BRSM 
Systems: QMS (9001 :2008)QMSMDD ISO 13485 (2003) 

Assessment Report/Checklist 
Form 009 

 
CLIENT‐ORGANIZATION (NAME):   
Panam Azma

PHYSICAL LOCATION(s):  
Unit 4, No. 9, Zohreh Ave., North Mofateh St.,
Tehran, Iran
Stage II Audit Date(s):    06.Jan .2016

Stage I Audit Date(s):    15.Feb .2016   

NAICS (or NACE) CODE 27.90 Manufacture of other electrical equipment /

Manufacture of non-domestic cooling and ventilation
equipment (28.25), MD1107 Active devices for
disinfection and sterilization
 

EXCLUSIONS:    Clauses :7.5.1.3, 7.5.2.2, 7.5.3.2.2 

 
Assessment objectives: Attesting requirements of QMS&QMS MDD systems
have been met in client’s management system 
 
 
ASSESSMENT TEAM INFORMATION 
Assessment Team Leader, ATL Mojtaba Ramezani
Assessor 2 Milad pourhasan
Assessor 3 Mohammad Reza Khoshgoo
 
 
 
Note: Adjusting the language within this form to the type of activity and nature of the organization is acceptable.
 REFERENCE, AS
This Clause

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

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 the developed Quality Manual (PMZ-QM-00) the scope of activity is:
QMSMDD: Manufacturing, Sales and After Sale Services of Hygiene Air Handling
Units & U.V.C.P Systems
2  Scope of activities  QMS: Manufacturing, Sales and After Sale Services of Air Handling Units &
U.V.C.P Systems
Excluded Clauses are: 7.5.1.3, 7.5.2.2, 7.5.3.2.2, 8.2.4.2
 
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  
IMOH License: 664/333368, organization identification
3  number in IMOH is 2276.
Obligatory applicable standard which  IMOH requirements about class A,B products
organization has to follow     

4  Quality Management System 
GENERAL REQUIREMENTS 
Does the organization establish, document, implement,  For each process there is a process profile (F01-W04) , the
maintain and continually improve a Quality 
inputs & outputs of the processes have been determined and
Management System (QMS) with due consideration 
given to  identification of processes needed for the  the interaction between processes has been defined in process
QMS and their application throughout the system;  map (F02-W04).
determination of sequence and interaction of these 
The processes are: management, sales, after sales services,
4.1  processes, determination of criteria and methods 
required to ensure effective operation and control of  purchasing, quality control, training, storage, preventive 
these processes; availability of resources and  maintenance, Production. They have outsourced the
information required to support the operation and 
monitoring of processes; measurement, monitoring and 
Calibration, steel parts painting, electronic board
analysis of the processes; implementation of action to  Manufacturing.
achieve  planned results and continual improvement 
‐If any, are the outsourced processes are defined? 
DOCUMENTATION REQUIREMENTS  
Is there a documented quality policy and documented 
quality objectives and are they appropriate?  The Quality Manual (PMZ-QM-00) was observed. All required
Is there a documented quality manual and are there 
documented procedures required by the standards??  standards clauses have been mentioned. The excluded clauses
are explained in the quality manual.
4.2 
Are required records for planning, acting and controlling 
processes efficiently available?  They have developed quality policy (PMZ-QP-00) 
Are the documents are created for every type of 
medical device including qms requirements and product  Technical file for productions is documented and approved by
specifications? (4.2.3) If these documents are applicable  IMOH.
to manufacturing processes, are montage and service 
defined? 
QUALITY MANUAL  According to quality manual: PMZ-QM-00, all applied
Does the Quality Manual include, scope of QMS and  standard requirements and exclusions are defined. The
details of exclusion? 
developed procedures and work instructions have been
4.2.2  Are documented procedures reference to mandatory 
procedures;  addressed in manual. 
Is description of interaction of the processes included in  The scope of activity and outsourced process have been
the QMS? 
mentioned.

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 2 of 17 
 REFERENCE, AS
This Clause

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

CONTROL OF DOCUMENTS 
Are mandatory procedures documented? 
Are control conditions pertaining to mandatory  Control of documents & records procedure is specified in P01.
documents proper? 
Are review, update and re‐approval situations and 
Master list with code of F02-P01 by determining the
changes and current review situations for documents  documents distribution was observed. The method of
traceable?  documents coding, approving and obsolescing the documents
Are the relevant documents usable, readable and 
4.2.3  recognizable at concerned usage points? 
was checked.
Are outsourced documents defined?  The records retention table with code of F03-P01 was
Are distribution of documents controlled, outdated  observed. For example the records of staff training will be
documents prevented from being used and appropriate 
definition method applied in case of being stored for 
retained as paper-based for 5 years and after that will be 
any purpose?  retained as electronic-based till 6 months after their departure
Are these subjects clear in the relevant procedure?  from the organization.
 CONTROL OF RECORDS  The method taking backup from electronic records are
Are documents readable, easily recognizable and stored  determined as daily, monthly and 6-months. For example the
in available manner?  record of customer orders (electronic-based) for 19-Apr-15
Has a documented procedure been established and 
4.2.4  applied for determination of required controls for  from Bahman Hospital for 2 U.V.C.P systems was observed.
storage, retrieval, retention time and disposition of 
records? 
Has the archiving defined for at least 2 years? 
5  Management responsibility 
MANAGEMENT COMMITTMENT  Quality policy with code of PMZ-QP-00 is available and
Has the top management ensured that requirement for 
meeting customer conditions and legal conditions 
management responsibility work instruction with code of W04
should be understood by all personnel?  is developed. Also by allocating the required resources,
5.1  Is a quality policy available? 
Are quality objectives available? 
assigning management representative and participation in 
Is management review established? 
management review meeting, the top management has proved
Does  the  management  provide  required  sources  for  his commitment to the implemented quality management
QMS?  systems.
CUSTOMER FOCUS  Customer focus is planned in Sales, Production & after sales
services work instruction with code of W01 and customer
5.2 
Does  top  management  have  methodologies  to  ensure 
that  customer  needs  and  expectations  are  determined  feedback procedure with code of P14 which is explained in 
and met for increasing customer satisfaction? 
related clauses
Quality policy, PMZ-QP-00 is approved by top management
QUALITY POLICY  and communicated to all departments. Quality policy is
Has top management established a Quality Policy in 
accordance with the objective of the organization? 
reviewing plan is determined annually. The main targets in
Does the Quality Policy include a statement of  quality policy are as follows:
5.3  commitment to meeting requirements and continual 
improvement of the QMS? 
1- Increasing rate of production 
Has the Quality Policy been revised for communication, 
2- entering to the Middle-East market
understanding and continuous compliance within the  3- abiding legal regulations
body of the Organization?  4- producing well quality products
5- considering the health and safety of the consumers
QUALITY OBJECTIVES  Quality objectives plan are recorded in F03-W04, the
Are quality objectives established by top management  organization has developed 3 quality objectives which as
at relevant functions and levels within the organization?  follows:
Are the objectives measurable and consistent with the 
Quality Policy  1‐ Increasing 7% of production rate
5.4  5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING 
Has the QMS been planned by Top Management in 
2‐ Increasing 5% of customer satisfaction 
order to meet the conditions and quality objectives 
3‐ Increasing 3% of market share
detailed in Section 4.1?  They have determined sub-actions for each quality objective;
When changes are initiated, is the integrity of the QMS  all steps including assigning the responsible and time table
maintained during the change process? 
were observed.
5.5  Responsibility, Authority and Communication

