BRSM Form 009 Qms MDD Rta

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

CLIENT‐ORGANIZATION (NAME):
RONAK TAJHIZ ARA CO. LTD
PHYSICAL LOCATION(s): Unit No.8, building No.46, Etemadian St.,

sadeghieh(2) Sq. , Tehran , Iran
Stage II Audit Date(s):
2 July 2016
Stage I Audit Date(s):
23 May 2016
NAICS (or NACE) CODE
MD1402

EXCLUSIONS: 7‐3/7.5.1.3/7.5.2.2/
7.5.3.2.2/8.2.4.2/7.5.2.1

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 Khoshgoo
TE Azimizan

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).
Manufacture, sales and after sales services of medical Intense Pulsed
2 Scope of activities
Light system (IPL)
MOH requirements about CLASS B products
Legal status IEC 60601‐1
IEC 60601‐2‐57
3
Obligatory applicable standard which IEC 62304
organization has to follow EMC 

4 Quality Management System
GENERAL REQUIREMENTS
Does the organization establish, document, implement,
maintain and continually improve a Quality
Management System (QMS) with due consideration
given to identification of processes needed for the Interaction between processes is specified in F11 and
QMS and their application throughout the system; sequence of processes in F12 determined. Criteria of
determination of sequence and interaction of these
4.1 processes, determination of criteria and methods
required to ensure effective operation and control of
monitoring and measuring of processes is determined 
these processes; availability of resources and
and be done.
information required to support the operation and Processes are: purchasing‐sale‐quality control‐
monitoring of processes; measurement, monitoring and
analysis of the processes; implementation of action to warehousing‐maintenance and repairing of
achieve planned results and continual improvement infrastructures‐training and management processes
‐If any, are the outsourced processes are defined?
DOCUMENTATION REQUIREMENTS are: analysis of data and continus improvement
Is there a documented quality policy and documented The Quality Manual (QM‐00) was observed. All
quality objectives and are they appropriate?
Is there a documented quality manual and are there required standards clauses have been mentioned. The
documented procedures required by the standards??
excluded clauses are explained in the quality manual.
4.2
Are required records for planning, acting and controlling
processes efficiently available? They have developed quality policy (QP‐00) 
Are the documents are created for every type of
medical device including qms requirements and product
Technical file for productions is not documented
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.
ISO14971:2007 and IMED regulations such as clause 8.4
QUALITY MANUAL
Does the Quality Manual include, scope of QMS and that related to 8.4 of ISO13485:2003 and it is about to
details of exclusion? gathering, monitoring, measurement and analysis of
4.2.2 Are documented procedures reference to mandatory
procedures; data based on F11, processes identification forms.

Is description of interaction of the processes included in
the QMS?
Some clauses are excluded including : 7‐
3/7.5.1.3/7.5.2.2/
7.5.3.2.2/8.2.4.2/7.5.2.1
Exclusions justification is : “nature of products”
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 Page 2 of 20
REFERENCE, AS
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APPLICABLE1
Has been
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CONTROL OF DOCUMENTS
Are mandatory procedures documented?
Procedure P01 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 the procedure.
changes and current review situations for documents Because company is small, all documentation are
traceable?
centered in F02 REFERENCE FILE.
4.2.3 Are the relevant documents usable, readable and
recognizable at concerned usage points? Mr. SAMIMI knew about where Documents are and 
Are outsourced documents defined?
Are distribution of documents controlled, outdated how he can print and fill them.
documents prevented from being used and appropriate
definition method applied in case of being stored for
Mr. samimi signature on 14/11/1394 (May 2016) has
any purpose? been observed on form “distribution key”. This record
Are these subjects clear in the relevant procedure? is kept on MR file on his room as ordered in form
CONTROL OF RECORDS “reference file”
Are documents readable, easily recognizable and stored Company shall keep record of “customer satisfaction”
in available manner?
two years in current records
4.2.4
Has a documented procedure been established and
applied for determination of required controls for Company shall keep record of “purchased verification” 
storage, retrieval, retention time and disposition of
records? for 5 years in current and two years in morgue
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 Management review on 11 Jan 2016
should be understood by all personnel? GMP
5.1 Is a quality policy available?
Are quality objectives available? Sources that could be required for QMS.
Is management review established?
Does the management provide required sources for
Ms.Shekari as MR was interviewed.
QMS?
Because of organization doesn’t have permission for
CUSTOMER FOCUS
sales , there is no customers but the methods of
5.2
Does top management have methodologies to ensure
that customer needs and expectations are determined
monitoring for customer satisfaction and customer

