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BRSM 
  QMSMDD ISO 13485 (2003) 

 
Assessment Report/Checklist 
Form 009 

 
CLIENT‐ORGANIZATION (NAME):    Teb Karan Iranian 

PHYSICAL LOCATION(s):   No.12 , Arghavan st. , Farkhondeh Ave. , Sanat 
Blvd , Parand industrial town , tehran‐saveh road 
, Iran 
Stage II Audit Date(s):    06&07 April 2016 

Stage I Audit Date(s):    17 March 2016 

NAICS (or NACE) CODE MD1109

EXCLUSIONS:    7.5.1.3/7.5.1.2.2/7.5.2.2/7.5.3.2.2/8.2.4.2/7.3 

 
Assessment objectives: Third party assessment of requirements of
QMSMDD ISO 13485 (2003), is met in
companies management system, as well as legal
requirements
 
 
ASSESSMENT TEAM INFORMATION 
Assessment Team Leader, ATL Ms. Azadmanesh 
Assessor 2 Mr. Pourhasan 
 
 
 
 
 
 
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). 
manufacture and after sale services of skin , hair , ophth  examination  
2  Scope of activities 
beds and gynecologicalental surgery and examination beds 
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  ISIRI 3368 and Good manufacturing practice for C
   
organization has to follow  medical device products from MOH. 
4  Quality Management System 
GENERAL REQUIREMENTS 
Does the organization establish, document, implement, 
maintain and continually improve a Quality 
Management System (QMS) with due consideration 
given to  identification of processes needed for the  Processes are: management, analysis of data, sale,
QMS and their application throughout the system; 
determination of sequence and interaction of these  procurement, production, aftersales services, quality
4.1  processes, determination of criteria and methods 
required to ensure effective operation and control of 
control, storage, preventive maintenance. 
these processes; availability of resources and  Acceptance criteria has determined in F01-P12.
information required to support the operation and 
monitoring of processes; measurement, monitoring and 
analysis of the processes; implementation of action to 
achieve  planned results and continual improvement 
‐If any, are the outsourced processes are defined? 
DOCUMENTATION REQUIREMENTS  
Is there a documented quality policy and documented 
quality objectives and are they appropriate? 
Is there a documented quality manual and are there 
documented procedures required by the standards??  Documentation process was checked in stage I
4.2 
Are required records for planning, acting and controlling 
processes efficiently available?  Quality manual QM/02 , Quality policy: QP/01 edited on 
Are the documents are created for every type of  march 2015 and all required procedures has documented.
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 
Does the Quality Manual include, scope of QMS and  Quality manual QM/02 observed. Identified procedures
details of exclusion? 
and instructions that organization has implemented.
4.2.2  Are documented procedures reference to mandatory 
procedures;  Scope of activities and QMS is determined in this 
Is description of interaction of the processes included in  document. 
the QMS? 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 2 of 17 
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Mandatory procedures have documented. control


CONTROL OF DOCUMENTS  conditions pertaining to mandatory documents are proper
Are mandatory procedures documented? 
Are control conditions pertaining to mandatory  and they have kept in separate archives. Review, update
documents proper?  and re-approval situations and changes and current
Are review, update and re‐approval situations and 
changes and current review situations for documents  review situations for documents traceable in list of
traceable?  documents and data. the relevant documents are usable,
4.2.3  Are the relevant documents usable, readable and 
recognizable at concerned usage points? 
readable and recognizable at concerned usage points .all 
Are outsourced documents defined?  documents has been typed. Outsourced documents such
Are distribution of documents controlled, outdated 
documents prevented from being used and appropriate 
as standards have defined.
definition method applied in case of being stored for  Distribution of documents is controlled and production
any purpose? 
line personal have related documents. Documents are
Are these subjects clear in the relevant procedure? 
readable, easily recognizable and stored in available
manner.
 CONTROL OF RECORDS 
Are documents readable, easily recognizable and stored 
in available manner?  Control of records procedure documented and storage,
4.2.4 
Has a documented procedure been established and 
applied for determination of required controls for  retrieval, retention time and disposition of records has 
storage, retrieval, retention time and disposition of  defined in that. 
records? 
Has the archiving defined for at least 2 years? 
5  Management responsibility 
MANAGEMENT COMMITTMENT 
Has the top management ensured that requirement for 
Top management communicated requirement for meeting
meeting customer conditions and legal conditions  customer conditions and legal conditions to personal by
should be understood by all personnel? 
weekly commissions. quality policy is available in
5.1  Is a quality policy available? 
Are quality objectives available?  production line and office. Management review has 
Is management review established?  established and holds annually. Equipment for production
Does  the  management  provide  required  sources  for 
QMS?  processes provided.
CUSTOMER FOCUS  Methodology to customer relation has determined such as
5.2 
Does  top  management  have  methodologies  to  ensure 
that  customer  needs  and  expectations  are  determined  : customer survey form and customer complaints records 
and met for increasing customer satisfaction?  form. 
QUALITY POLICY 
Has top management established a Quality Policy in 
accordance with the objective of the organization?  Quality policy: QP/01 edited on march 2015. Review
Does the Quality Policy include a statement of 
intervals is annual . Quality Policy includes item such as
5.3  commitment to meeting requirements and continual 
improvement of the QMS?  :development of market , enhancement of product quality