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 3 of 17 
 REFERENCE, AS
This Clause

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

All job positions relations have been determined in

RESPONSIBILITY AND AUTHORITY 
Has top management identified responsibility and  organization chart (F04-W04) and job description (F02-P10).
All responsibility & authorities have been mentioned in job
5.5.1 
authority and been communicated within the 
organization? 
position profile; for example the job descriptions of factory

Has top management defined responsibilities and 
authorizations for CE marking?  manager, electrical unit responsible were observed.
MANAGEMENT REPRESENTATIVE  Management representative is Ms. Davallou; The official letter
Has  top  management  appointed  a  member  as 
Management  Representative  with  responsibility  and  from the top management for her assignment in June-15 with
letter number of 94/335/19 was observed. The job description
5.5.2 
authority to ensure that the processes of the QMS are 
established,  implemented  and  maintained;  report  to  (F02-P10) for management representative was observed. 
top  management  on  the  performance  of  the  QMS, 
including  needs  for  improvement  and  promote 
awareness of customer requirements? 
Internal communication is implemented by: phone, email,
official letter & information board. the interaction between job
INTERNAL COMMUNICATION  positions for making communication are determined in
Has the top management ensured establishment of  developed procedures and work instructions, and organization
5.5.3 
appropriate communication processes within the 
organization? Has the top management ensured  chart (F04-W04) and job description (F02-P10). For example 
realization of communication considering the processes  the official letter from factory manager in Sep-2015 with letter
of the QMS and their effectiveness?  number of 94/362/27 to the sales manager about receiving the
technical data of hygienic air handling unit of Madaran
Hospital in May-15 was observed.
5.6  Management review
TOP MANAGEMENT REVIEW 
Does top management review the QMS to ensure its 
continuing suitability, adequacy and effectiveness at 
regular and planned intervals? 
5.6.1  Do reviews include assessing opportunities for  According to management responsibility work instruction
improvement including the need for changes to the 
QMS, quality policy, and quality objectives?  (W04), management review has been conducted in 94/08/26
Are management review records kept?  (Oct-15). All required inputs have been discussed and the
 REVIEW INPUT  outputs have been determined, the crucial outputs are:
Does review input include current performance and 
improvement opportunities related to:  - Purchasing a production unit in one of the Tehran
a) results of audits;  industrial zones and transferring to the new place
b) customer feedback;  - Assessing the condition of entering to the
5.6.2  c) process performance and product conformance; 
pharmaceutical factories sector market 
d) status of corrective and preventive actions; 
e) follow‐up action from earlier management reviews;  - Purchasing a steel sheet cutting device
f) changes that could affect the QMS,   - Conducting some meetings with commercial
g) recommendations for improvement 
h)  New or revised regulatory rules?  departments of Middle-East countries
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  Top management has provided appropriate resources for
Does the organization have methods to determine and 
implementing quality management systems; for managing the
6.1  provide resources needed to implement and improve 
the processes of the QMS and address customer  resources the organization has developed procedures/work  
satisfaction by meeting requirements?  instructions which are mentioned in next clauses.
6.2  Human Resources 
Are personnel assigned with responsibilities that affect 
product quality competent on the basis of applicable  Training & HR management procedure (P10) has been
6.2.1  education, training, skills, and experience? 
Are  trainings  performed  for  achievement  of  Required 
developed. The required experience, qualifications, 
Competence? 
competencies and skills for each job position has been

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 4 of 17 
 REFERENCE, AS
This Clause

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

determined in job description (F02-P10).

