Assessment Report/Checklist: BLVD., Boumehen, Tehran, Iran

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

Assessment Report/Checklist
Form 009

CLIENT‐ORGANIZATION (NAME): Kavoosh Dian Azma Co.
PHYSICAL LOCATION(s): No,40,Carbon Alley ,Kamyondaran St., Imam
Blvd., Boumehen, Tehran, Iran
Stage II Audit Date(s): 4‐5 March 2016
Stage I Audit Date(s): 6 Feb 2016
NAICS (or NACE) CODE MD1107/32.5/46.46
EXCLUSIONS: 7.3, 7.5.1.2.2, 7.5.13, 7.5.2.2, 7.5.3.2.2, 8.2.4.2

Assessment objectives: Third party assessment of requirements of QMS
ISO 9001 (2008)‐QMSMDD ISO 13485 (2003), is
met in companies management system, as well
as legal requirements

ASSESSMENT TEAM INFORMATION
Assessment Team Leader, ATL Mohammad Reza Khoshgoo
Assessor 2 Marjan Azadmanesh
Assessor 3 Zehtab (Observor)

Note: Adjusting the language within this form to the type of activity and nature of the organization is acceptable.
REFERENCE, AS
This Clause
APPLICABLE1
Has been
Reference Clause Observations Verified,
please Tick
mark √

We pursuit to assure that client‐organization adheres to the protection of communities and consumers. This is to
1 follow the intent to the substitution of the word “identify” to the word “determine” as part of the importance to
the processes being capable of achieving desired outputs (including consumer’s well‐being).
Manufacturing sales and after sales services of 25 and 75 liters laboratory
2 Scope of activities
autoclaves
IMED 6649952947, 6649952945 (for 25 and 75 liter
autoclaves) issue since 94/9 to one year
Legal status
ISIRI:4586- ISIRI4232
3
Obligatory applicable standard which
ISO13485:2003 , ISO 9001:2008 
organization has to follow
4 Quality Management System
GENERAL REQUIREMENTS
The organization Does establish, document, implement, maintain and continually
Does the organization establish, document, implement,
improve a Quality Management System (QMS) with due consideration given to
maintain and continually improve a Quality
identification of processes needed for the QMS and their application throughout the
Management System (QMS) with due consideration
system in process map. According to that, they planned this process: production and
given to identification of processes needed for the
control, management, customer relate, QA and training. The process categorized in 3
QMS and their application throughout the system;
groups: MOP, SOP and ROP.
determination of sequence and interaction of these
Sequence and interaction of these processes planned in processes map.
4.1 processes, determination of criteria and methods
criteria and methods required to ensure effective operation and control of these 
required to ensure effective operation and control of
processes:
these processes; availability of resources and
production and control: delivery time, rejected from customer
information required to support the operation and
management: resource providing
monitoring of processes; measurement, monitoring and
customer relate: compliance/satisfaction
analysis of the processes; implementation of action to
QA and training: effectiveness of training
achieve planned results and continual improvement
There is no any outsourced process.
‐If any, are the outsourced processes are defined?
DOCUMENTATION REQUIREMENTS
Is there a documented quality policy and documented
quality objectives and are they appropriate?
Is there a documented quality manual and are there
documented procedures required by the standards??
Documentation required for QMS is documented.
Are required records for planning, acting and controlling
4.2 processes efficiently available?
Quality manual, quality policy, procedures required in standards is documented as report 
in stage I.
Are the documents are created for every type of
medical device including qms requirements and product
specifications? (4.2.3) If these documents are applicable
to manufacturing processes, are montage and service
defined?
QUALITY MANUAL
Does the Quality Manual include scope of QMS and
Quality Manual includes scope of QMS and details of exclusion are documented.
details of exclusion?
Exclusions are: 7.3, 7.5.1.2.2, 7.5.13, 7.5.2.2, 7.5.3.2.2, 8.2.4.2
4.2.2 Are documented procedures reference to mandatory
Quality manual info: documented procedures are reference to mandatory procedures. 
procedures;
That code is: MF‐01, rev: 1, issue date: Jan 2015
Is description of interaction of the processes included in
the QMS?
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 Page 2 of 16
REFERENCE, AS
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Has been
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CONTROL OF DOCUMENTS
Are mandatory procedures documented?
Are control conditions pertaining to mandatory
documents proper?
Are review, update and re‐approval situations and
changes and current review situations for documents
traceable? Review, update and re‐approval situations and changes and current review situations for
Are the relevant documents usable, readable and documents are traceable. E.g: internal audit procedure.
4.2.3 recognizable at concerned usage points? List of documents is available that include distribution of documents and last version. 
Are outsourced documents defined? Outsourced documents are defined including standards (ISIRI 4586‐ ISIRI 4232).
Are distributions 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?
CONTROL OF RECORDS
Are documents readable, easily recognizable and stored
Documents readable, easily recognizable and stored in are available manner.
in available manner?
Has a documented procedure been established and The products shelf life is 10 years and the time of archive records according to this legal
4.2.4 applied for determination of required controls for requirement is 10 years.

