Assessment Report/Checklist: 9001:2008 and ISO 13485:2003, ISIRI and IMED Regulations Within Scope of Organization

BRSM
Systems:QMS ISO 9001 (2008)‐QMSMDD ISO 13485 (2003)
Assessment Report/Checklist
Form 009

CLIENT‐ORGANIZATION (NAME): OWZAN
PHYSICAL LOCATION(s): Salehi Blvd., Mohamad Shahr , Karaj, Iran
Phase II Audit Date(s): 10‐13 August 2015
Phase I Audit Date(s): 2‐August 2015
NAICS (or NACE) CODE 32.5

EXCLUSIONS: 7.3, 7.5.1.2.2, 7.5.1.2.3, 7.5.1.3, 7.5.2.2, 7.5.4

Assessment objectives: Assessing Organization Against QMS ISO
9001:2008 and ISO 13485:2003, ISIRI And IMED
regulations within scope of organization

ASSESSMENT TEAM INFORMATION
Assessment Team Leader, ATL Mr. Mohammad Reza Khoshgoo
Assessor 2 Ms. Montajebi as Technical Expert
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.
REFERENCE, AS
This Clause
APPLICABLE
Has been
Reference Clause Observations Verified,
please Tick
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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 Manufacturing and sale of dental amalgam
Institute of Standards & Industrial Research of Iran for ISIRI 2724
certificate No. 2187634
Legal status Ministry of Industries and mines certificate (No. 13381) 
IMED certificate “C01371”
3 NOTE: ISIRI 2724 is Iranian translation of EN 24234
Obligatory
applicable standard ISIRI 2724

which organization NOTE: ISIRI 2724 is Iranian translation of EN 24234
has to follow
4 Quality Management System
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 Page 2 of 31
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Organization hired a consultant company which is verified by IMED,
IMED is an accreditation Body established by ministry of health which
accredited CBs and Validate consultant companies to guarantee medical
device sector companies.
Consultant company has a good brand in the market of Iran.
QMS has been established from march of 2008, because the company
does not have certification from last year, Management representative
told us we can check all documents after March of 2015 so we assume
system implemented from March of 2015.
GENERAL REQUIREMENTS Owzan processes are defined in document “F‐QA‐012 “and some indexes
Does the organization
establish, document, are as below:
implement, maintain and
continually improve a Quality
1. Internal audit
Management System (QMS) 2. Management review (management oriented) (MR indexes are
with due consideration given
to identification of processes such as below)
needed for the QMS and their a. Ratio of reached management review outputs to all
application throughout the
system; determination of management review outputs
sequence and interaction of b. Percentage of fulfillment of goals as plans
these processes,
c. Average of customer satisfaction
4.1
determination of criteria and
methods required to ensure
3. Commercial

effective operation and
control of these processes; 4. Doc control
availability of resources and
information required to a. Number of non‐approved documents
support the operation and b. Period from document change inquiry to distribution of
monitoring of processes;
measurement, monitoring and changed documents.
analysis of the processes; 5. Sales (Sale indexes are such as below)
implementation of action to
achieve planned results and a. Quantity of sales (number)
continual improvement
‐If any, are the outsourced
b. Amount of sales (Rial)
processes are defined? c. Number of complaints
d. Average of customer satisfaction
e. Number of participation is fairs
6. Purchase
7. Stock
8. Training
9. Manufacturing
Outsourced process, calibration process is outsourced to a NACI
approved calibration institute name is Nahal.
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Quality Policy with code: Q‐MA‐001‐02 has been established in these 6
years. As sample I will write some part of quality policy:
"OWZAN Company with half a century experience in applying technical
knowledge, truly enjoys trust of customers and is to establish and
maintain an effective quality management system in its medical and
dental facilities and emergency medicine based on ISO9001: 2008,
ISO13485: 2003 and ISO 14001: 2004 standards . OWZAN tries to achieve
its goals based on its thoughts on achieving enterprise agility, being a
leading and influential organization in the field of medicine and
biomedical engineering based on the principles of customer‐
centeredness and commitment in order to identify and meet the
requirements of the environmental civil society not only to have an
DOCUMENTATION active role inside the country but also have a prominent role all over the
REQUIREMENTS
Is there a documented quality
world."
policy and documented quality At last part of QP,CEO says:
objectives and are they
appropriate? “Hereby, I announce my commitment for applying the Quality Policy in
Is there a documented quality order to meet the requirements and demands of our customers and
manual and are there
documented procedures public authorities in order to maintain an effective system of emergency
required by the standards?? medical equipment and pharmaceutical at OWZAN and I ask our
Are required records for
4.2 planning, acting and employees to actively pave the way to pull out all the stops and enhance 
controlling processes
efficiently available?
monitoring the system in order to maintain continuous improvement
Are the documents are and success of the business environment.”
created for every type of
medical device including qms Although company has EMS and QMS systems but audit objective is just
requirements and product QMS.
specifications? (4.2.3) If these
documents are applicable to Quality Objective are as below:
manufacturing processes, are
montage and service defined?
1. Maintain and increase customer satisfaction by identifying needs and speed of service.
2. Set the medical equipment market along with improving product quality.
3. Continues improvement
4. Increasing market share, sales and service
5. Medical needs of the country, including emergency drugs and single prescription.
6. Targeted investments in empowering the organization's internal capabilities.
7. Effective teaching staff to improve service quality.
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Quality Manual: M‐QA‐001‐00
There are 25 Procedures listed as F‐QA‐001 with this columns:
ROW‐ CODE OF DOCUMENTS‐ NAME OF DOCUMENT – DATE OF ISSUE –
REVIEW CODE ‐ DATE OF LAST REVIEW – IDENTIFICATION CODE OF
DOUMENT LIKE P FOR PROCEDURES AND W FOR WORK INSTRUCTION‐
DITURBUATION KEY – BACK UP PERIOD – STORAGE TIME AND PLACE –
EXPIRATION DATE – DISPOSITION
For example row 10 of master list belongs to corrective‐preventive

action form as below:

1‐ F‐QA‐004‐ ‫فرم‬ ‫درخواست‬ ‫اقدام‬ ‫اصالحی‬ ‫و‬ ‫پيشگيرانه‬ – 24/12/1388 – 00 – F –
QA – all departments – back up period seasonally ‐ Current Archive one
year‐ Morgue 10 years – QA department – empty – disposition method is
Elimination
Company uses “W‐QA‐001” for technical file of each product, which
contains work instructions, quality plan, OPC, BOM and risk
analysis.
Organization uses Manual with code M‐QA‐001‐00 contains QMS and
QMS MDD systems with an integrating approach.
Quality Manual has 8 parts using ISO 13485 clause coding system such
as:
Clause with title in Farsi as below:
"7‐5‐1‐2‐1 ‫”تميزي محصول و کنترل آلودگي‬ refers to same clause
“Cleanliness of product and contamination control” of ISO 13485:2003
or 7‐5‐1‐2‐2 of Manual refers to 7‐5‐1‐2‐2 of ISO 13458:2003 which is
QUALITY MANUAL
Does the Quality Manual not applicable for this organization, justification is as below:
include, scope of QMS and Because our production is Consumable and nature of product does not
details of exclusion?
Are documented procedures need installation. other exclusion are as below:
4.2.2 reference to mandatory

procedures;
7.3: D&D, Company has bought a formula and do not have plan for R&D
Is description of interaction of 7.5.1.2.2: Installation activities : installation is not applicable because of
the processes included in the
QMS?
nature of product
7.5.1.3: Particular requirements for sterile medical devices: product shall
not be sterile as nature
7.5.2.2: Particular requirements for sterile medical devices: product shall
not be sterile as nature
7.5.4: customer property: organization will not accept any customer
property.
7.5.1.2.3: It’s a consumable medical device.

