BRSM 
  Systems: QMSMDD ISO 13485 (2003) 

 
Assessment Report/Checklist 
Form 009 

 
CLIENT‐ORGANIZATION (NAME):    PARS AZMUN CO.

PHYSICAL LOCATION(s):   No.63-4th Golestan Alley-Baharestan Ind.Zone-

Alborz-Iran 

Phase II Audit Date(s):    2, 3 November 2015 

Phase I Audit Date(s):    24 Oct 2015 

NAICS (or NACE) CODE 20.59
IVD0101 (BRSM- MDD Code)

EXCLUSIONS:    7.3, 7.5.1.2.2, 7.5.1.2.3, 7.5.1.3, 7.5.2.1, 7.5.2.2, 
7.5.3.2.2, 7.5.4, 8.2.4.2 
 
Assessment objectives: Third party assessment of  requirements of ISO 
13485:2003 is met in companies management 
system, as well as legal requirements 
 
 
ASSESSMENT TEAM INFORMATION 
Assessment Team Leader, ATL Mohammad reza Khoshgoo 
Assessor 2 Marjan Azadmanesh 
TE Abdulah Sabri
Witness Observer Chun Keung Cheung (AB Evaluator) 
Interpreter Hodjat A Bagheri
 
 
 
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). 
Production of diagnostic kits, such as: biochemical,
2  Scope of activities  immunoturbidimetric, controls, calibrators, standards and detergents
of medical lab. Analyzers
BRSM requires that the organization’s legal obligations 
Legal status  and regulatory are met. Who are the main responsible   
3  for executing and monitoring of these regulations? 
Obligatory applicable standard which 
IMED and Food and drug requirements      
organization has to follow 

4  Quality Management System 
GENERAL REQUIREMENTS  All processes Executive processes are studied and planned
Does the organization establish, document, implement, 
maintain and continually improve a Quality  according to process map. The QA expert Ms. Ahmadi,
Management System (QMS) with due consideration  explained business processes from customer order to delivery.
given to  identification of processes needed for the  In it; sequence and interaction between processes is
QMS and their application throughout the system; 
determination of sequence and interaction of these  determined. As well as indicators of processes have been
4.1  processes, determination of criteria and methods 
required to ensure effective operation and control of 
developed according to the needs of the organization and the 
procedure P10. The outsourcing trend has been the only
these processes; availability of resources and 
information required to support the operation and  producer of vials Regent which the molds are also owned
monitoring of processes; measurement, monitoring and  .byPars Azmun and suppliers perform injection only
analysis of the processes; implementation of action to 
achieve  planned results and continual improvement  input controls on vials are also considered
‐If any, are the outsourced processes are defined? 
DOCUMENTATION REQUIREMENTS   Requirements for technical documents are explained in 7.1, the
Is there a documented quality policy and documented 
quality objectives and are they appropriate?  policy , objects and other supporting executive methods are
Is there a documented quality manual and are there  according to standards set by company
documented procedures required by the standards?? 

4.2 
Are required records for planning, acting and controlling 
processes efficiently available?  
Are the documents are created for every type of 
medical device including qms requirements and product 
specifications? (4.2.3) If these documents are applicable 
to manufacturing processes, are montage and service 
defined? 
QUALITY MANUAL  Quality manual with zero revision observed which is
Does the Quality Manual include, scope of QMS and  distributed in management and technical departments, last
details of exclusion? 
version of the manual is approved by top manager and the
4.2.2  Are documented procedures reference to mandatory 
procedures;  exclusions are mentioned with justification

Is description of interaction of the processes included in 
the QMS? 
CONTROL OF DOCUMENTS 
Are mandatory procedures documented?  all mandatory procedures are documented
Are control conditions pertaining to mandatory  control conditions pertaining to mandatory documents proper
documents proper? 
Are review, update and re‐approval situations and 
have been fully documented and explained in clause 7 and 8 of
changes and current review situations for documents  this report
traceable?  all documents are reviewed, updated (in case changed)
P01/0

4.2.3  Are the relevant documents usable, readable and 
recognizable at concerned usage points? 
all technical and system documents are usable, readable and AR
Are outsourced documents defined?  recognizable at concerned usage points
Are distribution of documents controlled, outdated  outsourced documents defined as for reagent vials
documents prevented from being used and appropriate 
definition method applied in case of being stored for 
Distribution of documents controlled, outdated documents
any purpose?  prevented from being used storage procedures are in place
Are these subjects clear in the relevant procedure?  these subjects clear in the relevant procedure

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 2 of 17 
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All documents readable, easily recognizable and stored in

available manner
 CONTROL OF RECORDS  Records of contract with supplier with Contract Number 92-
Are documents readable, easily recognizable and stored 
in available manner?  5464-678 in 2013 observed, it is retrievable and in place