storage, retrieval, retention time and disposition of
records? E.g.: product ID card
Has the archiving defined for at least 2 years?
5 Management responsibility
MANAGEMENT COMMITTMENT
Has the top management ensured that requirement for
meeting customer conditions and legal conditions
should be understood by all personnel? The top management has ensured that requirement for meeting customer conditions
5.1 Is a quality policy available? and legal conditions should be understood by all personnel. 
Are quality objectives available? Quality policy available and management review established.
Is management review established?
Does the management provide required sources for
QMS?
CUSTOMER FOCUS
Does top management have methodologies to ensure top management have methodologies to ensure that customer needs and expectations
5.2 that customer needs and expectations are determined are determined and met for increasing customer satisfaction by determine procedure.

and met for increasing customer satisfaction?
Top management has established a Quality Policy in accordance with the objective of the
QUALITY POLICY organization. Quality policy: QP‐MF‐02, Rev: 1, issue date: Jan 2016
Has top management established a Quality Policy in
accordance with the objective of the organization? The Quality Policy has been revised for communication, understanding and continuous
Does the Quality Policy include a statement of compliance within the body of the Organization.
5.3 commitment to meeting requirements and continual There are 4 policy in this document: 
improvement of the QMS?
Has the Quality Policy been revised for communication, 1‐ increasing the customer satisfaction
understanding and continuous compliance within the 2‐ determine safety work environment
body of the Organization?
3‐ increasing product Qty.
QUALITY OBJECTIVES
Are quality objectives established by top management
at relevant functions and levels within the organization? the objectives measurable and consistent with the Quality Policy:
Are the objectives measurable and consistent with the
1‐ up to 75%
Quality Policy
5.4 5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING 2‐ decreasing accident 
Has the QMS been planned by Top Management in
order to meet the conditions and quality objectives 3‐ 20% increase
detailed in Section 4.1? There are action plan to fulfill observed.
When changes are initiated, is the integrity of the QMS
maintained during the change process?
5.5 Responsibility, Authority and Communication
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Has been
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RESPONSIBILITY AND AUTHORITY
Has top management identified responsibility and Responsibility and authority determined according the top chart.
5.5.1 authority and been communicated within the 
Responsibility and authority technical supervisor, MR and services.
organization?
MANAGEMENT REPRESENTATIVE
Has top management appointed a member as
Mr. nofallah (warehouse manager) is management representative.
Management Representative with responsibility and
Responsibility and authority of management representative observed.
authority to ensure that the processes of the QMS are
5.5.2 established, implemented and maintained; report to
Established, implemented and maintained; report to top management on the 
performance of the QMS, including needs for improvement and promote awareness of
top management on the performance of the QMS,
customer requirements are in his Responsibility.
including needs for improvement and promote
awareness of customer requirements?
INTERNAL COMMUNICATION
Has the top management ensured establishment of Board, phone and periodic meeting are ways to make internal communication.
appropriate communication processes within the Also, technical supervisor responsible to make communication way with MOH by IMED.ir
5.5.3 organization? Has the top management ensured or distribution of official announcement. 
realization of communication considering the processes e.g.: pricing policy. Letter index: N/256/94, letter date: 94/02/25
of the QMS and their effectiveness?
5.6 Management review
TOP MANAGEMENT REVIEW
Does top management review the QMS to ensure its
continuing suitability, adequacy and effectiveness at
This meeting planned for annually.
regular and planned intervals?
5.6.1 Do reviews include assessing opportunities for
Last meeting date is jan 2016. 
All staff manager has been in this meeting, (MD, MR, Sales, Services)
improvement including the need for changes to the
QMS, quality policy, and quality objectives?
Are management review records kept?
REVIEW INPUT
Does review input include current performance and
improvement opportunities related to:
a) results of audits;
b) customer feedback; Review input include current performance and improvement opportunities dose related
5.6.2 c) process performance and product conformance; to ISO13485. 
d) status of corrective and preventive actions; There is a complete report from MR and other managers to
e) follow‐up action from earlier management reviews;
f) changes that could affect the QMS,
g) recommendations for improvement
h) New or revised regulatory rules?
REVIEW OUTPUT
Does output from management review include actions e.g. for outputs:
related to improvement of the QMS and its processes,
5.6.3 improvement of product related to customer 1‐ using the qualified staff 
requirements, actions and decisions relate to resource 2‐ increasing a new field of products (Portable autoclaves)
needs?
6 Resource Management
PROVISION OF RESOURCES
Does the organization have methods to determine and
The organization determines and provides resources needed to implement and improve
6.1 provide resources needed to implement and improve
the processes of the QMS.