and met for increasing customer satisfaction?
compliance was observed.
QUALITY POLICY
Has top management established a Quality Policy in top management established a Quality Policy(QP:00)
accordance with the objective of the organization?
Does the Quality Policy include a statement of
Quality & quantity improvement
5.3 commitment to meeting requirements and continual
improvement of the QMS?
Customer satisfaction improvement 
Has the Quality Policy been revised for communication, Human resource development
understanding and continuous compliance within the The quality policy signed by Mr.Amin Samimi
body of the Organization?
REFERENCE, AS
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APPLICABLE1
Has been
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Top management committed to:
IMED regulations
Continues improvement of processes
And quality policy, in mentioned document
QUALITY OBJECTIVES
Are quality objectives established by top management

at relevant functions and levels within the organization? Objective three shall be fulfills before end of 2016
Are the objectives measurable and consistent with the
Quality Policy Decreasing the average of repair time
5.4 5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING
Has the QMS been planned by Top Management in
Less than 24 hours (Tehran) 
order to meet the conditions and quality objectives Less than 72 hours (out of Tehran)
detailed in Section 4.1?
When changes are initiated, is the integrity of the QMS
maintained during the change process? Increasing the sales average
Over 100,000,000 IRR
Increasing the quantity of visits
Over 90 Visits per month
5.5 Responsibility, Authority and Communication

F26 is Personnel responsibility, authority and training
standards
Organization chart CH‐01 fulfills requirements, for
example after sales manager:
Documentation of request
Check the damage devices and complete the related
forms for required records based on procedure
RESPONSIBILITY AND AUTHORITY Monitoring the process and send related reports for
Has top management identified responsibility and
managing representative
5.5.1
authority and been communicated within the
organization? 
Has top management defined responsibilities and
authorizations for CE marking? Training standards for after sales manager:
Documentation of ISO 13485:2003
IMED recall
ELECTRONIC knowledge
As IMED regulations responsible for purchase
verification and dispatch QC shall be to technical
supervisor, which is mentioned in F26 of technical
supervisor.
MANAGEMENT REPRESENTATIVE
Has top management appointed a member as MR is Mrs.Shekari who officially appointed by Manager
Management Representative with responsibility and
from Jan 2016 .MD Defined her responsibilities and
5.5.2
authority to ensure that the processes of the QMS are
established, implemented and maintained; report to
authorities in F26. she is responsible for internal audit

top management on the performance of the QMS,
including needs for improvement and promote and gathering data for management review
awareness of customer requirements?
REFERENCE, AS
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Has been
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Organization chart CH‐01 demonstrated relation
INTERNAL COMMUNICATION between Units and positions
Has the top management ensured establishment of
Communication is done thought emails, letter, verbal
5.5.3
appropriate communication processes within the
organization? Has the top management ensured communication based on activity that is stated in 
realization of communication considering the processes
of the QMS and their effectiveness? related documented information,