Has the Quality Policy been revised for communication, 
understanding and continuous compliance within the 
, enhancement of customer satisfaction 
body of the Organization? 
For enhancement of customer satisfaction, organization
QUALITY OBJECTIVES  has developed infrastructure such as: purchasing of
Are quality objectives established by top management  machinery. By this operation both on time delivery and
at relevant functions and levels within the organization? 
Are the objectives measurable and consistent with the  quality of parts has been better.
Quality Policy  Installation of painting line. Timing of objective access
5.4  5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING 
Has the QMS been planned by Top Management in  has planned. 
order to meet the conditions and quality objectives  For enhancement of product quality, power supply has
detailed in Section 4.1? 
When changes are initiated, is the integrity of the QMS  purchased from valid brand also using of concentrated
maintained during the change process? 
foam and using of ABS cover.

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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RESPONSIBILITY AND AUTHORITY 
Has top management identified responsibility and 
Job description for production operator Also for
5.5.1 
authority and been communicated within the 
organization? 
quality control manager observed in F02-P10.  

Has top management defined responsibilities and 
authorizations for CE marking? 

MANAGEMENT REPRESENTATIVE 
Has  top  management  appointed  a  member  as 
Management  Representative  with  responsibility  and 
Factory manager is management representative. He is
5.5.2 
authority to ensure that the processes of the QMS are 
established,  implemented  and  maintained;  report  to 
aware about his responsibilities. 

top  management  on  the  performance  of  the  QMS, 
including  needs  for  improvement  and  promote 
awareness of customer requirements? 

INTERNAL COMMUNICATION 
Has the top management ensured establishment of 
Internal communication is implemented by: tel., face
5.5.3 
appropriate communication processes within the 
organization? Has the top management ensured 
to face ,letter, internal committee. 

realization of communication considering the processes 
of the QMS and their effectiveness? 

5.6  Management review
TOP MANAGEMENT REVIEW 
Does top management review the QMS to ensure its 
continuing suitability, adequacy and effectiveness at 
Management review has planned on quality manual
5.6.1 
regular and planned intervals? 
Do reviews include assessing opportunities for  annually and has held on feb.2016.  
improvement including the need for changes to the 
QMS, quality policy, and quality objectives? 
Are management review records kept? 
 REVIEW INPUT 
Does review input include current performance and 
improvement opportunities related to: 
a) results of audits; 
b) customer feedback; 
All inputs has reviewed .such as : internal audit result ,
5.6.2  c) process performance and product conformance; 
d) status of corrective and preventive actions;  customer feedback , … 

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? 

REVIEW OUTPUT 
Does output from management review include actions 
Some Outputs for improvement of product quality and
needed sources are; provision of LASER cut equipment
5.6.3 
related to improvement of the QMS and its processes, 
improvement of product related to customer 
and thickness meter tool , …. Also for improvement of

requirements, actions and decisions relate to resource 
needs?  processes determined new method. 

6  Resource Management
PROVISION OF RESOURCES 
Does the organization have methods to determine and 
Human resources, infrastructure provided for support of
6.1  provide resources needed to implement and improve  
the processes of the QMS and address customer  processes.
satisfaction by meeting requirements? 
6.2  Human Resources 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 4 of 17 
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Needed qualifications for production operator and quality


