaging and delivery), admin, QC activities. 
Is there a procedure for  The method used is FMEA including severity, occurrence and 
 
identifying environmental  detective. 
 
aspects relevant to the  Acceptable RPN is 50 for each Risk and environmental aspects. 
 
activities, processes,  e.g for significant environmental aspects and risks: 
  1‐ To work safely with the machine> RPN:40‐ 
products, and services of the 
  Action for control: use safety equipment 
4.3.1 
organization, et all 
2‐ Well earth and risk electrocution> RPN: 36 

considering risk?   Action control: periodic assessment to check the well 
 
and  3‐ Painting and fan filter exhaust.> RPN: 32 
 
Hazard identification, risk  Action control: periodic change the filter and measuring exhaust in 
 
assessment and determining   annually 
   
controls 
All significant environmental aspects and risks are evaluated since 
2009 and there are not any residual significant environmental aspects 
and risks. 

The entire legal requirement is identified according to procedure.  
‐ labor office regulation 
‐ waste management, Environmental Protection Agency 
‐ Self‐declaration environmental 
Legal Requirements and 
4.3.2 
Others 
‐ Protection of public workshops procedures  
‐ TLV requirements 
‐ environmental codex 
The organization used those requirements to evaluation of risk and 
significant aspects 
4.4  Environmental/ Oh&S implementation and operation
the organization With regard to its  environmental aspects and 
Communication  environmental management system established, implement and 
maintained a procedure for internal communication among the 
various levels and functions of the organization and receiving, 
4.4.3 
4.4.3.2  documenting and responding to relevant communication from  
external interested parties and Communication with contractors 
Participation and
consultation and other visitors to the workplace. 
The HSE expert was responsible to make those communications. 
The organization make some operational control for which significant 
aspect and risk that was out of range. We check some example: 
‐ Well earth approved with “Imen faraz mehr co.” for 3 well at 
94/10/19(Jan) –report ID: 94/639, the test method is: fall‐of‐poetical. 
‐ Preparation the PM for painting system. This program has a plan for 
4.4.6  Operational control changing back filters.  
‐ Contract for transferring chemical waste.  
‐ We can see warning signage in Throughout of the organization. 
   e.g: use the safety equipment, eye glass… 
‐ MSDS for Ferro Phosphate is available. 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 5 of 23 
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There is no record for accident. 
For emergency situation in workshop, there are many bran new first 
aid boxes. 
4.4.7  Emergency preparedness The emergency preparedness procedure observed.   
and response Earth quick and fire mock at 94/7/15 (Oct) observed. This Maneuver 
had to approach: environment and Oh&S 
They have developed an annually plan for Maneuvers.  

4.5  Checking
The organization establishes, implement and maintain a procedure to 
Environmental/ Performance 
monitor and measure significant environmental impact/OH&S 
4.5.1  Monitoring and  performance on a regular basis.  
Measurement  To monitoring/measuring the significant environmental impact/OH&S 
performance, the organization uses some checklists. To name Fire 
Evaluation and Compliance  inspection, restaurant, rest rooms, assembly unit, ergonomic 
4.5.2.1  situations, admin aria and warehouse. 
a‐ labor office mandatory periodic clinical test for 93/10/9 (Jan‐15) 
Consistent with its commitment to 
compliance  observed. The last test report not received yet. HSE expert check and 
analyze that result for Biennial. Record of analyze for 92 and 93 
observed. 
b‐ Measure of Harmful factors at workshop including: sound(max 85 
4.5.2  db), light(max 200 Lux), ray, oil mist, particle and ergonomic.  
4.5.2.2  According to report all the factors is in range. For some place the staff 
needs to use the safety equipment. 
Evaluation of Compliance with other 
Also, monitoring and measuring the environmental factor is in range.  
requirements the organization 
subscribes to  BOD: 35 / 50 
COD: 90 / 100 
Not only that factor is in the range, but also according to test report 
result, we can see the evaluation of compliance. We can name range 
of particle, light, noise and radiations.  
The organization established, implemented and maintained a 
procedure for dealing with actual and potential nonconformity and for 
taking corrective action and preventive action.  
4.5.3.1  They used that procedure for covered Evaluation and Compliance and 
4.5.3  make a decision for bad situations.   
Incident investigation 
Record: to Decrease noise in polishing process, they have issued a 
corrective action to buy a new machine. 
There is no record for accident yet. 
5  Management responsibility 
MANAGEMENT COMMITTMENT 
Has the top management ensured that 
requirement for meeting customer conditions  Top management communicated requirement for meeting
and legal conditions should be understood by all  customer conditions and legal conditions to personal by
5.1 
personnel? 
Is a quality policy available?  weekly meetings. quality policy is available in production line 
Are quality objectives available?  and office. Management review has established and holds
Is management review established? 
Does the management provide required sources  annually. Equipments for production processes provided.
for QMS? 