COMPETENCE, AWARENESS, AND TRAINING 
Has the organization identified the experience, 
For each staff there is a staff profile with code of F01-P10 that
qualifications, competencies and skills of the personnel  all previous and current experience, qualifications,
performing activities affecting safety and efficiency of  competencies is recorded for example the record of Mr. Abiar
medical devices particularly being manufactured and 
provided to customer?   as factory manager was observed.
Is training provided by the organization to satisfy the  training plan (F03-P10) by determining 6 courses such as
6.2.2  competency needs?  “welding principles”, “assembly on electronic board
Does the organization ensure that its employees are 
aware of the relevance and importance of their  principles”, “IMED regulations”; the record of conducting the
activities and how they contribute to the achievement  training course in F04-P10 and records of evaluating training
of quality objectives?  effectiveness for the assembly on electronic board principles”
Are  records  of  education,  experience,  training  and 
qualifications maintained?  in Aug-15 for Mr. Asgharpour with grade of 74% was
observed.
INFRASTRUCTURE 
Has manufacturing equipment been designed, 
The PM work instruction (W03) has been developed and
constructed, properly established and placed for proper  observed. The list of equipment (F01-W03) and their profile
operation, maintenance, adjustment and cleaning?   (F02-W03) were checked. They have identified 16 equipment.
In case of applicability, has the organization ensured 
documentation of natural limits or permissible 
The profiles of bending machine, welding machine were
tolerances in manufacturing process and measuring and  observed.
test equipment and availability of the same for  PM schedule in F03-W03 for welding machine & air
6.3 
operators? 
Are documented processes available for maintenance,  compressor machine was observed. The records of PM action    
cleaning and control of all equipment used in  taken in F04-W03 for these machines for July & Aug-2015
manufacturing process and control of work  were observed.
environment? 
Are required adjustments and maintenance intervals  The record of repairing the equipment is recorded in its profile
identified?   (F02-W03) for example the record of repairing the air
Is maintenance plan placed normally on or near the  compressor machine in Nov-15 about changing its strap was
equipment and easily reachable? 
Is maintenance realized based on the relevant plan?  checked.

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 5 of 17 
 REFERENCE, AS
This Clause

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

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  Working environment monitoring & control with code of P11
process? 
Have indicators been identified for a controlled  was observed. The instructions for cleaning of the working
environment which covers valid cleaning and packaging  environment have been determined. Cleaning plan (weekly &
processes including the organizations holding a valid 
monthly) in F01-P11 was observed. The cleaning checklist in
6.4  cleaning process? 
(Temperature, Humidity, Air Current, Filtration of Air,  F02-P11 has been developed and the record of controlling the  
Ionization of Air, Pressure differences, Lighting (along  environmental condition in July-15 was observed. Based on the
with its spectral content and severity), Sound, Vibration, 
cleaning of Working surfaces and processes, Water 
conducted site visit, the cleanliness level in the organization is
quality, number of persons in the work environment)  appropriate and according to the IMOH regulations.
 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? 

7  Product Realization 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 6 of 17 
 REFERENCE, AS
This Clause

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

For product & service realization, organization has developed

Sales, Production & after sales services work instruction (W01),
management of nonconforming products and quality control
procedure (P04), Purchasing procedure (P06), controlling the
measuring devices ( P05), storage procedure (P07) which are
explained in their related clauses. In all mentioned procedures &
work instruction, the legal regulations have been considered.
Risk assessment work instruction (W02) and technical files
approved by IMED were observed. All technical files are
included the risk assessments. For example the technical file of
hygienic air handling unit (model of FD 8000) with UMNDS
code of 18112 was observed.
PLANNING OF PRODUCT REALIZATION 
Has the organization considered the scope of its own  Risk assessment question list (F01-W02) & risk analysis form
quality management system in planning of product  (F02-W02) was observed. The method of calculating the RPN is
realization?  
Has the organization prepared required records for a 
based on the determining each risk severity, occurrence and its
proof indicating that quality objectives and product  diagnosis; RPN quantity is categorized in 3 sections:
rules, processes established, documents and product‐
specific necessary resources, verification, validation, 
- acceptable, the RPN is lower than 3
tracking, measuring, inspection and product‐specific  - acceptable with condition, the RPN is between 4
test activities , realization processes and the product  and 6
meet the rules? 
In the event that inspection and test are conducted by 
- Non-acceptable, the RPN is higher than 6
manufacturing personnel, do inspection and test  For example hygienic air handling unit (model of FD 8000) risk
results, processes, organization’s procedures ensure 
impartiality of inspection and test results? 
assessment:
7.1  Risk management   Risk type : Incorrect connection of electricity,  
Has the organization prepared a procedure containing 
all processes of product realization for risk management  Root cause: Electrical wiring problem
activities and realized the following? 
Keeping the records 
Result: stopping the performance of equipment
Preparation of Risk Management Plan  Impact: equipment stopping and probability of entering the
Determination of Risk team and its Responsibilities 
Determination of Intended Use of Device and Safety 
infection to the clean room of the healthcare
Characteristics of Device  RPN number: 12
Definition of hazards 
Risk Estimation for Hazards  Action should be taken: Preparation of standard and appropriate
Evaluation of Risks  wire, 100% QC for wiring step.
Risk Control Measures 
Definition of Residual Risks   Modified RPN number: 6
Risk/Benefit Analysis 
Preparation of Risk Management Report  And for U.V.C.P systems risk assessment:
Risk type : U.V lamp breaking
Root cause: inappropriate transferring and handling the final
product
Result: wreckage of equipment
Impact: wreckage of equipment and customer unsatisfactory
RPN number: 4
Action should be taken: developing a packaging instruction,
using appropriate packaging items and 100% QC for
transferring/handling step
Modified RPN number: 3

7.2  Customer‐Related Processes 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 7 of 17 
 REFERENCE, AS
This Clause