the processes of the QMS and address customer
satisfaction by meeting requirements?
6.2 Human Resources
Personnel assigned with responsibilities that affect product quality competent on the
Are personnel assigned with responsibilities that affect
basis of applicable education, training, skills, and experience.
product quality competent on the basis of applicable
6.2.1 education, training, skills, and experience? e.g.: 
Are trainings performed for achievement of Required
Competence? Technical supervisor: mechanic, 7 years’ experience, technical supervisor MOH certificate
and ICDL skill.
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COMPETENCE, AWARENESS, AND TRAINING
Has the organization identified the experience, 1394 training schedule observed.
qualifications, competencies and skills of the personnel
There are 4 train course planed in this schedule:
performing activities affecting safety and efficiency of
medical devices particularly being manufactured and 1‐ assembling
provided to customer?
Is training provided by the organization to satisfy the 2‐ warehousing: trainer Mr. Nofallah, he is product manager and he has experience in
6.2.2 competency needs? warehousing. Effectiveness of that course down in 30 days after. Record of course for Mr. 
Does the organization ensure that its employees are Nejati observed.
aware of the relevance and importance of their 3‐ work environment safety
activities and how they contribute to the achievement
of quality objectives? 4‐ internal audit
Are records of education, experience, training and All education, experience, training and qualifications Mr. nejati records observed.
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 Manufacture facility is suitable for product requirements
test equipment and availability of the same for
operators? There is a list for all facility and there is ID card for each equipment. E.g.: Press‐break
6.3 Are documented processes available for maintenance, 
And the PM plan observed.
cleaning and control of all equipment used in
manufacturing process and control of work Cleaning process not any effect to product.
environment?
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?
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WORK ENVIRONMENT
Does the organization identify and manage required
work environment needed to achieve conformity of
product?
Are the following factors which could affect product
quality in the work environment identified?
‐ Process equipment,
‐ Work environment,
‐ Personnel in this work environment
Are qualified and quantified limit values of the work
environment identified for a desired quality of the work
environment?
Are pollution levels of microbial and solid particles
controlled during product manufacturing where sterile
product or pollution of solid particle which is stipulated
to be sterilized or could live or not live during its
manufacture or utilization is important?
Has exclusion been applied during all manufacturing
processes for a controlled environment? As valid
ground of exclusion, is pollution reduced to known,
consistent and controlled level by an approved cleaning
method and packaging kept at this level through control
process?
Have indicators been identified for a controlled
environment which covers valid cleaning and packaging There is no IMED regulation for this kind of Medical Devices, company uses 5s and PM to
processes including the organizations holding a valid ensure work environment is good for manufacturing.
6.4 cleaning process? Record of 5S for February 2016 of housekeeping checklist has been observed. 
(Temperature, Humidity, Air Current, Filtration of Air, Record of PM for entrance door on November 2016 has been observed.
Ionization of Air, Pressure differences, Lighting (along
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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PLANNING OF PRODUCT REALIZATION
Has the organization considered the scope of its own
quality management system in planning of product
realization?
Has the organization prepared required records for a
proof indicating that quality objectives and product
The organization considered the scope of its own quality management system in planning
rules, processes established, documents and product‐
of product realization.
specific necessary resources, verification, validation,
In the technical file, for a proof indicating that quality objectives and product rules,
tracking, measuring, inspection and product‐specific
processes established, documents and product‐specific necessary resources, verification,
test activities , realization processes and the product
validation, tracking, measuring, inspection and product‐specific test activities, realization
meet the rules?
processes and the product meet the rules with BOM, OPC and quality control plan. In
In the event that inspection and test are conducted by
QCP there are product/process indicate, responsible, devices and sampling inspection
manufacturing personnel, do inspection and test
method.
results, processes, organization’s procedures ensure
The organization prepared a procedure containing all processes of product realization for
impartiality of inspection and test results?
risk management activities.
7.1 Risk management
Risk Management Plan observed. 
Has the organization prepared a procedure containing
Risk team and its Responsibilities: QC man, Produce manager, Technical supervisor and
all processes of product realization for risk management
top manager.
activities and realized the following?
Intended Use of Device and Safety Characteristics: laboratory autoclave (25, 75 liter) for
Keeping the records
sterile.
Preparation of Risk Management Plan
Definition of hazards, Evaluation of Risks: hazards identified. E.g.: pressure, temperature,
Determination of Risk team and its Responsibilities
explosion …
Determination of Intended Use of Device and Safety
Method of risk management is FMEA.
Characteristics of Device
RPN=<50
Definition of hazards
There is not Residual Risks in products.
Risk Estimation for Hazards
Evaluation of Risks
Risk Control Measures
Definition of Residual Risks
Risk/Benefit Analysis
Preparation of Risk Management Report
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
The organization has defined the requirements of customer including the requirements
to the market
for the activities on delivery and after delivery.
‐ anticipated utilization,
Customer order was recorded in sale software and that software generated the customer
‐ Performance expectations,
invoice.
‐ Design factors
Invoice no: 445
7.2.1 ‐ Delivery plans
Date of generated: Oct 2015 
‐Unclear customer expectations
Client name: SARA TEB
Does the organization record customer’s expectations
Order description: autoclave 25 liter
related to product/service in order to revise the same?
Qty.: 1
In the event of any change in order or offer or both for
Product S/N: 259425
any reason whatsoever, are changes revised and an
agreement is reached on the changes as it is in original
order or offer?
In the event that changes are accepted, are all
personnel being affected by the changes within the
organization informed?
Are relevant documents affected by these changes
amended?
7.2 Customer‐Related Processes
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REVIEW OF REQUIREMENTS RELATED TO THE

