BRSM Form 009 Qms MDD Fts

BRSM
Systems: QMSMDD ISO 13485 (2003)
Assessment Report/Checklist
Form 009

CLIENT‐ORGANIZATION (NAME):
Farad Tajhiz Sepanta Engineering Co.
PHYSICAL LOCATION(s):
No. 30, Alley No. 30, Toohid St., Isfahan, Iran
Stage II Audit Date(s):
11 Jan 2016
Stage I Audit Date(s):
2 Jan 2016
NAICS (or NACE) CODE MD0101,
MD0104 & MD1405

EXCLUSIONS: 7‐5‐2‐1/7.5.1.3/7.5.2.2/
7.5.3.2.2/7.5.4/8.2.4.2

Assessment objectives: Verifying the company’s scope and
documentation for the requested regulators and
ISO13485:2003 & IMED requirements to protect
consumers and communities

ASSESSMENT TEAM INFORMATION
Assessment Team Leader, ATL Milad Pourhasan
Assessor 2 Farhang Mohajer
TE

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).
Design and production of Medical Gases Systems such as: Oxygen Flow
meters , Oxygen and Anaesthesia Regulators , non‐electrical Nebulizer and
2 Scope of activities
Isolation Panels for operation room

ISIRI certificate: 664188025
Legal status Ministry of Industrial and mines certificate: 11748
IMED Certificate: 664188025
3
Obligatory applicable standard which Technical supervisor certificate: 8901011-1452088
organization has to follow Applicable ISIRIs: 3368-1-8 (Active medical device) 
8629 General requirements and 2360 for flow meters
4 Quality Management System
GENERAL REQUIREMENTS
Does the organization establish, document, implement,
maintain and continually improve a Quality In stage I, we check documentation system and GMP
Management System (QMS) with due consideration
given to identification of processes needed for the
Company have requirement developed, installed and
QMS and their application throughout the system; maintained effectively as form 002 report, there was an RA
determination of sequence and interaction of these “FTS ‐01‐2016” which is removed and implemented effectively
4.1 processes, determination of criteria and methods
required to ensure effective operation and control of as this file section 8.4. 
these processes; availability of resources and Such as documentation referred in form 002 and
information required to support the operation and
monitoring of processes; measurement, monitoring and FTS‐PR‐009, identification of process sales
analysis of the processes; implementation of action to input: Customer needs from customers/ warehouse
achieve planned results and continual improvement
‐If any, are the outsourced processes are defined? inventory from store
DOCUMENTATION REQUIREMENTS output: Customer feedback to MR, Orders to
Is there a documented quality policy and documented
quality objectives and are they appropriate? Warehouse,
Is there a documented quality manual and are there
documented procedures required by the standards??
owner/responsible: Mrs. Tavakolian
index: sales, calculation method is percentage of sales
4.2
Are required records for planning, acting and controlling
processes efficiently available? 
Are the documents are created for every type of done to planned sales
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 included how company developed and
installed identified processes based on ISO13485:2003.
QUALITY MANUAL
Does the Quality Manual include, scope of QMS and ISO14971:2007 and IMED regulations such as clause 8.4
details of exclusion? that related to 8.4 of ISO13485:2003 and it is about to
4.2.2 Are documented procedures reference to mandatory
procedures; gathering, monitoring, measurement and analysis of

Is description of interaction of the processes included in
the QMS?
data based on FTS‐PR‐009, processes identification
forms.
Exclusions justification is : “nature of products”
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 Page 2 of 20
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CONTROL OF DOCUMENTS
Are mandatory procedures documented?
Procedure FTS‐WP‐005 has been prepared for control of
Are control conditions pertaining to mandatory documents and records.
documents proper?
Are review, update and re‐approval situations and
Method of coding has been observed in FTS‐WP‐005,
changes and current review situations for documents clause 5.3
traceable?
Because company is small, all documentation are
4.2.3 Are the relevant documents usable, readable and
recognizable at concerned usage points? centered in MRs PC except current records which are in 
Are outsourced documents defined?
Are distribution of documents controlled, outdated departments, such as manufacturing daily report on Mr.
documents prevented from being used and appropriate
definition method applied in case of being stored for
Masoudi.
any purpose? Mr. Masoudi knew about where Documents are and
Are these subjects clear in the relevant procedure? how he can print and fill them.
Mr. Masoudi signature on 21/3/1394 (May 2016) has
been observed on form “distribution key”. This record is
CONTROL OF RECORDS
Are documents readable, easily recognizable and stored
kept on MR file on his room as ordered in form “master
in available manner? list of documents”
4.2.4
Has a documented procedure been established and
applied for determination of required controls for
Company shall keep record of “temporary recipe of ware 
storage, retrieval, retention time and disposition of house” two years in current records
records?
Has the archiving defined for at least 2 years? Company shall keep record of “purchased verification”
for 2 years in current and two years in morgue
D&D records shall be Eliminated after ten years.
5 Management responsibility
MANAGEMENT COMMITTMENT
Has the top management ensured that requirement for Below evidences shows management commitment:
meeting customer conditions and legal conditions
should be understood by all personnel? Management review on 28 Nov 2015
5.1 Is a quality policy available? GMP
Are quality objectives available?
Is management review established? Customer complaints records
Does the management provide required sources for Putting Mr. Ziwari as MR with related resources
QMS?
Yes, for example, a customer with name of ashrafi has a
complaint about price of products; MD called him and
told him about quality and innovation of product that
CUSTOMER FOCUS
will affect on total life cycle price.
5.2
Does top management have methodologies to ensure
that customer needs and expectations are determined
She investigated the problem and talked to customer in

