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

 
Assessment Report/Checklist 
Form 009 

 
CLIENT‐ORGANIZATION (NAME):    Avan Teb 

PHYSICAL LOCATION(s):   No. 126, Moezzi St. Between Khayam and 
Fatholmobin Blvd.  Dezfool, Iran 

Phase II Audit Date(s):    19‐20, June‐15 

Phase I Audit Date(s):    8‐June‐15 

NAICS (or NACE) CODE Nace Code: 26.6

EXCLUSIONS:    7-5-1-3,7.5.1.2.2, 7-5-2-2, 7-5-3-2-2, 8-2-4-2

 
Assessment objectives: assessing requirement conformity of ISO 9001 and ISO
13485 systems in production of electrosurgical units 

 
 
ASSESSMENT TEAM INFORMATION 
Assessment Team Leader, ATL M.R.Khoshgoo 
Assessor 2 Farhang Mohajer 
Assessor 3  
Assessor 4  
Assessor 5  
Assessor 6  
 
 
 
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). 

2  Scope of activities  Production of Electrosurgical units 

BRSM requires that the organization’s legal obligations 
and regulatory are met. Who are the main responsible 
Legal status   
for executing and monitoring of these regulations? 
3  Mr. Amin Varshowsaz 
Ministry of Health of Iran, Medical Device Section, IEC
Obligatory applicable standard which  60601-1 :2005, IEC 60601-2-2 : 2006, ISO 13485:2003, IEC    
organization has to follow  60601-1-4, ISO 14971: 2012, ISO 10993,, EN 1041:2008, IEC
60950-1:2005, ISO 14155:2011,, ISO 15223-1
4  Quality Management System 
Avan teb company
GENERAL REQUIREMENTS 
Does the organization establish, document, implement,  has registration according to their local regulations, registration
maintain and continually improve a Quality  certificate was observed and controlled and got manufacturer
Management System (QMS) with due consideration  license of medical devices according to MOH (ministry of health of
given to  identification of processes needed for the  Iran) regulation as the below.
QMS and their application throughout the system; 
1.Business License: from industrial ministry
determination of sequence and interaction of these 
4.1  processes, determination of criteria and methods  - Certificate No. : 06001934 
required to ensure effective operation and control of  - Issued on 16 dec-2006
these processes; availability of resources and  2.MOH license
information required to support the operation and 
monitoring of processes; measurement, monitoring and 
‐ Certificate No. 664/173273
analysis of the processes; implementation of action to  - renewed on 6-aug-13
achieve  planned results and continual improvement  Class IIb (Rule 9), Annex IX of the Medical Device Directive
‐If any, are the outsourced processes are defined?  93/42/EEC amended by Directive 2007/47/EC
Company’s production processes are according to OPC in F01-
DOCUMENTATION REQUIREMENTS   P04/0
Is there a documented quality policy and documented  EN ISO 10993-1:2009
quality objectives and are they appropriate? 
Is there a documented quality manual and are there 
Category: active device
documented procedures required by the standards??  Contact: skin and tissue via electrodes
Are required records for planning, acting and controlling  All required procedures have been established , refer to document
4.2  processes efficiently available?  review report form 002

Are the documents are created for every type of 
7-5-1-3, 7-5-2-2 sterilizing, 7-5-3-2-2 Implantable devices, 8-2-4-2
medical device including qms requirements and product 
specifications? (4.2.3) If these documents are applicable  active implantable devices-7-5-4 customer property, as these are
to manufacturing processes, are montage and service  not applicable due to nature of the device
defined?  interaction of the processes included in process map attached to
QUALITY MANUAL  Manual
Does the Quality Manual include, scope of QMS and  Products: Smart 3 and 4: Avan Teb has provided technical files for
details of exclusion?  these 2 products. ATTFEU4 for both Smart 3 and 4
4.2.2  Are documented procedures reference to mandatory  The quality manual addresses the processes and exclusion as 
procedures; 
Is description of interaction of the processes included in 
explained above, the procedure for document and record control
the QMS?  was verified against document review phase audit

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 2 of 17 
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All criteria has been considered in Document and record control

CONTROL OF DOCUMENTS  P01
Are mandatory procedures documented?  List F02-P01
Are control conditions pertaining to mandatory  Terms and definition of the quality manual
documents proper?  P0x Procedure, W0x work instruction
Are review, update and re‐approval situations and 
changes and current review situations for documents 
Refer to Form 002 report
traceable?  documents and records of the MDD system are under control by
Document and records Procedure P01 for all documents a version
4.2.3  Are the relevant documents usable, readable and 
recognizable at concerned usage points?  has been defined and for forms procedure and work instructions a 
Are outsourced documents defined?  coding system has been defined, list of documents are recorded in
Are distribution of documents controlled, outdated 
documents prevented from being used and appropriate 
F02-P01any changes in documents are recorded in F01-P01, time
definition method applied in case of being stored for  of retention of records has been defined in F03-P01, as sample
any purpose?  F02-P01was checked in case of version and approvals, it was
Are these subjects clear in the relevant procedure?  approved by top management.
Related forms to each staff was accessible according to list of
distribution
 CONTROL OF RECORDS 
Are documents readable, easily recognizable and stored 
All criteria has been considered in Document and record control
in available manner?  P01
Records are kept at least 2 years, they are kept in classified files
4.2.4 
Has a documented procedure been established and 
applied for determination of required controls for  The records of products are kept 10 years for guarantee and 
storage, retrieval, retention time and disposition of  warrantee, records of Smart 3 device sold to Shomare 2 hospital
records? 
Has the archiving defined for at least 2 years?  seen.
5  Management responsibility 
MANAGEMENT COMMITTMENT 
Has the top management ensured that requirement for 
meeting customer conditions and legal conditions  policy QP/0
should be understood by all personnel? 
Management has committed to provide all needed resources
5.1  Is a quality policy available? 
Are quality objectives available?  Organization Chart OC/0 
Is management review established?  objectives QO
Does  the  management  provide  required  sources  for 
QMS? 