PRODUCT/SERVICE
Does the organization review the requirements related The organization has defined the requirements of customer including the requirements
to the product? for the activities on delivery and after delivery.
Are review records kept? Customer order was recorded in sale software and that software generated the customer
Has this review been realized prior to commitment of invoice.
the organization for provision of the product to Invoice no: 445
7.2.2 customer? Date of generated: Oct 2015 
Has the organization ensured settlement of contract or Client name: SARA TEB
order requirements which are different from previously Order description: autoclave 25 liter
defined? Qty.: 1
Does the organization have the ability to meet defined Product S/N: 259425
requirements? There is no change since company installed QMS system.
Are the results of review and subsequent follow‐up
actions recorded?
CUSTOMER COMMUNICATION
Are arrangements for communication identified and
implemented relating to product information, demands,
7.2.3
applications, contracts or realization of order including
amendments?
Purchase requests and follow‐up telephone communication measured by unit sales and
after‐sales customer comments. 
Are required arrangements identified and implemented
for customer feedback and communication with
customers including customer complaints?
7.3 Design and Development
DESIGN AND DEVELOPMENT PLANNING
Have the stages of design and/or development been
identified?
Have review, verification and validation activities
appropriate to each design and/or development stage,
7.3.1 responsibilities and authorities been identified in design NA
and development planning?
Are design and development planning updated when
planning output is appropriate and in the progress of
design and development?
DESIGN AND DEVELOPMENT INPUTS
Are inputs related to product requirements identified
and relevant records maintained?
Do these inputs include functional and performance
7.3.2 requirements, applicable regulatory and legal NA
requirements, applicable information derived from
previous and similar designs a any other requirements
essential for design?
Have the inputs been reviewed in terms of adequacy?
DESIGN AND DEVELOPMENT OUTPUTS
Are design and/or development outputs approved
before prior to release and in a manner that enables
verification against the design and/or development
inputs?
Do the design and/or development outputs meet the
7.3.3 design input requirements and NA
‐provide appropriate information for purchasing,
manufacture and service performance,
‐ contain or reference product acceptance criteria
‐ define the characteristics of the product that are
essential to its safe and proper use?
DESIGN AND DEVELOPMENT REVIEW
Does the organization identify suitable stages for
systematic reviews of design and/or development?
7.3.4 Are the results of review and subsequent follow‐up NA
actions recorded in order to evaluate the ability to
fulfill requirements and identify problems and
propose corrective actions?
DESIGN AND DEVELOPMENT VERIFICATION
7.3.5 Does the organization in planned arrangements ensure NA
that design output meets input criteria
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DESIGN AND DEVELOPMENT VALIDATION
Is the design and/or development validation performed
in accordance with planned arrangements to confirm
that final product is capable of meeting the
requirements of intended use or application
7.3.6 requirements defined? NA
Is verification completed (if applicable) prior to delivery
or implementation of product? Ara relevant records
maintained?
Are results of review and required actions recorded?
CONTROL OF DESIGN AND DEVELOPMENT CHANGES
Have design and development changes been identified
and recorded?
Have design and development changes been reviewed,
verified, validated and approved prior to
implementation?
7.3.7 Does the review of design and development changes NA
include evaluation of the effect of changes on
previously delivered product and the parts constituting
the product?
Are the results of review of changes and subsequent
follow‐up actions documented?
7.4 Purchasing
Purchasing Process; Has the organization prepared
documented process to ensure that purchased product
conforms to purchasing requirements?
Are criteria for selection of suppliers defined?
Are evaluation and reevaluation of suppliers have been
defined?
Has the organization defined tracking frequency of
supplier’s performance?
Does the organization have the proofs indicating that Criteria for selection of suppliers are defined and evaluation and reevaluation of
supplier monitoring activities, outsourced processes are suppliers have been defined.
controlled and the products or services conform to the There is a list of current supply. Such as: welding supply Mr. Nezam. His contract is about
7.4.1
rules of the organization containing customer demands
and regulatory rules?
production of main steel tank. Grade is A.