5.6 Management review
TOP MANAGEMENT REVIEW
Does top management review the QMS to ensure its
continuing suitability, adequacy and effectiveness at Management Review has plan annually .the last
regular and planned intervals?
5.6.1 Do reviews include assessing opportunities for Management review was held on Jan 2016.
improvement including the need for changes to the Participants are:
QMS, quality policy, and quality objectives?
Are management review records kept? Mrs.Shekari, Mr. Samimi
REVIEW INPUT All inputs were review such as
Does review input include current performance and
improvement opportunities related to: 1‐ quality policy
a) results of audits;
b) customer feedback;
2‐ quality objectives
5.6.2 c) process performance and product conformance;
d) status of corrective and preventive actions;
3‐ Process’s performance such as 
e) follow‐up action from earlier management reviews; …sale department has been reach to 100% of program
f) changes that could affect the QMS, 4‐ Risk analysis are prepared this year with no error
g) recommendations for improvement
h) New or revised regulatory rules? from IMED, so they want to review risk analysis in next
REVIEW OUTPUT
year
Does output from management review include actions Outputs are 2 items such as:
5.6.3
related to improvement of the QMS and its processes,
improvement of product related to customer
Holding a 5s courses 
requirements, actions and decisions relate to resource Purchasing a special software for storage system
needs?
6 Resource Management
PROVISION OF RESOURCES
Does the organization have methods to determine and
The company has been provided planned resources
6.1 provide resources needed to implement and improve
the processes of the QMS and address customer
such as fax, PC, printer, and referring to 5.6.3 company 
satisfaction by meeting requirements? 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
There are 4 persons in organization, they all are
6.2.1 education, training, skills, and experience?
Are trainings performed for achievement of Required
innovative, regarding F26 is Personnel responsibility, 
Competence? authority and training standards
REFERENCE, AS
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Has been
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And organization chart CH‐01, evidences, shows
conformity of planed and real system.
Such As Mrs. shekari as MR which he knew about his
responsibilities and duties.
COMPETENCE, AWARENESS, AND TRAINING
Has the organization identified the experience, she has 2 years experience as MR in another
qualifications, competencies and skills of the personnel organization and has internal audit. As requirement
performing activities affecting safety and efficiency of
medical devices particularly being manufactured and mentioned in F26.
provided to customer?
Company uses Training, awareness and competence
6.2.2
Is training provided by the organization to satisfy the
competency needs? procedure : P03 
Does the organization ensure that its employees are
aware of the relevance and importance of their Responsibility of training procedure is by Ms. shekari.
activities and how they contribute to the achievement training for MR and after Sales Manager was checked.
of quality objectives?
Are records of education, experience, training and 24/3/94 , ISO 13485 internal course from 22 to 24
qualifications maintained? khordad , QS academy
courses effectiveness is 100% , documented in F27 form
. 01/06/94

INFRASTRUCTURE
Has manufacturing equipment been designed, All the related department which have to cover GMP
constructed, properly established and placed for proper requirements were Visited including such as production
operation, maintenance, adjustment and cleaning?
In case of applicability, has the organization ensured and storage the GMP situation is appropriated and
documentation of natural limits or permissible
tolerances in manufacturing process and measuring and
there were no any finding non conformity based on
test equipment and availability of the same for GMP requirement.
6.3
operators?
Are documented processes available for maintenance, Based on nature of production devices the PM is not 
cleaning and control of all equipment used in applicable. (Refer to .6) devices are under control.
manufacturing process and control of work
environment? Organization identified and managed required work
Are required adjustments and maintenance intervals environment needed to achieve conformity of
identified?
Is maintenance plan placed normally on or near the products.
equipment and easily reachable?
Is maintenance realized based on the relevant plan?
Quantified limit values of the work environment
REFERENCE, AS
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Has been
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WORK ENVIRONMENT
Does the organization identify and manage required
identified for a desired quality of the work
work environment needed to achieve conformity of environment.
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
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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Has been
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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
rules, processes established, documents and product‐
specific necessary resources, verification, validation,
tracking, measuring, inspection and product‐specific
test activities , realization processes and the product
meet the rules? Risk Management Procedure P11 was established by
In the event that inspection and test are conducted by
manufacturing personnel, do inspection and test the organization.
results, processes, organization’s procedures ensure
impartiality of inspection and test results?
Risk Analysis Questions according to EN ISO14971:2007
7.1 Risk management were prepared and completed by the organization.
Has the organization prepared a procedure containing
all processes of product realization for risk management Questions were answered to determined risks related
activities and realized the following? to the product.
Keeping the records
Preparation of Risk Management Plan Results of risk management were recorded in Risk
Determination of Risk team and its Responsibilities Management form F18.
Determination of Intended Use of Device and Safety
Characteristics of Device The risks of Products are divided in two categories:
Definition of hazards
Risk Estimation for Hazards
production and usage.
Evaluation of Risks Severity, occurrence and Detection Tables were
Risk Control Measures
Definition of Residual Risks determined in Risk Management Form. Risks are
Risk/Benefit Analysis differed from 1 to 1000
Preparation of Risk Management Report
DETERMINATION OF REQUIREMENTS RELATED TO THE Results of risks management for equipment were
PRODUCT/SERVICE checked
Has the organization defined the requirements of
customer including the requirements for the activities The members of risk management team were defined
on delivery and after delivery?
Do these requirements include the following?:
by organization.
‐ regulatory and legal requirements related to the The last review of risk assessment was dated
countries and territories where the product is supplied
to the market 01.04.1394.
‐ anticipated utilization, Advisory Notices F44 FOR IPL was observed
‐ Performance expectations,
‐ Design factors
7.2.1 ‐ Delivery plans 