CUSTOMER FOCUS  The company produces each device based on orders received

from hospital clients, so its focus is in meeting customer
5.2 
Does  top  management  have  methodologies  to  ensure 
that  customer  needs  and  expectations  are  determined  requirements as well as regulations, meeting customer needs is 
and met for increasing customer satisfaction?  conveyed to staff through Policy and procedures
QUALITY POLICY 
Has top management established a Quality Policy in  Criteria by ISO publication has been considered in Policy quality
accordance with the objective of the organization?  policy: increase of customer satisfaction- training and developing
Does the Quality Policy include a statement of 
human resources – continuous improvement
5.3  commitment to meeting requirements and continual 
improvement of the QMS?  When asked about the quality policy form the staff they knew about 
Has the Quality Policy been revised for communication,  it, the policy is also attached on the walls, Ehsan Varshowsaz was
understanding and continuous compliance within the  asked about Policy, he knew it
body of the Organization? 
QUALITY OBJECTIVES  the policy is in accord with other quality management system and
Are quality objectives established by top management 
is backed by quality objectives QO/, As an example to increase
at relevant functions and levels within the organization? 
Are the objectives measurable and consistent with the  the satisfaction of clients the company has decided to extend the
Quality Policy  guarantee period and after sale services to clients and to have a
5.4  5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING 
Has the QMS been planned by Top Management in 
better behavior with clients 
objectives are SMART
order to meet the conditions and quality objectives 
detailed in Section 4.1? 
they are checked annually, the last update was in January 2015
When changes are initiated, is the integrity of the QMS  as sample the objective of client satisfaction was considered 80%
maintained during the change process?  and it was 83% as measured in January 2015
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  Top management has defined authorities and responsibilities
according to Organization Chart OC/0
5.5.1 
authority and been communicated within the 
organization?  Each staff has job description 
Has top management defined responsibilities and  Jon descriptions of Mr Amin Varshowsaz observed 
authorizations for CE marking? 

MANAGEMENT REPRESENTATIVE 
Has  top  management  appointed  a  member  as 
Management  Representative  with  responsibility  and 
Mr Amin. Varshowsaz has been assigned duties as MR , his job
5.5.2 
authority to ensure that the processes of the QMS are 
established,  implemented  and  maintained;  report  to  description as MR observed  
top  management  on  the  performance  of  the  QMS, 
including  needs  for  improvement  and  promote 
awareness of customer requirements? 

INTERNAL COMMUNICATION  The internal and external communications have been effectively

Has the top management ensured establishment of  processed within organization and thru liaison with IMED
5.5.3 
appropriate communication processes within the 
organization? Has the top management ensured  The company is small in size and number of staff, most of the 
realization of communication considering the processes  communications is verbal but effective. As explained the
of the QMS and their effectiveness?  manager 

5.6  Management review
TOP MANAGEMENT REVIEW 
Does top management review the QMS to ensure its 
continuing suitability, adequacy and effectiveness at 

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?  Management review is conducted annually, records of the last
 REVIEW INPUT  management system review observed during assessment, all
Does review input include current performance and 
inputs of the management review have been considered within
improvement opportunities related to: 
a) results of audits;  the session, the following results were output from management
b) customer feedback;  review at May 2015: to review training plan and updating it with
5.6.2  c) process performance and product conformance; 
d) status of corrective and preventive actions; 
the needs of the company- to evaluate the client satisfaction 
with more seriously and to increase number of users asked
e) follow‐up action from earlier management reviews; 
f) changes that could affect the QMS,  
about the quality of the products in hospitals, to revise risk
g) recommendations for improvement  analysis program, the production room be separated from other
h)  New or revised regulatory rules?  areas and ensure its cleanliness 
REVIEW OUTPUT 
Does output from management review include actions 
5.6.3 
related to improvement of the QMS and its processes, 
improvement of product related to customer  
requirements, actions and decisions relate to resource 
needs? 