control manager observed in F02-P10. For quality control
Are personnel assigned with responsibilities that affect  manager was: awareness about production and quality
product quality competent on the basis of applicable 
6.2.1  education, training, skills, and experience? 
Are  trainings  performed  for  achievement  of  Required 
control requirements. 
Competence?  In training records of one of production operator ,
observed training records and meet to determined job
qualifications.
COMPETENCE, AWARENESS, AND TRAINING 
Has the organization identified the experience, 
Training plan of 94 was observed.(F05- P10)
qualifications, competencies and skills of the personnel  Training course of assembling of products has held on
performing activities affecting safety and efficiency of  Apr.2015 for one of production staff (score 82). Also in
medical devices particularly being manufactured and 
provided to customer?   training plan of this year, painting course has held on
6.2.2 
Is training provided by the organization to satisfy the 
competency needs? 
march 2015. 
Does the organization ensure that its employees are  Effectiveness of training course “assembling of products”
aware of the relevance and importance of their 
activities and how they contribute to the achievement  has recorded on July.2015 by management
of quality objectives?  representative. the effectiveness score for production
Are  records  of  education,  experience,  training  and 
qualifications maintained?  staff was 75.
INFRASTRUCTURE 
Has manufacturing equipment been designed, 
constructed, properly established and placed for proper 
operation, maintenance, adjustment and cleaning?  
In case of applicability, has the organization ensured 
documentation of natural limits or permissible  for painting line , interval checks includes : change of
tolerances in manufacturing process and measuring and 
test equipment and availability of the same for  filter every 2 mounts and cleaning of filter after every
operators?  running.
6.3  Are documented processes available for maintenance,     
cleaning and control of all equipment used in  Records of visual check for furnace of painting line
manufacturing process and control of work 
environment?  observed on feb.2016. 
Are required adjustments and maintenance intervals 
identified?  
Is maintenance plan placed normally on or near the 
equipment and easily reachable? 
Is maintenance realized based on the relevant plan? 

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 environment needed to achieve conformity of 
product? 
Are the following factors which could affect product 
quality in the work environment identified?  
‐ Process equipment,  
‐ Work environment,  
‐ Personnel in this work environment  
Are qualified and quantified limit values of the work 
environment identified for a desired quality of the work 
environment? 
Are pollution levels of microbial and solid particles 
controlled during product manufacturing where sterile 
product or pollution of solid particle which is stipulated 
to be sterilized or could live or not live during its 
manufacture or utilization is important?  
Has exclusion been applied during all manufacturing 
processes for a controlled environment? As valid 
ground of exclusion, is pollution reduced to known, 
consistent and controlled level by an approved cleaning 
method and packaging kept at this level through control 
process?  According to monitoring and control of work
Have indicators been identified for a controlled 
environment which covers valid cleaning and packaging 
environment procedure: P11, work environment controls
processes including the organizations holding a valid  about cleaning weekly. This procedure, meets legal
6.4  cleaning process? 
requirements about GMP for A, B medical devices .    
(Temperature, Humidity, Air Current, Filtration of Air, 
Ionization of Air, Pressure differences, Lighting (along  For example: cleaning of warehouse. Checklist of Jun
with its spectral content and severity), Sound, Vibration, 
cleaning of Working surfaces and processes, Water  2015 was observed. 
quality, number of persons in the work environment) 
 Have dressing conditions, cleaning conditions and 
health conditions for any person being in contact with 
the product or the work environment including those 
persons who enter the area sterilized prior to use or 
temporarily or for a short period in terms of importance 
microbiologic cleaning holds been identified?  
Are personnel to work in special work conditions or a 
controlled environment provided with special training 
and/or supervision? In the event that any personnel 
including temporary and trained personnel for 
performance of special tasks in a controlled 
environment are assigned for performance of the works 
such as production, maintenance, cleaning or repair, are 
such personnel supervised by an appropriately trained 
person? Have the procedures for product introduction, 
product polluted or being likely to be polluted, manual 
working for working surfaces or personnel, cleaning or 
removal of contamination in order to prevent cross 
pollution of product, work environment or personnel? 
Are  the  records  indicating  appropriateness  for  all 
conditions kept? 

7  Product Realization 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 6 of 17 
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Risk analysis for hair, skin and ophth examination beds