P01/0
Document and record control P01/0
4.2.4 
Has a documented procedure been established and 
applied for determination of required controls for  procedure been established and applied for determination of AR
storage, retrieval, retention time and disposition of 
records?  required controls for storage, retrieval, retention time and
Has the archiving defined for at least 2 years?  disposition of records,
documents are archived for at least 2 years and as long as the
product expires and enforced by law
5  Management responsibility
MANAGEMENT COMMITTMENT  Attendance at all audit activities during the audit, as well as
Has the top management ensured that requirement for 
meeting customer conditions and legal conditions  meeting the criteria set forth in Article 5 such as management
should be understood by all personnel?  roles demonstrates the commitment by top manager
5.1  Is a quality policy available? 
Are quality objectives available? 
And the use of experts as well as policy advisor for proper 
Is management review established?  implementation of the ISO system and ensure the permanent
Does  the  management  provide  required  sources  for  .monitoring of the performance of processes makes it evident
QMS? 
The commercial manager at the same time is also considered as
CUSTOMER FOCUS  management representative who is knowledgeable in legal
5.2  Does  top  management  have  methodologies  to  ensure 
that customer needs and expectations are determined? 
requirements, customer needs, so he is competent in conveying 
new updates from legal authorities to company
QUALITY POLICY  Policy was checked, version 0, reviewed in March 2015 and
Has top management established a Quality Policy in 
accordance with the objective of the organization?  for understanding of staff it has been nailed on the wall close to
Does the Quality Policy include a statement of  attendance time of staff on the board and on the wall of
5.3  commitment to meeting requirements and continual 
improvement of the QMS? 
restaurant, 
Has the Quality Policy been revised for communication,  Samples in Items in policy; quality objectives, commitment to
understanding and continuous compliance within the  legal regulation
body of the Organization? 

QUALITY OBJECTIVES 
Objectives : these objectives are in line with objectives and are
Are quality objectives established by top management  measurable in time frame
at relevant functions and levels within the organization?  Such as
Are the objectives measurable and consistent with the 
Quality Policy 
Provision and procurement of suitable equipment for
5.4  5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING 
Has the QMS been planned by Top Management in 
production of new kits 
Provision and procurement of suitable infrastructure for import
order to meet the conditions and quality objectives 
detailed in Section 4.1?  of auto-analyzer
When changes are initiated, is the integrity of the QMS  All objectives are to be met at the end of 2016
maintained during the change process? 

5.5  Responsibility, Authority and Communication

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 3 of 17 
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Organization chart has been approved in June 2015. QC, 
packaging, manufacturing unit’s are under supervision of 
technical manager. 
Job description of personnel are in form F02‐P09, there 
are all descriptions mentioned, such as ensuring cold 
RESPONSIBILITY AND AUTHORITY  chain till packages are delved to customer which is 
Has top management identified responsibility and 
mentioned in job description of "dispatch personnel" 
5.5.1 
authority and been communicated within the 
organization? 
and "controlling raw material according to packing list, 

Has top management defined responsibilities and 
authorizations for CE marking?  controlling order and cleanness of environment & 
ensuring calibration of manufacturing section" are some 
of job description of manufacturing technician. 
Manufacturing supervisor which is a legal mandated job 
position in QMS manufacturers are according to IMED 
regulations. 
MANAGEMENT REPRESENTATIVE  The commercial manager/technical supervisor at the same time
Has  top  management  appointed  a  member  as 
Management  Representative  with  responsibility  and 
is also considered as management representative who is
knowledgeable in legal requirements, customer needs, so he is
5.5.2 
authority to ensure that the processes of the QMS are 
established,  implemented  and  maintained;  report  to  competent in conveying new updates from legal authorities to 
top  management  on  the  performance  of  the  QMS, 
including  needs  for  improvement  and  promote 
company
awareness of customer requirements?  Mr. Goudarzi 
description have been established such as duties of
management representative, technical supervisor and quality
manager
Internal communication is done by pager and boards on the
wall and also in written
INTERNAL COMMUNICATION 
Has the top management ensured establishment of  External communications is done effectively thru emails and
calls.
5.5.3 
appropriate communication processes within the 
organization? Has the top management ensured  IT unit applies following servers to maintain internal and 
realization of communication considering the processes 
of the QMS and their effectiveness?  external communications thru following 4 servers
DC: Domain control
ISA: Individual saving services
WSUS: windows server updates services
Panda: anti-virus
Modiran: financial software
5.6  Management review
TOP MANAGEMENT REVIEW  Management review in done in 12 months
Does top management review the QMS to ensure its 
continuing suitability, adequacy and effectiveness at  In last session in august 2015
5.6.1 
regular and planned intervals? 
Do reviews include assessing opportunities for  
improvement including the need for changes to the 
QMS, quality policy, and quality objectives? 
Are management review records kept? 
 REVIEW INPUT  All inputs were considered in management review
Does review input include current performance and 
improvement opportunities related to:  Results of previous audits, feedback from client, process
a) results of audits; 
b) customer feedback; 
performance, corrective and preventive actions, and changes to
5.6.2  c) process performance and product conformance; 
d) status of corrective and preventive actions; 
system were considered in last management meeting. 
e) follow‐up action from earlier management reviews; 
f) changes that could affect the QMS,  
g) recommendations for improvement 
h)  New or revised regulatory rules? 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 4 of 17 
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Examples of output from management review

REVIEW OUTPUT 
Does output from management review include actions  Supplying CRM infrastructure
Registering new Kits I MOH
5.6.3 
related to improvement of the QMS and its processes, 
improvement of product related to customer 
Upgrading from paper base to paperless

requirements, actions and decisions relate to resource 
needs? 