‐Unclear customer expectations
Does the organization record customer’s expectations
related to product/service in order to revise the same?
In the event of any change in order or offer or both for
any reason whatsoever, are changes revised and an
agreement is reached on the changes as it is in original
order or offer?
In the event that changes are accepted, are all
personnel being affected by the changes within the
organization informed?
Are relevant documents affected by these changes
amended?
7.2 Customer‐Related Processes
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Has been
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Ms. Shekari was interviewed as Sales Manager.
Sales and Clearance Procedure P05 was established by
the organization. Orders are received in one category:
normal orders.
REVIEW OF REQUIREMENTS RELATED TO THE Order request Form F63 is completed by the
PRODUCT/SERVICE
Does the organization review the requirements related organization. Records: IMAM Hospital, dated
to the product? 23.06.1394, quantity : 1 , MODEL R110
Are review records kept?
Has this review been realized prior to commitment of Customer feedback Procedure P011 was established by
the organization for provision of the product to the organization to receive and follow up feedback.
7.2.2 customer?
Has the organization ensured settlement of contract or Customer’s feedbacks are monitored every 12 months.

order requirements which are different from previously
defined?
Records of customer's satisfaction are recorded in
Does the organization have the ability to meet defined Customer’s Satisfaction Form F42. Records of
requirements?
Are the results of review and subsequent follow‐up monitoring of customer’s satisfaction were checked
actions recorded? e.g. IMAM HOSPITAL SCORE : 90.5% ,
Any complaints are recorded in Corrective and
preventive action Form according to the Procedure. No
P02 complaint was received from customers.

Customer communication is done through telephone
lines, email, appointments and fax.
Communication of company with IMAM hospital of
Tehran has been observed, in the letter 3528 dated
CUSTOMER COMMUNICATION
Are arrangements for communication identified and 12/09/94 , S/N : RT9411010103
implemented relating to product information, demands,
This is the only record of sales which is for clinical
7.2.3
applications, contracts or realization of order including
amendments? evaluation sampling based on MOH requirement. 
Are required arrangements identified and implemented
for customer feedback and communication with Advisory Notice , F44 was observed including all related
customers including customer complaints? users risk which found in risk assessment.
Customer satisfaction measured based on F42 and the
results are in acceptable range.(85.8%)