6  Resource Management
PROVISION OF RESOURCES 
Does the organization have methods to determine and 
6.1  provide resources needed to implement and improve 
the processes of the QMS and address customer 
Refer to 6.2, 7.4 and 7.2.3  
satisfaction by meeting requirements? 
6.2  Human Resources 
Are personnel assigned with responsibilities that affect 
product quality competent on the basis of applicable  According to Training Procedure W03, training needs are
6.2.1  education, training, skills, and experience? 
Are  trainings  performed  for  achievement  of  Required 
assessed for staff affecting quality and then trained and the 
results effectiveness is assessed
Competence? 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 4 of 17 
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COMPETENCE, AWARENESS, AND TRAINING 
Has the organization identified the experience, 
qualifications, competencies and skills of the personnel  experience, qualifications, competencies and skills of the
performing activities affecting safety and efficiency of  personnel performing activities affecting safety and efficiency of
medical devices particularly being manufactured and  medical devices have been recorded in Resumes, and personal
provided to customer?   profiles, the records of one of the QC staff reviewed,
6.2.2 
Is training provided by the organization to satisfy the 
competency needs?  2 training programs have been conducted during the year for 
Does the organization ensure that its employees are  assembling of boards in order to prevent any electromagnetic
aware of the relevance and importance of their  interference in electrosurgical units for staff working in
activities and how they contribute to the achievement  assembly line. results were provided in percent, acceptance
of quality objectives? 
was 75% and the training result was 82% effective
Are  records  of  education,  experience,  training  and 
qualifications maintained? 
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 
tolerances in manufacturing process and measuring and 
according to W02 work instruction the company has a list of
test equipment and availability of the same for  equipment, for each there is an identification paper F02-W02,
data of the name of the equipment, for each there is a form of
6.3 
operators? 
Are documented processes available for maintenance,  w02-f05 which explains the instruction of the working of each    
cleaning and control of all equipment used in  machine, which prevents the device from malfunction such as
manufacturing process and control of work 
environment?  the Soldering machines. 
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?   As the device is not sterile (sterile electrode pen is purchased)
Has exclusion been applied during all manufacturing 
processes for a controlled environment? As valid  so the production needs not to be done in clean room. The
ground of exclusion, is pollution reduced to known,  environment is appropriate for production of device, the room
consistent and controlled level by an approved cleaning  that the boards are produced in a closed area and the staff
method and packaging kept at this level through control  enter to the room change their shoes to prevent dust and
process? 
foreign particles, The production is carried on in clean room.
Have indicators been identified for a controlled 
environment which covers valid cleaning and packaging  Before starting the production, raw material is purchased from
processes including the organizations holding a valid  outsourced suppliers, the main source of raw material is so
6.4  cleaning process?  different, the results of the quality control and the criteria of the    
(Temperature, Humidity, Air Current, Filtration of Air,  control are recorded in purchase order F01- P06 according to
Ionization of Air, Pressure differences, Lighting (along 
with its spectral content and severity), Sound, Vibration, 
W01 production instruction, data including; in form of F02-P06
cleaning of Working surfaces and processes, Water  regarding items such as criteria of the quality of the product of
quality, number of persons in the work environment)  the supplier, price after sale services and CE certificates for
 Have dressing conditions, cleaning conditions and  accessories such as electrodes bought from foreign companies
health conditions for any person being in contact with  through domestic companies were observed.
the product or the work environment including those 
persons who enter the area sterilized prior to use or 
The product is cleaned generally and packed and delivered to
temporarily or for a short period in terms of importance  client 
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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Smart 3 and 4: Avan Teb purchases the electrical parts such as

transistors, resistors, capacitors, wires, frame, the company
also buys the accessories such as electrodes, pencils, forceps,
parts of the pedals switches and buttons/keys, after all material
is purchased the electronic parts (BoM) are installed on boards,
which have been designed by engineers in AVAN TEB and
produced based on this design by outsourced supplier. After the
board circuits are completed they are assembled in the frame of
the device, and the wiring of internal circuits is completed the
monitoring displays and the ICs and switches, transformers and
adaptors are also installed, then the product is tested against
the criteria defined in quality plan based on IEC applicable
standards, and then it is calibrated, then it is labeled, and
packed with other accessories in cartons
Risks: risk management W02
PLANNING OF PRODUCT REALIZATION 
Has the organization considered the scope of its own 
Risk Analysis is performed according to EN ISO 14971
quality management system in planning of product  The list of the risks was documented according to the standard
realization?   and identification of the risks documented.
Has the organization prepared required records for a  document code for control table: F03-W02/0
proof indicating that quality objectives and product  observation: Name of the product has been mistranslated
rules, processes established, documents and product‐
specific necessary resources, verification, validation,  “electro cutter”
tracking, measuring, inspection and product‐specific  Risk management plan and report No: annex II of Technical File
test activities , realization processes and the product  F01-W06/02 Essential Requirement Checklist Arising from
meet the rules?  Revision 2007/47/EC
In the event that inspection and test are conducted by 
As an example risk of Electromagnetic interference with
manufacturing personnel, do inspection and test 
results, processes, organization’s procedures ensure  pacemakers has been seen in Risk analysis; before: S=4, p=4,
impartiality of inspection and test results?  to reduce the risk the company has provided Tips and Warnings  
7.1  Risk management   on the accompanying documentation to users to meet cautious  
Has the organization prepared a procedure containing  procedures mentioned in accompanying documents (OBS) 
all processes of product realization for risk management 
activities and realized the following? 
After: s=4 and p= 2 which will be at the verge of acceptable
Keeping the records  level.
Preparation of Risk Management Plan  Risk assessment is very comprehensive and includes risk
Determination of Risk team and its Responsibilities  assessment plan, and F03-W02/0 risk control table.
Determination of Intended Use of Device and Safety  the only object contacted with body is Electrodes/Plates which
Characteristics of Device 
Definition of hazards 
are not produced by the company but purchased from
Risk Estimation for Hazards  manufacturers holding CE mark, following Biological effects
Evaluation of Risks  applies for the electrodes: Cytotoxicity - Sensitization –
Risk Control Measures  Irritation. Intended use and security characteristics of device:
Definition of Residual Risks   use of alarms and Electrical hazards explained in - Appendix II
Risk/Benefit Analysis 
Preparation of Risk Management Report  of technical file
Risk analysis table :There are 168 risks where 12 are again in
ALARP criteria after control, Described as risk-benefit, the
benefits outweighs risks in risk control

Tests: Performance test of the electrical surgical device based

on IEC60601-1(2005) Annex III of Technical file
1. Testing items: Items specified in part 1 of the standard for
safety of the device The test has been done by an internally
accredited in Iran, Lab and the results and the credibility of the
2. Test lab.: The quality control department of holding company
pharmaceutical and medical devices of Iran.

There have been no tests for electromagnetic (IEC 60601-2-2)

interference test results available at the day of assessment and
in the Technical file documents.