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

DETERMINATION OF REQUIREMENTS RELATED TO THE 
PRODUCT/SERVICE  Sales, Production & after sales services work instruction with
Has the organization defined the requirements of 
customer including the requirements for the activities  code of W01 and designing work instruction (W05) were
on delivery and after delivery?  observed. All requirements needed from the customer are
Do these requirements include the following?: 
‐ regulatory and legal requirements related to the 
recorded in the mutual contract between organization and
countries and territories where the product is supplied  customer; for example the contract of “Ibne Sina hospital” in
to the market  Tehran city for purchasing U.V.C.P systems with order number
‐ anticipated utilization, 
‐ Performance expectations,  
of PMZ/U94/37 in Sep-15 was observed.
‐ Design factors  The contract number with “Ibne Sina hospital” is 94/178; the
7.2.1  ‐ Delivery plans  order registration form with code of F01-W01 for this order was    
‐Unclear customer expectations 
 Does the organization record customer’s expectations 
observed.
related to product/service in order to revise the same?  Also the order from “Tehran rehabilitation center” order for
In the event of any change in order or offer or both for  hygienic air handling unit with order number of PMZ/A94/24 in
any reason whatsoever, are changes revised and an 
agreement is reached on the changes as it is in original  Aug-15 with of 94/166 was observed. The requirements of
order or offer?  product which declares by the customer are recorded in the
In the event that changes are accepted, are all  contract and order and then in the designing process it will be
personnel being affected by the changes within the 
organization informed?  reviewed which is explained in related clause.
Are  relevant  documents  affected  by  these  changes 
amended? 
REVIEW  OF  REQUIREMENTS  RELATED  TO  THE 
PRODUCT/SERVICE 
Does the organization review the requirements related  Based on the Sales, Production & after sales services work
to the product? 
Are review records kept?  instruction (W01), designing work instruction (W05), all
Has  this  review  been  realized  prior  to  commitment  of  requirements related to the product will be reviewed by factory
the  organization  for  provision  of  the  product  to 
manager. The design process applies only for air handling units.
7.2.2  customer? 
Has the organization ensured settlement of contract or  For U.V.C.P systems, reviewing technical data and requirements    
order requirements which are different from previously  after recording the orders, will be confirmed in an official letter
defined? 
Does the organization have the ability to meet defined 
with customers such as the confirmation letter with “Ibne Sina
requirements?  hospital” in Sep-15 was observed.
Are the results of review and subsequent follow‐up 
actions recorded? 

CUSTOMER COMMUNICATION 
All communication with customers are handled and recorded
Are arrangements for communication identified and  based on developed Sales, Production & after sales services work
implemented relating to product information, demands,  instruction with code of W01 and customer feedback procedure
7.2.3 
applications, contracts or realization of order including 
amendments?  with code of P14; for example the records for communication   
Are required arrangements identified and implemented  with “Shafa Yahyaian hospital” in Tehran in July-15 for
for customer feedback and communication with  arranging a visit for obtaining additional technical data for
customers including customer complaints? 
designing hygienic air handling unit was observed.
7.3  Design and Development 
DESIGN AND DEVELOPMENT PLANNING 
Have the stages of design and/or development been  The Designing work instruction (W05) was observed. All
identified?  required steps for designing have been developed. For example
Have review, verification and validation activities 
the designing records of hygienic air handling unit for “Shafa
appropriate to each design and/or development stage, 
7.3.1  responsibilities and authorities been identified in design  Yahyaian hospital” model of FD8000 in Tehran in July-15  
and development planning?  were as follows:
Are design and development planning updated when 
planning output is appropriate and  in the progress of 
Site visit report in F01-W05 for confirming the technical data
design and development?  specially size of the equipment in July-15;
DESIGN AND DEVELOPMENT INPUTS  Initial calculation of the equipment technical data in F02-W05,  
Are inputs related to product requirements identified  equipment drawing in F03-W05, equipment installation plant
and relevant records maintained? 
Do these inputs include functional and performance 
layout drawing in F04-W05 in the same month have been
7.3.2  requirements, applicable regulatory and legal  generated and were observed.  
requirements, applicable information derived from  The design output in F05-W05 in Aug-15 was checked such as:
previous and similar designs a any other requirements 
essential for design? 
Electricity consumption: 0.14 amp, required electricity: 220 v,
Have the inputs been reviewed in terms of adequacy?  50 Hz, 2 amp, equipment installation height: 170 cm, UVC

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 8 of 17 
 REFERENCE, AS
This Clause

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

DESIGN AND DEVELOPMENT OUTPUTS  lamp life cycle: 8000 Hrs;

Are design and/or development outputs approved 
before prior to release and in a manner that enables  Design review and customer confirmation in F06-W05 in Aug-
verification against the design and/or development  15 was observed.
inputs?  For verification of designing, the organization executes a
Do the design and/or development outputs meet the 
7.3.3  design input requirements and  performance test which named FAT (factory assessment test);  
‐provide appropriate information for purchasing,  this test before product releasing is executed by QC staff and
manufacture and service performance,  recorded in F07-W05 which the related record of this project in
‐ contain or reference product acceptance criteria 
‐ define the characteristics of the product that are  Sep-15 was observed. For validation of the designing,
essential to its safe and proper use?  installation of the product process is applied which is explained
DESIGN AND DEVELOPMENT REVIEW  in Sales, Production & after sales services work instruction
Does the organization identify suitable stages for 
systematic reviews of design and/or development?  (W01); the record of validation of this project in forms of
7.3.4  Are the results of review and subsequent follow‐up  installation checklist (F04-W01) & MOM of product delivery  
actions recorded in order to evaluate the ability to  and training (F05-W01) in Sep-15 was checked such as:
fulfill requirements and identify problems and 
propose corrective actions?  UVC lamp: 90 cm, 4 pcs,
DESIGN AND DEVELOPMENT VERIFICATION  Hepa filter: 59.5 * 59.5 * 29.5 dimension, 6 pcs, efficiency
7.3.5  Does the organization in planned arrangements ensure  95%  
that design output meets input criteria 
Bag filter: 59.5 * 59.5 * 29.5 dimension, 6 pcs, efficiency 95%  
DESIGN AND DEVELOPMENT VALIDATION 
Is the design and/or development validation performed 
(yellow)
in accordance with planned arrangements to confirm  Wire filter: 63.5 * 49.5 * 5 dimension, 9 pcs
that final product is capable of meeting the  Electromotor: SIEMENS model, 3PH, 400-690 v, 1460
requirements of intended use or application 
7.3.6  requirements defined? 
Route/minute  
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   
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  Purchasing procedure with code of P06 was observed; all
conforms to purchasing requirements?  purchase orders are generated from the customer orders. After
Are criteria for selection of suppliers defined? 
Are evaluation and reevaluation of suppliers have been 
finalizing the contract, a copy of the purchase will be delivered
defined?  to the purchasing department.
 Has the organization defined tracking frequency of  Purchase order in form of F01-P06 for capacitor and resistance
supplier’s performance? 
Does the organization have the proofs indicating that 
for “Ibne Sina hospital” order as U.V.C.P systems with order
supplier monitoring activities, outsourced processes are  number of PMZ/U94/37 in Sep-15 was observed.
controlled and the products or services conform to the  Supplier list in F02-P06 with identifying 18 suppliers and
7.4.1 
rules of the organization containing customer demands 
records of supplier evaluation (F03-P06) were available such 
 