and met for increasing customer satisfaction?
a “customer focused” manner.
Records has been observed for date 12/6/1394
(September 2015)
QUALITY POLICY
Has top management established a Quality Policy in 1. Development of All suppliers to produce better
accordance with the objective of the organization?
Does the Quality Policy include a statement of products
5.3 commitment to meeting requirements and continual
improvement of the QMS?
2. Continuous improvement in customer satisfaction and 
Has the Quality Policy been revised for communication, stakeholder
understanding and continuous compliance within the 3. Developing domestic and foreign markets
body of the Organization?
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Are three columns of organization’s objective which is
mentioned in “quality policy FTS‐SO‐001”
Top management committed to:
IMED rules
Continues improvement of processes
And quality policy, in mentioned document
QUALITY OBJECTIVES Objective three shall be fulfills before 2017
Are quality objectives established by top management Index is: number of customers
at relevant functions and levels within the organization?
Are the objectives measurable and consistent with the Criteria is: at least 30 domestic and 5 international
Quality Policy customers
5.4 5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING
Has the QMS been planned by Top Management in Other goals are related to above columns such as:

order to meet the conditions and quality objectives
detailed in Section 4.1?
Developing suppliers grade from 143 to 172 by:
When changes are initiated, is the integrity of the QMS 1‐ identification and
maintained during the change process?
2‐ assessment
3‐ auditing them
4‐ working with them and recheck them
Or
Increasing sales from 100000000 to 500000000 through
1‐ review marketing system
2‐ participating in fairs
5.5 Responsibility, Authority and Communication
QAF017A0 is Personnel responsibility, authority and
training standards
Organization chart FTS‐CH‐001 fulfills requirements,
such as sales manager:
 Determines annual unit and gross‐profit plans by
implementing marketing strategies; analyzing trends
and results.
 Establishes sales objectives by forecasting and
RESPONSIBILITY AND AUTHORITY developing annual sales quotas for regions and
Has top management identified responsibility and
territories; projecting expected sales volume and
5.5.1
authority and been communicated within the
organization? profit for existing and new products. 
Has top management defined responsibilities and
authorizations for CE marking?  Implements national sales programs by developing
field sales action plans.
Training standards for sale manager:
Documentation of ISO 13485:2003
IMED recall
Forecasting methods
As IMED regulations responsible for purchase
verification and dispatch qc shall be to technical
supervisor, which is mentioned in QAF017A0 of technical
supervisor.
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MANAGEMENT REPRESENTATIVE
Has top management appointed a member as MR is Mr. Ziwari by a letter signed by Mrs. Tavakolian
Management Representative with responsibility and
from Jan 2015 and give him his responsibilities and
5.5.2
authority to ensure that the processes of the QMS are
established, implemented and maintained; report to
authorities as QAF017A0. He is responsible for internal

top management on the performance of the QMS,
including needs for improvement and promote audit and gathering data for management review
awareness of customer requirements?
Organization chart FTS-CH-001 demonstrated relation

between boxes which is done thought emails, letter, and
INTERNAL COMMUNICATION
Has the top management ensured establishment of
mostly verbal communication based on activity that is
stated in related documented information, such as letter
5.5.3
appropriate communication processes within the
organization? Has the top management ensured
No.123863- ‫ ب‬from Technical supervisor (Mrs

realization of communication considering the processes
of the QMS and their effectiveness? tavakolian” about rejecting pressure gauges on order 150-
94, because of quality control reject, to purchase
department.
5.6 Management review
TOP MANAGEMENT REVIEW
Does top management review the QMS to ensure its
continuing suitability, adequacy and effectiveness at
regular and planned intervals? Participants are:
5.6.1 Do reviews include assessing opportunities for
improvement including the need for changes to the Mrs. Tavakolian, Mr. Ziwari
QMS, quality policy, and quality objectives?
Are management review records kept?
They reviews
REVIEW INPUT 1‐ quality policy
Does review input include current performance and
improvement opportunities related to: 2‐ quality objectives
a) results of audits;
b) customer feedback; 3‐ Process’s performance such as
5.6.2 c) process performance and product conformance;
d) status of corrective and preventive actions; …sale department has been reach to 70% of program