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 7 of 17 
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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  Device is delivered to clients according to clients/hospitals
to the market  ordered arrangements, all required tests and certificates are
‐ anticipated utilization, 
‐ Performance expectations,   passed to provide the device in market of Iran, IFU IFU/01 – 
‐ Design factors  ESU – SMART-4&3 documents explains the anticipated
7.2.1  ‐ Delivery plans  utilization, and the performance and design factors have been    
‐Unclear customer expectations 
derived from customer expectation and bench marking with
 Does the organization record customer’s expectations 
related to product/service in order to revise the same?  other brands for improvement. As the design is in improvement
In the event of any change in order or offer or both for  process any time an improvement happens the design form are
any reason whatsoever, are changes revised and an  revised. 
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 
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  As the product is produced based on orders by hospitals there
the  organization  for  provision  of  the  product  to 
for the customer requirements are kept and recorded, the
7.2.2  customer? 
records of orders from Tamin Ejtemayee hospital was seen in
   
Has the organization ensured settlement of contract or 
order requirements which are different from previously  form F01-W04
defined? 
Does the organization have the ability to meet defined 
requirements? 
Are the results of review and subsequent follow‐up 
actions recorded? 
Post Market Surveillance is documented in the customer
complaint form (F01-W04) and Customer satisfaction survey
form (F02-W04). The results are recorded in Customer
complaint are tracked and resolved according to Customer
CUSTOMER COMMUNICATION  feedback work instruction (w04), The correction and prevention
Are arrangements for communication identified and  measure result is documented in report of the correction and
implemented relating to product information, demands,  prevention. The company has also prepared a Clinical
applications, contracts or realization of order including 
7.2.3  amendments?  Evaluation Report-ATCR/01, which includes clinical experience   
Are required arrangements identified and implemented  from its clients, adverse events from other manufacturers which
for customer feedback and communication with  has been an input to risk analysis.
customers including customer complaints?  Records of customer satisfaction evaluated by Company
observed: Records of these evaluations observed for Mehran
Hospital in Ahwaz 80%, chamran hospital of Zabol 86%, Tehran
Rajayee 84%, Tabriz Doostan Clinic 90%. No complaint were
available to audit
7.3  Design and Development 

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DESIGN AND DEVELOPMENT PLANNING 
Have the stages of design and/or development been 
identified?  Design has been planned in procedure 07
Have review, verification and validation activities  The stages of design were defined
appropriate to each design and/or development stage, 
7.3.1  responsibilities and authorities been identified in design  Authorities for design was defined    
and development planning?  Exchange and transfer of data
Are design and development planning updated when  Records for Smart 4 was reviewed
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? 
inputs are collected from
Do these inputs include functional and performance  Clinical evaluation, risk assessment, clinical experience,
7.3.2  requirements, applicable regulatory and legal  adverse events, requirements by clients and legal obligations    
requirements, applicable information derived from  as well as benchmarking with other products
previous and similar designs a any other requirements 
essential for design?  Input design records were observed in design P07 
Have the inputs been reviewed in terms of adequacy? 
DESIGN AND DEVELOPMENT OUTPUTS  According to input design items the out puts have been
Are design and/or development outputs approved  reviewed according to legal and applicable information
before prior to release and in a manner that enables 
verification against the design and/or development 
derived from previous and similar designs
inputs?  According to P07
Do the design and/or development outputs meet the  Electronic drawing of circuits
7.3.3  design input requirements and  BoM, CP, OPC, Assemble procedure, acceptance test plan,
   
‐provide appropriate information for purchasing,  IFU, Risk Updates, production technology and QC tools
manufacture and service performance, 
‐ contain or reference product acceptance criteria  needed and trainings, these have been observed for smart 4
‐ define the characteristics of the product that are  which were provided by Amin Varshowsaz and approved by
essential to its safe and proper use?  Ahmad Varshowsaz
DESIGN AND DEVELOPMENT REVIEW  According to P07 Design is reviewed in case of adverse
Does the organization identify suitable stages for  event, change in regulations, major change in clients
systematic reviews of design and/or development? 
requests, upgrade of technologies and in management
7.3.4  Are the results of review and subsequent follow‐up 
reviews
   
actions recorded in order to evaluate the ability to 
fulfill requirements and identify problems and  Smart 4 was reviewed in case design outputs by Mr. Amin
propose corrective actions?  Varshowsaz in September 2013
DESIGN AND DEVELOPMENT VERIFICATION  the company designs the products boards and the orders of
7.3.5  Does the organization in planned arrangements ensure  the ICs which are the core fundamental sections of the    
that design output meets input criteria 
device and these designs are verified by comparing the
results of the output of the device with the norms of the
DESIGN AND DEVELOPMENT VALIDATION  applicable standards and the criteria defined in technical file
Is the design and/or development validation performed  of the product, where the operator compares the output
in accordance with planned arrangements to confirm  power charts with the acceptable criteria and calibrates the
that final product is capable of meeting the  device (refer to technical file calibration part), device is also

Recodes of EMC 
requirements of intended use or application 
7.3.6  requirements defined?  validated and controlled by standard organization for its AR 
Is verification completed (if applicable) prior to delivery  EMC. Recodes of EMC test not seen.
or implementation of product? Ara relevant records  EMC tests and safety tests were done by external lab
maintained?  Behineh Sadra Organization, dated in October 2013,
Are results of review and required actions recorded? 
The clinical evaluations in Heart center hospital (Rajayee)
observed in November 2013
 CONTROL OF DESIGN AND DEVELOPMENT CHANGES 
Have design and development changes  been identified 
and recorded? 
Have design and development changes been reviewed, 
As the initial designed devices could not pass the EMC tests
verified,  validated  and  approved  prior  to  the design has been changed continuously and the
implementation?  plots/drawing and previous qc forms have been recorded,
7.3.7  Does the review of design and development changes  and the risk assessment has been updated according design
   
include evaluation of the effect of changes on  changes to evaluate changes in design
previously delivered product and the parts constituting 
the product?  After changes applied it has passed the test 
Are  the  results  of  review  of  changes  and  subsequent 
follow‐up actions documented? 
7.4  Purchasing 