CUSTOMER FOCUS 
Does  top  management  have  methodologies  to 
Methodology to customer relation has determined such as :
5.2  ensure  that  customer  needs  and  expectations 
are  determined  and  met  for  increasing  customer feedback forms. 
customer satisfaction? 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 6 of 23 
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QUALITY POLICY  Quality policy principle was established in March

Has top management established a Quality 
2015(94/03):
Policy in accordance with the objective of the 
organization?  Provide safe and high quality products at the level of national
Does the Quality Policy include a statement of 
and international standards, increase customer satisfaction
5.3  commitment to meeting requirements and 
continual improvement of the QMS?  levels and the interested parties ,to reduce consumption of 
Has the Quality Policy been revised for  non-renewable energy sources, reduce environmental
communication, understanding and continuous 
compliance within the body of the  pollution, compliance processes, and products with legal
Organization?  regulations,
The quality objective has been established in line the policy
For example: for increasing customer satisfaction (10%)
Decreasing delivery time,
The main targets which mentioned in the policy are:
- Abiding IMED regulations
- Respecting consumers right and responding their
complaints with prompt actions
- Respecting to the environmental area and abiding
legal regulations
QUALITY OBJECTIVES 
Are quality objectives established by top  - Increasing quality level of the services
management at relevant functions and levels  - Movement toward continual improvement
within the organization? Are the objectives 
measurable and consistent with the Quality  - Health and safety
Policy  The interval of quality policy has been determined once in a
5.4.2 QUALITY MANAGEMENT SYSTEM 
5.4  PLANNING  year. 
Has the QMS been planned by Top  Policy was understood Mr. Ataee who was working in
Management in order to meet the conditions 
and quality objectives detailed in Section 4.1?  warehouse was asked about the policy
When changes are initiated, is the integrity of  The organization establishes, implement and maintain
the QMS maintained during the change 
process?  documented environmental/risks objectives and targets, at
relevant functions and levels within the organization.
The objectives and targets is measurable, where practicable,
and consistent with the environmental/Oh&S policy, including
the commitments to prevention of pollution, to compliance
with applicable legal requirements and with other
requirements to which the organization subscribes, and to
continual improvement.
e.g: Reduce waste(Ferro phosphate) washing process to 700
liter out of 2300 liter till the end of year 1395
5.5  Responsibility, Authority and Communication
Responsibility and Authority for all personal defined in
F/W/01 . Top management approved.
Two Production personnel are aware of their responsibility
RESPONSIBILITY AND AUTHORITY  and authority.
Has top management identified responsibility 
Job Description Forms for them observed
5.5.1  and authority and been communicated within 
the organization?  Top management takes ultimate responsibility for EMS and 
  the OH&S management system in organization chart.
The HSE expert responsibility was observed.
She make the internal and external communication within
organization and legal organization

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MANAGEMENT REPRESENTATIVE 
Has  top  management  appointed  a  member  as 
Management Representative with responsibility 
and  authority  to  ensure  that  the  processes  of  Management representative is factory manager and he is
5.5.2  the  QMS  are  established,  implemented  and 
maintained;  report  to  top  management  on  the 
aware about his responsibilities in QMS. 
performance  of  the  QMS,  including  needs  for  MD appointed through letter on March 2015.
improvement  and  promote  awareness  of 
customer requirements? 
INTERNAL COMMUNICATION 
Has the top management ensured  Communications determined in organization chart. Which has
establishment of appropriate communication 
been defined appropriated? Internal communication is done
5.5.3  processes within the organization? Has the top 
management ensured realization of  properly verbally and through email and written 
communication considering the processes of  correspondence.
the QMS and their effectiveness? 

5.6  Management review
TOP MANAGEMENT REVIEW  Management Review meeting was conducted in accordance
Does top management review the QMS to 
ensure its continuing suitability, adequacy and  with plan and management review procedure PO-MA001.
effectiveness at regular and planned intervals?  Management review meeting is held every six month and last
5.6.1  Do reviews include assessing opportunities for 
improvement including the need for changes to  meeting was on 94/3/3 (Jun) 
the QMS, quality policy, and quality objectives? 
Are management review records kept?  All relevant inputs are discussed in the meeting for examples
 REVIEW INPUT  changes that could affect the QMSMDD such as changing
Does review input include current performance 
and improvement opportunities related to:  clean rooms ventilator in March 2015,(for ensuring the
a) results of audits;  performance of new ventilator check list was filled out one a
b) customer feedback; 
c) process performance and product  week in April 2015 by PM unit),
5.6.2  conformance; 
Following decisions were made in the meeting:
d) status of corrective and preventive actions; 
e) follow‐up action from earlier management  Overhauling ventilator system in Nouroz (vacation for iranian
reviews; 
f) changes that could affect the QMS,  
new year) 
g) recommendations for improvement  Changing shifts time for daylight saving from march
h)  New or revised regulatory rules? 
There is a management review report at 94/3/3 (Jun-15)
The input is completed (according to OH&S/ Environmental
management system).
REVIEW OUTPUT  About output:
Does output from management review include 
actions related to improvement of the QMS and 
1- obtaining legal approval for children beds and CPR beds to
5.6.3  its processes, improvement of product related  end 94
to customer requirements, actions and 
decisions relate to resource needs? 
2- repair of electrical earth system
3- providing a filtering system for welding unit

6  Resource Management
PROVISION OF RESOURCES 
Does the organization have methods to 
Human resources, infrastructure provided for support of
6.1 
determine and provide resources needed to 
implement and improve the processes of the  processes. Refer to 6.2 and 7.4  
QMS and address customer satisfaction by 
meeting requirements? 
6.2  Human Resources 
Are personnel assigned with responsibilities 
that affect product quality competent on the 
Applicable education, training, skills, and experience, has
determined. Training procedure documented in: P/T/01.
6.2.1 
basis of applicable education, training, skills, 
and experience? 
Training needs has gathered and has planned.. Training

Are  trainings  performed  for  achievement  of 
Required Competence?  planned in every year. Such as: retraining of risk management

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 8 of 23 
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for technical team. Training of GMP requirements.