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CONTROL OF DOCUMENTS
Are mandatory procedures
Organization provided procedure of control of documents and records
documented? “P‐QA‐003” to provide the preparation, approval, distribution, and
Are control conditions
pertaining to mandatory
control of all documents of the current system of quality management in
documents proper? medical devices, pharmaceuticals, as well as to identify, collect, classify,
Are review, update and re‐
approval situations and preserve records related to the quality management system medical,
changes and current review pharmaceutical and outdated or invalid records the organization's
situations for documents
traceable? control as part 1‐ purpose of this procedure.
Are the relevant documents
usable, readable and
Such as part 7‐1‐1 of this procedure that include qualified job positions
4.2.3 recognizable at concerned
usage points?
which shall approve documents such as: 
Are outsourced documents
Procedures shall prepare by “related unit manager” and review by
defined? “management representative” and approved by “CEO”
Are distribution of documents
controlled, outdated
documents prevented from
being used and appropriate
definition method applied in
case of being stored for any
purpose?
Are these subjects clear in the
relevant procedure?
Organization provided procedure of control of documents and records
“P‐QA‐003” to provide the preparation, approval, distribution, and
control of all documents of the current system of quality management in
medical devices, pharmaceuticals, as well as to identify, collect, classify,
preserve records related to the quality management system medical,
pharmaceutical and outdated or invalid records the organization's
control as part 1‐ purpose of this procedure.
Such as part 7‐1‐1 of this procedure that include qualified job positions
CONTROL OF RECORDS which shall approve documents such as:
Are documents readable, Procedures shall prepare by “related unit manager” and review by
easily recognizable and stored
in available manner? “management representative” and approved by “CEO”
Has a documented procedure
There are 25 Procedures listed as F‐QA‐001 with this columns which are
4.2.4
been established and applied
for determination of required connected to processes through all : 
controls for storage, retrieval,
retention time and disposition
ROW‐ CODE OF DOCUMENTS‐ NAME OF DOCUMENT – DATE OF ISSUE –
of records? REVIEW CODE ‐ DATE OF LAST REVIEW – IDENTIFICATION CODE OF
Has the archiving defined for
at least 2 years? DOUMENT LIKE P FOR PROCEDURES AND W FOR WORK INSTRUCTION‐
DITURBUATION KEY – BACK UP PERIOD – STORAGE TIME AND PLACE –
EXPIRATION DATE – DISPOSITION
For example row 10 of master list belongs to corrective‐preventive
action form as below:
1‐ F‐QA‐004‐ ‫فرم‬ ‫درخواست‬ ‫اقدام‬ ‫اصالحی‬ ‫و‬ ‫پيشگيرانه‬ – 24/12/1388 – 00 – F –
QA – all departments – back up period seasonally ‐ Current Archive one
year‐ Morgue 10 years – QA department – empty – disposition method is
Elimination
Management
5
responsibility
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OWZAN Company with half a century experience in applying technical
leading and influential organization in the field of medicine and
biomedical engineering based on the principles of customer‐
MANAGEMENT centeredness and commitment in order to identify and meet the
COMMITTMENT
Has the top management requirements of the environmental civil society not only to have an
ensured that requirement for active role inside the country but also have a prominent role all over the
meeting customer conditions
and legal conditions should be world.
5.1
understood by all personnel?
Is a quality policy available?
At last part of QP,CEO says: 
Are quality objectives “Hereby, I announce my commitment for applying the Quality Policy in
available?
Is management review
order to meet the requirements and demands of our customers and
established? public authorities in order to maintain an effective system of emergency
Does the management provide
required sources for QMS? medical equipment and pharmaceutical at OWZAN and I ask our
employees to actively pave the way to pull out all the stops and enhance
and success of the business environment.”
Although company has EMS and QMS systems but audit objective is just
QMS.
Quality Objective are as below:
Maintain and increase customer satisfaction by identifying needs and speed of service.
Set the medical equipment market along with improving product quality.
Continues improvement
Increasing market share, sales and service
Medical needs of the country, including emergency drugs and single prescription.
Targeted investments in empowering the organization's internal capabilities.
Effective teaching staff to improve service quality.
CUSTOMER FOCUS
Does top management have Quality Policy and quality objectives are observed as evidence may show
methodologies to ensure that
customer focus
5.2 customer needs and
expectations are determined

and met for increasing
customer satisfaction?
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OWZAN Company with half a century experience in applying technical
QUALITY POLICY leading and influential organization in the field of medicine and
Has top management biomedical engineering based on the principles of customer‐
established a Quality Policy in
accordance with the objective centeredness and commitment in order to identify and meet the
of the organization? requirements of the environmental civil society not only to have an
Does the Quality Policy include
a statement of commitment to active role inside the country but also have a prominent role all over the
5.3 meeting requirements and
continual improvement of the
world. 
QMS? At last part of QP,CEO says:
Has the Quality Policy been
revised for communication, “Hereby, I announce my commitment for applying the Quality Policy in
understanding and continuous order to meet the requirements and demands of our customers and
compliance within the body of
the Organization? public authorities in order to maintain an effective system of emergency
medical equipment and pharmaceutical at OWZAN and I ask our
employees to actively pave the way to pull out all the stops and enhance
and success of the business environment.”
Although company has EMS and QMS systems but audit objective is just
QMS MDD.
Quality objective review period is annually and since 2008 have been
revised 2 times, last revision is for end of march 2010
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These are objectives:
Maintain and increase customer satisfaction by identifying needs and speed of service.
Set the medical equipment market along with improving product quality.
Continues improvement
Increasing market share, sales and service
Medical needs of the country, including emergency drugs and single prescription.
Targeted investments in empowering the organization's internal capabilities.
QUALITY OBJECTIVES
Are quality objectives Effective teaching staff to improve service quality.
established by top
management at relevant Above objective are planned to goals in document “F‐MA‐002” such as
functions and levels within the first objective break down to two goals:
organization? Are the
objectives measurable and 1‐ 5% reduction of production time
consistent with the Quality
Policy a‐ Employing qualified manpower
5.4
5.4.2 QUALITY MANAGEMENT
SYSTEM PLANNING
b‐ Organizing training for staff after‐sales service