6  Resource Managementr
PROVISION OF RESOURCES 
Does the organization have methods to determine and  The organization determines and provides resources needed to
6.1  provide resources needed to implement and improve 
the processes of the QMS and address customer 
implement and improve the processes of the QMS MDD and 
satisfaction by meeting requirements? 
address customer satisfaction.
6.2  Human Resources 
Are personnel assigned with responsibilities that affect 
product quality competent on the basis of applicable 
Qualification criteria of distribution of goods are such as:
6.2.1  education, training, skills, and experience? 
Are  trainings  performed  for  achievement  of  Required 
Driving license   
Competence? 
At least 6 month experience 
Mandated trainings: 
Cold chain 
PARS AZMOON goods special requirements which are 
COMPETENCE, AWARENESS, AND TRAINING  based on Dinasys requirements. 
Has the organization identified the experience, 
qualifications, competencies and skills of the personnel  And I checked manufacturing supervisor and quality 
performing activities affecting safety and efficiency of  manager "Mr. Bakhshi" 
medical devices particularly being manufactured and 
provided to customer?   I checked Mr. Bakhsshi's Master of Science certification; 
6.2.2 
Is training provided by the organization to satisfy the 
competency needs? 
it was biochemistry as job requirements  
Does the organization ensure that its employees are  He has passed below training effectively: 
aware of the relevance and importance of their 
activities and how they contribute to the achievement 
Quality control 
of quality objectives?  Operation of Clima 
Are  records  of  education,  experience,  training  and 
qualifications maintained?  Operation of Hitachi 
Operation of Response 
Internal audit of ISO 13485:2003 based on ISO 19011 
 
INFRASTRUCTURE 
Has manufacturing equipment been designed, constructed,  Pm work instruction is according to W03. Such as 
properly established and placed for proper operation, 
maintenance, adjustment and cleaning?  
monthly PM for Hitachi or filling machines. 
In case of applicability, has the organization ensured  Below are items that they checked for lift in raw 
documentation of natural limits or permissible tolerances in 
manufacturing process and measuring and test equipment and 
material store: 
6.3  availability of the same for operators?  Hydraulic oil inspection     
Are documented processes available for maintenance, cleaning 
and control of all equipment used in manufacturing process and  Fixing 
control of work environment?  Greasing 
Are required adjustments and maintenance intervals identified?  
Is maintenance plan placed normally on or near the equipment  Below are items for refrigerators: 
and easily reachable? 
Is maintenance realized based on the relevant plan? 
Torture control 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 5 of 17 
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WORK ENVIRONMENT 
Does the organization identify and manage required work 
Leakage control 
environment needed to achieve conformity of product?  Oil inspection 
Are the following factors which could affect product quality in the 
work environment identified?  
Condensers inspection 
‐ Process equipment,   Evaporator's inspection 
‐ Work environment,  
‐ Personnel in this work environment   Doors fixing 
Are qualified and quantified limit values of the work environment  I checked related records for September 2015   
identified for a desired quality of the work environment? 
Are pollution levels of microbial and solid particles controlled  EM: there some emergency maintenance records, 
during product manufacturing where sterile product or pollution 
of solid particle which is stipulated to be sterilized or could live or 
such as: 
not live during its manufacture or utilization is important?   Case for 1‐Nov 2015 fixing leakage from cup No 
Has exclusion been applied during all manufacturing processes 
for a controlled environment? As valid ground of exclusion, is 
2383 and resin change for pre‐ water deionizer 
pollution reduced to known, consistent and controlled level by an  Controlling ionized water checklist has been 
approved cleaning method and packaging kept at this level 
through control process?  observed for September  2015 which for first step 
Have indicators been identified for a controlled environment  TDS= 0.4 mg/l based on Dynasts checklists (<0.45) 
which covers valid cleaning and packaging processes including 
the organizations holding a valid cleaning process? 
(Temperature, Humidity, Air Current, Filtration of Air, Ionization 
 
6.4  of Air, Pressure differences, Lighting (along with its spectral  Resources and work environment for each job has     
content and severity), Sound, Vibration, cleaning of Working 
surfaces and processes, Water quality, number of persons in the 
been documented on Job description such as for 
work environment)  manufacturing technicians: 
 Have dressing conditions, cleaning conditions and health 
conditions for any person being in contact with the product or 
Cold room big enough for 800 liters cups  
the work environment including those persons who enter the  Ph meters and … 
area sterilized prior to use or temporarily or for a short period in 
terms of importance microbiologic cleaning holds been  On the first day of audit they were manufacturing 
identified?   "amilaz" which shall manufacturing on dark 
Are personnel to work in special work conditions or a controlled 
environment provided with special training and/or supervision?  environment; they have mobile wall and proper 
In the event that any personnel including temporary and trained 
personnel for performance of special tasks in a controlled 
conditions due to SOP. 
environment are assigned for performance of the works such as  Records of cleanness of hood have been observed 
production, maintenance, cleaning or repair, are such personnel 
supervised by an appropriately trained person? Have the 
which is maintained weekly. Responsible for 
procedures for product introduction, product polluted or being  cleanness is manufacturing technician. In the 
likely to be polluted, manual working for working surfaces or 
personnel, cleaning or removal of contamination in order to  record mentioned in manufacturing floor, tables, 
prevent cross pollution of product, work environment or  manufacturing equipments are recorded 
personnel? 
Are  the  records  indicating  appropriateness  for  all  conditions  effectively.   
kept? 