For GMP course: The courses were held timely, Production
COMPETENCE, AWARENESS, AND TRAINING 
Has particularly being manufactured and the 
station operator evaluation score was 80%
organization identified the experience,  The effectiveness of the courses was evaluated. The evaluation
qualifications, competencies and skills of the 
personnel performing activities affecting safety 
record of GMP for production staff was observed. his score
and efficiency of medical devices provided to  was 75%
customer?  
The organization ensures that any people under its control
6.2.2  Is training provided by the organization to 
satisfy the competency needs?  performing tasks that can impact on Environmental/OH&S are
Does the organization ensure that its employees  competent on the basis of appropriate education, training or
are aware of the relevance and importance of 
their activities and how they contribute to the  experience, and shall retain associated records.
achievement of quality objectives?  The HSE expert education and training record observed.
Are  records  of  education,  experience,  training 
and qualifications maintained?  In the training schedule we can see ISO19011 and fire fighter
course planed at 94/11/30 (Feb-16)
Record of ISO 19011 effectiveness observed.
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  Manufacturing equipment have been designed, constructed,
ensured documentation of natural limits or 
permissible tolerances in manufacturing process  properly established and placed for proper operation.
and measuring and test equipment and  Preventive maintenance of manufacturing equipments is
6.3 
availability of the same for operators? 
Are documented processes available for  determined in calibration, maintenance and repairmen    
maintenance, cleaning and control of all  instruction with code I/M/11.
equipment used in manufacturing process and 
control of work environment?  Such as cleanness inspection by technical supervisor on
Are required adjustments and maintenance  12/7/1394 October 2015
intervals identified?  
Is maintenance plan placed normally on or near 
the equipment and easily reachable? 
Is  maintenance  realized  based  on  the  relevant 
plan? 

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WORK ENVIRONMENT 
Does the organization identify and manage 
required work environment needed to achieve 
conformity of product? 
Are the following factors which could affect 
product quality in the work environment 
identified?  
‐ Process equipment,  
‐ Work environment,  
‐ Personnel in this work environment  
Are qualified and quantified limit values of the 
work environment identified for a desired 
quality of the work environment? 
Are pollution levels of microbial and solid 
particles controlled during product 
manufacturing where sterile product or 
pollution of solid particle which is stipulated to 
be sterilized or could live or not live during its 
manufacture or utilization is important?  
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  GMP principle and requirements is implementing.
control process?  Periodic health care examinations of staff that are in direct
Have indicators been identified for a controlled 
environment which covers valid cleaning and  contact with the products have been conducted by the
packaging processes including the organizations  Provincial Health Center. Health cards of production personnel
holding a valid cleaning process? 
in the clean room were issued on 12/16/93(March 2015).
6.4 
(Temperature, Humidity, Air Current, Filtration 
of Air, Ionization of Air, Pressure differences,  Cleaning checklist for clean rooms on Oct 2015 was  
Lighting (along with its spectral content and 
severity), Sound, Vibration, cleaning of Working  Observed.
surfaces and processes, Water quality, number  The record of IMED inspection was observed. There was no
of persons in the work environment) 
 Have dressing conditions, cleaning conditions  NC in this record.
and health conditions for any person being in  Regarding risk level of productions (B IMED) GMP is very
contact with the product or the work 
environment including those persons who enter  more than needed, and that may show management
the area sterilized prior to use or temporarily or  commitment 
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? 

7  Product Realization 

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Risk analysis for Beds, Stretchers, Cabinets has been observed,

PLANNING OF PRODUCT REALIZATION  All of them have stamped by IMED.
Has the organization considered the scope of its 
own quality management system in planning of  Such as:
product realization?   ICU stretcher documented in technical file. OPC of this product
Has the organization prepared required records 
for a proof indicating that quality objectives and 
defined in C/M/5.
product rules, processes established,  Risk analysis for psychiatry bed, examination bed, mechanical
documents and product‐specific necessary 
resources, verification, validation, tracking, 
bed and cabinet observed. Such as:
measuring, inspection and product‐specific test  Falling out of bed and injuries and other physical risks to the
activities , realization processes and the product 
meet the rules? 
patient because of:
In the event that inspection and test are  1. Lack of sufficient strength base and bed frame and wheels and
conducted by manufacturing personnel, do 
inspection and test results, processes, 
joints, leading to fracture the bed. RPN=6
organization’s procedures ensure impartiality of  2. Insufficient strength Bedside RPN=6
inspection and test results? 
3. Lack of proper operation of the wheel brakes in downhill
7.1  Risk management  
Has the organization prepared a procedure  RPN=8  
containing all processes of product realization  For all three company defined controls and post RPN for all is=6
for risk management activities and realized the 
following?  that is tolerable.
Keeping the records  Hazards, causes, degree of risk and controls determined in risk
Preparation of Risk Management Plan 
Determination of Risk team and its  analysis.
Responsibilities  Or
Determination of Intended Use of Device and 
Safety Characteristics of Device  Electric shock patients because of electrical leakage due to
Definition of hazards  lack of proper connection to the power supply is 8, the Post RPN
Risk Estimation for Hazards 
Evaluation of Risks  is 3.
Risk Control Measures 
Definition of Residual Risks  
Risk/Benefit Analysis  Work instruction for quality control: I/S/01 observed. Reference
Preparation of Risk Management Report  for quality control in operation: F/S/23.