and for genycology beds : F02-W02/1. Hazards , effects ,
risk level , control action ,risk reassessment and residual
PLANNING OF PRODUCT REALIZATION 
Has the organization considered the scope of its own  risk observed. Some hazards are:
quality management system in planning of product  fraction of sitting part , risk level is : acceptable , control
realization?  
Has the organization prepared required records for a 
action is : welding test and weight test of product.
proof indicating that quality objectives and product  For electrical hazards such as ;
rules, processes established, documents and product‐
specific necessary resources, verification, validation, 
leakage current , electromagnetic interface , … quality
tracking, measuring, inspection and product‐specific  action is purchasing of electrical panel from Valis
test activities , realization processes and the product 
meet the rules? 
supplier with CE certificate.
In the event that inspection and test are conducted by  Risk analysis for hair, skin bed such as:
manufacturing personnel, do inspection and test 
results, processes, organization’s procedures ensure 
Fracture location of the waist
impartiality of inspection and test results?  Risks of life-threatening dysfunction and the
7.1  Risk management      
Has the organization prepared a procedure containing  patient's extremities
all processes of product realization for risk management  RPN=8
activities and realized the following? 
Keeping the records  Control: welding test and weight test of product
Preparation of Risk Management Plan  RPN after control=4
Determination of Risk team and its Responsibilities 
Determination of Intended Use of Device and Safety  General Surgery bed:
Characteristics of Device  Electromagnetic interference 
Definition of hazards 
Risk Estimation for Hazards  Risks life and limb‐threatening lesions of the disease 
Evaluation of Risks 
Risk Control Measures 
RPN=15 
Definition of Residual Risks   Control: purchasing EMC parts, EMC tests. 
Risk/Benefit Analysis 
Preparation of Risk Management Report  RPN after control=5
Stages of production of all kinds of beds has determined
in control of production instruction. Quality controls
duration production according to OPC: F07-W01 be done
DETERMINATION OF REQUIREMENTS RELATED TO THE 
PRODUCT/SERVICE 
Has the organization defined the requirements of 
customer including the requirements for the activities 
on delivery and after delivery? 
Do these requirements include the following?: 
‐ regulatory and legal requirements related to the 
countries and territories where the product is supplied 
to the market 
‐ anticipated utilization,  According to production control and sales instruction:
‐ Performance expectations,  
‐ Design factors  W01 , customer orders receives and by form F01-W01
7.2.1  ‐ Delivery plans  accepted orders , communicated to production line. order   
‐Unclear customer expectations 
 Does the organization record customer’s expectations  2325 on Oct 2015 and Order 2339 on Nov 2015 were
related to product/service in order to revise the same?  checked.
In the event of any change in order or offer or both for 
any reason whatsoever, are changes revised and an 
agreement is reached on the changes as it is in original 
order or offer? 
In the event that changes are accepted, are all 
personnel being affected by the changes within the 
organization informed? 
Are  relevant  documents  affected  by  these  changes 
amended? 

7.2  Customer‐Related Processes 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 7 of 17 
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REVIEW  OF  REQUIREMENTS  RELATED  TO  THE 


PRODUCT/SERVICE 
Does the organization review the requirements related 
to the product? 
Are review records kept? 
Has  this  review  been  realized  prior  to  commitment  of  All orders reviewed based on time delivery. This is done
the  organization  for  provision  of  the  product  to 
7.2.2  customer? 
by manufactory and communicated to sale department.    
Has the organization ensured settlement of contract or  For order 2325 , time delivery was 25 days after
order requirements which are different from previously 
defined? 
receiving order.(base on customer requirements) 
Does the organization have the ability to meet defined 
requirements? 
Are the results of review and subsequent follow‐up 
actions recorded? 

CUSTOMER COMMUNICATION  User manual of beds for customer information provided


Are arrangements for communication identified and  and includes : specifications of accessories , functional
implemented relating to product information, demands, 
specification , maintenance notices , cleaning instruction
7.2.3 
applications, contracts or realization of order including 
amendments?  , changing of lamp , trobleshot.   
Are required arrangements identified and implemented 
for customer feedback and communication with  Also for handling of customers feedback , according to
customers including customer complaints? 
procedure : P13 all feedbacks recieves .
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  excluded     
and development planning? 
Are design and development planning updated when 
planning output is appropriate and  in the progress of 
design and development? 
DESIGN AND DEVELOPMENT INPUTS 
Are inputs related to product requirements identified 
and relevant records maintained? 
Do these inputs include functional and performance 
7.3.2  requirements, applicable regulatory and legal  excluded     
requirements, applicable information derived from 
previous and similar designs a any other requirements 
essential for design? 
Have the inputs been reviewed in terms of adequacy? 
DESIGN AND DEVELOPMENT OUTPUTS 
Are design and/or development outputs approved 
before prior to release and in a manner that enables 
verification against the design and/or development 
inputs? 
Do the design and/or development outputs meet the 
7.3.3  design input requirements and  excluded     
‐provide appropriate information for purchasing, 
manufacture and service performance, 
‐ contain or reference product acceptance criteria 
‐ define the characteristics of the product that are 
essential to its safe and proper use? 
DESIGN AND DEVELOPMENT REVIEW 
Does the organization identify suitable stages for 
systematic reviews of design and/or development? 
7.3.4  Are the results of review and subsequent follow‐up  excluded     
actions recorded in order to evaluate the ability to 
fulfill requirements and identify problems and 
propose corrective actions? 
DESIGN AND DEVELOPMENT VERIFICATION 
7.3.5  Does the organization in planned arrangements ensure  excluded     
that design output meets input criteria 