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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  Before starting the production, raw material is purchased from 
defined? 
 Has the organization defined tracking frequency of  outsourced suppliers, the main source of raw material is so different, 
supplier’s performance?  the results of the quality control and the criteria of the control are 
Does the organization have the proofs indicating that  recorded in purchase order F01‐ P06 according to W01 production 
supplier monitoring activities, outsourced processes are 
controlled and the products or services conform to the 
instruction, data including; in form of F02‐P06  regarding issues such 
as criteria of the quality of the product of the supplier, price after 
7.4.1 
rules of the organization containing customer demands 
and regulatory rules?  sale services and CE certificates for accessories such as electrodes    
Have the requirements of purchasing information  bought from foreign companies through domestic markets of the 
(containing the rules related to supplier records) 
including outsourced processes been identified to  Medisa Teb company were observed. 
ensure product and service quality? 
List of suppliers F02‐P06, and checklist for suppliers evaluation F01‐
Does the organization have the methodology to 
communicate these requirements to the supplier?  P06 observed , Abadan Electronic has gained 88% , Chamran Ahwaz 
Are purchasing contracts available?  92%, Laksar 84% 
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?  According to the procedure of procurement and supplier evaluation 
Where appropriate, does purchasing information  P06, Order for electrosurgical generator parts are limited to the 
include product approval, procedures, requirements for  purchase of imported electronic components. The other noteworthy 
7.4.2 
process and equipment, Personnel qualification and the 
requirements of Quality Management System?  suppliers are that supply frame of the machine. Necessary    
How does organization ensure the adequacy of  parameters to authenticate buy frames include overall size, 
specified requirements in the purchasing information  accessories, hole positions, color quality and delivery control system 
prior to their release to the supplier? 
Are records for the information related to purchased 
for smart 4 order by Tamin Ejtemayee Hospital 
product available? 
VERIFICATION OF PURCHASED PRODUCT 
Has the organization identified a method in order to 
ensure that the product received conforms to the 
specifications, is finished, holds appropriate identity 
and is free from any damage?  
Do the processes include the provisions in order to  Purchase data is compared with QC requirements and the QC staff 
verify that incoming product is provided along with  accept or reject the purchased item, 
7.4.3 
support documentation (e.g. conformity certificates, 
acceptance test reports)?  Records of ESU pen (medical electrode) purchased observed, the CE  
Has data been provided related to analysis of previous  certificate No. 08 0013 QS/NB a kept as a criteria for purchase 
acceptance inspection data, rejection history in the 
plant or customer complaints, required inspection 
requirements. Date February 2015 
quantity  and necessity of reevaluation of supplier? 
Has the organization identified the authorized person 
for conformity approval of incoming material? 
Are verification records retained? 

7.5  Production and Service Provision 

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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?  Organization has  identified control requirements for production and 
 Has  the  characteristic  qualities  of  product  been  service process, in production w01, non conforming product 
identified?  When  required,  have  documented 
procedures,  documented  rules,  work  instructions  and 
control/qc p04 
reference  materials  reference  materials  and  reference  labeling instruction is done according to technical file of each device 
measuring processes been made available?  qc and traceability are explained further in report 
Has  appropriate  equipment  been  selected  in  the  production planning is developed for quarterly; the latest order is 
manner that enables process and product specifications 
to be obtained?  received from MOH for 30 SMART 4; according to the production 
Have  the  documents  for  using  appropriate  equipment  planning they have estimated to deliver this order in 3 months; 
been established?  production work instructions were available; production is executed 
Has  it  been  verified  that  new  and/or  significantly 
modified  equipment  meets  purchasing/design 
in parallel system and from the beginning they have assigned 30 
specifications  and  posses  the  ability  to  operate  within  serial numbers for this order; at the moment this order is on LCD 
7.5.1  the limits defined and process operating limits?  
Have control devices been identified? 
board assembly step;     
QC records of assembly of main board with amount of 30 pieces 
Has  a  document  been  prepared  for  using  control 
devices?  were observed. 
Have  implementation  and  control  requirements  for  Company’s production processes are according to OPC in F01‐P04/0 
labeling and packaging been identified?  the company follows procedures of P04 to control the quality of the 
Are the records obtained during manufacturing process 
of  any  product  lot  and  facilitating  traceability  and 
products for all raw material after being controlled they are kept 
review of the manufacture of this lot retained?   under the table of the work in production room that is specified for 
Do the records include the following information?  checked (qc) materials, during the production and at the end of the 
‐  When  applicable,  quantity  of  raw  materials,  production each device is tested so a 100% sampling test is being 
components  and  intermediate  products  and  lot 
numbers of those materials,  done and recorded in F01‐P04, results of the quality control of the 
‐  When  applicable,  start  and  completion  dates  of  final product is recorded in F03‐P04, as evidence records of the 
different  stages  of  manufacture  including  sterilization  controls 
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?  The device is produced in general clean 
Have the materials and substances used during manufacturing process been adequately 
conditions and the forceps and electrodes 
7.5.1.2.1  defined and labeled in order to prevent complexity and process faults? 
Have certain medical devices been cleaned and/or cleared of contamination so as to  that need to be sterile are bought from    
prevent employees and other product from being exposed to any contamination  suppliers in sterile packages 
Have cleaning and implementation requirements been documented?
Assembly activities 
Have assembly activities and responsibility for medical device been identified? 
In the event that any medical device should be assembled and mounted in the location 
where the user is present, have guiding instructions been prepared by the organization 
7.5.1.2.2  for accurate assembly, montage, tests and/or calibrations?  Excluded  n/a  
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? 