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Order of Stretcher received on (july-2015) observed:

Stretchers with mattress , 4 wheels with central locking , stands,
Time delivery determined (aug-2015).
Final production control is done by Mr. Ataee, he checked appearance
and qc log of all serials (Serial SS-94821090 to . SS-94821105). And
after that he permitted the dispatch on 14/06/1394 (end of September
DETERMINATION OF REQUIREMENTS RELATED 
TO THE PRODUCT/SERVICE 
2015)
Has the organization defined the requirements  On process QC has been checked by Mr Ataee again, he signed
of customer including the requirements for the  manufacturing report for date 09 September for assembly line based on
activities on delivery and after delivery? 
Do these requirements include the following?: 
cp 10/06/1394 (sep. 2015)
‐ regulatory and legal requirements related to  Purchased verification for lock wheels has been observed, purchase
the countries and territories where the product  order was for July 2015 because of storage inventory reached the order
is supplied to the market 
‐ anticipated utilization, 
point (120 wheels), order has been delivered to organization in 11 days
‐ Performance expectations,   (9 working days) supplier is Charkhiran and grade is 81.
‐ Design factors  Another order was: electrical bed with column base and had of beds
‐ Delivery plans 
7.2.1  ‐Unclear customer expectations  was ABS and another specifications recorded in F/L/01. Received on    
 Does the organization record customer’s  10/9/1394 (Oct 2015) and has been sent to customer on 30/9/1394
expectations related to product/service in order  (Nov 2015)
to revise the same? 
In the event of any change in order or offer or 
both for any reason whatsoever, are changes  Final production control is done by Mr. Ataee, he checked appearance
revised and an agreement is reached on the  and qc log of all of beds (Serial EB-94132170 to . EB-94132210) And
changes as it is in original order or offer? 
In the event that changes are accepted, are all  after that he permitted the dispatch on 26/09/1394 (Nov 2015)
personnel being affected by the changes within  On process QC has been checked by Mr Ataee again, he signed
the organization informed?  manufacturing report for date 12-16/09/1394 (Nov) for assembly line
Are  relevant  documents  affected  by  these 
changes amended?  based on cp
Purchased verification for painting has been observed, supplier is
Behin Rang grade is A (93) Company send beds on 16/09/1394 and
recived them on 20/09/1394 in 4 days,
Color coating is more than 110 Micrometer, crashing test was
successful on 20/9/1394 (Nov 2015)

7.2  Customer‐Related Processes 
REVIEW  OF  REQUIREMENTS  RELATED  TO  THE 
PRODUCT/SERVICE 
Does the organization review the requirements  In production order list FM01, all orders listed. According to time
related to the product?  delivery for previous orders, determined time and duration of
Are review records kept? 
Has  this  review  been  realized  prior  to 
production for every order. Such as :
commitment of the organization for provision of  Order no: 940061, production no.: 29 must be produced as soon as
7.2.2  the product to customer? 
Has  the  organization  ensured  settlement  of 
possible. Technical specification of This order was the same as other    
contract  or  order  requirements  which  are 
products and was in production list of organization and need no
different from previously defined?  review technically. For every order the first check if there is in
Does  the  organization  have  the  ability  to  meet  warehouse or no. for example : order no.: 940044 , there are in
defined requirements? 
Are the results of review and subsequent 
warehouse and therefore release in same day.
follow‐up actions recorded? 
CUSTOMER COMMUNICATION 
Are arrangements for communication identified 
and implemented relating to product 
Communication with Customer is established through the website,
information, demands, applications, contracts  catalogs, training of operators after delivery.
7.2.3  or realization of order including amendments? 
Are required arrangements identified and 
After delivery of 10 stretchers for one of customers, training has held   
implemented for customer feedback and 
and recorded in stretcher training form such as: training about using
communication with customers including  of parts of beds.
customer complaints? 

7.3  Design and Development 

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DESIGN AND DEVELOPMENT PLANNING  Design Planning for order no.: 940061 , in commission of design