and regulatory rules? 
Have the requirements of purchasing information  as “saman electric co.” as producer of electric board with score
(containing the rules related to supplier records)  of 80% and grade of A, “peykar varagh” as distributor of steel
including outsourced processes been identified to 
ensure product and service quality?  sheets with score of 68% and grade of B, “laksar” as calibrator
Does the organization have the methodology to  company with score of 74% and grade of B;
communicate these requirements to the supplier?  The verification of purchased product is the responsibility of
Are purchasing contracts available? 
Do the type and content of the control on supplier and  QC staff and storekeeper which is explained in nonconforming
purchased product depend on the next product  products and quality control procedure (P04) for example UVC
realization of purchased product or final product?  lamp verification of purchasing record in F02-P04 in Oct-15
Are purchasing records retained? 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 9 of 17 
 REFERENCE, AS
This Clause

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

PURCHASING INFORMATION  for “Ibne Sina hospital” order.

Does purchasing information define the product to be 
purchased? 
Where appropriate, does purchasing information 
include product approval, procedures, requirements for 

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? 
VERIFICATION OF PURCHASED PRODUCT 
Has the organization identified a method in order to 
ensure that the product received conforms to the 
specifications, is finished, holds appropriate identity 
and is free from any damage?  
Do the processes include the provisions in order to 
verify that incoming product is provided along with 

7.4.3 
support documentation (e.g. conformity certificates, 
acceptance test reports)?  
Has data been provided related to analysis of previous 
acceptance inspection data, rejection history in the 
plant or customer complaints, required inspection 
quantity  and necessity of reevaluation of supplier? 
Has the organization identified the authorized person 
for conformity approval of incoming material? 
Are verification records retained? 

7.5  Production and Service Provision 
CONTROL OF PRODUCTION AND SERVICE PROVISION 
7.5.1.1 General rules  Sales, Production & after sales services work instruction with
Has the organization identified control requirements for  code of W01 was observed.
production and service process? 
Is  control  quantity  and  control  detail  level  The organization produces its products based on the mutual
proportionate to criticality level of its process?  contract with customer such as:
 Has  the  characteristic  qualities  of  product  been  hygienic air handling unit for “Shafa Yahyaian hospital”
identified?  When  required,  have  documented 
procedures,  documented  rules,  work  instructions  and  model of FD8000 in Tehran in July-15; F01-W01 order
reference  materials  reference  materials  and  reference  registration, F02-W01 for production planning including
measuring processes been made available?  manufacturing steps such as base-structure producing, cutting
Has  appropriate  equipment  been  selected  in  the 
manner that enables process and product specifications  and producing of body panels, welding, painting, foam
to be obtained?  injection, frame assembly, installing interior parts, wiring and
Have  the  documents  for  using  appropriate  equipment 
installation of electrical components, and production report
been established? 
Has  it  been  verified  that  new  and/or  significantly  (F03-W01) in Aug-15 and finally installation checklist (F04-
modified  equipment  meets  purchasing/design  W01) & MOM of product delivery and training (F05-W01) in
specifications  and  posses  the  ability  to  operate  within 
Sep-15 was checked such as:
7.5.1  the limits defined and process operating limits?  
Have control devices been identified?  UVC lamp: 90 cm, 4 pcs,   
Has  a  document  been  prepared  for  using  control  Hepa filter: 59.5 * 59.5 * 29.5 dimension, 6 pcs, efficiency
devices? 
Have  implementation  and  control  requirements  for 
95%
labeling and packaging been identified?  Bag filter: 59.5 * 59.5 * 29.5 dimension, 6 pcs, efficiency 95%
Are the records obtained during manufacturing process  (yellow)
of  any  product  lot  and  facilitating  traceability  and 
review of the manufacture of this lot retained?  
Wire filter: 63.5 * 49.5 * 5 dimension, 9 pcs
Do the records include the following information?  Electromotor: SIEMENS model, 3PH, 400-690 v, 1460
‐  When  applicable,  quantity  of  raw  materials,  Route/minute
components  and  intermediate  products  and  lot 
numbers of those materials, 
Also the record of producing and delivery of the for “Ibne
‐  When  applicable,  start  and  completion  dates  of  Sina hospital” order as U.V.C.P systems with order number of
different  stages  of  manufacture  including  sterilization  PMZ/U94/37 from Sep-15 till Oct-15 with serial number of
records, 
‐ Quantity of manufactured product,  EA-94102601AHU was observed. The main steps of producing
‐  Signed results of all inspections and tests,  are frame producing, installing interior parts, wiring and
‐ Representation of production line used,  installation of electrical components and labeling.
‐  Any deviation from manufacturing specifications. 
7.5.1.2  Control of production and service‐Special rules 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 10 of 17 
 REFERENCE, AS
This Clause