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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  Intended For Use document provides comprehensive information on 
activity?  how to use the device 
Has the organization identified service responsibilities 
between distributors and users?  As  the  device  is  sold  with  after  sale  services  warranty  the  company 
Have service activities carried out by the organization or  commits to provide such services to clients 
a separate agency been planned?  Inputs from problems in repairs are considered in design validation of 
Have the design and functionality of equipment or 
devices with special purpose related to manual 
device 
operation and service after assembly been validated?  In  IFU  the  description  of  spare  parts  have  been  specified  such  as 
7.5.1.2.3  Are measuring and test equipment used for site service 
and tests controlled? 
forceps and electrodes,     
Using device does not need training but if any hospital asks for such 
Have instructions related to the lists of spare parts or 
parts and for use in product service been prepared?  service, it would be provided, while the company communicates with 
Has the infrastructure covering technical consultancy  clients the complaints are received and evaluated to act upon them 
and technical support, customer training and spare   As  sample  a  repair  at  client  site  in  Reza  Hospital  in  Mashahd 
parts or provision of parts been established? 
Are service personnel trained? 
observed, the generator of the device was replaced, the time frame 
Are specialized service personnel available?  for providing the repair service was within 72 hours, repair person : 
Has the organization formed a system for receiving  Gholam Satrapi at December 2014 
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?  Excluded  N/A  
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 
The  software  validation/verification  for  programmed  ICs  have  been 
involved  completed in W06 according to black box method 
7.5.2.1  c) use of specific methods and procedures 
d)records requirements 
The software life cycle and revision period is annual and in case there    
is a problem from users, 
e)revalidation 
documented procedure for validation of  Records of software validation /verification is in W06 attachments 
software/computer applications, and records of 
validation 
Special rules for sterile medical devices 
Have sterilization processes been validated prior to  As the pen is bought in sterile packs from the supplier with CE mark, 
use? 
periodically  the  Pack  sterile  is  checked  by  external  lab  (3  times  per 
7.5.2.2  Have the standards used for validation of sterilization 
year)  the  records  of  November  2014  from  Soha  Lab,  the  results  of 
N/A  
process been identified and implemented? 
Have the requirements in the Article no.  7.5.2.1 Been  sterility were ok such as residual gas. 
met? 
7.5.3  Identification and Traceability 
Identification  Traceability procedure has been covered in w01 production 
Has the organization identified and documented the  instruction 
product through appropriate methods during product 
Non‐conforming products are labeled according to non conforming 
7.5.3.1  realization? 
How has the organization identified product situations  product control/QC P04,     
in accordance with tracing and measuring  Throughout the process, at the day of assessment no Non‐
requirements?  conforming product was observed

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Traceability procedure has been covered in w01 production 
instruction 
For tracking individual products, each product has a unique serial 
TRACEABILITY  number. This number is the number that is listed in the check list and 
75.3.2.1  General  final product quality control and validation are records in it .The 
How is the product traced?  number is also recorded in Form F04‐W04 of product sale. In this 
7.5.3.2  Has any method been documented for traceability? 
Does the organization ensure traceability of the medical 
form specifications of customers with all types of products sold and    
device  during  typically  production  and  storage  process  their serial numbers are recorded. 
up to expiration of ownership?  As AVE931217‐2  for an electrosurgical device all stages could be 
traced back to raw material, measurements and the final client (Atieh 
Hospital) 
 
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  N/A   
  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? 
Non‐conforming products are labeled according to non conforming 
Status Identification 
product control/QC P04 as in production room 
7.5.3.3  Organization has identified status of product with   
respect to measurement and monitoring requirements  Throughout the process, at the day of assessment no Non‐
conforming product was observed 
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  As observed during assessment, there were 2 devices from SHomare 
while it is under the organization’s control or being  2 Hospital, each were labeled for identification, the devices were put 
7.5.4  used? 
  
in production room on the table dedicated to customer property 
Does the process ensure that occurrence of any 
customer property that is lost, damaged or otherwise 
repair stack area 
found to be unsuitable for use are recorded and 
reported to the customer? 
PRESERVATION OF PRODUCT 
Are methods and controls established to preserve  methods and controls established to preserve conformity of product 
conformity of product during internal processing and 
until delivery to intended destination? 
during internal processing and until delivery to intended destination 
Has the organization established documented processes  P09  the storage condition is explained in form F01‐P09 , the 
or documented work instructions for control of the  products entering and exiting from storage are recorded in storage 
product with limited shelf life or which requires special 
software,  
7.5.5  storage? 
Are such special storage requirements controlled and  if any section of company asks for parts from storage they ask via    
recorded?  request form F02‐P09 as sample requests for Boards in March 2015 
Does this preservation include definition, transport,  seen in exited product receipt of F03‐P09
packaging, storage and protection of the product and 
the parts constituting the product? 
as sterile pens/electrodes are kept in storage room the condition 
Is there a logo on product? Is it proper to its  checked, the temperature was 22 and the humidity was 35%
instructions? 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 13 of 17 
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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  the  company  has  a  procedure  for  controlling  of  measuring  devices 
required to ensure conformity of product to specified  P05,  for  this  reason,  all  measuring  tools  are  listed  in  F01‐P05  and 
requirement?  matters  such  as  environmental conditions  of  their  storage  has been 
a) Be calibrated or verified at specified intervals, or 
prior to use, against measurement standards traceable  defined for each or the need for calibration is also mentioned, there 
to international or national measurement standards;  is  also  form  F02‐P05  which  is  used  as  a  guide  for  planning  the  time 
where no such standards exist, the basis used for  for  calibration  of  measuring  tools,  when  tools  are  calibrated  results 
7.6  calibration or verification s hall be recorded;  
are recorded in tags and attached on the device, to be specified that    
b) Be adjusted or re‐adjusted as necessary;  
c) Be identified to enable the calibration status to be  the tool is calibrated, as an instance the results of the calibration of 
determined;   Multi‐meter,  calibrated  at  internally  in  18‐8‐14,  observed  during 
d) Be safeguarded from adjustments that would  assessment  it  should  be  kept  in  dry  environment  and  below  25 
invalidate the measurement result;  
e) Be protected from damage and deterioration during  degrees.  The  certificate  of  calibration  of  oscilloscope  by  Laksar  Lab 
handling, maintenance and storage.   observed code: LK‐64783C6‐B, at 24 of February 2015. 
 