Have the stages of design and/or development 
been identified?  changing on Aug.2015 observed. Number of team includes:
Have review, verification and validation  production head , assemble head , quality control and production
activities appropriate to each design and/or  manager . actions determined in this commission. Planning and
development stage, responsibilities and 
7.3.1  authorities been identified in design and  development of design form F/D/01 for electrical bed with fixed    
development planning?  height observed. Stages of designing from provision of primary
Are design and development planning  standards to mass production and Responsibilities and needed
updated when planning output is appropriate 
and  in the progress of design and  resources defined in this form.
development? 
DESIGN AND DEVELOPMENT INPUTS  Input design received from customer in suggested specifications of
Are inputs related to product requirements 
identified and relevant records maintained?  stretchers. Such as : wheel specifications and size of beds in
Do these inputs include functional and  200cm*85cm
performance requirements, applicable  In form of electrical bed inputs design with code F/D/02 , inputs are :
7.3.2  regulatory and legal requirements, applicable 
applications , packing specifications , user manual.    
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  In commission of design changing for order no.: 940061, drawing
Are design and/or development outputs 
approved before prior to release and in a  no.|: 2-1,2-2,2-3 and 7-1 changed dimensionally.
manner that enables verification against the  Also risk analysis of stretcher has reviewed for this order. Part list
design and/or development inputs?  for electrical bed includes: technical specifications and required
Do the design and/or development outputs 
meet the design input requirements and  amount for every bed determined in form F/D/0. Also drawing no: 1
7.3.3  ‐provide appropriate information for  for electrical bed observed.    
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  Review of Design has done by customer representative on the
Does the organization identify suitable stages 
for systematic reviews of design and/or 
primary sample of stretcher order no: 940061. The first sample
development?  approved and this result has been declared oral.
7.3.4  Are the results of review and subsequent  Design Review of electrical bed F/D/04 observed. Reviewed cases    
follow‐up actions recorded in order to 
evaluate the ability to fulfill requirements and 
are: standards of parts , products and packing , risk analysis
identify problems and propose corrective  documents , … this documents approved by design and development
actions?  manager.
Drawing no: 2-2 , 2-3 and 7-1 verified by design changing
DESIGN AND DEVELOPMENT VERIFICATION  commission. Test report of electrical bed according to IEC 60601-2-
7.3.5  Does the organization in planned arrangements  38 observed on Feb-2010.  
ensure that design output meets input criteria 

DESIGN AND DEVELOPMENT VALIDATION 
Is the design and/or development validation 
For order no: 940061 , stretcher tested and used in one of hospital  
performed in accordance with planned  and validated clinically .
arrangements to confirm that final product is 
capable of meeting the requirements of 
intended use or application requirements 
7.3.6  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? 

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 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  Technical specification of stretcher for order no: 940061, has
7.3.7  to implementation?  changed according to customer requirements. This changes recorded    
Does the review of design and development 
changes include evaluation of the effect of 
in drawing no: 2-2 , 2-3 and 7-1
changes on previously delivered product and 
the parts constituting the product? 
Are  the  results  of  review  of  changes  and 
subsequent follow‐up actions documented? 
7.4  Purchasing 
Purchasing Process; Has the organization 
prepared documented process to ensure that 
purchased product conforms to purchasing 
requirements? 
Are criteria for selection of suppliers defined? 
Are evaluation and reevaluation of suppliers 
have been defined? 
 Has the organization defined tracking 
frequency of supplier’s performance? 
Does the organization have the proofs  Test report for profile according to ISIRI 17003-1:1392 Grade
indicating that supplier monitoring activities, 
outsourced processes are controlled and the 
s235JRH(1.0039) observed with no.: 11107-2 . this part about
products or services conform to the rules of the  chemical test and bending test was passed but about tension test was
organization containing customer demands and  fail.
7.4.1  regulatory rules?  

 
Have the requirements of purchasing  Reference information for purchasing observed in F/P/08. Such as:
information (containing the rules related to 
supplier records) including outsourced 
correct function, size and type of wheels.
processes been identified to ensure product  Purchasing data for motor of electrical beds observed for order no.:
and service quality? 
Does the organization have the methodology to  141 . Included: linear motor for under knee with technical code (item
communicate these requirements to the  no.): 170117. This order purchased and controlled on: 94.05.06 with
supplier?  no.: 11836. Acceptance limit is: meet to order for size and item no.
Are purchasing contracts available? 
Do the type and content of the control on  Technical data for purchasing hydraulic part observed . Includes:
supplier and purchased product depend on the 
next product realization of purchased product 
size : 140mm . verification records observed on: 93.11.12
or final product? 
Are purchasing records retained? 
Entrance parts must control by QC manager. Record for above order
PURCHASING INFORMATION  observed. These parts verified and were without error.
Does purchasing information define the product 
to be purchased?  Records of suppliers evaluation observed in form F/P/07. For
Where appropriate, does purchasing  example: supplier of galvanization parts evaluated about: price,
information include product approval,  quality, on-time delivery. Score was 83 and acceptance score is: 60.
procedures, requirements for process and 

7.4.2 
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. 