7  Product Realization 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 6 of 17 
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Risk management of products was observed; considering that

PLANNING OF PRODUCT REALIZATION  all products formulation are applied based on Diasys Co., the
Has the organization considered the scope of its own 
quality management system in planning of product  identified risks are only in Main Mix preparation area. risk
realization?   assessment method is according to FMEA and RPN is
Has the organization prepared required records for a  determined equal or more than 144. They have identified 6
proof indicating that quality objectives and product 
rules, processes established, documents and product‐ risks which one of them has been reduced and the others are
specific necessary resources, verification, validation,  about product users methods that can not be reduced. Such as
tracking, measuring, inspection and product‐specific  not matching product to the auto analyzer device which leads
test activities , realization processes and the product 
meet the rules?  to failure test result. All advisory notices have been provided in
In the event that inspection and test are conducted by  product brochure; in risk assessment meeting , all these risks
manufacturing personnel, do inspection and test 
results, processes, organization’s procedures ensure 
have been discussed.
impartiality of inspection and test results?  Brochure of CK-MB kit was observed the advisory notices :
7.1  Risk management   Ingestion and contact with mouth and eyes, Waste disposal AR   
Has the organization prepared a procedure containing 
all processes of product realization for risk management 
method, instruction for use, solutions preparation, appropriate
activities and realized the following?  use of calibrators and controls, test temperature acceptance
Keeping the records  level, maintenance, volume & and type of reagents, expected
Preparation of Risk Management Plan 
Determination of Risk team and its Responsibilities 
results at 37 °. Labeling and other technical documents
Determination of Intended Use of Device and Safety  including reference laboratory tests results about kit validation
Characteristics of Device  & performance in addition the result of clinical evaluation from
Definition of hazards 
Risk Estimation for Hazards 
Milad Hospital central laboratory in June-15 was observed.
Evaluation of Risks  All developed SOP’s for production, cleaning, mixing,
Risk Control Measures  packaging, labeling and dispatch (cold chain). The records for
Definition of Residual Risks  
Risk/Benefit Analysis 
CK-MB & Bilirubin were observed.
Preparation of Risk Management Report  AR: the risk assessment technical documents have not been
approved by technical team.
DETERMINATION OF REQUIREMENTS RELATED TO THE  All application & performance requirements are according to
PRODUCT/SERVICE 
Has the organization defined the requirements of  to Diasys Co. formulation. Production license from this
customer including the requirements for the activities  company is vali till 2020 which was observed.
on delivery and after delivery?  Production is executed according to the SOP’s and have been
Do these requirements include the following?: 
‐ regulatory and legal requirements related to the  approved by Diasys Co. for example production work
countries and territories where the product is supplied  instruction including expected chemical specifications, PH,
to the market  time & temperature, QC methods and QC parameters was
‐ anticipated utilization, 
‐ Performance expectations,   checked. Reference laboratory is supervising kits results and
‐ Design factors  renewing the sales license is based on not having complaint in
7.2.1  ‐ Delivery plans  last year.    
‐Unclear customer expectations 
 Does the organization record customer’s expectations 
related to product/service in order to revise the same?  Inquiry for "sotode bahar" on date 3‐Nov 2015 has been 
In the event of any change in order or offer or both for 
any reason whatsoever, are changes revised and an  observed: 
agreement is reached on the changes as it is in original  HDL‐C‐Direct * 2 one 
order or offer? 
In the event that changes are accepted, are all  LDL‐C‐Drirect * 3 One 
personnel being affected by the changes within the 
organization informed? 
Which has been dispatched same day 
Are  relevant  documents  affected  by  these  changes 
amended? 

7.2  Customer‐Related Processes 

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REVIEW  OF  REQUIREMENTS  RELATED  TO  THE 

PRODUCT/SERVICE 
Does the organization review the requirements related 
to the product? 
Are review records kept? 
Has  this  review  been  realized  prior  to  commitment  of  Inquiry of parsa tajhiz ghom "Trulab‐Lipid" because 
the  organization  for  provision  of  the  product  to  customer needed same lot (because of same controls) 
7.2.2  customer?     
Has the organization ensured settlement of contract or  they send inquiry in 5 days (after confirming 7 days as 
order requirements which are different from previously 
defined? 
dispatch with customer)  
Does the organization have the ability to meet defined 
requirements? 
Are the results of review and subsequent follow‐up 
actions recorded? 
CUSTOMER COMMUNICATION 
Are arrangements for communication identified and 
In the website, production lists with code and properties 
implemented relating to product information, demands,  are on the website. In properties sheet of this kit, 
7.2.3 
applications, contracts or realization of order including 
amendments?  customers can order from other side there is methods of    
Are required arrangements identified and implemented  use, preservation, safety, reagents, standards, 
for customer feedback and communication with 
customers including customer complaints?  calibrators, CV. Average and disposal. 
7.3  Design and Development 
DESIGN AND DEVELOPMENT PLANNING 
Have the stages of design and/or development been 
identified? 
Have review, verification and validation activities 
appropriate to each design and/or development stage, 
7.3.1  responsibilities and authorities been identified in design  NA     
and development planning? 
Are design and development planning updated when 
planning output is appropriate and  in the progress of 
design and development? 
DESIGN AND DEVELOPMENT INPUTS 
Are inputs related to product requirements identified 
and relevant records maintained? 
Do these inputs include functional and performance 
7.3.2  requirements, applicable regulatory and legal  NA     
requirements, applicable information derived from 
previous and similar designs a any other requirements 
essential for design? 
Have the inputs been reviewed in terms of adequacy? 
DESIGN AND DEVELOPMENT OUTPUTS 
Are design and/or development outputs approved 
before prior to release and in a manner that enables 
verification against the design and/or development 
inputs? 
Do the design and/or development outputs meet the 
7.3.3  design input requirements and  NA     
‐provide appropriate information for purchasing, 
manufacture and service performance, 
‐ contain or reference product acceptance criteria 
‐ define the characteristics of the product that are 
essential to its safe and proper use? 
DESIGN AND DEVELOPMENT REVIEW 
Does the organization identify suitable stages for 
systematic reviews of design and/or development? 
7.3.4  Are the results of review and subsequent follow‐up  NA     
actions recorded in order to evaluate the ability to 
fulfill requirements and identify problems and 
propose corrective actions? 
DESIGN AND DEVELOPMENT VERIFICATION 
7.3.5  Does the organization in planned arrangements ensure  NA     
that design output meets input criteria 