e) follow‐up action from earlier management reviews;
f) changes that could affect the QMS, 4‐ Risk analysis are prepared this year with no error from
g) recommendations for improvement
h) New or revised regulatory rules?
IMED, so they want to review risk analysis in next year
REVIEW OUTPUT
Outputs are 5 items such as:
Does output from management review include actions Holding a 5s courses
5.6.3
related to improvement of the QMS and its processes,
improvement of product related to customer Holding a team work course for all personnel 
requirements, actions and decisions relate to resource
needs?
6 Resource Management
Comparing recourses mentioned in “FTS‐PR‐009,
PROVISION OF RESOURCES
Does the organization have methods to determine and
identification of process sales” to evidences company
6.1 provide resources needed to implement and improve
the processes of the QMS and address customer
has been provided planned resources such as fax, PC, 
satisfaction by meeting requirements?
printer, and referring to 5.6.3 company will provide
necessary resources which is determined.
6.2 Human Resources
Are personnel assigned with responsibilities that affect
product quality competent on the basis of applicable
Company is not more than five persons, they all are
6.2.1 education, training, skills, and experience? 
Are trainings performed for achievement of Required innovative, regarding QAF017A0 is Personnel
Competence?
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responsibility, authority and training standards
And organization chart FTS‐CH‐001, evidences, shows
conformity of planed and real system.
Such As Mr. Ziwari as MR which he knew about his
responsibilities and duties.
He has 3 years experience as MR in another organization
and has internal audit and BS in industrial engineering
COMPETENCE, AWARENESS, AND TRAINING and MBA. As requirement mentioned in QAF017A0
Has the organization identified the experience,
qualifications, competencies and skills of the personnel Company uses Training procedure FTS‐WP‐003.
performing activities affecting safety and efficiency of
medical devices particularly being manufactured and Responsibility of training procedure is by Mr. Ziwari.
provided to customer?
I checked training for MR and Sales Manager.
6.2.2
Is training provided by the organization to satisfy the
competency needs? 
Does the organization ensure that its employees are Courses on September 2016 about CRM system, sales
aware of the relevance and importance of their
activities and how they contribute to the achievement
manager is MD and as her belief course was effective
of quality objectives? because they developed a CRM and this CRM increased
Are records of education, experience, training and
qualifications maintained? sales 10 % more than trend.
Mr. Ziwari has been on a course, Risk Based thinking, to
develop ISO9001:2015, as effectiveness measurement
form FORM‐031courses effectiveness is 100%.
MD believes training is investment not cost.
I checked Mr. Borhanian training log and training agenda
for year 1394. He has passes training course 1/10/1394
(September 2015) for internal audit.
INFRASTRUCTURE
Has manufacturing equipment been designed, IMED has an audit on the GMP and they passed
constructed, properly established and placed for proper
operation, maintenance, adjustment and cleaning? companies GMP without any comments.
In case of applicability, has the organization ensured
documentation of natural limits or permissible
Company has good manufacturing practice to produce
tolerances in manufacturing process and measuring and class A and B medical device as evidences.
test equipment and availability of the same for
Company uses PM procedure “EPW003A” to prevent
6.3
operators?
Are documented processes available for maintenance, 
cleaning and control of all equipment used in cost of emergency break downs, there were no record
manufacturing process and control of work for EM from establishment of company and all records
environment?
Are required adjustments and maintenance intervals are for PM.
identified?
Is maintenance plan placed normally on or near the There was EPW006A to ensure company and products
equipment and easily reachable? are clean. Such as yesterday’s log on cleaning after work
Is maintenance realized based on the relevant plan?
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WORK ENVIRONMENT
Does the organization identify and manage required
and today’s log on cleaning before work.
work environment needed to achieve conformity of Record of logging humidity and temperature for last
product?
Are the following factors which could affect product week has been observed, temperature was 21 on
quality in the work environment identified?
‐ Process equipment,
Monday and humidity was 35%.
‐ 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
processes including the organizations holding a valid
6.4 cleaning process?
(Temperature, Humidity, Air Current, Filtration of Air,