Have the requirements of purchasing information To evaluation and selection of welding supply, sub‐contractor has to give radiation test
(containing the rules related to supplier records) report.
including outsourced processes been identified to Other suppliers evaluated per 6 months.
ensure product and service quality?
Does the organization have the methodology to
communicate these requirements to the supplier?
Are purchasing contracts available?
Do the type and content of the control on supplier and
purchased product depend on the next product
realization of purchased product or final product?
Are purchasing records retained?
PURCHASING INFORMATION
Does purchasing information define the product to be
purchased?
Where appropriate, does purchasing information For welding process, organization takes a WPS (ASME IX) and PQR for technical
include product approval, procedures, requirements for requirements and radiation tests.
7.4.2
process and equipment, Personnel qualification and the
requirements of Quality Management System?
Other purchase information determined in purchase orders.
Order no.: 3625 
How does organization ensure the adequacy of Date: Sep 2015
specified requirements in the purchasing information Order description: screw number 26L 2, Qty. 2500
prior to their release to the supplier?
Are records for the information related to purchased
product available?
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VERIFICATION OF PURCHASED PRODUCT
Has the organization identified a method in order to
ensure that the product received conforms to the
For steel tank that product by Mr. Nezam, it need radiography test in the start of process.
specifications, is finished, holds appropriate identity
Methodology of testing is a reference laboratory of RAZI Co.
and is free from any damage?
Test report of RAZI about welding test info:
Do the processes include the provisions in order to
Date: Oct 2015
verify that incoming product is provided along with
Ref. No. : 19259‐1
7.4.3
support documentation (e.g. conformity certificates,
acceptance test reports)?
STD: ASME E1686‐14 for test method
STD: ASME A240‐2015 grade steel 316 L >> Anti Acid

Has data been provided related to analysis of previous
Radiation test: date of report: 5 Sep 2009
acceptance inspection data, rejection history in the
Hydrostatic test refer to 8.2.401
plant or customer complaints, required inspection
In Sep 2015 there is a purchase verification of main steel tank(Qty. 64) observed.
quantity and necessity of reevaluation of supplier?
The hydrostatic test is zero defects. (100%)
Has the organization identified the authorized person
for conformity approval of incoming material?
Are verification records retained?
7.5 Production and Service Provision
CONTROL OF PRODUCTION AND SERVICE PROVISION
7.5.1.1 General rules
Has the organization identified control requirements for
production and service process?
Is control quantity and control detail level
proportionate to criticality level of its process?
Has the characteristic qualities of product been
identified? When required, have documented
procedures, documented rules, work instructions and
reference materials reference materials and reference
measuring processes been made available?
Has appropriate equipment been selected in the
The organization has identified control requirements for production and service process
manner that enables process and product specifications
and control quantity and control detail level proportionate to criticality level of its
to be obtained?
process. Appropriate equipment has been selected in the manner that enables process
Have the documents for using appropriate equipment
and product specifications to be obtained. An implementation and control requirement
been established?
for labeling and packaging has been identified.
Has it been verified that new and/or significantly
Production plan started by sale order.
modified equipment meets purchasing/design
Date of last order is May 2015
specifications and possess the ability to operate within
7.5.1 the limits defined and process operating limits?
Have control devices been identified?
There are some record for control in process:
Id: 94‐05 
For 5 Qty. products (25 liter)
Has a document been prepared for using control
Dimensional controls: 94‐7‐6
devices?
Analysis documents
Have implementation and control requirements for
Material control report: 94‐7‐06
labeling and packaging been identified?
Hydrostatic test report 94‐7‐3
Are the records obtained during manufacturing process
Acceptant test 94‐7‐6
of any product lot and facilitating traceability and
Packaging requirements 94‐7‐06
review of the manufacture of this lot retained?
Do the records include the following information?
‐ When applicable, quantity of raw materials,
components and intermediate products and lot
numbers of those materials,
‐ When applicable, start and completion dates of
different stages of manufacture including sterilization
records,
‐ Quantity of manufactured product,
‐ Signed results of all inspections and tests,
‐ Representation of production line used,
‐ Any deviation from manufacturing specifications.
7.5.1.2 Control of production and service‐Special rules
Control of product cleanliness and contamination
Has the organization identified product cleanliness
rules?
Have the materials and substances used during
manufacturing process been adequately defined and
labeled in order to prevent complexity and process
7.5.1.2.1 faults?
Have certain medical devices been cleaned and/or
According to 6.4 
cleared of contamination so as to prevent employees
and other product from being exposed to any
contamination
Have cleaning and implementation requirements been
documented?
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Assembly activities
Have assembly activities and responsibility for medical
device been identified?
In the event that any medical device should be
assembled and mounted in the location where the user
is present, have guiding instructions been prepared by
7.5.1.2.2 the organization for accurate assembly, montage, tests
and/or calibrations?
NA 
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 The organization has identified service responsibilities between distributors and users
a separate agency been planned? and service activities carried out by the organization.
Have the design and functionality of equipment or Service personnel trained by organization, but the IFU are enough.
BA‐RE‐04
devices with special purpose related to manual The organization has formed a system for receiving customer demands so as to
operation and service after assembly been validated? determine whether customer complaints and rules are handled.
7.5.1.2.3 Are measuring and test equipment used for site service
and tests controlled?
Date of order: Nov 2015
Product S/N: 759104
RA
Have instructions related to the lists of spare parts or Service records are not complete.
parts and for use in product service been prepared? Record of two samples observed:
Has the infrastructure covering technical consultancy 75 liter: 9104
and technical support, customer training and spare 25 liter: 9213
parts or provision of parts been established?
Are service personnel trained?
Are specialized service personnel available?
Has the organization formed a system for receiving
customer demands so as to determine whether
customer complaints and rules are handled?
Are service records retained?
Special rules for sterile devices
Does the organization record process parameters
related to sterilization process and used for each
7.5.1.3 sterilization lot? NA
Are sterilization records tracked for each production lot
related to medical devices?
7.5.2 VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION
General rules
a)defined criteria for review and approval of the
process
b)approval of equipment and qualification of staff
involved
7.5.2.1 c) use of specific methods and procedures
d)records requirements
According to 7.4.3 
e)revalidation
documented procedure for validation of
software/computer applications, and records of
validation
Special rules for sterile medical devices
Have sterilization processes been validated prior to
use?
7.5.2.2 Have the standards used for validation of sterilization NA
process been identified and implemented?
Have the requirements in the Article no. 7.5.2.1 been
met?
7.5.3 Identification and Traceability
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Identification
Has the organization identified and documented the
product through appropriate methods during product The organization has identified and documented the product by using some boards and
7.5.3.1 realization?
How has the organization identified product situations
labels.
QC Pass product has an ID label.