7.4.3 
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  Work instruction for cutting documented in :I/M/01 , drilling :
identified?  When  required,  have  documented  I/M/02 , bending : I/M/03 , CO2 welding , acetylene welding
procedures,  documented  rules,  work  ,select welding , wire gauze welding documented in : I/M/06
instructions  and  reference  materials  reference 
materials  and  reference  measuring  processes  Painting : I/M/07 , assembling & packaging : I/M/08 , turnery :
been made available?  I/M/12 , electrical pressing :I/M/13 ,
Has  appropriate  equipment  been  selected  in 
Work instruction for quality control: I/S/01 observed. Reference for
the  manner  that  enables  process  and  product 
specifications to be obtained?  quality control in operation: F/S/23.
Have  the  documents  for  using  appropriate  Control during production in tracing production form F/M/02 for
equipment been established? 
Has  it  been  verified  that  new  and/or 
order no: 940061 observed. Steps: cutting, bending, drilling,
significantly  modified  equipment  meets  welding, painting and assembling has done according to acceptance
purchasing/design specifications and posses the  criteria.
7.5.1 
ability  to  operate within  the  limits  defined  and 
process operating limits?  
The production planning for Aug-15 was observed:   
Have control devices been identified?  - Stretchers: 16 pcs
Has  a  document  been  prepared  for  using  - Cabinets: 6 pcs
control devices? 
Have implementation and control requirements 
- Mechanical Beds: 4 pcs
for labeling and packaging been identified?  - Emergency Trolleys: 7 pcs
Are the records obtained during manufacturing  The record of production report for aforementioned month was
process  of  any  product  lot  and  facilitating 
traceability  and  review  of  the  manufacture  of 
observed:
this lot retained?   - Stretchers: 16 pcs
Do  the  records  include  the  following  - Cabinets: 9 pcs
information? 
‐  When  applicable,  quantity  of  raw  materials,  - Mechanical Beds: 4 pcs
components and intermediate products and lot  - Emergency Trolleys: 10 pcs
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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Control of product cleanliness and 
contamination  
Has the organization identified product 
cleanliness rules? 
Have the materials and substances used during 
manufacturing process been adequately  During packaging, removed every external part on surface of bed.
defined and labeled in order to prevent 
7.5.1.2.1  complexity and process faults?  After welding and before sending assembly, welded points fold up.   
Have certain medical devices been cleaned  This cases controlled in final product control form.
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? 
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 
7.5.1.2.2  been prepared by 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? 
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 
For service activities, the first Customer call to office and declare
or devices with special purpose related to  failure and then this subject communicated to after sales services in
manual operation and service after assembly  factory. One of them was failure in jack og bed. In form F/A/01 this
been validated? 
case recorded. Specification of bed such as: serial number recorded
7.5.1.2.3  Are measuring and test equipment used for site 
service and tests controlled?  in this form. Another case was for order no.: 9400170. Failure   
Have instructions related to the lists of spare  description recorded and action for this case was: substitution of jack
parts or parts and for use in product service 
been prepared? 
and hydraulic handle jack. This activities approved by head of
Has the infrastructure covering technical  hospital.
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 
7.5.1.3  excluded
 

used for each 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 

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CO2 welding, acetylene welding, select a welding, wire gauze

welding documented in: I/M/06.
For validation of these processes, instruction documented 
and operation defined. 
On 94.04.08 co2 welding controlled. According to this 
instruction, acceptance criteria identified in F/S/23. Such as:  
General rules  Inspection of width, height and fitness to thickness of welded 
a)defined criteria for review and approval of the 
process  part, inspection of penetrate depth and weld root. For order 
b)approval of equipment and qualification of  no.: 940061 according to quality control form no.: 94‐061 
staff involved 
7.5.2.1  c) use of specific methods and procedures 
d)records requirements 
according to quality control form 94‐061, welding was  
e)revalidation 
approved.
documented procedure for validation of  Penetrated test report for molded profile on 94.05.05 
software/computer applications, and records of 
validation  observed. Weld surface of the mentioned sample was 
investigated through penetrated method and crater pipe was 
observed. Final result was rejected .this test repeated annual. 
Painting is another special process. For control of this 
process, temperature and duration of process is important. 
This parameters specified in painting work instruction.
Electrical leakage controlled according to related instruction 
with code: I/S/03.    

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  excluded 
implemented? 
Have the requirements in the Article no.  7.5.2.1 
been met? 
7.5.3  Identification and Traceability 
Identification 
Has the organization identified and documented 
Identifying and tractability is establishing according to Production
the product through appropriate methods  procedure : P/M/01. All products is traceable by S/N o all steps of
7.5.3.1  during product realization? 
How has the organization identified product 
production and quality control results.   
situations in accordance with tracing and 
Order of Stretcher received on (july-2015) observed:
measuring requirements?  Stretchers with mattress , 4 wheels with central locking , stands,

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Time delivery determined (aug-2015).

Final production control is done by Mr. Ataee, he checked
appearance and qc log of all serials (Serial SS-94821090 to . SS-
94821105). And after that he permitted the dispatch on 14/06/1394
(end of September 2015)
On process QC has been checked by Mr Ataee again, he signed
manufacturing report for date 09 September for assembly line based
on cp 10/06/1394 (sep. 2015)
Purchased verification for lock wheels has been observed, purchase
order was for July 2015 because of storage inventory reached the
order point (120 wheels), order has been delivered to organization in
11 days (9 working days) supplier is Charkhiran and grade is 81.
TRACEABILITY 
Another order was: electrical bed with column base and had of beds
75.3.2.1  General  was ABS and another specifications recorded in F/L/01. Received on
How is the product traced?  10/9/1394 (Oct 2015) and has been sent to customer on 30/9/1394
Has  any  method  been  documented  for 
7.5.3.2  traceability?  (Nov 2015)  
Does the organization ensure traceability of the 
medical  device  during  typically  production  and  Final production control is done by Mr. Ataee, he checked
storage process up to expiration of ownership? 
appearance and qc log of all of beds (Serial EB-94132170 to . EB-
94132210) And after that he permitted the dispatch on 26/09/1394
(Nov 2015)
On process QC has been checked by Mr Ataee again, he signed
manufacturing report for date 12-16/09/1394 (Nov) for assembly line
based on cp
Purchased verification for painting has been observed, supplier is
Behin Rang grade is A (93) Company send beds on 16/09/1394 and
received them on 20/09/1394 in 4 days,
Color coating is more than 110 Micrometer, crashing test was
successful on 20/9/1394 (Nov 2015)