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 Main procedure related to manufacturing and QC Is
quality management system in planning of product
realization?
“Identification and traceability, manufacturing and QC:
Has the organization prepared required records for a FTS‐WI‐001” Company uses operation flowchart and
proof indicating that quality objectives and product
rules, processes established, documents and product‐ control plan FTS‐FO‐027 to ensure common
specific necessary resources, verification, validation, understanding of procedures, I checked Identification
tracking, measuring, inspection and product‐specific
test activities , realization processes and the product and traceability, manufacturing and QC: FTS‐WI‐001
meet the rules?
In the event that inspection and test are conducted by
For regulator “R1500”, flow meter “EXTRA” which I send
manufacturing personnel, do inspection and test a picture from it in this report, isolate panel for
results, processes, organization’s procedures ensure
impartiality of inspection and test results?
operation room “sepanta”. FTS –
7.1 Risk management Company outsourced plastic injection and lathing to FO –
Has the organization prepared a procedure containing 012
all processes of product realization for risk management three suppliers and assembles products in the assembly
activities and realized the following? hall.
Keeping the records
Preparation of Risk Management Plan Company starts to manufacture based on “safe stock
Determination of Risk team and its Responsibilities
Determination of Intended Use of Device and Safety
inventory” and “customers inquiry” so if after inquiries
Characteristics of Device inventory of stock become less than SSI, company starts
Definition of hazards
Risk Estimation for Hazards
to manufacturing the required items.
Evaluation of Risks Determination of need related to products are came
Risk Control Measures
Definition of Residual Risks from:
Risk/Benefit Analysis D&D
Preparation of Risk Management Report
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And
Sales department.
Most important thing is in Iran, companies that are
newly started to work shall apply iso13485:2003 and
after that IMED give them certificate for sale.
DETERMINATION OF REQUIREMENTS RELATED TO THE
There is no order recorded.
PRODUCT/SERVICE I observed three approved technical file from IMED on
Has the organization defined the requirements of
customer including the requirements for the activities letters:
on delivery and after delivery? 7530/‫ب‬/1394
Do these requirements include the following?:
‐ regulatory and legal requirements related to the 7531/‫ب‬/1394
countries and territories where the product is supplied
to the market
7532/‫ب‬/1394
‐ anticipated utilization, Flow meter risk analysis has been checked
FTS – FO – 012
‐ Performance expectations,
‐ Design factors
Totally 15 operation and 30 risk identified, such as:
7.2.1 ‐ Delivery plans 1‐ No exhaust due to a dirty air filter moisturizer risk is AR
‐Unclear customer expectations
Does the organization record customer’s expectations low
related to product/service in order to revise the same? 2‐ Improper storage of flow meter getting wet due to
In the event of any change in order or offer or both for
any reason whatsoever, are changes revised and an rain risk is low
agreement is reached on the changes as it is in original
order or offer?
For regulator:
In the event that changes are accepted, are all 1‐ improper assembly, assembly of failed gauge risk is
personnel being affected by the changes within the
organization informed?
high, control= QC, validation is sending a random flow
Are relevant documents affected by these changes meter to “behine sanjesh sadra”
amended?
2‐ bad performance because of corruption of o‐ring, risk
is high, control is changing o‐rings every six month in
installed place.
For isolation board:
Not documented mention to risk of leakage current and
adaption failure due usage.
7.2 Customer‐Related Processes
Companies that are newly started to work shall apply
iso13485:2003 and after that IMED give them certificate
REVIEW OF REQUIREMENTS RELATED TO THE
PRODUCT/SERVICE for sale.
Does the organization review the requirements related
to the product?
There is no real order recorded.
Are review records kept? Order No.001 has been observed “mock record” from
Has this review been realized prior to commitment of
the organization for provision of the product to
Ghaem Hospital of Isfahan 3 items from all products.
7.2.2 customer?
Has the organization ensured settlement of contract or
Order signed by Mrs. Tavakolian and dispatched after 
order requirements which are different from previously recheck of QC from stock.
defined? In Isfahan Amin hospital case, order on 21/6/1394,
Does the organization have the ability to meet defined
requirements? delivery date is 28/6/1394 for 50 felow meter EXTRA
Are the results of review and subsequent follow‐up
actions recorded?
Record of reviewing of manufacturing department,
financial department and MD has been observed on the
form.
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Customer communication is done through telephone
lines, email, appointments and fax.
Communication of company with Ghaem hospital of
Isfahan has been observed, in the letter 910023/‫ب‬ to
CUSTOMER COMMUNICATION FTS, Hospital approved use of
Are arrangements for communication identified and
implemented relating to product information, demands,
Regulators
7.2.3
applications, contracts or realization of order including
amendments?
Flow meters

Are required arrangements identified and implemented
for customer feedback and communication with
customers including customer complaints? Isolation Panels
Of FTS, Hospital has been sent same letter to IMED
which has been recorded in Technical file of
organization.