Has the QMS been planned by
Top Management in order to
meet the conditions and c‐ Provision of service for more accurate calendar Portfolio
quality objectives detailed in
Section 4.1? d‐ The schedule and carry out repairs at the customer site
When changes are initiated, is
the integrity of the QMS 2‐ Improve the quality of its website and its content
maintained during the change
process? a‐ Identify new suppliers for network tasks
b‐ Supplier evaluation and selection of the best of them
c‐ Launch and development of the Company
before management review sessions, all objectives shall be measured
such as management review which I will write in 5.6.2
5.5 Responsibility, Authority and Communication
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Authority and responsibility of personnel’s are in form
“F‐TR‐005” such as management representative:
ensures that processes needed for the Quality
Management System are established and implemented;
reports to the Shareholders on the performance of
the Quality Management System;
promotes awareness of customer requirements
throughout the organization;
acts as a liaison with external parties, such as
RESPONSIBILITY AND AUTHORITY
Has top management identified responsibility and customers or auditors on matters relating to the Quality
5.5.1
authority and been communicated within the Management System; 
organization?
Has top management defined responsibilities and resolves matters pertaining to quality issues;
authorizations for CE marking?
is in charge to approve the Annual Internal Audit Plan;
is in charge to approve the Internal Audit Reports;
is responsible to manage the interface between
different groups to ensure effective communication and
clear assignment of responsibilities in the design and
development process.
Organization chart “N‐MA‐001” was observed on
organization board on entrance hall.
And recall investigation team head boss
MANAGEMENT REPRESENTATIVE
Has top management appointed a member as Mr farzinnia is management rep. since 2010
Management Representative with responsibility and
Top management appointed him by a letter from Oct.
5.5.2
authority to ensure that the processes of the QMS are
established, implemented and maintained; report to
2010

top management on the performance of the QMS,
including needs for improvement and promote
awareness of customer requirements? I wrote his responsibilities in 5.5.1
Internal communication channels are based on
organization chart “N‐MA‐001” and are done by Email,
INTERNAL COMMUNICATION
Has the top management ensured establishment of verbal
5.5.3
appropriate communication processes within the
organization? Has the top management ensured Process performance reporting are based on form “: F‐ 
realization of communication considering the processes QA‐012” which can be with chart or not
of the QMS and their effectiveness?
For record: letter no. 32544.‫س‬11 to IMED for extending
certificate.
5.6 Management review
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Organization provided procedure for management
review “P‐MA‐001’ which has been held on “15/5/1395”
Period is at least once a year"
which is around July 2015, all required inputs and
meeting highlights are mentioned in MOM such as:
Item 3, Customer feedback:
As sales department report, Based on the measurement
of customer satisfaction of medical products, the overall
satisfaction rate of 91% has been found that successful
performance of the organization to clients. Based on the
analysis conducted on the customer feedback
parameters, the variety has been increased due to the
company's goals of increasing variety in later periods are
expected to be fulfilled customer satisfaction. In
addition, during the last 6 months have been no
complaints to the organization.
TOP MANAGEMENT REVIEW
Item 10, regulation changes:
Does top management review the QMS to ensure its
continuing suitability, adequacy and effectiveness at
Regard to the requirements in the organization of IMED
Mr farzinia has monthly connection and in last letter
5.6.1
regular and planned intervals?
Do reviews include assessing opportunities for
there is no update in regulation in IMED as like as ISIRI.

improvement including the need for changes to the
QMS, quality policy, and quality objectives?
Are management review records kept?
Item 8: fulfillment of objectives and goals:
On the basis of quality objectives and planning necessary
for achieving quality goals is running properly. Quality
goals that the organization is designed to be almost
entirely carried out in the relevant time period, and the
related monitoring is done in this regard.
Such as:
5% reduction of production time, in year 1394 shamsi
(march 2015) new goal was set, and in this five month
average of production time have been reduced 2
percent and in second phase of project which will be
done till end October, it shall be finished. Based on
production unit report
Or
Base on sales department report: In goal “10% increase
in sales” rates shows a 8% increase in sale till now which
we can have at least 15% increase in sale.
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Management review session has been held on
“15/5/1395” which is around July 2015, all required
inputs and meeting highlights are mentioned in MOM
such as:
Item 3, Customer feedback:
analysis conducted on the customer feedback
Item 10, regulation changes:
Regard to the requirements in the organization of IMED
Mr farzinia has monthly connection and in last letter
REVIEW INPUT
Does review input include current performance and
there is no update in regulation in IMED as like as ISIRI.
improvement opportunities related to: Item 8: fulfillment of objectives and goals:
a) results of audits;
b) customer feedback; On the basis of quality objectives and planning necessary
5.6.2 c) process performance and product conformance;
d) status of corrective and preventive actions; for achieving quality goals is running properly. Quality 
e) follow‐up action from earlier management reviews; goals that the organization is designed to be almost
f) changes that could affect the QMS,
g) recommendations for improvement entirely carried out in the relevant time period, and the
h) New or revised regulatory rules?
related monitoring is done in this regard.
Such as:
done till end October, it shall be finished. Based on
production unit report
Or
Base on sales department report: In goal “10% increase
in sales” rates shows a 8% increase in sale till now which
we can have at least 15% increase in sale.
Item 11‐ risk management and recalls:
Last review of risk assessment are first of july 2015 and
TOTAL RPN has a 7.2 % reduces. This can show
effectiveness of actions.
There is no recall.
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Outputs are as requirements such as:
Putting The customer feedback form on the website of
REVIEW OUTPUT
Does output from management review include actions the company
5.6.3
related to improvement of the QMS and its processes,
improvement of product related to customer Technical supervisor shall participate training courses 
requirements, actions and decisions relate to resource
needs? Check to increase the production capacity / production
space and improving infrastructure Company
All managers based on organization chart signed MOM.
6 Resource Management
PROVISION OF RESOURCES
Does the organization have methods to determine and Company has a 25 years old history manufacturing
6.1 provide resources needed to implement and improve medical device and has certification of IMED (GMP of 
the processes of the QMS and address customer
satisfaction by meeting requirements? Iran) for dental amalgam more than 7 years.
6.2 Human Resources
Mr Farzinnia MR, were to go to training courses of
technical supervision which he did not go to course due
to job problem which is against law, IMED regulation
mandates technical supervision to go to this course
every two years, but he didn’t go to this course in 25
months.
P‐TR‐001
Are personnel assigned with responsibilities that affect
product quality competent on the basis of applicable
6.2.1 education, training, skills, and experience?
Are trainings performed for achievement of Required
From IMED point of view is a NC but not a Major one. AR
Competence?
Because Mr Farzin Nia have certificate from IMED and
this course is for updating information.
Mrs Zahra Hasanzade, packaging operator, have training
courses certification and job experience as required in
form “F‐TR‐005”