8  Measurement, Analysis and Improvement 
General 
Does the organization plan to implement the 
monitoring, measurement, analysis, and improvement  Thru measuring feedbacks from clients, complaints and the feedback 
8.1 
processes required for conformity of the product and 
QMS and improvement of its efficiency? 
from  authorities    the  processes  are  improved  according  to  annual     
Are measurement, analysis and improvement  analysis of data  
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 
organization  monitors  the  information  related  to  customer 
to customer perception in order to understand whether  perception in forms F06‐W04  
8.2.1  customer requirements are met or not? 
Has the organization determined methodologies for 
Records of these evaluations observed for Mehran Hospital in Ahwaz    
80%,  chamran  hospital  of  Zabol  86%,  Tehran  Rajayee  84%,  Tabriz 
obtaining and using information on customer 
satisfaction and/or dissatisfaction?  Doostan Clinic 90%. No complaint were available to audit 
INTERNAL AUDIT 
Has a documented procedure been established that  records  of  internal  audit  done  trained  personnel  (Management 
includes responsibilities and requirements,  Representative  and  Technical  Officer)  in  accordance  to  procedure 
requirements for planning and conducting the audit,  P03,  the  last  internal  audit  was  conducted  before  management 
reporting the results, maintaining the records? 
Are audits planned in the form of an audit program?  review in April 2015 based on internal audit program F01‐P03, results 
recorded  in  internal  audit  with  form  code  F02‐P03,  several  NCs  had 
8.2.2 
Does audit programme take importance and status of 
the fields and processes to be audited including the  been  raised  such  as  no  label  designed  for  smart  4,  the  corrective    
results of previous audits? 
Do selection of auditors and implementation of audit 
action  for  this  reason  was  to  design  labels  and  it  was  designed  and 
ensure objectivity and impartiality of the process?  observed  during  this  assessment,  the  internal  audit  was  performed 
Do auditors audit their works?  by Mr.Amin Varshowsaz/Ehsan Varshowsaz 
Do follow‐up actions cover verification of the measures   
taken and reporting of verification results? 
MONITORING AND MEASUREMENT OF PROCESSES 
Does the organization implement appropriate methods  The  process  measurements  are  under  control  by  process  indices 
8.2.3 
for monitoring QMS processes and where applicable, 
for measurement such WMS processes? 
where  the  results  of  process  measures  are  shown  in  data  analysis    
When planned results are not achieved, is corrective  table and if the criteria is not met , corrective action is considered 
action taken for product conformity? 
8.2.4  MONITORING AND MEASUREMENT OF PRODUCT 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 14 of 17 
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the company follows procedures of P04 to control the quality of the 
products.  for  all  raw  material  after  being  controlled  they  are  kept 
under the table of the work in production room that is specified for 
checked (qc) materials, during the production and at the end of the 
production  each  device  is  tested  so  a  100%  sampling  test  is  being 
done  and  recorded  in  F01‐P04,  results  of  the  quality  control  of  the 
General rules  final  product  is  recorded  in  F03‐P04,  as  evidence  records  of  the 
Does the organization establish appropriate stages to 
measure and monitor product characteristics? 
controls  for  the  Device  No.  1101351  was  observed  during  the 
Have verification methods been documented?  assessment  as  follows:  the  device  was  tested  against  too  many 
Is this verification process realized in accordance with  criteria  in  different  modes  such  as  in  pure  cut,  blend,  coagulation 
the arrangements planned during appropriate stages of 
(bipolar  and  mono),  spray  coagulation,  and  the  display  and  the 
8.2.4.1  product realization process? 
Are conformity evidences along with acceptance criteria  controls  were  checked,  as  an  example:  when  in  resistance  load  of    
maintained?  400 Ω, the maximum power of the cut mode was around 300 watt, 
Are the records approved by the authorized  which was acceptable range according to quality plan 
person/persons in the process of product release? 
Are product release and distribution of service, planned 
Instruction  for  use  is  documented  in  technical  file  annex  IV; 
regulations (Article 7.1) completed satisfactorily?  Instruction for use includes the following lists. 
Product  description  and  method  applied  to  work  ,  Intended  use, 
Indications  for  use,  Factors  affecting  the  quality  of  performance, 
Accessories,  Directions  for  use,  Warnings  and  Prohibitions 
Contraindications, functioning modes of the device, Label 
The  label  includes:  Product  name,  Product  specification,  Serial  no, 
Date of manufacture, Manufacturer, Symbols, warnings 
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 N/A  
personnel carrying out any inspection or test? 
CONTROL OF NON‐CONFORMING PRODUCT 
Does the organization have methodologies to ensure 
that product that does not conform to requirements is 
identified and controlled to prevent unintended use or 
delivery? 
Is there a documented procedure related to non‐ No non‐conforming product was detected during past year although 
conforming product?  the  products  may  be sent  back  to  the  company  to  be  repaired.  The 
Does the organization take measures to remove non‐ company has a procedure for this purpose P04, if any nonconforming 
conformity related to product? 
When applicable, do the processes identify the methods  product  is  detected  the  records  are  recorded  in  F03‐P04,  and 
according to corrective and preventive procedure the root reasons of 
8.3 
authorizing the non‐conformity’s use, release or 
acceptance in agreement with customer?  the  nonconforming  product  is  found  to  prevent  any  future    
Are required measures taken to preclude the product’s 
original intended use or application? 
happenings.  The  manager  is  responsible  to  permit  for  use  of  non‐
Are records related to the nature of nonconformities  conforming  products  in  other  initial  purposes,  and  then  is  the 
and the measures taken later maintained?  Production manager in void of manager. 
Is corrected nonconforming product subject to re‐  
verification to demonstrate conformity to the 
requirements? 
Do the processes ensure that appropriate corrective 
action is initiated when non‐conforming product is 
detected after delivery or use has started? 
DATA ANALYSIS 
Does the organization collect, identify and analyze 
appropriate data to demonstrate efficiency and  the  organization  collect,  identify  and  analyze  data  to  demonstrate 
appropriateness of QMS and the fields where QMS’s  efficiency and appropriateness of QMS in form F01‐P14 
efficiency can be continuously improved? 
Has a documented procedure been prepared for these 
As sample in sales department the indicator of the process is on‐time 
delivery  of  products  to  clients  in  order‐time,  which  was  considered 
8.4 
analyses? 