7.3 Design and Development
DESIGN AND DEVELOPMENT PLANNING
Have the stages of design and/or development been
identified?
Procedure for design and development FTS-FO-016 is
Have review, verification and validation activities done.
appropriate to each design and/or development stage, Company uses reverse engineering method to fulfill
7.3.1 responsibilities and authorities been identified in design
and development planning? market needs.
Are design and development planning updated when I observed isolation board for operation room record base
planning output is appropriate and in the progress of
design and development?
DESIGN AND DEVELOPMENT INPUTS
on 5 pages project D&D: FTS -FO -016 which is 
recorded on March 2015
Are inputs related to product requirements identified
and relevant records maintained? D&D team are Mrs. Tavakolian and Mr Ziwari and Mr.
Do these inputs include functional and performance Borhanian.
7.3.2 requirements, applicable regulatory and legal
requirements, applicable information derived from Inputs are recorded such as:
previous and similar designs a any other requirements Item brand is Lim Squar D made in USA,
essential for design?
Have the inputs been reviewed in terms of adequacy? BS standard
DESIGN AND DEVELOPMENT OUTPUTS Review and verification are recorded by controlling the
Are design and/or development outputs approved
before prior to release and in a manner that enables product with design on paper to see everything is in
verification against the design and/or development place, D&D: FTS -FO -016
inputs?
Do the design and/or development outputs meet the Alarm system for more than 4.9 MA for Leakage current,
7.3.3 design input requirements and
‐provide appropriate information for purchasing,
has been checked it’s based on BS standards
manufacture and service performance, Validation is done by “behine sanjesh sadra” and
‐ contain or reference product acceptance criteria
‐ define the characteristics of the product that are
“Ghaem Hospital clinical test” both of them approved
essential to its safe and proper use? the product. 
DESIGN AND DEVELOPMENT REVIEW
Does the organization identify suitable stages for There were two labeling errors which are reported by
systematic reviews of design and/or development? “behine sanjesh sadra” and company corrected errors
7.3.4 Are the results of review and subsequent follow‐up
within a week and “behine sanjesh sadra” finally
actions recorded in order to evaluate the ability to
fulfill requirements and identify problems and approved the product on June 2015 report No.ylg47254
propose corrective actions?
DESIGN AND DEVELOPMENT VERIFICATION
7.3.5 Does the organization in planned arrangements ensure
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?
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
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? I Observed vendor list of TFS such as:
Are criteria for selection of suppliers defined?
Are evaluation and reevaluation of suppliers have been Sepahan Hydraulic with Score 200 grade A
defined?
Has the organization defined tracking frequency of Mr. Akbari with score 150 Grade A
supplier’s performance?
Does the organization have the proofs indicating that I checked Purchased order No. 008‐1394 from Mr Akabri
supplier monitoring activities, outsourced processes are
controlled and the products or services conform to the as below:
7.4.1
rules of the organization containing customer demands
and regulatory rules? O‐ring cap 52 by 2.6 quantity 1000 which Mrs. 
Have the requirements of purchasing information Tavakolian approved
(containing the rules related to supplier records)
including outsourced processes been identified to
ensure product and service quality?
And order No. 003‐1394 (date 12/06/1394) on
Does the organization have the methodology to September 2015 Nut size 4, quantity 1000 from
communicate these requirements to the supplier?
Are purchasing contracts available?
“Sepahan Hydraulic” which is purchased in three
Do the type and content of the control on supplier and days(date 15/06/1394), verified by Mr. Ziwari Records
purchased product depend on the next product
realization of purchased product or final product? shows Mr Ziawari checked it one day after purchase
Are purchasing records retained? (date 16/06/1394) and Mr Bohemian’s warehouse
PURCHASING INFORMATION
Does purchasing information define the product to be receipt is for (date 16/06/1394)
purchased?
Where appropriate, does purchasing information Items Mr. Ziwari checked are based on CP FTS‐FO‐009
include product approval, procedures, requirements for
which is recorded on back of “form Bohemian’s
7.4.2
process and equipment, Personnel qualification and the
requirements of Quality Management System? warehouse receipt” 
How does organization ensure the adequacy of
specified requirements in the purchasing information Mr Borhanian notes purchased order “No. 003‐1394” on
prior to their release to the supplier?
Are records for the information related to purchased “warehouse receipt”
product available?
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Records of verification of “Screw Valve Regulator” code
1011‐01‐001, lot 1000, sample 10
VERIFICATION OF PURCHASED PRODUCT Thread shall be 10 ± 1 mm, sizes aer 10, 9.97, 10.05 and
Has the organization identified a method in order to
ensure that the product received conforms to the
10.01
specifications, is finished, holds appropriate identity
and is free from any damage?
The diameter of the bottom hole of valve shall be 5±0.05
Do the processes include the provisions in order to mm, sample 10
verify that incoming product is provided along with
Recorded size are 4.98, 5.03, 5.02, 5,01,
7.4.3
support documentation (e.g. conformity certificates,
acceptance test reports)? Regulators cap item 1011‐01‐004on 11/7/1394 Oct 2015 
Has data been provided related to analysis of previous
acceptance inspection data, rejection history in the The inner diameter of the lower thread
plant or customer complaints, required inspection size shall be 22± 0.1 measured results are: 21.98,22.03,
quantity and necessity of reevaluation of supplier?
Has the organization identified the authorized person 22.01,
for conformity approval of incoming material?
Are verification records retained?
Total height shall be 28.5 ± 0.1
Measured results are:
28.6, 28.59, 28.5
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 Main procedure related to manufacturing and QC Is
proportionate to criticality level of its process?
Has the characteristic qualities of product been “Identification and traceability, manufacturing and QC:
identified? When required, have documented FTS‐WI‐001” Company uses operation flowchart and
procedures, documented rules, work instructions and
reference materials reference materials and reference control plan FTS‐FO‐027 to ensure common
measuring processes been made available?
Has appropriate equipment been selected in the
understanding of procedures, I checked Identification
manner that enables process and product specifications and traceability, manufacturing and QC: FTS‐WI‐001
to be obtained?
Have the documents for using appropriate equipment For regulator “R1500”, flow meter “EXTRA” which I send
been established? a picture from it in this report, isolate panel for
Has it been verified that new and/or significantly
modified equipment meets purchasing/design operation room “sepanta”.
specifications and posses the ability to operate within Company outsourced plastic injection and lathing to
7.5.1 the limits defined and process operating limits?
Have control devices been identified? three suppliers and assembles products in the assembly