in accordance with tracing and measuring
requirements?
TRACEABILITY
75.3.2.1 General
Each product has a special S/N: 25 liter >> 259425 is a exclusive code.
How is the product traced?
7.5.3.2 Has any method been documented for traceability?
Does the organization ensure traceability of the medical
There is a special file for each product.
the organization has ensure traceability of the medical device during typically production 
and storage process up to expiration of ownership with S/N on each product.
device during typically production and storage process
up to expiration of ownership?
Special rules related to active implantable medical
devices and implantable medical devices
Does the organization ensure traceability in inspection
and stock records for the changes of the personnel
performing a work traceability of which belongs to an
7.5.3.2.2 introductory (e.g. serial number, data code, lot code,

party number) special to operation source, changes in NA
raw materials, changes in the works performed through
tools, new or different machine devices, changes of
process methods?
When applicable, are special personnel assigned to act
during processing medical device or each stage of
delivery traced?
Status Identification
7.5.3.3 Organization has identified status of product with
respect to measurement and monitoring requirements
According to 7.5.3.1 
CUSTOMER PROPERTY
Does the organization ensure identification, verification,
protection and safety of customer property provided
Customer property is customer product that sent to service dept. of company. For every
for product or in the manner that it creates product
one repair situation, organization will send technical person to customer place to repair.
7.5.4
while it is under the organization’s control or being
used?
the technical repair person of organization ensure that occurrence of any customer
property(customer product) that is damaged or otherwise found to be unsuitable for use

Does the process ensure that occurrence of any
are recorded and reported to the customer, but there is no any record.
customer property that is lost, damaged or otherwise
found to be unsuitable for use are recorded and
reported to the customer?
PRESERVATION OF PRODUCT
Are methods and controls established to preserve
conformity of product during internal processing and
until delivery to intended destination?
Has the organization established documented processes Methods and controls are established to preserve conformity of product during
or documented work instructions for control of the processing. It’s simple because that product has not limited shelf life and any
product with limited shelf life or which requires special environmental preservation.
7.5.5 storage?
Are such special storage requirements controlled and
this preservation include definition, packaging, storage and protection of the product and
the parts constituting the product. The warehouse manager has full control for entries