Mrs Zahra Hasanzade, packaging operator, have training
COMPETENCE, AWARENESS, AND TRAINING
Has the organization identified the experience, courses certification and job experience as required in
qualifications, competencies and skills of the personnel form “F‐TR‐005”
performing activities affecting safety and efficiency of
medical devices particularly being manufactured and Last training courses was “cross infections in medical
provided to customer?
industry” held by IMED on March of 2015, effectiveness
6.2.2
Is training provided by the organization to satisfy the
competency needs? have been measured on May 2015 by Mr. Asghari her, 
Does the organization ensure that its employees are
aware of the relevance and importance of their foreman “F‐TR‐003” which total grade is 87% which is
activities and how they contribute to the achievement
of quality objectives?
acceptable base on training procedure “P‐TR‐001”
Are records of education, experience, training and “P‐TR‐001” has been implemented to ensure company
qualifications maintained?
to fulfill, maintain and enhance personnel’s competency
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Company has a 25 years old history manufacturing
medical device and has certification of IMED (GMP of
Iran) for dental amalgam more than 7 years.
Company provided “P‐AS‐01” to ensure cleanness and
tidiness to manufacture safe and with high quality.
INFRASTRUCTURE There is a weekly inspection form “F‐AS‐012” which is
Has manufacturing equipment been designed, filled by Mr asghari for every personnel of organization
constructed, properly established and placed for proper
operation, maintenance, adjustment and cleaning? inspected start of shifts, second time before going to
In case of applicability, has the organization ensured lunch and third time one hour after lunch, supervision is
documentation of natural limits or permissible
tolerances in manufacturing process and measuring and done by camera such as filled form of “24/06/1395”
test equipment and availability of the same for
operators?
And there is another form “F‐AS‐006” which Mr. asghari
6.3 Are documented processes available for maintenance, shall complete it monthly for infrastructure and work 
cleaning and control of all equipment used in
manufacturing process and control of work environment, such as form “31/3/1394” which is aroung
environment? may of 2015. There are some NCs in this form such as
Are required adjustments and maintenance intervals
identified? Broken window of restaurant
Is maintenance plan placed normally on or near the Broken window of PM warehouse
equipment and easily reachable?
Is maintenance realized based on the relevant plan? Entrance to manufacturing line need mending
Which all are mentioned in form corrective action “F‐
QA‐004” and closed on 22 days later.
Record of Atomizer Pm has been checked for August
2015, Mr asghari signed PMs report, for record:
Cleaning of entrance of azoth, inspection electrical
board by Ahmad Akbarzadeh on 21/4/1394
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WORK ENVIRONMENT
Does the organization identify and manage required Company has a 25 years old history manufacturing
work environment needed to achieve conformity of
product?
medical device and have certification of IMED (GMP of
Are the following factors which could affect product Iran) for dental amalgam more than 7 years.
quality in the work environment identified?
‐ Process equipment, Company provided “P‐AS‐01” to ensure cleanness and
‐ Work environment,
‐ Personnel in this work environment
Are qualified and quantified limit values of the work There is a weekly inspection form “F‐AS‐012” which is
environment identified for a desired quality of the work
environment? filled by Mr asghari for every personnel of organization
Are pollution levels of microbial and solid particles inspected start of shifts, second time before going to
controlled during product manufacturing where sterile
product or pollution of solid particle which is stipulated lunch and third time one hour after lunch, supervision is
to be sterilized or could live or not live during its
manufacture or utilization is important?
done by camera such as filled form of “24/06/1395”
Has exclusion been applied during all manufacturing And there is another form “F‐AS‐006” which Mr. asghari
processes for a controlled environment? As valid
ground of exclusion, is pollution reduced to known,
shall complete it monthly for infrastructure and work
consistent and controlled level by an approved cleaning environment, such as form “31/3/1394” which is aroung
method and packaging kept at this level through control
process? may of 2015. There are some NCs in this form such as
Have indicators been identified for a controlled Broken window of restaurant
environment which covers valid cleaning and packaging
processes including the organizations holding a valid Broken window of PM warehouse
6.4 cleaning process?
Entrance to manufacturing line need mending 
(Temperature, Humidity, Air Current, Filtration of Air,
Ionization of Air, Pressure differences, Lighting (along Which all are mentioned in form corrective action “F‐
with its spectral content and severity), Sound, Vibration,
cleaning of Working surfaces and processes, Water
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
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ISIRI 2724, contains Iranian not‐mandatory standard for
manufacturing dental amalgam, it is not‐mandatory because
of market demand.
But it (ISIRI 2724)has based on international standard for
dental amalgam,
Owzan provided technical file for dental amalgam capsule
Company “W‐QA‐001” which contains work instructions,
quality plan, OPC, BOM, advisory notice and risk analysis.
Company uses procedure “P‐SA‐001’ to ensure asking
PLANNING OF PRODUCT REALIZATION customer needs like quantity, price and …
Has the organization considered the scope of its own
quality management system in planning of product
Such as:
realization? Invoice to “Tehran central dental clinic” No. 223‐94 which
Has the organization prepared required records for a contains 1500 capsules of amalgam before 11/5/1394
proof indicating that quality objectives and product
rules, processes established, documents and product‐ (September 2015) which have been granted by Mr azarm
specific necessary resources, verification, validation, Sales manager.
tracking, measuring, inspection and product‐specific
test activities , realization processes and the product Company has risk analysis procedure “P‐AS‐002” based on ISO
meet the rules? 14971 and IMED regulations.
In the event that inspection and test are conducted by
manufacturing personnel, do inspection and test
Record of “F‐AS‐020” risk assessment of Amalgam has been
results, processes, organization’s procedures ensure observed, there were 28 identified risks such as:
impartiality of inspection and test results? a) Hazard of amalgam fracture during patient chewing
7.1 Risk management 
Has the organization prepared a procedure containing because of “lack of Compressive strength”
all processes of product realization for risk management RPN is 85 and severity is 9, as procedure “P‐AS‐002” if RPN
activities and realized the following?
Keeping the records become above 150 or Severity become more than 8,
Preparation of Risk Management Plan organization shall define an effective control to reduce
Determination of Risk team and its Responsibilities
Determination of Intended Use of Device and Safety
severity, occurrence or control, in this case company
Characteristics of Device explained a control table 2 which depends on :
Definition of hazards 1‐ Grain sizing
Risk Estimation for Hazards
Evaluation of Risks 2‐ Grain pattern
Risk Control Measures 3‐ Final Production Comprehensive strength
Definition of Residual Risks
Risk/Benefit Analysis I checked records of QC of dispatched inquiry No. “223‐94”
Preparation of Risk Management Report which I mentioned above:
Final QC shows Comprehensive strength for this batch is 85
N/mm2 in 1 hour and 300 N/mm2 in 24 hours, inspector was
Ms. Musavi
Weight of each capsule from 2.06 to 2.68 Grams.
B) hazard of Hazard of amalgam
Dimensional changes and breaking tooth and another hazard
is amalgam came out, for first and second both RPNs are 85
and severity is 9, control is ‐0.1 < Dimensional changes< +0.2
mm as ISIRI requirements
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Test Report
Test Name: Determination of creep
Reference Standard: EN ISO 24234:2004
Lot Number: Cinalux:94389, Cinasilver:94510
Test Procedure:

Apply a stress of (36,0 0.2) MPa normally and uniformly over the cylinder ends, continuously
for
4 h at a temperature of (37,0 0.5) ‫؛‬C. Record the change in specimen length between

(1,00 0.05) h and (4,0 0.1) h to an accuracy of 0.01 mm.