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

Control of product cleanliness and contamination  
Has the organization identified product cleanliness  Instructions for cleaning of the working environment have
rules?  been determined in working environment monitoring & control
Have the materials and substances used during 
manufacturing process been adequately defined and 
with code of P11 was checked.
labeled in order to prevent complexity and process  Because of the nature of the product, the GMP situation needs
7.5.1.2.1  faults? 
Have certain medical devices been cleaned and/or 
basic requirement. The working environment cleanliness has a   
cleared of contamination so as to prevent employees 
checklist with code of F01-P11, cleaning plan with code of
and other product from being exposed to any  F02-P11 was observed. The record of checking the cleanliness
contamination  of the organization for production hall, storage in Sep-15 was
Have cleaning and implementation requirements been 
documented? 
observed.
Sales, Production & after sales services work instruction with
code of W01 was observed. The related record for “Shafa
Yahyaian hospital” project installation checklist (F04-W01) &
Assembly activities 
Have assembly activities and responsibility for medical  MOM of product delivery and training (F05-W01) in Sep-15
device been identified?  was checked such as:
In the event that any medical device should be 
assembled and mounted in the location where the user 
UVC lamp: 90 cm, 4 pcs,
is present, have guiding instructions been prepared by  Hepa filter: 59.5 * 59.5 * 29.5 dimension, 6 pcs, efficiency
7.5.1.2.2  the organization for accurate assembly, montage, tests 
and/or calibrations? 
95%   
Has the organization provided the instructions which 
Bag filter: 59.5 * 59.5 * 29.5 dimension, 6 pcs, efficiency 95%
allow assembler to confirm proper operation of the  (yellow)
device?  Wire filter: 63.5 * 49.5 * 5 dimension, 9 pcs
Are the results of assembly or commissioning tests 
recorded? 
Electromotor: SIEMENS model, 3PH, 400-690 v, 1460
Route/minute

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  Based on the Sales, Production & after sales services work
between distributors and users?  instruction (W01), the after sales services include installation
Have service activities carried out by the organization or  and manual training (which is explained in above sections) and
a separate agency been planned? 
Have the design and functionality of equipment or  repairing the product after installation. The record of
devices with special purpose related to manual  registration repairing request in F06-W01 for “Shahriar
operation and service after assembly been validated? 
Hospital” in Tabriz city for repairing hygienic air handling
7.5.1.2.3  Are measuring and test equipment used for site service 
and tests controlled?  controlling monitor and changing Hepa filters in June-15 was   
Have instructions related to the lists of spare parts or  observed.
parts and for use in product service been prepared? 
Has the infrastructure covering technical consultancy 
Checklist of required parts and tools in F07-W01 and record of
and technical support, customer training and spare  delivered required services in F08-W01 in that month (36 Hrs
parts or provision of parts been established?  after receiving the request) was observed.
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 
7.5.1.3 
related to sterilization process and used for each 
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 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 11 of 17 
 REFERENCE, AS
This Clause

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

Welding is the only process in organization which is identified

General rules 
a)defined criteria for review and approval of the 
as specific process; the instruction and suitable condition of
process  welding process has been determined in nonconforming
b)approval of equipment and qualification of staff  products and quality control procedure (P04) and they have
involved 
developed a checklist for each welding process (F05-P04) and
7.5.2.1  c) use of specific methods and procedures 
d)records requirements  the records of welding process for hygienic air handling unit 
e)revalidation  for “Shafa Yahyaian hospital” model of FD8000 in July-15
documented procedure for validation of 
software/computer applications, and records of 
was observed. Also the certificate of welding principles for Mr.
validation  Rahimi (welding staff) issued from Technical and Vocational
Organization of Iran in Apr-2011 was observed.
Special rules for sterile medical devices 
Have sterilization processes been validated prior to 
use? 
7.5.2.2  Have the standards used for validation of sterilization 
process been identified and implemented? 
Excluded ---
Have the requirements in the Article no.  7.5.2.1 been 
met? 
7.5.3  Identification and Traceability 
Identification  The requirements of traceability and identification have been
Has the organization identified and documented the 
product through appropriate methods during product  determined in related procedure with code of P08; all processes
7.5.3.1  realization?  in order to produce and provide services to the customer are  
How has the organization identified product situations  traceable based on the developed procedures and work
in accordance with tracing and measuring 
requirements?  instructions; when a contract is finalized, from the beginning
the serial number of the product is generated and be mentioned
in all production & QC records.
TRACEABILITY  For preventing any fault in traceability process, organization 
75.3.2.1  General  has developed a serial numbers list (F01-P08), in this list all
How is the product traced?  delivered products are registered with their serial numbers
7.5.3.2  Has any method been documented for traceability?   
Does the organization ensure traceability of the medical  which was observed.
device  during  typically  production  and  storage  process  A sample for traceability was assessed for “Ibne Sina hospital”
up to expiration of ownership?  order as U.V.C.P systems with order number of PMZ/U94/37
from Sep-15 till Oct-15 with serial number of EA-
94102601AHU.
Special  rules  related  to  active  implantable  medical 
devices and implantable medical devices  
Does  the  organization  ensure  traceability  in  inspection 
and  stock  records  for  the  changes  of  the  personnel 
performing  a  work  traceability  of  which  belongs  to  an 
7.5.3.2.2  introductory  (e.g.  serial  number,  data  code,  lot  code, 
 
party  number)  special  to  operation  source,  changes  in 
raw materials, changes in the works performed through 
Excluded ---  
tools,  new  or  different  machine  devices,  changes  of 
process methods? 
When applicable, are special personnel assigned to act 
during  processing  medical  device  or  each  stage  of 
delivery traced? 
According to the storage procedure (P07) and quality manual,
all items including equipment and consumable items and spare
Status Identification  parts, tools and production process waste are labeled.
7.5.3.3  Organization  has  identified  status  of  product  with 
respect to measurement and monitoring requirements 
The applied method for separating items in organization is   
appropriate such as putting steel waste in red bulks and non-
steel waste in blue bulks, the place for tools layout has been
identified with a sign.