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
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
NA
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
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?
REFERENCE, AS
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Has been
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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
‐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
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
that design output meets input criteria
DESIGN AND DEVELOPMENT VALIDATION
NA
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 Mr.Samimi was interviewed as COMMERICAL Manager.
conforms to purchasing requirements? Purchasing and Supplier’s Evaluation Procedure P08
Are criteria for selection of suppliers defined?
Are evaluation and reevaluation of suppliers have been was established by the organization. If there were
defined? requests goods in warehouse, it will be supplied by
Has the organization defined tracking frequency of
supplier’s performance? warehouse, otherwise depended on the goods that
Does the organization have the proofs indicating that
supplier monitoring activities, outsourced processes are
requested, Foreign Purchasing Request Form F33 are
controlled and the products or services conform to the completed to start purchasing process.
7.4.1
rules of the organization containing customer demands
and regulatory rules? Foreign Purchasing Request Form F34 dated 25.06.94, 
Have the requirements of purchasing information for GAGE 0‐6 BAR , quantity : 12 ,
(containing the rules related to supplier records)
including outsourced processes been identified to PROFORMA NO.PI1110375 DATED 01.07.94 FROM
ensure product and service quality? behyar Store.
Does the organization have the methodology to
communicate these requirements to the supplier? Periodic Evaluation of Suppliers was recorded in
Are purchasing contracts available?
Do the type and content of the control on supplier and
Supplier’s Performance Evaluation Form F41.
purchased product depend on the next product The organization determined its acceptable score in
realization of purchased product or final product?
Are purchasing records retained? supplier evaluation as 70.
REFERENCE, AS
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PURCHASING INFORMATION
Does purchasing information define the product to be
Records of supplier’s evaluation were checked e.g.
purchased? PERIODIC Evaluation: BEHYAR Company 1394(74%) ,
Where appropriate, does purchasing information
include product approval, procedures, requirements for
BRS Company 1394(90%) , ASA engineering co.
7.4.2
process and equipment, Personnel qualification and the 1394(85%) 
requirements of Quality Management System?
How does organization ensure the adequacy of
specified requirements in the purchasing information
prior to their release to the supplier?
Are records for the information related to purchased
product available?
VERIFICATION OF PURCHASED PRODUCT
Has the organization identified a method in order to
ensure that the product received conforms to the
specifications, is finished, holds appropriate identity
and is free from any damage?
Do the processes include the provisions in order to
verify that incoming product is provided along with
7.4.3
support documentation (e.g. conformity certificates,
acceptance test reports)? 
Has data been provided related to analysis of previous
acceptance inspection data, rejection history in the
plant or customer complaints, required inspection
quantity and necessity of reevaluation of supplier?
Has the organization identified the authorized person
for conformity approval of incoming material?
Are verification records retained?
7.5 Production and Service Provision
CONTROL OF PRODUCTION AND SERVICE PROVISION
7.5.1.1 General rules
Has the organization identified control requirements for
production and service process? MR.samimi was interviewed as QC operator.
Is control quantity and control detail level Products that was controlled based on Procedure of
proportionate to criticality level of its process?
Has the characteristic qualities of product been product realization : P13
identified? When required, have documented QUALITY CONTROL FORM F52 NO.14002 DATED
procedures, documented rules, work instructions and
reference materials reference materials and reference 94.09.06 FOR IPL MODEL R110 FOR IMAM HOSPITAL
measuring processes been made available?
Has appropriate equipment been selected in the
TEHRAN .
manner that enables process and product specifications RAW MATERIAL CONTROL FORM F53 DATED 94.08.10 ,
to be obtained?
Have the documents for using appropriate equipment FOR VACCUMM , motor , pipe , housing , gage , power
been established? supply, wheels , INSPECTOR Mr.Samimi
Has it been verified that new and/or significantly
modified equipment meets purchasing/design Mr. Ghelichkhani was interviewed as Production
specifications and posses the ability to operate within Manager.
7.5.1 the limits defined and process operating limits?
Have control devices been identified? Production Procedure P13 FOR IPL was established in RA
Has a document been prepared for using control
devices?
which necessary controls on production process were
Have implementation and control requirements for defined.
labeling and packaging been identified?
Are the records obtained during manufacturing process QUALITY CONTROL PLAN for IPL was not defined
of any product lot and facilitating traceability and according to current controls.
review of the manufacture of this lot retained?
Do the records include the following information? Final test method and related checklist must be
‐ When applicable, quantity of raw materials, reviewed based on current method.
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
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Has been
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Control of product cleanliness and contamination
Has the organization identified product cleanliness
rules? Regarding 7.5.1 of this report and weekly
Have the materials and substances used during
manufacturing process been adequately defined and manufacturing plan on 4/7/1394 (Oct 2015) company
labeled in order to prevent complexity and process controls necessary items which shall be monitored the
7.5.1.2.1 faults?
Have certain medical devices been cleaned and/or situation of production saloon.

cleared of contamination so as to prevent employees
and other product from being exposed to any

contamination
Have cleaning and implementation requirements been
documented?
Company uses Install procedure P04 for installing.
Assembly activities Based on P04 procedure device installing must be
Have assembly activities and responsibility for medical
device been identified?
conducted by organization .
In the event that any medical device should be All the records could be observed in F49 (after sales
assembled and mounted in the location where the user
is present, have guiding instructions been prepared by
form).
7.5.1.2.2 the organization for accurate assembly, montage, tests
and/or calibrations?
S/N : RT9411010103 
Has the organization provided the instructions which Date: 23.06.94
allow assembler to confirm proper operation of the IPL
device?
Are the results of assembly or commissioning tests Imam hospital
recorded?
Installed by : Mr.Samimi

Service activities
In the event that functionality of products needs service
or maintenance for proper utilization of products, have
documented requirements been established for service
activity?
Has the organization identified service responsibilities
between distributors and users?
Have service activities carried out by the organization or
a separate agency been planned? No Records , because at the moment the organization
Have the design and functionality of equipment or is not permitted for sales the products .
devices with special purpose related to manual
operation and service after assembly been validated? Installation and after sales service procedure : P04 was
7.5.1.2.3 Are measuring and test equipment used for site service
and tests controlled?
observed . 
Have instructions related to the lists of spare parts or
parts and for use in product service been prepared?
Has the infrastructure covering technical consultancy
and technical support, customer training and spare
parts or provision of parts been established?
Are service personnel trained?
Are specialized service personnel available?
Has the organization formed a system for receiving
customer demands so as to determine whether
customer complaints and rules are handled?
Are service records retained?
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
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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 white pallet for approved products
requirements?
Company uses specific operators for specified activities,
for example, Mr samimi was specified specially for
TRACEABILITY
75.3.2.1 General testing the devices and no one can qc the products if he
How is the product traced? is absent.
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