Calculate the creep strain, to the nearest 0.1 %.

In this test, either three out of three, or four out of five specimens shall meet the requirement
in
Table 2.
Test Result:
Maximum Creep:
Cinalux : 0.12 %
Cinasilver : 0.21%
Results be verified by: Q.C Manager

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DETERMINATION OF REQUIREMENTS RELATED TO THE
PRODUCT/SERVICE Company has 4 kind of productions:
Has the organization defined the requirements of
customer including the requirements for the activities 1‐ one unite capsule 390‐405 milligram
on delivery and after delivery?
Do these requirements include the following?: 2‐ two unite capsule 600‐615 milligram
‐ regulatory and legal requirements related to the
countries and territories where the product is supplied 3‐ three unite capsule 785‐800 milligram
to the market
‐ anticipated utilization, 4‐ four unite capsule 1187‐1192 milligram
‐ Performance expectations,
‐ Design factors Company uses procedure “P‐SA‐001’ to ensure asking
7.2.1 ‐ Delivery plans 
‐Unclear customer expectations customer needs like quantity, price and …
Does the organization record customer’s expectations Such as:
related to product/service in order to revise the same?
In the event of any change in order or offer or both for Invoice to “Tehran central dental clinic” No. 223‐94
any reason whatsoever, are changes revised and an
agreement is reached on the changes as it is in original
which contains 1500 capsules of amalgam before
order or offer? 11/5/1394 (September 2015) which have been granted
In the event that changes are accepted, are all
personnel being affected by the changes within the by Mr azarm Sales manager.
organization informed?
Are relevant documents affected by these changes
amended?
7.2 Customer‐Related Processes
REVIEW OF REQUIREMENTS RELATED TO THE
PRODUCT/SERVICE customer needs like quantity, price and …
Does the organization review the requirements related Such as:
to the product?
Are review records kept? Invoice to “Tehran central dental clinic” No. 223‐94 which
Has this review been realized prior to commitment of contains 1500 capsules of amalgam before 11/5/1394
the organization for provision of the product to
(September 2015) which have been granted by Mr azarm
7.2.2 customer?
Has the organization ensured settlement of contract or Sales manager. There is not record for change of contracts but
order requirements which are different from previously if it happens as procedure Sale manager shall prepare an
defined?
Does the organization have the ability to meet defined amendment to contract with unique serial
requirements?
Are the results of review and subsequent follow‐up Organization has IMED and ISIRI certification due to
actions recorded?
product requirements
CUSTOMER COMMUNICATION customer needs like quantity, price and …
Are arrangements for communication identified and
implemented relating to product information, demands,
Such as:
Invoice to “Tehran central dental clinic” No. 223‐94 which
7.2.3
applications, contracts or realization of order including
amendments? contains 1500 capsules of amalgam before 11/5/1394 
Are required arrangements identified and implemented
for customer feedback and communication with (September 2015) which have been granted by Mr azarm
customers including customer complaints? Sales manager.

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 N/A
and development planning?
Are design and development planning updated when
planning output is appropriate and in the progress of
design and development?
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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 N/A
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 N/A
‐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 N/A
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 N/A
that design output meets input criteria
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? N/A
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 N/A
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
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Organization purchases calibration from NAHAL
Calibration lab. Which have accreditation from NACI
Purchasing Process; Has the organization prepared Organization purchases copper from NICICO through
documented process to ensure that purchased product
conforms to purchasing requirements?
stock market
Are criteria for selection of suppliers defined?
Are evaluation and reevaluation of suppliers have been Organization uses RAZI metallographic services for its
defined? alloys; RAZI is a NACI accredited lab.
Has the organization defined tracking frequency of
supplier’s performance? Organization uses procedure “P‐PU‐001” for purchasing
Does the organization have the proofs indicating that
supplier monitoring activities, outsourced processes are and assessment of suppliers
controlled and the products or services conform to the
Records of purchasing of Order No.312 “100 KG of
7.4.1
rules of the organization containing customer demands
and regulatory rules?
99.99 Copper” from NICICO has been observed,

Have the requirements of purchasing information
(containing the rules related to supplier records) demander warehouse due to “order point” on
including outsourced processes been identified to
ensure product and service quality? 10/3/1394 and item delivered on 5/4/1394 to
Does the organization have the methodology to warehouse, in 10/4/1394 QC approved the item and
communicate these requirements to the supplier?
Are purchasing contracts available? company reassessed NICICO, last grade was 60 and
Do the type and content of the control on supplier and recent grade is 60 too. 60 is grade “C” and company can
purchased product depend on the next product
realization of purchased product or final product? only cooperate with grade “C” companies just if have
Are purchasing records retained?
monopoly like NICICO.
Grade is not high because of lead‐time and way that
organization shall pay NICICO
PURCHASING INFORMATION
Does purchasing information define the product to be In Order No. 312 there was complete information to buy
purchased?
Where appropriate, does purchasing information
such as date of need, Purity and supplier. CEO approved
include product approval, procedures, requirements for demand, date of need is before 31/4/1394
7.4.2
process and equipment, Personnel qualification and the
requirements of Quality Management System? Refer to Technical file "W‐QA‐001" 
How does organization ensure the adequacy of
specified requirements in the purchasing information
prior to their release to the supplier?
Are records for the information related to purchased
product available?
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For Order No. 312, in 10/4/1394 QC approved the item
through cp, they checked:
RAZI test results.
Quantity and Appreance
There was two records of returning to suppliers before
march of 2015 but after implementation of system due
to organization long experience there was no record for
“returning to suppliers”
Such as:
Test Name: Free‐pouring of mercury
Lot Number:8709
VERIFICATION OF PURCHASED PRODUCT Test Procedure:
Has the organization identified a method in order to The mercury shall pour freely and completely without tailing. Small droplets
ensure that the product received conforms to the not coalesced with the bulk after shaking shall not be construed as evidence
specifications, is finished, holds appropriate identity of non‐compliance.
and is free from any damage? Pour the mercury. Use visual inspection to observe whether the mercury
Do the processes include the provisions in order to
verify that incoming product is provided along with
pours freely and completely without tailing. Carry out the inspection at an
support documentation (e.g. conformity certificates, luminance of at least 1 000 lx and at a distance not exceeding 250 mm.
acceptance test reports)? Test Result:
Has data been provided related to analysis of previous Mercury have poured freely without tailing.
acceptance inspection data, rejection history in the Results be verified by: Q.C Manager
plant or customer complaints, required inspection
quantity and necessity of reevaluation of supplier? And
7.4.3 Has the organization identified the authorized person
for conformity approval of incoming material?
Test Report 
Are verification records retained? Test Name: Contamination of the mercury by oil, water or foreign material