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DESIGN AND DEVELOPMENT VALIDATION 
Is the design and/or development validation performed 
in accordance with planned arrangements to confirm 
that final product is capable of meeting the 
requirements of intended use or application 
7.3.6  requirements defined?  NA     
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  NA     
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  Approved supplier list and records of supplier evaluation for
documented process to ensure that purchased product 
conforms to purchasing requirements?  last 12 months was observed. Raw material are provided from
Are criteria for selection of suppliers defined?  Diasys Co.; the record of evaluation of “Shenase Gostar Co.”
Are evaluation and reevaluation of suppliers have been  for labeling products, “Armita Metal Co.” for kit Vial were
defined? 
 Has the organization defined tracking frequency of  observed. Also the contracts (92-5464-678) for Vial production
supplier’s performance?  according to the drawing and needed order quantity in2013
Does the organization have the proofs indicating that  which is renewed till the end of March-2016 was observed. In
supplier monitoring activities, outsourced processes are 
controlled and the products or services conform to the  supplier evaluation, legal regulations situations, production
method & standard with high weight coefficient have been
7.4.1 
rules of the organization containing customer demands 
and regulatory rules?  determined & applied. 
  
Have the requirements of purchasing information 
(containing the rules related to supplier records) 
including outsourced processes been identified to 
ensure product and service quality? 
Does the organization have the methodology to 
communicate these requirements to the supplier? 
Are purchasing contracts available? 
Do the type and content of the control on supplier and 
purchased product depend on the next product 
realization of purchased product or final product? 
Are purchasing records retained? 
PURCHASING INFORMATION  In purchase order records, all aforementioned data have been
Does purchasing information define the product to be 
purchased?  registered. Because of the Diasys Co. formulation and raw
Where appropriate, does purchasing information  material data, organization uses Diasys CoA’s and cannot
include product approval, procedures, requirements for  change the specifications. Vials production technical data are
7.4.2 
process and equipment, Personnel qualification and the 
requirements of Quality Management System?  provided according to contract, drawing and moulds.    
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  All purchased raw material according to the delivered CoA

Has the organization identified a method in order to 
ensure that the product received conforms to the  from Diasys are controlled and validated based on SOP’s such
specifications, is finished, holds appropriate identity  as Potassium’s CoA with charging number of SZBF0300V for
and is free from any damage?   2015 was observed:
Do the processes include the provisions in order to 
verify that incoming product is provided along with  Production No: 60220
CAS No: 7778.77.0
7.4.3 
support documentation (e.g. conformity certificates, 
acceptance test reports)?  Formula: KH2PO4

Has data been provided related to analysis of previous 
acceptance inspection data, rejection history in the  Storing situation of the product is between 15 to 25 degree.
plant or customer complaints, required inspection  Material name: Product name: 4-Aminoantipyrine-reagent
quantity  and necessity of reevaluation of supplier?  grade
Has the organization identified the authorized person 
for conformity approval of incoming material?  With charging number of 1002
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?  As observed, Manufacturing is 
 Has  the  characteristic  qualities  of  product  been  identified?  When  required,  have 
documented  procedures,  documented  rules,  work  instructions  and  reference  materials 
based on SOP of filling and 
reference materials and reference measuring processes been made available?  manufacturing resources and 
Has appropriate equipment been selected in the manner that enables process and product 
specifications to be obtained?  equipments are mentioned such 
Have the documents for using appropriate equipment been established?  as mixer, scale with resolution of 
Has  it  been  verified  that  new  and/or  significantly  modified  equipment  meets 
purchasing/design specifications and posses the ability to operate within the limits defined  0.001 and 0.0001 gr. 
and process operating limits?   Records of control of batch 
7.5.1  Have control devices been identified? 
Has a document been prepared for using control devices?  94005 contains: 
  
Have implementation and control requirements for labeling and packaging been identified? 
Are  the  records  obtained  during  manufacturing  process  of  any  product  lot  and  facilitating 
Vial tests 
traceability and review of the manufacture of this lot retained?   Labeling tests 
Do the records include the following information? 
‐  When  applicable,  quantity  of  raw  materials,  components  and  intermediate  products  and  Packing list 
lot numbers of those materials,  Brochure which includes work 
‐ When applicable, start and completion dates of different stages of manufacture including 
sterilization records,  instruction, calibration and IFU
‐ Quantity of manufactured product,   
‐  Signed results of all inspections and tests, 
‐ Representation of production line used, 
‐  Any deviation from manufacturing specifications. 