device during typically production and storage process
up to expiration of ownership?
order, company is not store raw material and raw
material will 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 serial no, to identify status.
Company uses yellow box 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 123 for Qty:12 pressure gauge 16 bar was
purchased dated : 25.06.94
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

CUSTOMER PROPERTY
Does the organization ensure identification, verification,
protection and safety of customer property provided
All of damaged devices which are sent by customer
for product or in the manner that it creates product could be Marked by F29 Lable .
7.5.4
while it is under the organization’s control or being
used? Most of information related to customer including : --- ‐‐‐
Does the process ensure that occurrence of any name , brief of problem , date , … could be provided in
customer property that is lost, damaged or otherwise
found to be unsuitable for use are recorded and this lable.
reported to the customer?
MS.HOSSEINI was interviewed as Warehouse Manager.
the related procedure P06 was defined .
Warehouse was visited and some products were
PRESERVATION OF PRODUCT checked.
Are methods and controls established to preserve
conformity of product during internal processing and
until delivery to intended destination? Order Points were defined in warehouse software
Has the organization established documented processes
or documented work instructions for control of the developed by the organization.
product with limited shelf life or which requires special
All products were identifiable in warehouse by an
7.5.5 storage?
Are such special storage requirements controlled and individual label.

recorded?
Does this preservation include definition, transport,
Product Information software NOAVARAN SYSTEM was
packaging, storage and protection of the product and developed by the organization in which proper
the parts constituting the product?
Is there a logo on product? Is it proper to its condition of preservation of products were mentioned
instructions? e.g. there is an open range for temperature,
arrangement, humidity and light sensitivity condition
for all products.
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

Calibration certificate for following devices was

observed :
Temp meter :
S/N:ED1124901
MODEL : GM700
REPORT NO:94‐C‐27921

OSCILLOSCOPE:
S/N:MEV100P1151012
CONTROL OF MONITORING AND MEASURING DEVICES
Has the organization identified the measurements to be
MODEL : GPS‐110213
made and the measuring and monitoring devices REPORT NO:94‐C‐27924
required to ensure conformity of product to specified
requirement?

a) Be calibrated or verified at specified intervals, or MULTI METER:
prior to use, against measurement standards traceable
to international or national measurement standards; S/N:140918748
7.6 where no such standards exist, the basis used for
calibration or verification s hall be recorded;
MODEL : HIOKI 
b) Be adjusted or re‐adjusted as necessary; REPORT NO:94‐C‐27922
c) Be identified to enable the calibration status to be
determined;

d) Be safeguarded from adjustments that would LCR METER:
invalidate the measurement result;
e) Be protected from damage and deterioration during
S/N:13000344
handling, maintenance and storage. MODEL : GPS‐132A
REPORT NO:94‐C‐27923

The list of all devices which need to be calibrated are
defined in F44
The normal period for calibration considered every one
year
8 Measurement, Analysis and Improvement
Customer feedback: from imam hospital was
observed, average is 92.5% as analisys written in
recorded form, company shall have more customers
to gain better results.
General Average of suppliers grade is an index for logistic
Does the organization plan to implement the process, criteria is over 120, and result is 164, criteria
monitoring, measurement, analysis, and improvement
change from 120 to 150 for next period.
8.1
processes required for conformity of the product and
QMS and improvement of its efficiency?
Manufacturing plan’s process’s index is fulfillment of

Are measurement, analysis and improvement
processes are carried out through statistical plan, criteria is 85% and result is 85% corrective
techniques and applicable methods?
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 √