Lot Number:8709

Test Procedure:

When the procedure in 6.3.1 and 6.3.2 is followed, the dental mercury shall
be visibly free from contamination by oil, water or foreign material and shall
have a bright mirror‐like surface that does not form a scum in air within the
specified period.
If the dental mercury is supplied in bulk form and does not have a bright
mirror‐like surface, then the
Procedures in 6.3.3 and 6.3.4 shall be carried out. After this procedure has
been completed, the dental mercury shall have a bright, mirror‐like surface
that does not form a scum in air within the specified period.
Use visual inspection, without magnification, to determine whether the
dental mercury is free from
contamination, has the required appearance and that the surface remains
scum‐free for 20 min. Carry out the inspection at an illuminance of at least 1
000 lx and at a distance not exceeding
250 mm.
Test Result:
Mercury visibly free from contamination by oil, water, and it has a bright
mirror‐like surface.
Results be verified by: Q.C Manager Ms. Musavi

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7.5 Production and Service Provision
Company uses “W‐QA‐001” for technical file of each
CONTROL OF PRODUCTION AND SERVICE PROVISION
7.5.1.1 General rules
product, which contains work instructions, quality
Has the organization identified control requirements for plan, OPC, BOM and risk analysis.
production and service process?
Is control quantity and control detail level As management review MOM, product conformity
proportionate to criticality level of its process?
Has the characteristic qualities of product been
is result of experience and quality control and
identified? When required, have documented company did not have any recall or customer
procedures, documented rules, work instructions and
reference materials reference materials and reference complaint related to quality yet, they conclude it
measuring processes been made available?
Has appropriate equipment been selected in the that organization QA is effective.
manner that enables process and product specifications
to be obtained?
As 7.1 of this table
Have the documents for using appropriate equipment Controller: inspector
been established?
Has it been verified that new and/or significantly Equipment: CSM 01
modified equipment meets purchasing/design
specifications and posses the ability to operate within
Place Lab.
7.5.1 the limits defined and process operating limits?
Have control devices been identified?
Period: 1 sample from packed final products, every 
Has a document been prepared for using control batch or in case of material change from set up
devices?
Have implementation and control requirements for manufacturing line to the end every 2.5 hour
labeling and packaging been identified?
Are the records obtained during manufacturing process
And shall be ‐0.1 < Dimensional changes< +0.2 mm
of any product lot and facilitating traceability and due to document ““W‐QA‐001” for technical file”
review of the manufacture of this lot retained?
Do the records include the following information? Controller: inspector
‐ When applicable, quantity of raw materials,
components and intermediate products and lot
Equipment: DCM 01
numbers of those materials, Place Lab.
‐ When applicable, start and completion dates of
different stages of manufacture including sterilization Period: 1 sample from packed final products, every
records,
‐ Quantity of manufactured product, batch or in case of material change from set up
‐ Signed results of all inspections and tests,
‐ Representation of production line used,
manufacturing line to the end every 2.5 hour
‐ Any deviation from manufacturing specifications. Company was packaging "one unites dental
amalgam" in a pack of 50.
7.5.1.2 Control of production and service‐Special rules
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Company provided “P‐AS‐01” to ensure cleanness and
There is a weekly inspection form “F‐AS‐012” which is
filled by Mr asghari for every personnel of organization
inspected start of shifts, second time before going to
lunch and third time one hour after lunch, supervision is
Control of product cleanliness and contamination done by camera such as filled form of “24/06/1395”
Has the organization identified product cleanliness
rules?
And there is another form “F‐AS‐006” which Mr. asghari
Have the materials and substances used during shall complete it monthly for infrastructure and work
manufacturing process been adequately defined and
labeled in order to prevent complexity and process
environment, such as form “31/3/1394” which is aroung
7.5.1.2.1 faults?
Have certain medical devices been cleaned and/or
may of 2015. There are some NCs in this form such as 
cleared of contamination so as to prevent employees Broken window of restaurant
and other product from being exposed to any Broken window of PM warehouse
contamination
Have cleaning and implementation requirements been Entrance to manufacturing line need mending
documented?
Which all are mentioned in form corrective action “F‐
Company have “w‐AS‐01” about how company shall
clean and disinfection, such as disinfection tables:
Pure 10 Ml of dermosept into one Lt of water, and spray
it to tables after work on Thursdays.
NOTE: dermosept is an IMED validated company.
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 N/A
and/or calibrations?
Has the organization provided the instructions which
allow assembler to confirm proper operation of the
device?
Are the results of assembly or commissioning tests
recorded?
Service activities
In the event that functionality of products needs service
or maintenance for proper utilization of products, have
documented requirements been established for service
activity?
Has the organization identified service responsibilities
between distributors and users?
Have service activities carried out by the organization or
a separate agency been planned?
Have the design and functionality of equipment or
devices with special purpose related to manual
operation and service after assembly been validated?
7.5.1.2.3 Are measuring and test equipment used for site service N/A
and tests controlled?
Have instructions related to the lists of spare parts or
parts and for use in product service been prepared?
Has the infrastructure covering technical consultancy
and technical support, customer training and spare
parts or provision of parts been established?
Are service personnel trained?
Are specialized service personnel available?
Has the organization formed a system for receiving
customer demands so as to determine whether
customer complaints and rules are handled?
Are service records retained?
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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? 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 Alloy making is special process in company; they use same
a)defined criteria for review and approval of the
process formulation which they bought first.
b)approval of equipment and qualification of staff Quantity 25000 Grams, name of melt pouring personnel,
involved
temperature, nozzle No. and atomizer pressure is registered
7.5.2.1 c) use of specific methods and procedures
d)records requirements as original sop; Mr Farzinnia told I shall not record the criteria

e)revalidation
documented procedure for validation of
due to confidentiality. But work criteria were as practical
software/computer applications, and records of situation that I observed.
validation
Special rules for sterile medical devices
Have sterilization processes been validated prior to
use?
7.5.2.2 Have the standards used for validation of sterilization N/A
process been identified and implemented?
Have the requirements in the Article no. 7.5.2.1 been
met?
7.5.3 Identification and Traceability
Identification in raw warehouse: every material in
warehouse has a special place based on layout planning
Non‐approved material will not store. Such as copper is
Identification
Has the organization identified and documented the in section B, R2.
product through appropriate methods during product All accepted material will be store, Non identified and
7.5.3.1 realization?
How has the organization identified product situations rejected do not enter to warehouse places.

in accordance with tracing and measuring
requirements?
From raw warehouse to final product, identification will
be done via label or stamp on final products capsules.
Rejected items are labeled red or sent directly to
suppliers. Refer to 7.4.3
Traceability begins from “alloy making” process, with labeling