7.5.1.2  Control of production and service‐Special rules 
Control of product cleanliness and contamination  
Has the organization identified product cleanliness 
rules? 
Have the materials and substances used during 
manufacturing process been adequately defined and 
labeled in order to prevent complexity and process 
GMP requirements of MOH  for  PRODUCTION OF Kits 
7.5.1.2.1  faults? 
Have certain medical devices been cleaned and/or 
have been met    
cleared of contamination so as to prevent employees  Refer to 6.4 
and other product from being exposed to any 
contamination 
Have cleaning and implementation requirements been 
documented? 

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Assembly activities 
Have assembly activities and responsibility for medical 
device been identified? 
In the event that any medical device should be 
assembled and mounted in the location where the user 
is present, have guiding instructions been prepared by 
7.5.1.2.2  the organization for accurate assembly, montage, tests  NA   
and/or calibrations? 
Has the organization provided the instructions which 
allow assembler to confirm proper operation of the 
device? 
Are the results of assembly or commissioning tests 
recorded? 
Service activities  
In the event that functionality of products needs service 
or maintenance for proper utilization of products, have 
documented requirements been established for service 
activity? 
Has the organization identified service responsibilities 
between distributors and users? 
Have service activities carried out by the organization or 
a separate agency been planned? 
Have the design and functionality of equipment or 
devices with special purpose related to manual 
operation and service after assembly been validated? 
7.5.1.2.3  Are measuring and test equipment used for site service  NA   
and tests controlled? 
Have instructions related to the lists of spare parts or 
parts and for use in product service been prepared? 
Has the infrastructure covering technical consultancy 
and technical support, customer training and spare 
parts or provision of parts been established? 
Are service personnel trained? 
Are specialized service personnel available? 
Has the organization formed a system for receiving 
customer demands so as to determine whether 
customer complaints and rules are handled?  
Are service records retained? 
Special rules for sterile devices 
Does the organization record process parameters 
related to sterilization process and used for each 
7.5.1.3  sterilization lot?  NA   
Are sterilization records tracked for each production lot 
related to medical devices? 
7.5.2  VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION 
General rules 
a)defined criteria for review and approval of the 
process 
b)approval of equipment and qualification of staff 
involved 
7.5.2.1  c) use of specific methods and procedures  NA   
d)records requirements 
e)revalidation 
documented procedure for validation of 
software/computer applications, and records of 
validation 
Special rules for sterile medical devices 
Have sterilization processes been validated prior to 
use? 
7.5.2.2  Have the standards used for validation of sterilization  NA   
process been identified and implemented? 
Have the requirements in the Article no.  7.5.2.1 been 
met? 
7.5.3  Identification and Traceability 

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Identification 
Has the organization identified and documented the 
product through appropriate methods during product 
Identification and traceability P07 has been established. 
7.5.3.1  realization? 
How has the organization identified product situations 
Batch contains five characters:    
in accordance with tracing and measuring  Serial/manufacturing year 
requirements? 
Batch no. 94040 for manufacturing order no. 22 October 
2015 observed which is traceable to raw material. Such 
TRACEABILITY 
75.3.2.1  General  as raw material code 10002,  LOT NO.: SABFSLBF8908V 
How is the product traced?  In inquiry no 440441, kit alkaline phosphate Lot No. 
7.5.3.2  Has any method been documented for traceability? 
Does the organization ensure traceability of the medical  94005 Exp.date: 2016‐02, manufacturing order No. 
  
device  during  typically  production  and  storage  process 
up to expiration of ownership? 
00042 for April 2015  has been observed. Qc report was 
observed. Results are recorded comparing last batch No. 
which are validated and verified 
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  NA   
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? 
All non conforming products are separated from other 
Status Identification 
products,  
7.5.3.3  Organization  has  identified  status  of  product  with 
respect to measurement and monitoring requirements 
Identification and traceability P07 has been established.    
Batch contains five characters: 
Serial/manufacturing year 
CUSTOMER PROPERTY 
Does the organization ensure identification, verification, 
protection and safety of customer property provided 
for product or in the manner that it creates product 
while it is under the organization’s control or being 
7.5.4  used?  NA   
Does the process ensure that occurrence of any 
customer property that is lost, damaged or otherwise 
found to be unsuitable for use are recorded and 
reported to the customer? 
PRESERVATION OF PRODUCT 
Are methods and controls established to preserve  Preservation and storing procedure is P06. Storing and 
conformity of product during internal processing and 
until delivery to intended destination? 
layout are as Dinasys SOPs such as temperature, 
Has the organization established documented processes  humidity, light, time, composition and other related 
or documented work instructions for control of the 
product with limited shelf life or which requires special 
thing. 
7.5.5  storage? 
Are such special storage requirements controlled and 
For record, Kit C3, temperature is 2‐8, during audit    
recorded?  temperature was 7.8, and dispatch cold room is 6 
Does this preservation include definition, transport,  degree centigrade. For the case 7.8 in on‐going store, 
packaging, storage and protection of the product and 
the parts constituting the product?  operator says because you opened the door, 
Is there a logo on product? Is it proper to its 
instructions? 
temperature is became 7.8. 