 

Do the characteristics and tendencies of the processes  90%  and  in  reality  it  was  almost  100%  of  orders  were  delivered  in 
and products including data analysis, customer  time to be delivered to clients.  
satisfaction, conformance to product requirements, 
opportunities for corrective actions provide information  Before the indication was 87% which proves the soaring trend. 
related to suppliers?   
Have data types for data analysis been defined? 
Are data analyses recorded? 

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 organization established documented procedures 
for the issue and implementation of advisory notices.  
Documented advisory notice has been documented in technical file,  
To be implemented at any time.  
Records of all customer complaint investigations  It is also embedded in Labels, IFU and accompanying documents. 
maintained. If investigation determines that the  The recall procedure is also documented In procedure P12 
activities outside the organization contributed to the   
8.5.1 
customer complaint, relevant information is exchanged 
between the organizations involved  
No adverse event associated with products of this company has been    
If any customer complaint is not followed by corrective  recorded. 
and/or preventive action, the reason is authorized and  Thru  the  procedures  policies  and  objectives  of  the  management 
recorded  
system and corrective and preventive actions the system improves 
If national or regional regulations require notification of 
adverse events that meet specified reporting criteria,  Before the indication was 87% which proves the soaring trend. 
the organization shall establish documented procedures 
to such notification to regulatory authorities. 
8.5.2. CORRECTIVE ACTION  documented procedure for corrective action P02
Is there a documented procedure for Corrective and 
Preventive Action? 
Corrective actions include cause analysis to eliminate root cause of 
Are corrective actions taken to eliminate causes of  NCs. 
nonconformities effective in preventing recurrences?  Effectiveness of corrective actions can be evaluated by using form 
Does this procedure include the requirements of 
P02‐F01. 
8.5.2  reviewing non‐conformities (including customer 
complaints), determining the causes of non‐conformity,  several NCs had been raised such as no label designed for smart 4,    
evaluating the actions needed to ensure that  the corrective action for this reason was to design labels and it was 
nonconformities do not recur, determining and  designed and effectively label was designed and observed during this 
implementing the corrective action needed, and review 
of the results of the action initiated? 
assessment,  
Is adequacy of corrective‐preventive actions identified?   
PREVENTIVE ACTION 
Has  the  organization  established  a  documented 
procedure  for  preventive  action  with  defined 
requirements for identifying potential non‐conformities  documented procedure for preventive action P02 
8.5.3 
and  their  causes;  evaluating  the  need  for  action  to 
prevent  occurrence;  determining  and  implementing 
covers required criteria    
preventive  action  needed;  recording  results  of  action  Organization has not issued any preventive action yet.
taken; reviewing preventive action taken. 
What are the methods for identifying the adequacy of 
corrective‐preventive actions? 
 

FORM‐009_V4_QMS MDD                                     Issued: July 9, 2003                                                        Revised: March 2013                                                       Page 16 of 17 
 By exception, we indicate the specific Strengths and weakness of the organization in light of the management system, as we perceive and seen through
processes in reference to requirements of the criteria being ascribed as these apply and relate to the assessment plan and planning of the assessment.
This aspect relates to Accreditation Body as it does to the protection of consumers in the client-organization’s role within their respective supply – chain.

Disclaimers: (1) herein, we reiterate that any suggestion or opinion that the assessment team expresses does not construe to be a contractual
requirement. (2) The degree of certainty in conclusions increases by the competence of the assessment team as well as the attestation within the
assessment protocol, values, mission and vision under which we operate for the protection of consumers, still remains a certain level of uncertainty.

Strength Weakness

Some of the standards are not up to date such as standard for

High knowledge of technical staff
use labels ISO 15223-1
Good collaboration with state hospitals Small space
Record Keeping
 

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:

No test result for EMC test was available at the day of assessment

Observation Form-018 – with uniquely specific identification:

Name of the product has been mistranslated “electro cutter”

ATL:M.R.Khoshgoo DATE: 20 June 2015

END of REPORT

FORM-014 – Opening Meeting Checklist FORM-009 – MS Reporting,

FORM-017 – Closing Meeting Checklist FORM-008 – RA / AR, as requires
FORM-005 – Participants of opening & closing meetings FORM-018 – OBS, as requires
FORM-004 – Assessment Plan FORM-010 – As requires, recommendation for CoR
FORM-007 – Planning onto -004, as process determined FORM-026 – Assessment documents check-sheet, optional