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DESIGN AND DEVELOPMENT VALIDATION 
Is the design and/or development validation performed 
in accordance with planned arrangements to confirm 
that final product is capable of meeting the 
requirements of intended use or application 
7.3.6  requirements defined?  excluded     
Is verification completed (if applicable) prior to delivery 
or implementation of product? Ara relevant records 
maintained? 
Are results of review and required actions recorded? 
 CONTROL OF DESIGN AND DEVELOPMENT CHANGES 
Have design and development changes  been identified 
and recorded? 
Have design and development changes been reviewed, 
verified,  validated  and  approved  prior  to 
implementation? 
7.3.7  Does the review of design and development changes  excluded     
include evaluation of the effect of changes on 
previously delivered product and the parts constituting 
the product? 
Are  the  results  of  review  of  changes  and  subsequent 
follow‐up actions documented? 
7.4  Purchasing 
Purchasing Process; Has the organization prepared 
documented process to ensure that purchased product 
conforms to purchasing requirements? 
Are criteria for selection of suppliers defined? 
Are evaluation and reevaluation of suppliers have been 
defined? 
 Has the organization defined tracking frequency of 
supplier’s performance? 
Does the organization have the proofs indicating that 
supplier monitoring activities, outsourced processes are 
Records of suppliers evaluation for chromium
controlled and the products or services conform to the  electroplating parts observed based on: records of
7.4.1 
rules of the organization containing customer demands 
and regulatory rules? 
activity, price, quality of service, distance from factory.   
Have the requirements of purchasing information  Score was 69 and grade: B.
(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 
Does purchasing information define the product to be 
purchased? 
Where appropriate, does purchasing information  Purchasing data for row material determined in BOM in
include product approval, procedures, requirements for 
technical file.
7.4.2 
process and equipment, Personnel qualification and the 
requirements of Quality Management System?    
How does organization ensure the adequacy of  On dec.2015 purchase order no.: 364 observed for foam
specified requirements in the purchasing information  60*180 . this order is accordant with BOM.  
prior to their release to the supplier? 
Are records for the information related to purchased 
product available? 

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VERIFICATION OF PURCHASED PRODUCT 
Has the organization identified a method in order to 
ensure that the product received conforms to the 
specifications, is finished, holds appropriate identity 
and is free from any damage?   One cromium electroplating part on jan.2016 purchased
Do the processes include the provisions in order to  from supplier. 10 number testes based on instruction
verify that incoming product is provided along with 
(strength and humidity test) and verified.
7.4.3 
support documentation (e.g. conformity certificates, 
acceptance test reports)?  
Has data been provided related to analysis of previous  On jan.2016 , trans 24v purchased from supplier and
acceptance inspection data, rejection history in the  tested based on amper of trans and verified. Records of
plant or customer complaints, required inspection 
quantity  and necessity of reevaluation of supplier?  this verification observed on F01-P04. 
Has the organization identified the authorized person 
for conformity approval of incoming material? 
Are verification records retained? 

7.5  Production and Service Provision 
CONTROL OF PRODUCTION AND SERVICE PROVISION 
7.5.1.1 General rules 
Has the organization identified control requirements for 
production and service process? 
Is  control  quantity  and  control  detail  level 
proportionate to criticality level of its process? 
 Has  the  characteristic  qualities  of  product  been 
identified?  When  required,  have  documented 
procedures,  documented  rules,  work  instructions  and 
reference  materials  reference  materials  and  reference 
measuring processes been made available? 
Has  appropriate  equipment  been  selected  in  the 
manner that enables process and product specifications 
to be obtained? 
Have  the  documents  for  using  appropriate  equipment  After receiving order , communicated to warehouse ,
been established?  assemble , manufacture of body . such as , order no: 2325
Has  it  been  verified  that  new  and/or  significantly 
modified  equipment  meets  purchasing/design  for genycology bed with 2 motors and code : GM2.N .
specifications  and  posses  the  ability  to  operate  within 
7.5.1  the limits defined and process operating limits?  
Have control devices been identified? 
Control duration production according to form F02-P04   
on jan.2015 observed. Such as : for measuring and
Has  a  document  been  prepared  for  using  control 
devices?  cutting of parts , welding of frame and skelet ,
Have  implementation  and  control  requirements  for  assembling and painting . this controls has done based on
labeling and packaging been identified? 
Are the records obtained during manufacturing process  quality control plan. 
of  any  product  lot  and  facilitating  traceability  and 
review of the manufacture of this lot retained?  
Do the records include the following information? 
‐  When  applicable,  quantity  of  raw  materials, 
components  and  intermediate  products  and  lot 
numbers of those materials, 
‐  When  applicable,  start  and  completion  dates  of 
different  stages  of  manufacture  including  sterilization 
records, 
‐ Quantity of manufactured product, 
‐  Signed results of all inspections and tests, 
‐ Representation of production line used, 
‐  Any deviation from manufacturing specifications. 
7.5.1.2  Control of production and service‐Special rules 
Control of product cleanliness and contamination  
Has the organization identified product cleanliness 
rules? 
Have the materials and substances used during 
manufacturing process been adequately defined and 
labeled in order to prevent complexity and process 
After all steps of production , products cleans by and
7.5.1.2.1  faults? 
Have certain medical devices been cleaned and/or  also after welding , welded parts , cleans by antox gel. 
  
cleared of contamination so as to prevent employees 
and other product from being exposed to any 
contamination 
Have cleaning and implementation requirements been 
documented? 