Customer feedback: from imam hospital was
8.2.1 CUSTOMER SATISFACTION
Does the organization monitor the information related observed, average is 92.5% as analysis written in
to customer perception in order to understand whether recorded form, company shall have more customers
8.2.1 customer requirements are met or not?
Has the organization determined methodologies for 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 1‐11‐1394 for all
INTERNAL AUDIT processes such as financial, administration, production
Has a documented procedure been established that
includes responsibilities and requirements, and QA
requirements for planning and conducting the audit,
reporting the results, maintaining the records?
We checked QA checklist, auditor was Mr.Kavoosian
Are audits planned in the form of an audit program? was impartial and competent
8.2.2
Does audit programme take importance and status of
the fields and processes to be audited including the Checklist contains related clauses questioned such as 
results of previous audits? clauses 4.2, 4.3, 8‐3 and 7.5
Do selection of auditors and implementation of audit
ensure objectivity and impartiality of the process? Checking risk analysis has been recorded
Do auditors audit their works? NC is following through from F36 such as filled form for
Do follow‐up actions cover verification of the measures
taken and reporting of verification results? nc: “MR JOB DECRIPTION WAS NOT DEFINED”

Customer feedback: from IMAM hospital was
observed, average is 92.5% as analysis written in
recorded form, company shall have more customers
MONITORING AND MEASUREMENT OF PROCESSES
to gain better results after getting the approval from
Does the organization implement appropriate methods MOH.
8.2.3
for monitoring QMS processes and where applicable,
for measurement such WMS processes? Average of suppliers grade is an index for logistic 
When planned results are not achieved, is corrective process, criteria is over 150, and result is 180, criteria
action taken for product conformity?
change from 150 to 180 for next period.
Manufacturing plan’s process’s index is fulfillment of
plan, criteria is 90% and result shall be measured on
end of march 2016 after getting the MOH approval.
8.2.4 MONITORING AND MEASUREMENT OF PRODUCT
Mr.samimi is responsible for controlling and releasing
General rules the final product.
Does the organization establish appropriate stages to
measure and monitor product characteristics?
The only record related to IPL WITH S/N :
Have verification methods been documented? RT9411010103 , Date: 23.06.94 was observed .
Is this verification process realized in accordance with
the arrangements planned during appropriate stages of The final Qc procedure needs to be reviewed based on
8.2.4.1 product realization process?
Are conformity evidences along with acceptance criteria
current controls. 
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?
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

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‐ Control of nonconformity procedure: P07 was
conformity related to product?
When applicable, do the processes identify the methods
observed.
8.3
authorizing the non‐conformity’s use, release or
acceptance in agreement with customer?
Since the implementation of QMSMDD in organization,

Are required measures taken to preclude the product’s
original intended use or application? they have not issued any preventive action yet
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
appropriateness of QMS and the fields where QMS’s Records of data analysis was observed as planned.
efficiency can be continuously improved?
Has a documented procedure been prepared for these
Process was measured based on citeria . such as :
8.4
analyses?


Do the characteristics and tendencies of the processes
and products including data analysis, customer
satisfaction, conformance to product requirements, Training process : efficient : 79%
opportunities for corrective actions provide information
related to suppliers?
Have data types for data analysis been defined?
Are data analyses recorded?
8.5 Improvement
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

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 There are some evidences that show company has
order that advisory warnings can be published and
implemented? improvements such as:
Are the records of all examinations related to customer
complaint maintained?
Have the complaints been evaluated within the scope of No comments in IMED GMP audit
the following points?:
‐ whether the organization fails to comply with its own
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

specifications Internal communication
In the event that the activities outside the organization
are identified through examination of the contribution
of such activities to customer complaint, has the Suppliers management
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
corrective action No 9402 about process index “PPM”,
root cause is delay because of reject and re‐order O‐
rings
corrective action is removing gauge provider from
8.5.2. CORRECTIVE ACTION vendor list which is done
Is there a documented procedure for Corrective and
Preventive Action?
Are corrective actions taken to eliminate causes of
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 9402 against production index 
evaluating the actions needed to ensure that plan fulfillment,
nonconformities do not recur, determining and
implementing the corrective action needed, and review
of the results of the action initiated? Root cause: for the first time this quantity of
Is adequacy of corrective‐preventive actions identified?
production happened.
corrective action is changing assembly table and adding
lights, which is done, effectiveness shall be measured
on end of Dec 2016
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

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
Management Corporation The System is new and need to enhance

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:
Not document was observed for 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: 2 July 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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PHYSICAL LOCATION(s): Unit No.8, building No.46, Etemadian St.,

5.5 Responsibility, Authority and Communication

Calibration certificate for following devices was

Special rules related to active implantable medical

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

ATL: Milad Pourhasan DATE: 2 July 2016

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

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