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 
7.5.3.2.2  which  belongs  to  an  introductory  (e.g.  serial 
 
number,  data  code,  lot  code,  party  number)  Excluded  
special  to  operation  source,  changes  in  raw 
materials,  changes  in  the  works  performed 
through  tools,  new  or  different  machine 
devices, changes of process methods? 
When applicable, are special personnel assigned 
to act during processing medical device or each 
stage of delivery traced? 
Status Identification 
Non conform product in final production warehouse has lable for
7.5.3.3 
Organization  has  identified  status  of  product 
with  respect  to  measurement  and  monitoring  status identification   
requirements 
CUSTOMER PROPERTY 
Does the organization ensure identification, 
verification, protection and safety of customer 
property provided for product or in the manner 
that it creates product while it is under the 
7.5.4  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?

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PRESERVATION OF PRODUCT 
Are methods and controls established to 
preserve conformity of product during internal 
processing and until delivery to intended 
Methods and controls established to preserve conformity of product
destination? 
Has the organization established documented  during internal processing and until delivery to intended destination
processes or documented work instructions for  following were evaluated:
control of the product with limited shelf life or 
Storage of Row Material and products was clean and all row
7.5.5  which requires special storage? 
Are such special storage requirements  Material and products have ID cart.   
controlled and recorded?  Identification and traceability is possible
Does this preservation include definition, 
transport, packaging, storage and protection of 
Storage general condition is appropriate with sterile product, in case
the product and the parts constituting the  of temperature and moisture, 27c with 32% humidity
product? 
Is there a logo on product? Is it proper to its 
instructions? 
CONTROL OF MONITORING AND MEASURING 
DEVICES 
Has the organization identified the 
measurements to be made and the measuring 
and monitoring devices required to ensure 
conformity of product to specified 
requirement? 
a) Be calibrated or verified at specified intervals,  According to measuring equipment list, there is 5 welding with CO2
or prior to use, against measurement standards  machine. Calibration of this machine is determined annually.
7.6 
traceable to international or national 
measurement standards; where no such  Manometer of CO2 welding No.: 54501 were calibrated according to   
standards exist, the basis used for calibration or  DIN EN 837. Protractor no.: 58885 were calibrated according to BS
verification s hall be recorded;   1685 and error was at acceptable range.
b) Be adjusted or re‐adjusted as necessary;  
c) Be identified to enable the calibration status 
to be determined;  
d) Be safeguarded from adjustments that would 
invalidate the measurement result;  
e) Be protected from damage and deterioration 
during handling, maintenance and storage.  

8  Measurement, Analysis and Improvement 
General 
Does the organization plan to implement the 
monitoring, measurement, analysis, and 
improvement processes required for conformity  measurement, analysis and improvement processes are carried out
8.1  of the product and QMS and improvement of its 
efficiency? 
through statistical techniques and applicable methods according to    
Are measurement, analysis and improvement 
Statistic analysis procedure: P/S/01
processes are carried out through statistical 
techniques and applicable methods? 

8.2  Monitoring and Measuring 
8.2.1 CUSTOMER SATISFACTION 
Does the organization monitor the information 
related to customer perception in order to  Customer feedbacks evaluation about: ease of use, design and
understand whether customer requirements 
beauty, information in user manual, packing, quality and painting,
8.2.1  are met or not? 
Has the organization determined  arterials services. Such as: evaluation of customer feedback on   
methodologies for obtaining and using  November 2015.
information on customer satisfaction and/or 
dissatisfaction? 

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Planning and records of internal audit for all requirements observed.

In planning, observed audit independence. Planning of audit is
appropriate to processes and activities.
records of internal audit done in October 2015 observed in form,
next audit is planned in Audit Plan for October 2015,
INTERNAL AUDIT  6 NCs have been raised during internal audit, and for all NCs
Has a documented procedure been established  correction, corrective action were done .also effectiveness were
that includes responsibilities and requirements, 
requirements for planning and conducting the 
checked.
audit, reporting the results, maintaining the  NC 3: 94122, there are no understanding from integrated system
records?  policy in organization on End of October 2015
Are audits planned in the form of an audit 
program?  Corrective action: training course
Checking this training course done before third party audit, Mr.
8.2.2 
Does audit program take importance and status 


 
of the fields and processes to be audited  Ataee asked MR. Abbasi and Mr Moheghodin about quality policy,
including the results of previous audits? 
Do selection of auditors and implementation of  both of them were aware of it.
audit ensure objectivity and impartiality of the  Planning for internal audit is Twice in year.
process?  Last internal audit date is 94/5 (October 2015) and they used 2
Do auditors audit their works? 
Do follow‐up actions cover verification of the  different checklist for 2 standards (OH&S/Environmental
measures taken and reporting of verification  management system).
results?  They have 3 expert auditors to make independency.
There are 37 non-conformity in that audit.
We checked corrective action report no. 94E19 at 94/8/26 (Nov-15)
about safety warehouse Layout. And, they have some action to
change that.
In next assess activity; the affectivity of that action is approved.