recorded? and exit and record that. E.g.: id form>>3450 date>>Jun 2015 for exit 27th screw. For this
Does this preservation include definition, transport, sample minimum Qty. to make a purchasing order is 150.
packaging, storage and protection of the product and
the parts constituting the product?
Is there a logo on product? Is it proper to its
instructions?
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CONTROL OF MONITORING AND MEASURING DEVICES
Has the organization identified the measurements to be
made and the measuring and monitoring devices
required to ensure conformity of product to specified
requirement?
the organization has identified the measurements to be made and the measuring and
a) Be calibrated or verified at specified intervals, or
monitoring devices required to ensure conformity of product to specified requirement.
prior to use, against measurement standards traceable
The pressure gage for hydrostatic test is very important in all product process and that
to international or national measurement standards;
7.6 where no such standards exist, the basis used for
calibration or verification s hall be recorded;
calibrated by SANJESH AZMA Co. in Oct 2015 and certificate id. Is 94‐B‐2138.
There is some another device to control of dimensional product spec. those are 
calibrated same that device.
b) Be adjusted or re‐adjusted as necessary;
There is a calibration plan and the organization monitored device situation by that.
c) Be identified to enable the calibration status to be
All devices will be calibration anuually.
determined;
d) Be safeguarded from adjustments that would
invalidate the measurement result;
e) Be protected from damage and deterioration during
handling, maintenance and storage.
8 Measurement, Analysis and Improvement
General
Does the organization plan to implement the
The organization dose plan to implement the monitoring, measurement, analysis, and
monitoring, measurement, analysis, and improvement
improvement processes required for conformity of the product and QMS and
8.1
processes required for conformity of the product and
QMS and improvement of its efficiency?
improvement of its efficiency and measurement, analysis and improvement processes
are carried out through statistical techniques and applicable methods by Analysis

Are measurement, analysis and improvement
procedures.
processes are carried out through statistical
techniques and applicable methods?
8.2 Monitoring and Measuring
8.2.1 CUSTOMER SATISFACTION The organization monitor the information related to customer perception in order to
Does the organization monitor the information related understand whether customer requirements and determined methodologies for
to customer perception in order to understand whether obtaining and using information on customer satisfaction and/or dissatisfaction by
8.2.1 customer requirements are met or not?
Has the organization determined methodologies for
corrective/preventive action procedure.
There is no any record for customer compliance and recall.

obtaining and using information on customer Level of satisfaction is good (73%). They analysis that information in the management
satisfaction and/or dissatisfaction? review meeting each 12 months.
INTERNAL AUDIT
Has a documented procedure been established that
includes responsibilities and requirements,
requirements for planning and conducting the audit,
The audits planned in the form of an audit program in 12 months by qualified person and
reporting the results, maintaining the records?
audit program has taken importance and status of the fields and processes to be audited.
Are audits planned in the form of an audit program?
There are 2 internal auditors (MR and Sale) from two different departments.
8.2.2
Does audit programme take importance and status of
the fields and processes to be audited including the
The last audit date is Jan 2016 and 4 NCRs detective in this audit.
Action plan for resolved observed.

results of previous audits?
It was effectiveness.
Do selection of auditors and implementation of audit

ensure objectivity and impartiality of the process?
Do auditors audit their works?
Do follow‐up actions cover verification of the measures
taken and reporting of verification results?
the organization implement appropriate methods for monitoring/ measurement QMS
MONITORING AND MEASUREMENT OF PROCESSES processes according to a documented procedure.
Does the organization implement appropriate methods e.g.:
8.2.3 for monitoring QMS processes
When planned results are not achieved, is corrective
sales: increasing up to 7%
production: increasing Qty. of product up to 2200 products

action taken for product conformity? all indicators in progress until end of 1395 and MR make a progress report to make a
decision for not achieved targets.
8.2.4 MONITORING AND MEASUREMENT OF PRODUCT
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General rules The organization establishes appropriate stages to measure and monitor product
Does the organization establish appropriate stages to characteristics by QCP documents that have verification methods by acceptance tests.
measure and monitor product characteristics? E.g.:
Have verification methods been documented? There are some record for control in process:
Is this verification process realized in accordance with Id: 94‐05
the arrangements planned during appropriate stages of For 5 Qty. products (25 liter)
8.2.4.1 product realization process?
Are conformity evidences along with acceptance criteria
Dimensional controls: 94‐7‐6
Analysis documents

maintained? Material control report: 94‐7‐06
Are the records approved by the authorized Hydrostatic test report 94‐7‐3
person/persons in the process of product release? Acceptant test 94‐7‐6
Are product release and distribution of service, planned Packaging requirements 94‐7‐06
regulations (Article 7.1) completed satisfactorily? Approved by QC manager
Special rules related to active implantable medical
devices and implantable medical devices
8.2.4.2 Does the organization record the identity of the NA
personnel carrying out any inspection or test?
CONTROL OF NON‐CONFORMING PRODUCT
Does the organization have methodologies to ensure
that product that does not conform to requirements is
identified and controlled to prevent unintended use or
delivery?
Is there a documented procedure related to non‐
conforming product?
Does the organization take measures to remove non‐ There is no any non‐conforming product
conformity related to product? The B.A.P Co. is an accredited laboratory for test and in the last test report in Oct 2015
When applicable, do the processes identify the methods according to STD: 4538, 4586, 42‐32, there is no any fault in products. But, The
8.3
authorizing the non‐conformity’s use, release or
acceptance in agreement with customer?
organization has methodologies to ensure that product that does not conform to
requirements is identified and controlled to prevent unintended use or delivery by QC