Has a document been prepared for using control
devices?
hall.
Have implementation and control requirements for Determination of need related to products are came
labeling and packaging been identified?
Are the records obtained during manufacturing process from:
of any product lot and facilitating traceability and D&D
review of the manufacture of this lot retained?
Do the records include the following information? And
‐ When applicable, quantity of raw materials, Sales department.
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
REFERENCE, AS
This Clause
APPLICABLE1
Has been
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mark √

Control of product cleanliness and contamination
Has the organization identified product cleanliness
rules?
Have the materials and substances used during Regarding 7.5.1 of this report and weekly manufacturing
manufacturing process been adequately defined and
labeled in order to prevent complexity and process
plan on 4/7/1394 (Oct 2015) company controls
7.5.1.2.1 faults?
Have certain medical devices been cleaned and/or
necessary items which shall be monitored or measured 
cleared of contamination so as to prevent employees such as
and other product from being exposed to any Cleanliness of the parts and the tubes
contamination
Have cleaning and implementation requirements been
documented?
Company uses Install procedure OHA -WI -001-A0 for
assembly and service.
Assembly flow and drawing for regulator FTS‐1019‐02‐
Assembly activities
Have assembly activities and responsibility for medical 001 has been observed
device been identified? Assembly flow and drawing for flow meter FTS‐1010‐02‐
In the event that any medical device should be
assembled and mounted in the location where the user 001 has been observed
is present, have guiding instructions been prepared by Assembly flow and drawing for isolation plans for
7.5.1.2.2 the organization for accurate assembly, montage, tests
and/or calibrations? operation room FTS‐1018‐02‐001 has been observed 
Has the organization provided the instructions which
allow assembler to confirm proper operation of the
Such as:
device? Changing o‐rings of flow meter every six month
Are the results of assembly or commissioning tests
recorded? Or installing isolation board, company shall have yellow
permit from place of install and shall check the alarms,
or in servicing servicemen shall put out of circle and
after that diagnose the problem
Service activities
In the event that functionality of products needs service
or maintenance for proper utilization of products, have Company uses Install procedure OHA -WI -001-A0 for
documented requirements been established for service
activity?
assembly and service.
Has the organization identified service responsibilities Assembly flow and drawing for regulator FTS‐1019‐02‐
between distributors and users?
Have service activities carried out by the organization or 001 has been observed
a separate agency been planned? Assembly flow and drawing for flow meter FTS‐1010‐02‐
Have the design and functionality of equipment or
devices with special purpose related to manual 001 has been observed
operation and service after assembly been validated? Assembly flow and drawing for isolation plans for
7.5.1.2.3 Are measuring and test equipment used for site service
and tests controlled? operation room FTS‐1018‐02‐001 has been observed 
Have instructions related to the lists of spare parts or
parts and for use in product service been prepared?
Such as:
Has the infrastructure covering technical consultancy Changing o‐rings of flow meter every six month
and technical support, customer training and spare
parts or provision of parts been established? Or installing isolation board, company shall have yellow
Are service personnel trained? permit from place of install and shall check the alarms,
Are specialized service personnel available?
Has the organization formed a system for receiving or in servicing servicemen shall put out of circle and
customer demands so as to determine whether after that diagnose the problem
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
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

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
NA --- ‐‐‐
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
process been identified and implemented?
NA --- ‐‐‐
Have the requirements in the Article no. 7.5.2.1 been
met?
7.5.3 Identification and Traceability
Identification
Has the organization identified and documented the
product through appropriate methods during product
Company uses yellow pallet for waiting for inspection
7.5.3.1 realization?
How has the organization identified product situations
Red pallet for non conforming products 
in accordance with tracing and measuring And blue pallet for approved products
requirements?
Company uses specific operators for specified activities,
TRACEABILITY and as Mrs. Tavakoulian says if, for example, Mr ziwary
75.3.2.1 General
How is the product traced?
was not at organization no one can qc the products.
7.5.3.2 Has any method been documented for traceability?
Does the organization ensure traceability of the medical
Company uses one supplier in one manufacturing order, 
device during typically production and storage process company is not store raw material and raw material will
up to expiration of ownership? be bought just for specified production order. So
everything will be traceable.
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
raw materials, changes in the works performed through
NA --- ‐‐‐
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?
Company uses batch no, to identify status.
Company uses yellow pallet for waiting for inspection
Status Identification Red pallet for non conforming products
7.5.3.3 Organization has identified status of product with
respect to measurement and monitoring requirements And blue pallet for approved products