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Assembly activities 
Have assembly activities and responsibility for medical 
device been identified? 
In the event that any medical device should be 
assembled and mounted in the location where the user 
is present, have guiding instructions been prepared by 
7.5.1.2.2  the organization for accurate assembly, montage, tests  excluded   
and/or calibrations? 
Has the organization provided the instructions which 
allow assembler to confirm proper operation of the 
device? 
Are the results of assembly or commissioning tests 
recorded? 
Service activities  
In the event that functionality of products needs service 
or maintenance for proper utilization of products, have 
documented requirements been established for service 
activity? 
Has the organization identified service responsibilities 
between distributors and users? 
Have service activities carried out by the organization or 
a separate agency been planned? 
Have the design and functionality of equipment or  One sample for aftersales services request on jan.2015
devices with special purpose related to manual 
operation and service after assembly been validated?  observed. About failoure in function of remote control of
7.5.1.2.3  Are measuring and test equipment used for site service 
and tests controlled? 
beds. Records includes : failure description , result of   
Have instructions related to the lists of spare parts or  actions and customer satisfaction observed in form F05-
parts and for use in product service been prepared?  W01. Action was changing of remote board. 
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?  exluded   
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  Painting , chromium electroplating and welding are


a)defined criteria for review and approval of the 
process 
special processes according to Control of production ,
b)approval of equipment and qualification of staff  sale and after sale services instruction : W01. Records of

W01 
involved 
validation of welding operation observed in training
7.5.2.1  c) use of specific methods and procedures 
d)records requirements  records of operator. Records of validation of chromium
AR
e)revalidation 
documented procedure for validation of 
electroplating operation observed for purchased material
software/computer applications, and records of  such as on jan.2016. For painting operation , records of
validation 
parameters controls has not recorded. 
Special rules for sterile medical devices 
Have sterilization processes been validated prior to 
use? 
7.5.2.2  Have the standards used for validation of sterilization  excluded   
process been identified and implemented? 
Have the requirements in the Article no.  7.5.2.1 been 
met? 
7.5.3  Identification and Traceability 

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Identification 
Has the organization identified and documented the 
product through appropriate methods during product 
All beds in assemble line have S/N and lable includes
7.5.3.1  realization? 
How has the organization identified product situations  name and model of product . such as : S/N: 9412012.
  
in accordance with tracing and measuring 
requirements? 

TRACEABILITY  For skin exaination bed with S/N: 9412006 for order no.:
75.3.2.1  General 
How is the product traced?  2456 , traceability and control of produced productions
7.5.3.2  Has any method been documented for traceability? 
Does the organization ensure traceability of the medical 
observed. S/N recorded in that. Specifications of parts   
device  during  typically  production  and  storage  process  such as : upper motor , electronic board , wheels ,… .type
up to expiration of ownership?  of motor identified in that.
Special  rules  related  to  active  implantable  medical 
devices and implantable medical devices  
Does  the  organization  ensure  traceability  in  inspection 
and  stock  records  for  the  changes  of  the  personnel 
performing  a  work  traceability  of  which  belongs  to  an 
7.5.3.2.2  introductory  (e.g.  serial  number,  data  code,  lot  code, 
 
party  number)  special  to  operation  source,  changes  in  excluded   
raw materials, changes in the works performed through 
tools,  new  or  different  machine  devices,  changes  of 
process methods? 
When applicable, are special personnel assigned to act 
during  processing  medical  device  or  each  stage  of 
delivery traced? 

Status identification of production during manufacturing


Status Identification 
is recorded in form traceability and control of produced
7.5.3.3  Organization  has  identified  status  of  product  with 
respect to measurement and monitoring requirements  productions . one sample observed in production line :
  
S/N: 9409049.
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 
No customer property observed on after sale services.
Head of this department told that , devices need to repair
7.5.4 
while it is under the organization’s control or being 
used? 
, kept away from other products and in suitable place
  
Does the process ensure that occurrence of any 
customer property that is lost, damaged or otherwise  with identification labeling.
found to be unsuitable for use are recorded and 
reported to the customer? 
PRESERVATION OF PRODUCT 
Are methods and controls established to preserve 
conformity of product during internal processing and 
until delivery to intended destination? 
Has the organization established documented processes 
Genicology beds observed in final warehouse. Packing of
or documented work instructions for control of the  this product was according to packing instruction. All
product with limited shelf life or which requires special 
final products in warehouse have technical specification
7.5.5  storage? 
Are such special storage requirements controlled and  lable includes : S/N , name of product , specifications of   
recorded?  electrical unit , …. This product has kept away from
Does this preservation include definition, transport, 
packaging, storage and protection of the product and  humidity.
the parts constituting the product? 
Is there a logo on product? Is it proper to its 
instructions? 