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 12 of 17 
 REFERENCE, AS
This Clause

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

CUSTOMER PROPERTY  The strategy of protecting the customer property has been

Does the organization ensure identification, verification,  mentioned in quality manual (PMZ-QM-00). The type of
protection and safety of customer property provided 
for product or in the manner that it creates product  customer property is defined as information and final product
which remains in organization before transferring to the
7.5.4 
while it is under the organization’s control or being 
used?  customer. Based on the quality manual, organization commits   
Does the process ensure that occurrence of any 
customer property that is lost, damaged or otherwise  to preserve customer property at its best and in any case of
found to be unsuitable for use are recorded and  damages, shall pay the related compensation and obtains its
reported to the customer?  customer satisfaction again.
Storage procedure (P07) was checked. Organization uses
software for storage management (hamkaran System software);
PRESERVATION OF PRODUCT  for each type of the product, organization has determined basic
Are methods and controls established to preserve 

Storage procedure (P07) 

conformity of product during internal processing and  BOM in F01-P07, the BOM of UVCP systems was observed.
until delivery to intended destination?  The table of determining for items layout in storage in form of
Has the organization established documented processes 
or documented work instructions for control of the 
F02-P07 was observed. All layouts in the storage are according
product with limited shelf life or which requires special  to this form (F02-P07), for example the paper rolls for Hepa
7.5.5  storage? 
Are such special storage requirements controlled and 
filters are maintained in a nylon package, vertical on plastic AR
recorded? 
pallet.
Does this preservation include definition, transport,  The needed raw material form (F03-P07) from storage from
packaging, storage and protection of the product and  electrical unit for capacitor and resistance in Oct-15 and for
the parts constituting the product? 
Is there a logo on product? Is it proper to its 
steel nets in Aug-15 was observed.
instructions?  The inventory level updating has determined every 3 days but
in reality, storekeeper updates the inventory level once in a
week.
CONTROL OF MONITORING AND MEASURING DEVICES  Controlling and measuring the performance of measuring
Has the organization identified the measurements to be  devices are explained in P05 (procedure).
made and the measuring and monitoring devices 
required to ensure conformity of product to specified  The list measuring device (F01- P05) with determining of 10
requirement?  devices and calibration plan (F02- P05) and measuring device
a) Be calibrated or verified at specified intervals, or 
prior to use, against measurement standards traceable 
profile (F03- P05) were checked. The profile of Smoothness
to international or national measurement standards;  Tester and multi-meter number 1 was checked. The calibration
7.6  where no such standards exist, the basis used for 
calibration or verification s hall be recorded;  
has been performed by Laksar Co. in May-15:   
b) Be adjusted or re‐adjusted as necessary;  
- Smoothness Tester calibration certificate: LK-
c) Be identified to enable the calibration status to be  94/ST5214-03
determined;   - multi-meter number 1 calibration certificate: LK-
d) Be safeguarded from adjustments that would 
invalidate the measurement result;  
94/MD5219-01
e) Be protected from damage and deterioration during 
handling, maintenance and storage.  

8  Measurement, Analysis and Improvement 
General 
By developing Data analyzing & process monitoring procedure
Does the organization plan to implement the  (P13), customer feedback procedure (P14). Internal audit
monitoring, measurement, analysis, and improvement  procedure (P03), control of nonconforming products and
8.1 
processes required for conformity of the product and 
QMS and improvement of its efficiency?  quality control procedure (P04), corrective and preventive    
Are measurement, analysis and improvement  action procedure (P02), the organization measures, analyzes its
processes are carried out through statistical  performance and ensure its movement toward the
techniques and applicable methods? 
improvement.
8.2  Monitoring and Measuring 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 13 of 17 
 REFERENCE, AS
This Clause

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

Customer feedback procedure (P14) was checked. The records

8.2.1 CUSTOMER SATISFACTION 
Does the organization monitor the information related 
of customer feedback for sales process in F01-P14: Ibne sina
to customer perception in order to understand whether  hospital with grade of 79%, Bahman Hospital with grade of
8.2.1  customer requirements are met or not? 
Has the organization determined methodologies for 
82%;   
obtaining and using information on customer 
The records of customer feedback for after sales services
satisfaction and/or dissatisfaction?  process in F02-P14: Shafa Yahyaian hospital with grade of
80%, Shahriar hospital with grade of 88% were observed.
INTERNAL AUDIT  Internal audit procedure (P03) was checked.
Has a documented procedure been established that  Internal audit planned once in a year. The first has done on
includes responsibilities and requirements, 
requirements for planning and conducting the audit, 
94.07.19 (Sep 15). Internal audit plan in F01-P03, internal
reporting the results, maintaining the records?  audit checklist in F02-P03 were observed. They have issued 5
Are audits planned in the form of an audit program?  NCR’s; for all the NCR’s they have issued corrective action
8.2.2 
Does audit programme take importance and status of 
(F01-P02). All these actions have been taken and closed and 