Such as batch 3.313 for pressure gauge 250 bar on order
of Ghaem Hospital is tracable
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
7.5.4
while it is under the organization’s control or being
used? NA --- ‐‐‐
Does the process ensure that occurrence of any
customer property that is lost, damaged or otherwise
found to be unsuitable for use are recorded and
reported to the customer?
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

PRESERVATION OF PRODUCT
Are methods and controls established to preserve
conformity of product during internal processing and Pressure gauge 250 bar order point is 200, current
until delivery to intended destination? inventory is 200\
Has the organization established documented processes
or documented work instructions for control of the Inventory for washer for flow meter’s regulator is 200
product with limited shelf life or which requires special I checked “Stock transfer” form for date 12/7/94
7.5.5 storage?
Are such special storage requirements controlled and (16/6/1394 Sep. 2015) for Amin hospital inquiry to 
recorded? manufacturing department has been observed.
Does this preservation include definition, transport,
packaging, storage and protection of the product and On 21/6/1394 (September 2016) record of dispatch from
the parts constituting the product?
Is there a logo on product? Is it proper to its
store has been observed dispatch record no 002
instructions?
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? Calibration certificate for reference oxygen gauge
a) Be calibrated or verified at specified intervals, or 2800-94-11-03911 P
prior to use, against measurement standards traceable
to international or national measurement standards; Calibration certificate for reference pressure gauge:
7.6 where no such standards exist, the basis used for
calibration or verification s hall be recorded;
94/1161/00361 
b) Be adjusted or re‐adjusted as necessary; This gauge has +0.8% error in 0-50 bar, and I observed
c) Be identified to enable the calibration status to be that operator knew about error and it was highlighted
determined;
d) Be safeguarded from adjustments that would with a green marker on gauge to identify status
invalidate the measurement result;
e) Be protected from damage and deterioration during
handling, maintenance and storage.
8 Measurement, Analysis and Improvement
Customer feedback: from Amin hospital and Ghaem
hospital has been observed, average is 92.5% as
analisys written in recorded form, company shall have
more customers to gain better results.
PPM shall be less than 150 and now it is 160, there is a
corrective action about PPM, corrective action is
General removing Asadi o-ring provider from vendor list
Does the organization plan to implement the which is done
monitoring, measurement, analysis, and improvement
Average of suppliers grade is an index for logistic
8.1
processes required for conformity of the product and
QMS and improvement of its efficiency? process, criteria is over 150, and result is 180, criteria 
Are measurement, analysis and improvement
processes are carried out through statistical change from 150 to 180 for next period.
techniques and applicable methods? Manufacturing plan’s process’s index is fulfillment of
plan, criteria is 90% and result is 85% corrective
action is changing assembly table and adding lights,
which is done, effectiveness shall be measured on end
of march 2016

8.2 Monitoring and Measuring
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

8.2.1 CUSTOMER SATISFACTION
Does the organization monitor the information related hospital has been observed, average is 92.5% as
to customer perception in order to understand whether
analysis written in recorded form, company shall have
8.2.1 customer requirements are met or not?
Has the organization determined methodologies for more customers to gain better results. 
obtaining and using information on customer
satisfaction and/or dissatisfaction?
There is no customer complaints
Internal audit has been planned for 1‐8‐1394 to 5‐8‐
INTERNAL AUDIT
1394 (October 2015) for all processes such as financial,
Has a documented procedure been established that administration, logistics and QA
includes responsibilities and requirements,
requirements for planning and conducting the audit, We checked QA checklist, auditor was mr borhanian was
reporting the results, maintaining the records? impartial and competent
Are audits planned in the form of an audit program?
Checklist contains related clauses questioned such as
8.2.2
Does audit programme take importance and status of
the fields and processes to be audited including the
clauses 4.2, 4.3, 8‐3 and 7.3

results of previous audits?
Do selection of auditors and implementation of audit Checking risk analysis has been recorded
ensure objectivity and impartiality of the process?
Do auditors audit their works?
NC is following through fromFTS‐f0‐122 such as filled
Do follow‐up actions cover verification of the measures form for nc: “master list of documents was not
taken and reporting of verification results?
completed”

PPM shall be less than 150 and now it is 160, there is
a corrective action about PPM, corrective action is
MONITORING AND MEASUREMENT OF PROCESSES removing Asadi o‐ring provider from vendor list which
Does the organization implement appropriate methods
is done
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? process, criteria is over 150, and result is 180, criteria
change from 150 to 180 for next period.
Manufacturing plan’s process’s index is fulfillment of
plan, criteria is 90% and result is 85% corrective action
is changing assembly table and adding lights, which is
done, effectiveness shall be measured on end of
march 2016
8.2.4 MONITORING AND MEASUREMENT OF PRODUCT
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

Flow meter test report from ISIRI 6230, in report

thab93‐25 @ 8‐6‐1394 (September 2015)
Report for ISIRI 6320 @ 30‐3‐1394 REPORT No. Tlab 94‐
19
This is place for final product testing of regulators and
flow meters. Record of final products test of flow meters
for Amin Hospital has been observed, QC Mr. Ziwari on
20/06/1394 (september 2015). It is tested in 5 points 0,
10, 20 , 35, 50 max using pressure is 35. Error was less
General rules than 10% which is acceptable.
Does the organization establish appropriate stages to Record of final product isolation board has been
measure and monitor product characteristics?
Have verification methods been documented? observed on 20/4/1394, board has been tested for 24
Is this verification process realized in accordance with hours, no current leakage. QC was Mr Ziwari.
the arrangements planned during appropriate stages of
8.2.4.1 product realization process?
Are conformity evidences along with acceptance criteria

maintained?