Data analysis table was observed and if the Acceptance criteria are
MONITORING AND MEASUREMENT OF  not met, corrective action is taken.
PROCESSES 
Does the organization implement appropriate  process Measuring Acceptance target result
8.2.3 
methods for monitoring QMS processes and 
where applicable, for measurement such WMS 
Indicator criteria
  
processes? 
production The percentage 2% 0.03% 0.035%
When planned results are not achieved, is 
of waste
corrective action taken for product conformity? 

training Per capita 50 80 65

man/hour man/hour man/hour

8.2.4  MONITORING AND MEASUREMENT OF PRODUCT 

General rules  Final quality control for S/N: 931105 in form no.: 09423 observed.
Does the organization establish appropriate  Specifications controlled and recorded in this form. Such as :
stages to measure and monitor product 
characteristics?  Strength of wheels , function of brakes , function of the head jack ,
Have verification methods been documented?  function of stretcher jack , function of height setting jack , control of
Is this verification process realized in 
accordance with the arrangements planned 
painting and other visual check according reference quality control
during appropriate stages of product realization  during production .
8.2.4.1  process? 
Are conformity evidences along with 
Final quality control for electrical bed S/N: 911440 , observed.   
acceptance criteria maintained? 
Electrical leakage test , check of function of motors and control of
Are the records approved by the authorized  box , check of bedsides , has done and records observed in form no.:
person/persons in the process of product  0-94-3-1.
release? 
Are product release and distribution of service, 
Also the final product QC report for 21 cabinets for “Razavi
planned regulations (Article 7.1) completed  Hospital” in Apr-15, for 8 stretchers for “Jam Hospital” in Aug-15
satisfactorily?  were observed.

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Special  rules  related  to  active  implantable 

medical  devices  and  implantable  medical 
8.2.4.2  devices  N/A  
Does the organization record the identity of the 
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 authorizing the non‐conformity’s use,  Test report of profiles about tensile test for no.: 111017 observed and

P/E/01 
release or acceptance in agreement with 
not approved. Range of allow leniency for this material has not
8.3  customer? 
Are required measures taken to preclude the  determined and was not specified cause of this allow leniency. AR
product’s original intended use or application? 
Are records related to the nature of 
nonconformities and the measures taken later 
maintained? 
Is corrected nonconforming product subject to 
re‐verification to demonstrate conformity to 
the requirements? 
Do the processes ensure that appropriate 
corrective action is initiated when non‐
conforming product is detected after delivery or 
use has started? 
Statistic analysis procedure with code: P/S/01 observed. Analysis of
DATA ANALYSIS  data about customer feedback and measuring of processes observed.
Does the organization collect, identify and 
analyze appropriate data to demonstrate 
This analysis recorded in management review records.
efficiency and appropriateness of QMS and the  About waste percentage there is analysis :
fields where QMS’s efficiency can be  We
continuously improved?  process Measuring Acceptance target result
Has a documented procedure been prepared  Indicator criteria assum
e our
8.4 
for these analyses? 


 
Do the characteristics and tendencies of the  production The percentage 2% 0.03% 0.035% target
processes and products including data analysis,  of waste
customer satisfaction, conformance to product  less
requirements, opportunities for corrective  than
actions provide information related to  we should but because we did not any referable data to mine.
suppliers? 
Have data types for data analysis been defined?  So, one of the issues we have from QMS is that we can control our
Are data analyses recorded?  processes more transparent.

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, 
One of continual improvement evidences is corrective and
preventive actions. This activities is doing according to Statistic 
8.5.1 
‐ whether the organization has caused problems 
to occur despite the fact that it has complied  analysis procedure: P/S/01.    
with its own specifications 
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 

8.5.2 
of reviewing non‐conformities (including  Follow of report no 4-11107 for penetrated test report of welded part
customer complaints), determining the causes 
of non‐conformity, evaluating the actions 
, and result was fail, corrective action planned. Rot cause was no
needed to ensure that nonconformities do not  calibrated manometer of welding tool. Corrective action was
recur, determining and implementing the  recalibration of manometer.
corrective action needed, and review of the 
In website, there is section for customer complaints. Following one
results of the action initiated? 
Is adequacy of corrective‐preventive actions  of them about stretcher for ICU, causes of that specified and was 
identified?  bad design of situation of pedal jack.
PREVENTIVE ACTION 
Has the organization established a documented 
Corrective action was done. Effectiveness of this action evaluated
procedure  for  preventive  action  with  defined  according to result of load test on the bed and evaluations of strength
requirements  for  identifying  potential  non‐ of bed and approved.
conformities  and  their  causes;  evaluating  the 
8.5.3  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 22 of 23 
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

cleanness ‐‐‐‐ 

Hazard Control  ‐‐‐‐ 
 

action Request Type I Form-008 – as we indicate and that each of the RA addresses the basic four (4) questions
as seen in Form-008: N/A

action Request Type II Form-008 – as we indicate and that each of the AR addresses the basic four (4) questions
as seen in Form-008:

1. Range of allow leniency for the steel profile has not been determined and was not specified cause of this alloy leniency.

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

ATL: Marjan Azadmanesh DATE: 28-Jan-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