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Measurement device lists are recorded in F05‐p04 such 
as: 
CONTROL OF MONITORING AND MEASURING DEVICES  Deionizer QC records has been observed for July 2015 
Has the organization identified the measurements to be 
made and the measuring and monitoring devices  interval of calibration is annual. Calibration certificate is 
required to ensure conformity of product to specified 
requirement? 
traceable to NACI standard SRM NIST.  
During audit, manufacturing technician told that they 

P04 Procedure 
a) Be calibrated or verified at specified intervals, or 
prior to use, against measurement standards traceable 
to international or national measurement standards; 
check on mixing station. But as calibration certificate 
7.6  where no such standards exist, the basis used for 
calibration or verification s hall be recorded;  
code PH178.2 shows it is calibrated to 35 degree of  AR
b) Be adjusted or re‐adjusted as necessary;   centigrade but applicable degree is 60‐70 degree of 
c) Be identified to enable the calibration status to be  centigrade. 
determined;  
d) Be safeguarded from adjustments that would  Internal verification for auto analyzer Hitachi has been 
invalidate the measurement result;  
e) Be protected from damage and deterioration during 
observed. Records are available but there is no 
handling, maintenance and storage.   documented SOP. 
Calibration certificate for sampler has been observed 
with code 2959848A on date 2015/06/09 with No. 677. 
8  Measurement, Analysis and Improvement 
General  Monitoring & measuring of the processes and data which affect
Does the organization plan to implement the 
monitoring, measurement, analysis, and improvement  on QMS has been conducted. Such as customer feedback
processes required for conformity of the product and  (P10), internal audit, sales rate and customer complaint. 
8.1  QMS and improvement of its efficiency?     
Are measurement, analysis and improvement 
processes are carried out through statistical 
techniques and applicable methods? 

8.2  Monitoring and Measuring 
Customer satisfaction from laboratories are executed
periodically; such as Razi Lab & Milad lab are the most
important customers which have assigned grades higher than
8.2.1 Feedback 
Does the organization monitor the information related 
75%; the complaints were about technical support which have
to customer perception in order to understand whether  been closed.
8.2.1  customer requirements are met or not? 
Has the organization determined methodologies for 
The record of complaint from Bahar lab in March-15 for CK-   
obtaining and using information on customer 
MB kits with number of 94/21 was observed. The complainant
satisfaction and/or dissatisfaction?  was Mrs. Zahra Armand Chour, the complaint number was
12/26 which has been closed by explaining how to match the
kit by using calibrators and detergents. Since now they have
not reported any recall.
According to internal audit procedure (P03), internal 
INTERNAL AUDIT  audit intervals have been determined 6 months; the 
Has a documented procedure been established that 
includes responsibilities and requirements,  qualification of internal auditors has been determined. 
requirements for planning and conducting the audit, 
reporting the results, maintaining the records? 
They have been trained on internal audit principles 
Are audits planned in the form of an audit program?  course. Internal audit has been conducted in July‐15. 
8.2.2 
Does audit programme take importance and status of 
the fields and processes to be audited including the  One of the Nc’s was about incompleteness of staff    
results of previous audits?  training records. Corrective action number of 9404, the 
Do selection of auditors and implementation of audit 
ensure objectivity and impartiality of the process?  root cause has been determined. The other Nc’s was 
Do auditors audit their works?  about incompleteness of environment cleanliness 
Do follow‐up actions cover verification of the measures 
taken and reporting of verification results?  supervision records and the related corrective action 
was observed. 

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. Monitoring and measuring the processes were observed such

MONITORING AND MEASUREMENT OF PROCESSES 
as:
Does the organization implement appropriate methods  Complaint responding shall be less than 24 Hrs; the average of
8.2.3 
for monitoring QMS processes and where applicable, 
for measurement such WMS processes? 
records was 13 Hrs.
Storage minimum stock shall not be zero and the records
  
When planned results are not achieved, is corrective 
action taken for product conformity?  indicate that this has not been happened yet.
There shall be no rejected kits and the records indicate that this
has not been happened yet.
8.2.4  MONITORING AND MEASUREMENT OF PRODUCT 

According to the developed procedure, the first approval of

bulk ( generally is 100 Ltrs) has been executed and after
production and mix according to Diasys SOP’s, QC staff take
their samples. The results are reported to QC manager and after
confirmation with Diasys, the batch will be accepted and
transferred for filling. This is identified by yellow abel which
installed on product bulk (Bilirubin direct); this product is the
dirs reagent of Bilirubin-Kit which for approving shall be
controlled second reagent. The second reagent solution also
shall be tested by first reagent. For this sample because of not
producing the second reagent, the sample product first reagent
has been tested by previous batch product second reagent. The
related records were observed. First reagent was produced,
approved and packaged in Oct-15
General rules  After approving and installing the yellow label, the batch of
Does the organization establish appropriate stages to 
filled vials has been packaged with first reagent. If the final
measure and monitor product characteristics? 
Have verification methods been documented?  product QC result is OK it will be labeled with green label
Is this verification process realized in accordance with  which implies on dispatch & sales permit. Green label for CK-
the arrangements planned during appropriate stages of 
MB in main cold home Sep-15 was observed.
8.2.4.1  product realization process? 
Are conformity evidences along with acceptance criteria  In the end the decision making of product dispatching will be   
maintained?  registered in a form named CoA and transferred to regulatory.
Are the records approved by the authorized 
person/persons in the process of product release? 
Such as the CoA of Glucose with serial number of 94009 in
Are product release and distribution of service, planned  Sep-15 and expiry date of 2017-03 was observed:
regulations (Article 7.1) completed satisfactorily?  Ph: 7.51
Control sera: trulab N, n=20, Rang=80.6-96-111
Within run: 97.8 +/- 0.83
Between run: 97.8 +/- 1.44
Sensitivity: 5 +/- 0
Limit of blank: 1.49
Limit of detection: 1.49
Recovery: 102%
Linearity: <2
Also the witness samples in storage from QC department with
expiry date of 2015-12 and production date ion 2014-09 was
observed.
The destruction method of expired products, collecting and
deliver to the municipality have been determined according to
contract number of 93-556r34.
Special  rules  related  to  active  implantable  medical 
devices and implantable medical devices 
8.2.4.2  Does the organization record the identity of the  NA  
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
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CONTROL OF NON‐CONFORMING PRODUCT  In reviewing of Non-conforming product, a sample test for