 
the fields and processes to be audited including the 
results of previous audits?  their effectiveness have been approved by the management
Do selection of auditors and implementation of audit  representative for example modifying the layout of electronic
ensure objectivity and impartiality of the process? 
Do auditors audit their works?  board (corrective action no.1) and completing customer
Do follow‐up actions cover verification of the measures  satisfaction forms for after sales services (corrective action
taken and reporting of verification results?  no.4) in Sep-15.
Data analyzing & process monitoring procedure (P13) was
observed. The form of criteria for all processes in F01-P13,
process profile in F01-W04, report of data analysis & process
monitoring in F02-P13 was observed; for example:
- average of customer satisfaction from sales process,
accepted criteria 75% in 6 months, the situation is
79%
MONITORING AND MEASUREMENT OF PROCESSES 
Does the organization implement appropriate methods  - average of customer satisfaction from after sales
services process, accepted criteria 75% in 6 months,
8.2.3 
for monitoring QMS processes and where applicable, 
for measurement such WMS processes?  the situation is 91%   
When planned results are not achieved, is corrective 
action taken for product conformity?  - deviation from production plan for each contract,
accepted criteria average of 2% for 10 contracts, the
situation is 0.7%
- delivery of after sales services (repairing), based on
IMED regulation less than 24 Hrs for Tehran province
and 72 Hrs for other provinces, the situation is for
Tehran province with average of 16 Hrs and for other
provinces with average of 41 Hrs
8.2.4  MONITORING AND MEASUREMENT OF PRODUCT 
General rules  Control of nonconforming products and quality control
Does the organization establish appropriate stages to 
measure and monitor product characteristics? 
procedure (P04) was observed.
Have verification methods been documented?  The QC plan for raw material & final product in form of F01-
Is this verification process realized in accordance with  P04 was observed. The record of QC of raw material such as
the arrangements planned during appropriate stages of 
UVC lamp verification of purchasing in F02-P04 in Oct-15,
8.2.4.1  product realization process? 
Are conformity evidences along with acceptance criteria  final product as UVCP lamp for Dr. Gharib Hospital in May-15   
maintained?  was checked.
Are the records approved by the authorized 
person/persons in the process of product release? 
The other records of QC process for special process (welding),
Are product release and distribution of service, planned  FAT test in Designing process have been explained in their
regulations (Article 7.1) completed satisfactorily?  related clauses.
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? 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 14 of 17 
 REFERENCE, AS
This Clause

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

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‐ Based on the control of nonconforming products and quality
conformity related to product? 
When applicable, do the processes identify the methods  control procedure (P04), all situation of that the nonconforming
product/service is raised have been determined. Since the
8.3 
authorizing the non‐conformity’s use, release or 
acceptance in agreement with customer?  implementation of the quality management systems in the   
Are required measures taken to preclude the product’s 
original intended use or application?  organization, there is no any report regarding finding
Are records related to the nature of nonconformities  nonconforming product/service.
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 analyzing & process monitoring procedure (P13) was
observed. The form of criteria for all processes in F01-P13,
process profile in F01-W04, report of data analysis & process
monitoring in F02-P13 was observed; for example:
DATA ANALYSIS 
Does the organization collect, identify and analyze 
- average of customer satisfaction from sales process,
appropriate data to demonstrate efficiency and  accepted criteria 75% in 6 months, the situation is
appropriateness of QMS and the fields where QMS’s  79%
efficiency can be continuously improved? 
Has a documented procedure been prepared for these  - average of customer satisfaction from after sales
services process, accepted criteria 75% in 6 months,
8.4 
analyses? 


 
Do the characteristics and tendencies of the processes  the situation is 91%
and products including data analysis, customer 
satisfaction, conformance to product requirements,  - deviation from production plan for each contract,
opportunities for corrective actions provide information  accepted criteria average of 2% for 10 contracts, the
related to suppliers?  situation is 0.7%
Have data types for data analysis been defined? 
Are data analyses recorded?  delivery of after sales services (repairing), based on IMED
regulation less than 24 Hrs for Tehran province and 72 Hrs for
other provinces, the situation is for Tehran province with
average of 16 Hrs and for other provinces with average of 41
Hrs
8.5  Improvement 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 15 of 17 
 REFERENCE, AS
This Clause

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

CONTINUAL IMPROVEMENT 
Has the organization identified required changes by 
using quality policy, quality objectives, audit results, 
analyses of data, corrective and preventive actions and 
management review in order to ensure and sustain 
ongoing conformity and efficiency of quality 
management system and does the organization 
implement such changes? 
Has the organization established written procedures in 
order that advisory warnings can be published and 
implemented? 
Are the records of all examinations related to customer 
complaint maintained? 
Have the complaints been evaluated within the scope of 
the following points?: 
‐  whether the organization fails to comply with its own 
specifications or not,  Organization concentrates on continual improvement by
8.5.1  ‐ whether the organization has caused problems to 
occur despite the fact that it has complied with its own 
conducting internal audit, process monitoring and data analysis   
specifications 
& determining quality objectives.
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 

Corrective and preventive action procedure P02

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 
Corrective and preventive action procedure P02 was observed.
8.5.2  reviewing non‐conformities (including customer  They have issued 8 corrective actions that 5 of them was the
complaints), determining the causes of non‐conformity,  result of internal audit; the other 3 were about changing the
evaluating the actions needed to ensure that 
nonconformities do not recur, determining and 
electronic board manufacturer (supplier) because of its delay in
implementing the corrective action needed, and review  delivery of the orders in Oct-15, changing the soldering
of the results of the action initiated? 
Is adequacy of corrective‐preventive actions identified? 
machines in electronic unit in Aug-15 & painting the AR
PREVENTIVE ACTION 
packaging unit wall in Sep-15. Only changing the soldering
Has  the  organization  established  a  documented  machines in electronic unit corrective action has not executed
procedure  for  preventive  action  with  defined  and there were no any report for controlling it.
requirements for identifying potential non‐conformities 
and  their  causes;  evaluating  the  need  for  action  to 
Since the implementation of the quality management systems
8.5.3  prevent  occurrence;  determining  and  implementing  in the organization, they have not issued any preventive action.
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 16 of 17 
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

Organization reputation in Healthcare organizations & skill 
No cases 
of the production staff
 

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- The inventory level updating has determined every 3 days but in reality, storekeeper updates the inventory level once in a
week.
2- Changing the soldering machines in electronic unit corrective action has not executed and there were no any report for
controlling it.

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

ATL: Mojtaba Ramezani DATE: 15-Feb-16

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

END of REPORT