Are required measures taken to preclude the product’s manager monitoring.
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?
DATA ANALYSIS
Does the organization collect, identify and analyze
appropriate data to demonstrate efficiency and
The organization collect, identify and analyze appropriate data to demonstrate efficiency
appropriateness of QMS and the fields where QMS’s
and appropriateness of QMS and the fields where QMS’s efficiency can be continuously
efficiency can be continuously improved?
improved. The analysis is including:
Has a documented procedure been prepared for these
 Feedback, according to 8‐2‐1 is ok.
8.4
analyses?
 Product requirements, according to 8‐2‐4 and 8‐3 is ok and there is not any non‐ 

Do the characteristics and tendencies of the processes
conformity in products.
and products including data analysis, customer
 Opportunities for corrective actions, according to 8‐5‐3 there is no any situation and
satisfaction, conformance to product requirements,
record.
opportunities for corrective actions provide information
 Suppliers, according to 7‐4‐1 the supply grade are correct for organization.
related to suppliers?
Have data types for data analysis been defined?
Are data analyses recorded?
8.5 Improvement
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CONTINUAL IMPROVEMENT
Has the organization identified required changes by
using quality policy, quality objectives, audit results,
analyses of data, corrective and preventive actions and
management review in order to ensure and sustain
ongoing conformity and efficiency of quality
management system and does the organization
implement such changes?
Has the organization established written procedures in
order that advisory warnings can be published and
implemented?
Are the records of all examinations related to customer
complaint maintained?
Have the complaints been evaluated within the scope of The organization established written procedures in order that advisory warnings can be
the following points?: published and implemented but the organization used that outputs onto IFU and user
‐ whether the organization fails to comply with its own manual.
specifications or not, According to 8‐2‐1 there is no any customer compliance.
8.5.1 ‐ whether the organization has caused problems to
occur despite the fact that it has complied with its own
So the organization identified required changes by using quality policy, quality objectives,
audit results, analyses of data, corrective and preventive actions and management

specifications review in order to ensure and sustain ongoing conformity and efficiency of quality
In the event that the activities outside the organization management system and does the organization implement such changes according to
are identified through examination of the contribution clause 5‐4
of such activities to customer complaint, has the
relevant information been shared among responsible
organizations?
In the event that any customer complaint is not
followed up through a corrective and/or preventive
action, has the reason of this failure been confirmed
and recorded?
Has the organization established a documented
procedure for notifying adverse events and alertness
within the scope of after‐sale supervision activities?
Does the process comply with international guides?
(MEDDEV 2.12.1 – MEDDEV 2.12.2)
Are the notices for adverse events recorded
8.5.2. CORRECTIVE ACTION
Is there a documented procedure for Corrective and
Preventive Action?
Are corrective actions taken to eliminate causes of There is a documented procedure for Corrective and Preventive Action and corrective
nonconformities effective in preventing recurrences? actions are taken to eliminate causes of nonconformities effective in preventing
Does this procedure include the requirements of recurrences. The organization uses this procedure about any product/process non‐
8.5.2 reviewing non‐conformities (including customer
complaints), determining the causes of non‐conformity,
conformity according to product/customer needs.
e.g.: internal audit non‐conformity reports.

evaluating the actions needed to ensure that Problem is wrong warehouse layout, root cause is limited place, corrective action is using
nonconformities do not recur, determining and the vertical distance and that was effectiveness.
implementing the corrective action needed, and review
of the results of the action initiated?
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
8.5.3
and their causes; evaluating the need for action to
prevent occurrence; determining and implementing
There is no any record about preventive action 
preventive action needed; recording results of action
taken; reviewing preventive action taken.
What are the methods for identifying the adequacy of
corrective‐preventive actions?

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
‐ After sales services records

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:
Service records are not complete
Observation Form-018 – with uniquely specific identification:
ATL: Mohammad Reza Khoshgoo DATE: 8 March 2016
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: BLVD., Boumehen, Tehran, Iran

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Assessment Report/Checklist: BLVD., Boumehen, Tehran, Iran

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REVIEW OF REQUIREMENTS RELATED TO THE

ATL: Mohammad Reza Khoshgoo DATE: 8 March 2016

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

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