I traced Invoice of “Tehran central dental clinic” No. 223‐94 to
raw material as 7.1 of this report, Lot No. is 94389 tracability
TRACEABILITY as below:
75.3.2.1 General Pouring molten material on 22/03/1394
How is the product traced?
7.5.3.2 Has any method been documented for traceability?
Does the organization ensure traceability of the medical
Atomizing on 22/03/1394 
device during typically production and storage process
Grading (grain sorting) same day
up to expiration of ownership? packing (Cap + amalgam + mercury) 31/03/1394
Scaling 31/03/1394
Quality Control of Weight same day (approved by Ms.
Mousavi)

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Special rules related to active implantable medical

devices and implantable medical devices
Contract no 2131/WS/11 was observed with "Azad
Does the organization ensure traceability in inspection distribution company", clause 4.5 is:
and stock records for the changes of the personnel
performing a work traceability of which belongs to an
Second part of contract, is committed to register,
7.5.3.2.2 introductory (e.g. serial number, data code, lot code, record, send and keep consumers details and contact

party number) special to operation source, changes in
data to Owzan, however, Owzan trace name, date,
raw materials, changes in the works performed through
tools, new or different machine devices, changes of equipment and batch no. for all productions refer to
process methods?
When applicable, are special personnel assigned to act 7.5.3.2
during processing medical device or each stage of
delivery traced?
Status Identification
From raw warehouse to final product, identification will
7.5.3.3 Organization has identified status of product with
respect to measurement and monitoring requirements
be done via label or stamp on final products capsules. 
Such as Lot Number: Cinalux:94389, Cinasilver:94510
CUSTOMER PROPERTY
Does the organization ensure identification, verification,
protection and safety of customer property provided
for product or in the manner that it creates product
while it is under the organization’s control or being
7.5.4 used? N/A
Does the process ensure that occurrence of any
customer property that is lost, damaged or otherwise
found to be unsuitable for use are recorded and
reported to the customer?
PRESERVATION OF PRODUCT Raw Warehouse:
Are methods and controls established to preserve
conformity of product during internal processing and Company designed a layout and put everything in a safe
until delivery to intended destination? place to ensure FIFO, company uses detection and
Has the organization established documented processes
or documented work instructions for control of the extinguisher system, table’s code is: F‐ST‐001 which
product with limited shelf life or which requires special includes:
7.5.5 storage?
Are such special storage requirements controlled and Storage and lay outing, protection, transport and

recorded?
Does this preservation include definition, transport,
packaging criteria’s, such as Nitrogen capsules which
packaging, storage and protection of the product and should be in section b, column B and first row, section B
the parts constituting the product?
Is there a logo on product? Is it proper to its is special for hazardous materials.
instructions?
Organization uses “P‐CL‐001‐02” procedure to
implement requirement is Owzan,
Master list of measuring device is “F‐CL‐01” which
CONTROL OF MONITORING AND MEASURING DEVICES includes 18 device or equipments.
Has the organization identified the measurements to be
made and the measuring and monitoring devices I checked nitrogen pressure gauge and thermometer of
required to ensure conformity of product to specified
requirement?
oven which company:
a) Be calibrated or verified at specified intervals, or Pressure gauge, certification is valid before march of
prior to use, against measurement standards traceable
to international or national measurement standards;
2016, there is no error. Certification No. is 2132/p/12
7.6 where no such standards exist, the basis used for
calibration or verification s hall be recorded;
Thermometer of oven, certifications code is 2132/t/12, 
b) Be adjusted or re‐adjusted as necessary; thermometer shows thermometer show ‐2 degree and
c) Be identified to enable the calibration status to be company put a label on it and operator (Mr. Rosta) knew
determined;
d) Be safeguarded from adjustments that would about it.
invalidate the measurement result;
e) Be protected from damage and deterioration during
Laboratory scale calibration certification no. is
handling, maintenance and storage. 2132/s/12 which is valid before march of 2016
Company uses “calibration planning of devices form “
with code “F‐CL‐011” which include protection
situations.
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8 Measurement, Analysis and Improvement
General
Does the organization plan to implement the
Quality is main document which refers to other
monitoring, measurement, analysis, and improvement procedure and forms to do measurement, analysis and
processes required for conformity of the product and
8.1 QMS and improvement of its efficiency?
improvement of systems. 
Are measurement, analysis and improvement
processes are carried out through statistical
techniques and applicable methods?
8.2 Monitoring and Measuring
8.2.1 FEEDBACK
Does the organization monitor the information related performance of the organization to clients. Based on the
to customer perception in order to understand whether analysis conducted on the customer feedback
8.2.1 customer requirements are met or not?
Has the organization determined methodologies for parameters, the variety has been increased due to the 
obtaining and using information on customer company's goals of increasing variety in later periods are
satisfaction and/or dissatisfaction?
Internal Audit procedure with code “P‐QA‐002” related
INTERNAL AUDIT
to internal audit process is implemented in Owzan.
Has a documented procedure been established that Internal audit is done by Mr Farzinia, Ms. Musavi and
includes responsibilities and requirements,
requirements for planning and conducting the audit, Mr. Azarm, all three have internal audit base of
reporting the results, maintaining the records? ISO19011 requirements, all auditor are independent due
Are audits planned in the form of an audit program?
to internal audit planning form F‐QA‐24 and they use
8.2.2
Does audit programme take importance and status of
the fields and processes to be audited including the
checklist F‐QA‐25 for each process.

results of previous audits?
Do selection of auditors and implementation of audit Last internal audit is done on may 2015 (12/4/1394) and
ensure objectivity and impartiality of the process?
Do auditors audit their works?
outcome had 7 NCs which are followed by corrective
Do follow‐up actions cover verification of the measures action forms, one of them was, purchase department
taken and reporting of verification results?
did not report indexes of first 3 month of 1394, which
have been closed one month later.
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Owzan process indexes are in format of “F‐QA‐012 “
which all process monitored and measured as plan
based on
MONITORING AND MEASUREMENT OF PROCESSES analysis conducted on the customer feedback
Does the organization implement appropriate methods
8.2.3
for monitoring QMS processes and where applicable,
for measurement such WMS processes?