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CONTROL OF MONITORING AND MEASURING DEVICES 
Has the organization identified the measurements to be 
made and the measuring and monitoring devices 
required to ensure conformity of product to specified  Caliper code vc02 in size: 30cm in quality control unit
requirement? 
a) Be calibrated or verified at specified intervals, or  and has not identified for calibration status and according
prior to use, against measurement standards traceable  to calibration planning, not observed calibration records.
to international or national measurement standards; 

P05 
7.6  where no such standards exist, the basis used for 
calibration or verification s hall be recorded;  
Caliper VC01 is calibrated and certificate No. is AR
934853‫ب‬194 calibration is valid before September 2016
b) Be adjusted or re‐adjusted as necessary;  
c) Be identified to enable the calibration status to be  Coating film calibration certificate is 934857‫ب‬194
determined;  
d) Be safeguarded from adjustments that would  calibration is valid before September 2017
invalidate the measurement result;  
e) Be protected from damage and deterioration during 
handling, maintenance and storage.  

8  Measurement, Analysis and Improvement 
General 
Does the organization plan to implement the 
monitoring, measurement, analysis, and improvement  Statistic technique and analysis of data P12, internal
processes required for conformity of the product and 
8.1  QMS and improvement of its efficiency?  audit , customer feedback handling procedure    
Are measurement, analysis and improvement  documented.  
processes are carried out through statistical 
techniques and applicable methods? 

8.2  Monitoring and Measuring 
8.2.1 CUSTOMER SATISFACTION 
Does the organization monitor the information related  Score of customer satisfaction was 92.84% . this score
to customer perception in order to understand whether 
has improved 10% from last year.
8.2.1  customer requirements are met or not? 
Has the organization determined methodologies for  No complaint from interested parties   
obtaining and using information on customer  No recall
satisfaction and/or dissatisfaction? 
Internal audit procedure: P03.
INTERNAL AUDIT 
Has a documented procedure been established that  Interval for internal audit is annual. Records observed
includes responsibilities and requirements,  on feb.2016.
requirements for planning and conducting the audit, 
reporting the results, maintaining the records?  they have issued 6 NCR’s (such as not evaluation
Are audits planned in the form of an audit program?  training effectiveness about storage method) and
8.2.2 
Does audit programme take importance and status of 
the fields and processes to be audited including the  related corrective action. All determined corrective   
results of previous audits?  actions have been closed and their effectiveness have
Do selection of auditors and implementation of audit 
ensure objectivity and impartiality of the process?  been evaluated by the management representative.
Do auditors audit their works?  As mentioned above, for non conformities, has issued
Do follow‐up actions cover verification of the measures 
taken and reporting of verification results? 
corrective actions. Some actions have finished and
effectiveness of them has evaluated.

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According to process acceptance level , all processes


has measured. Such as : purchasing process based on
number of fault parts , result was : zero. And based on
: quantity of no on time production for delay of
purchasing was zero.
- after sales services average of time is 36.5 hour,
MONITORING AND MEASUREMENT OF PROCESSES  last period was 39 hours.
Does the organization implement appropriate methods 
- Training effectiveness criteria 70%, the result
8.2.3 
for monitoring QMS processes and where applicable, 
for measurement such WMS processes? 
79%
  
When planned results are not achieved, is corrective 
action taken for product conformity?  - Number of equipment unpredicted wreckage
criteria 6 in 3 months, the result 4