Are the records approved by the authorized
person/persons in the process of product release?
Are product release and distribution of service, planned
regulations (Article 7.1) completed satisfactorily?

Special rules related to active implantable medical
8.2.4.2
devices and implantable medical devices
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? There is a corrective action about PPM, corrective action
Does the organization take measures to remove non‐
conformity related to product?
is removing Asadi o‐ring provider from vendor list which
When applicable, do the processes identify the methods is done
8.3
authorizing the non‐conformity’s use, release or
acceptance in agreement with customer? In other case 
Are required measures taken to preclude the product’s In red pallet there was 8 moisturizer that the cap was
original intended use or application?
Are records related to the nature of nonconformities not ok, company shall gather all NC of this caps till three
and the measures taken later maintained? days later and send them back to supplier.
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
APPLICABLE1
Has been
please Tick
mark √

DATA ANALYSIS
Does the organization collect, identify and analyze PPM shall be less than 150 and now it is 160, there is
appropriate data to demonstrate efficiency and
appropriateness of QMS and the fields where QMS’s a corrective action about PPM, corrective action is
efficiency can be continuously improved? removing Asadi o‐ring provider from vendor list which
Has a documented procedure been prepared for these
is done
8.4
analyses?


Do the characteristics and tendencies of the processes
and products including data analysis, customer
satisfaction, conformance to product requirements, process, criteria is over 150, and result is 180, criteria
opportunities for corrective actions provide information
related to suppliers?
change from 150 to 180 for next period.
Have data types for data analysis been defined? Manufacturing plan’s process’s index is fulfillment of
Are data analyses recorded?
plan, criteria is 90% and result is 85% corrective action is
changing assembly table and adding lights, which is
done, effectiveness shall be measured on end of march
2016
8.5 Improvement
CONTINUAL IMPROVEMENT
Has the organization identified required changes by
using quality policy, quality objectives, audit results,
analyses of data, corrective and preventive actions and
management review in order to ensure and sustain
ongoing conformity and efficiency of quality
management system and does the organization
implement such changes?
Has the organization established written procedures in
order that advisory warnings can be published and
implemented?
Are the records of all examinations related to customer
complaint maintained? There are some evidences that show company has
Have the complaints been evaluated within the scope of improvements such as:
the following points?:
‐ whether the organization fails to comply with its own No comments in IMED GMP audit
specifications or not, CRM installed
8.5.1 ‐ whether the organization has caused problems to
occur despite the fact that it has complied with its own Internal communication

specifications
In the event that the activities outside the organization
Suppliers management
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
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

corrective action No 94‐08 about process index “PPM”,
root cause is delay because of reject and re‐order O‐
8.5.2. CORRECTIVE ACTION rings
Is there a documented procedure for Corrective and
Preventive Action?
corrective action is removing Asadi o‐ring provider from
Are corrective actions taken to eliminate causes of vendor list which is done
nonconformities effective in preventing recurrences?
Does this procedure include the requirements of

8.5.2 reviewing non‐conformities (including customer
complaints), determining the causes of non‐conformity,
corrective action No 94‐08 against production index plan 
evaluating the actions needed to ensure that fulfillment,
nonconformities do not recur, determining and Root cause: for the first time this quantity of production
implementing the corrective action needed, and review
of the results of the action initiated? happened.
Is adequacy of corrective‐preventive actions identified?
corrective action is changing assembly table and adding
lights, which is done, effectiveness shall be measured on
end of march 2016
PREVENTIVE ACTION
Has the organization established a documented
procedure for preventive action with defined
requirements for identifying potential non‐conformities
Since the implementation of QMSMDD in organization,
8.5.3
and their causes; evaluating the need for action to
prevent occurrence; determining and implementing they have not issued any preventive action yet 
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
Dynamic environment, sharp to changes Staff familiarity with qms

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: N/A
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:
FTS-01-2016: Not documented identified risk leakage current and adaption failure due usage for isolation board.
Observation Form-018 – with uniquely specific identification: N/A
ATL: Milad Pourhasan DATE: 11‐Jan‐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

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Organization chart FTS-CH-001 demonstrated relation

Flow meter test report from ISIRI 6230, in report

Observation Form-018 – with uniquely specific identification: N/A

ATL: Milad Pourhasan DATE: 11‐Jan‐2016

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

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