When planned results are not achieved, is corrective
action taken for product conformity? expected to be fulfilled customer satisfaction.
Based on production unit report
done till end October, it shall be finished.
8.2.4 MONITORING AND MEASUREMENT OF PRODUCT
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Test Result:
Cinasilver Cinalux
General rules
Does the organization establish appropriate stages to Silver 59.1±0.2% 45.4±0.2%
measure and monitor product characteristics? Tin 25.1±0.2% 30.2±0.2%
Have verification methods been documented?
Is this verification process realized in accordance with Copper 14.3±0.2% 22.6±0.2%
the arrangements planned during appropriate stages of And for final product company has a test method as
8.2.4.1 product realization process?
Are conformity evidences along with acceptance criteria below: 
maintained? Package and capsule contamination
Are the records approved by the authorized The packaging container and the outer surface of Type 1 capsules are
person/persons in the process of product release?
Are product release and distribution of service, planned
free of mercury and/or alloy powder contamination.
regulations (Article 7.1) completed satisfactorily? Dimensions
‐Length tolerance
The overall length of activated Type 1 capsules is within 1 mm of the
length specified by the manufacturer.
‐Diameter tolerance
The maximum external diameter of Type 1 capsule is within 0.5 mm
of the diameter specified by the manufacturer.
Loss of mass
The loss in mass for Type 1 capsule during amalgamation is not
exceeding 0.5 mg.
Mercury and alloy retention
The mass of the retained material found within Type 1 capsule after
amalgamation is not exceed 1 % of the mass of alloy and mercury.
Special rules related to active implantable medical
devices and implantable medical devices
Refer to 7.5.3.2
8.2.4.2 Does the organization record the identity of the
personnel carrying out any inspection or test?
CONTROL OF NON‐CONFORMING PRODUCT
Does the organization have methodologies to ensure
Organization have provide “P‐QA‐004” for control of non
that product that does not conform to requirements is conforming products,
identified and controlled to prevent unintended use or
delivery?
Records of this procedure are in form “F‐QA‐010” such
Is there a documented procedure related to non‐ as:
conforming product?
Does the organization take measures to remove non‐ Form No. 001, Alloy making, lot 94109, 25000 grams,
conformity related to product? Copper is 30.9 % (It shall be <30%), correction is change
When applicable, do the processes identify the methods
alloy size to 50000 with a corrective formulation. Result
8.3
authorizing the non‐conformity’s use, release or
acceptance in agreement with customer?
Lot 94109 and Lot 94110 with a corrected alloy.

Are required measures taken to preclude the product’s
original intended use or application?
Are records related to the nature of nonconformities
and the measures taken later maintained?
Is corrected nonconforming product subject to re‐
verification to demonstrate conformity to the
requirements?
Do the processes ensure that appropriate corrective
action is initiated when non‐conforming product is
detected after delivery or use has started?
REFERENCE, AS
This Clause
APPLICABLE
Has been
please Tick
mark √

Owzan process indexes are in format of “F‐QA‐012 “
which all process monitored and measured as plan
based on
performance of the organization to clients (in compare
DATA ANALYSIS
Does the organization collect, identify and analyze to first half of last year customer satisfaction raised 8%).
appropriate data to demonstrate efficiency and Based on the analysis conducted on the customer
appropriateness of QMS and the fields where QMS’s
efficiency can be continuously improved? feedback parameters, the variety has been increased
Has a documented procedure been prepared for these
due to the company's goals of increasing variety in later
8.4
analyses?
AR

Do the characteristics and tendencies of the processes periods are expected to be fulfilled customer
and products including data analysis, customer
satisfaction, conformance to product requirements, satisfaction.
opportunities for corrective actions provide information
related to suppliers? Based on production unit report
Have data types for data analysis been defined?
Are data analyses recorded?
done till end October, it shall be finished.
PPM target was 100 but in first season of 1394 it was
102 comparing last year’s first season which PPM was
147, there was a progress
8.5 Improvement
REFERENCE, AS
This Clause
APPLICABLE
Has been
please Tick
mark √

CONTINUAL IMPROVEMENT
Has the organization identified required changes by
Due first audit this evidence shows improvement:
using quality policy, quality objectives, audit results, Increase of customer complaints
analyses of data, corrective and preventive actions and
management review in order to ensure and sustain
Manufacturing area is clean and tidy
ongoing conformity and efficiency of quality Objective are fulfilled
management system and does the organization
implement such changes? More than 85% of corrective/ preventive action are
Has the organization established written procedures in fulfilled effectively
order that advisory warnings can be published and
implemented? Sales goals are fulfilled
Are the records of all examinations related to customer
complaint maintained?
Customer satisfaction progress (8% in compare last year
Have the complaints been evaluated within the scope of first half)
the following points?:
‐ whether the organization fails to comply with its own
specifications or not,
8.5.1 ‐ whether the organization has caused problems to
occur despite the fact that it has complied with its own

specifications
In the event that the activities outside the organization
are identified through examination of the contribution
of such activities to customer complaint, has the
relevant information been shared among responsible
organizations?
In the event that any customer complaint is not
followed up through a corrective and/or preventive
action, has the reason of this failure been confirmed
and recorded?
Has the organization established a documented
procedure for notifying adverse events and alertness
within the scope of after‐sale supervision activities?
Does the process comply with international guides?
(MEDDEV 2.12.1 – MEDDEV 2.12.2)
Are the notices for adverse events recorded
8.5.2. CORRECTIVE ACTION
Is there a documented procedure for Corrective and
Organization has provide “P‐QA‐001” for
Preventive Action? corrective/preventive action procedure, records are in
Are corrective actions taken to eliminate causes of
nonconformities effective in preventing recurrences?
form corrective/preventive action “F‐QA‐004” such as:
Does this procedure include the requirements of Form 012, on may 2015 (12/4/1394),
8.5.2 reviewing non‐conformities (including customer
complaints), determining the causes of non‐conformity, Purchase department did not report indexes of first 3 
evaluating the actions needed to ensure that month of 1394
nonconformities do not recur, determining and
implementing the corrective action needed, and review Root cause: Rush work because of money rise for copper
of the results of the action initiated?
Is adequacy of corrective‐preventive actions identified?
alloy
Correction: reporting in 48 hours
Corrective action: QA has a two week free slack for
deadline so if any unite have a delay, QA have two
PREVENTIVE ACTION weeks to Compensate the Delay.
Has the organization established a documented Correction check: report sent on 13/4/1394 (next day)
procedure for preventive action with defined
requirements for identifying potential non‐conformities Effectiveness check: 15/Nov/2015 (next period which
8.5.3
and their causes; evaluating the need for action to
prevent occurrence; determining and implementing
purchase shall report) 
preventive action needed; recording results of action
taken; reviewing preventive action taken.
What are the methods for identifying the adequacy of
Preventive action: form 006, changing roof cover of
corrective‐preventive actions? Furnace to prevent Water infiltration and saving more
energy, due to audit I checked they changed cover of
roof with a new insulator

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
training fulfillment
GMP
PPM trend

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 RA addresses the basic four (4) questions
as seen in Form-008:
OW‐01‐15: Mr Farzinnia MR, were to go to training courses of technical supervision which he did not go to course due to
job problem
OW‐02‐15: There is no proper corrective action due to production index (PPM)
Observation Form-018 – with uniquely specific identification:
ATL: Mohammad Reza Khoshgoo DATE: 13-Aug-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

Assessment Report/Checklist: 9001:2008 and ISO 13485:2003, ISIRI and IMED Regulations Within Scope of Organization

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Assessment Report/Checklist: 9001:2008 and ISO 13485:2003, ISIRI and IMED Regulations Within Scope of Organization

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Special rules related to active implantable medical

Observation Form-018 – with uniquely specific identification:

ATL: Mohammad Reza Khoshgoo DATE: 13-Aug-2015

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

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