Analysis has been observed such as after sale service


index, it has progress which shows effectiveness of
objective of “enhancement of product quality” –refer
to 5.4-
8.2.4  MONITORING AND MEASUREMENT OF PRODUCT 
General rules 
Does the organization establish appropriate stages to 
measure and monitor product characteristics? 
Have verification methods been documented?  Final quality control form for S/N: 9310029 (skin
Is this verification process realized in accordance with 
the arrangements planned during appropriate stages of  examination bed) observed. Controls determined and
8.2.4.1  product realization process? 
Are conformity evidences along with acceptance criteria 
results recorded in that. Such as: control of circuit   
maintained?  includes: trans (power supply), capacity, micro switch ,
Are the records approved by the authorized  … angle test .
person/persons in the process of product release? 
Are product release and distribution of service, planned 
regulations (Article 7.1) completed satisfactorily? 
Special  rules  related  to  active  implantable  medical 
devices and implantable medical devices 
8.2.4.2  Does the organization record the identity of the  excluded  
personnel carrying out any inspection or test? 
CONTROL OF NON‐CONFORMING PRODUCT 
Does the organization have methodologies to ensure 
that product that does not conform to requirements is 
identified and controlled to prevent unintended use or 
delivery? 
Is there a documented procedure related to non‐
conforming product? 
Does the organization take measures to remove non‐
conformity related to product? 
When applicable, do the processes identify the methods  No nonconforming product has reported.
8.3 
authorizing the non‐conformity’s use, release or 
acceptance in agreement with customer?  Procedure for control of nonconforming products is P04.   
Are required measures taken to preclude the product’s  Responsibilities has determined in that.
original intended use or application? 
Are records related to the nature of nonconformities 
and the measures taken later maintained? 
Is corrected nonconforming product subject to re‐
verification to demonstrate conformity to the 
requirements? 
Do the processes ensure that appropriate corrective 
action is initiated when non‐conforming product is 
detected after delivery or use has started? 

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DATA ANALYSIS 
Does the organization collect, identify and analyze 
appropriate data to demonstrate efficiency and 
appropriateness of QMS and the fields where QMS’s 
efficiency can be continuously improved? 
Has a documented procedure been prepared for these  By improvement of parts quality with better quality 
8.4 
analyses? 
parts , customer satisfaction has got better 10%  

 
Do the characteristics and tendencies of the processes 
and products including data analysis, customer  comparing last year. 
satisfaction, conformance to product requirements, 
opportunities for corrective actions provide information 
related to suppliers? 
Have data types for data analysis been defined? 
Are data analyses recorded? 

8.5  Improvement 
CONTINUAL IMPROVEMENT 
Has the organization identified required changes by 
using quality policy, quality objectives, audit results, 
analyses of data, corrective and preventive actions and 
management review in order to ensure and sustain 
ongoing conformity and efficiency of quality 
management system and does the organization 
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  Improvement planning were: installation of painting line,
specifications or not, 
improvement of electrical panel of beds.
8.5.1  ‐ whether the organization has caused problems to 
occur despite the fact that it has complied with its own  These plans are based on quality policy and customer   
specifications  feedbacks. 
In the event that the activities outside the organization 
are identified through examination of the contribution 
of such activities to customer complaint, has the 
relevant information been shared among responsible 
organizations? 
In the event that any customer complaint is not 
followed up through a corrective and/or preventive 
action, has the reason of this failure been confirmed 
and recorded? 
Has the organization established a documented 
procedure for notifying adverse events and alertness 
within the scope of after‐sale supervision activities?  
Does the process comply with international guides? 
(MEDDEV 2.12.1 – MEDDEV 2.12.2) 
Are the notices for adverse events recorded 
8.5.2. CORRECTIVE ACTION 
Is there a documented procedure for Corrective and 
Preventive Action? 
Are corrective actions taken to eliminate causes of 
Corrective actions about result of internal audit , was
nonconformities effective in preventing recurrences?  checked. All root causes has detected and actions are
Does this procedure include the requirements of 
based on root causes. For example some semi-products
8.5.2  reviewing non‐conformities (including customer 
complaints), determining the causes of non‐conformity,  had not been labeled ,rout cause : the operator of who   
evaluating the actions needed to ensure that  was in charge was on vacation and his responsibility was
nonconformities do not recur, determining and 
implementing the corrective action needed, and review  not allocate to other staff.  
of the results of the action initiated? 
Is adequacy of corrective‐preventive actions identified? 

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 √ 
 

PREVENTIVE ACTION 
Has  the  organization  established  a  documented 
procedure  for  preventive  action  with  defined 
requirements for identifying potential non‐conformities 

8.5.3 
and  their  causes;  evaluating  the  need  for  action  to 
prevent  occurrence;  determining  and  implementing  No preventive actions has issued.   
preventive  action  needed;  recording  results  of  action 
taken; reviewing preventive action taken. 
What are the methods for identifying the adequacy of 
 
corrective‐preventive actions? 

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

cleaness  
 

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:NA

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. Caliper in size: 30cm in quality control unit has not identified for calibration status and according to calibration
planning, not observed calibration records.
2. For painting operation, records of parameters controls have not recorded.

Observation Form-018 – with uniquely specific identification:NA

ATL: Ms. Azadmanesh DATE: 9 April 2016

END of REPORT

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 16 of 17 
REFERENCE, AS
This Clause

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

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

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

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