Does the organization have methodologies to ensure 
that product that does not conform to requirements is  factors affecting quality of products were checked for Bilirubin
identified and controlled to prevent unintended use or  Assay Kits as it was considered as non conforming product
delivery?  The significant difference between measuring factors such as
Is there a documented procedure related to non‐
conforming product?  6875, 3612, 1924. Results for deciding were referred to QC
Does the organization take measures to remove non‐ manger and the reasons for discrepancies were detected
conformity related to product?  associated with vials used for sampling
When applicable, do the processes identify the methods 
The re-sampling and results from second sampling were
8.3 
authorizing the non‐conformity’s use, release or 
acceptance in agreement with customer?  consistent as follows 3482 and 3548   
Are required measures taken to preclude the product’s  Records related to Bilirubin with serial number 93002 and
original intended use or application? 
Are records related to the nature of nonconformities  expiration date 2015, May observed
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? 
Analysis was performed on two of the requested items as
provided:
DATA ANALYSIS  Customers: the customer with overall satisfaction of 70 percent
Does the organization collect, identify and analyze 
appropriate data to demonstrate efficiency and 
is very good, and that has been no rejected item, which is
appropriateness of QMS and the fields where QMS’s  assessed as favorable.
efficiency can be continuously improved? 
Has a documented procedure been prepared for these  Suppliers: Supplier Evaluation charts were reviewed. The
situation is due to the purchase of raw materials from relevant
8.4 
analyses? 


 
Do the characteristics and tendencies of the processes  agencies DiaSys is appropriate. Vial supplier is also very well
and products including data analysis, customer 
satisfaction, conformance to product requirements,  meets organization's needs. Generally the organization felt no
opportunities for corrective actions provide information  need to change avulsion suppliers.
related to suppliers? 
Have data types for data analysis been defined?  Preventive measures: the only preventive measure that has had
Are data analyses recorded?  an important impact on reduction of downtime was to buy
generator to be in line when electric cut out to maintain the
cold chain products.
8.5  Improvement 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 15 of 17 
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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?  Objectives were observed, one objective was to change the
Have the complaints been evaluated within the scope of 
the following points?  packaging the plan to achieve these objectives were planned,
‐  whether the organization fails to comply with its own  such as recognizing the packaging options for kits for auto-
specifications or not,  analyzers in the market
8.5.1  ‐ whether the organization has caused problems to 
occur despite the fact that it has complied with its own  The timetable to achieve the objectives is considered one year   
specifications  The project control indicator is considered as index to control
In the event that the activities outside the organization  the progress of the project
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 
One sample corrective action was related to numerous forms
Preventive Action? 
and confusing of processes of producing forms in document

P02 Procedure 
Are corrective actions taken to eliminate causes of 
nonconformities effective in preventing recurrences?  control, and also there was only one person available to
Does this procedure include the requirements of 
respond to auditors, so the action taken was to form ad-hoc
8.5.2  reviewing non‐conformities (including customer 
complaints), determining the causes of non‐conformity,  committees in each units to produce forms and respond to AR
evaluating the actions needed to ensure that  assessors in a time frame (in 5 months) the effectiveness of the
nonconformities do not recur, determining and 
implementing the corrective action needed, and review 
actions taken is provable as during the audit other staff could
of the results of the action initiated?  respond too 
Is adequacy of corrective‐preventive actions identified? 
PREVENTIVE ACTION 
Has  the  organization  established  a  documented 
procedure  for  preventive  action  with  defined 
Preventive measures: the only preventive measure that has had
requirements for identifying potential non‐conformities 
an important impact on reduction of downtime was to buy
8.5.3 
and  their  causes;  evaluating  the  need  for  action  to 
prevent  occurrence;  determining  and  implementing  generator to be in line when electric cut out to maintain the   
preventive  action  needed;  recording  results  of  action 
taken; reviewing preventive action taken. 
cold chain products.
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

GMP Record 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:

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 thermometer in production department is not calibrated, the other PH meter that is used for this department is not calibrated in the 
rage needed 
2- No documented document/SOP for method of calibration was not seen for Auto‐analyzer model 912, records of calibration does not 
reference the reference calibrator in 1‐March 2015
3- no evidence was provided that the effectiveness of the actions taken after internal audit are effective
4- One of the technical documents of the organization have not been approved by technical team (risk management)
5- Access to records and retrieving records is not effective (records of risk control  were not exactly in their place, and found in other place)

Observation Form-018 – with uniquely specific identification:

ATL: M.R.Khoshgoo DATE: 10-Nov-2015

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