BRSM Form 009 Qms MDD Pip

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

CLIENT‐ORGANIZATION (NAME): POLE IDEAL PARS Co.
PHYSICAL LOCATION(s):
1st Floor, No.12, Naghdi St., Jahantab St., Next to
Mofateh St., OstadMotahari St., Tehran, Iran
Phase II Audit Date(s): 1 July 2015
Phase I Audit Date(s): 10&11&12 July 2015
NAICS (or NACE) CODE 32.5, 22.21 nace code
EXCLUSIONS: 7-3, 7-5-1-3 and 7-5-1-2-2 and 7-5-1-2-3 and 7-

5-2-2 and 7-5-3-2-2 and 8 -2-4-2 and 7-5-4

Assessment objectives: Attesting requirements of QMS MDD and QMS
systems have been met in client’s management
system

ASSESSMENT TEAM INFORMATION
Assessment Team Leader, ATL Milad Pourhasan
Assessor 2
Assessor 3
Assessor 4
Assessor 5
Assessor 6

Note: Adjusting the language within this form to the type of activity and nature of the organization is acceptable.

REFERENCE, AS
This Clause
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).
Production of Sharps Container, Safety Equipment such as Ampoule
Opener, Sampling Instruments, Tube Racks, Tip Racks, Micro Tube Racks,
2 Scope of activities Microscopic and Staining Equipment, General Equipment including Cool
Box, First Aid Kit, Bed Pan, Pill Container, Sanitary Mask, Rotary Stand,
Sharp Container Bracket
BRSM requires that the organization’s legal obligations
and regulatory are met. Who are the main responsible
for executing and monitoring of these regulations?
Legal status Production license from MoH No. 307/957, valid to Feb √
3 2016, for in vitro diagnostic devices
License for production of medical containers No.
664/76451,
Obligatory applicable standard which Requirements of ISO 13485:2003& ISO 9001:2008
√
organization has to follow Regulation of Medical equipment Office of Iran
4 Quality Management System
GENERAL REQUIREMENTS
Does the organization establish, document, implement,
Quality Manual and all required procedure are
maintain and continually improve a Quality Documented
Management System (QMS) with due consideration
given to identification of processes needed for the
the organization has identified its processes and started
QMS and their application throughout the system; implementing more than 3 years
determination of sequence and interaction of these
4.1 processes, determination of criteria and methods Processes are specified. √
required to ensure effective operation and control of Process map is defined properly.
these processes; availability of resources and
information required to support the operation and There is not any outsource processes.
monitoring of processes; measurement, monitoring and
analysis of the processes; implementation of action to

achieve planned results and continual improvement
‐If any, are the outsourced processes are defined?
DOCUMENTATION REQUIREMENTS
Is there a documented quality policy and documented Quality Manual and all required procedure which
quality objectives and are they appropriate?
Is there a documented quality manual and are there
Documented are appropriate and cover requirements of
documented procedures required by the standards?? ISO 13485, ISO 9001, and other needed requirements
4.2
Are required records for planning, acting and controlling
processes efficiently available? and regional regulation. √
Are the documents are created for every type of Process map(GH05/0)demonstrate
medical device including qms requirements and product
specifications? (4.2.3) If these documents are applicable Interactions between processes.
to manufacturing processes, are montage and service Technical files are defined for each type of products.
defined?
QUALITY MANUAL The Quality Manual (GH01) includes scope of QMS and
Does the Quality Manual include, scope of QMS and
details of exclusion? QMS MDD details of exclusion.
4.2.2 Are documented procedures reference to mandatory
procedures;
following clause are excluded 7‐3 √
Is description of interaction of the processes included in 7-3, 7-5-1-3 and 7-5-1-2-2 and 7-5-1-2-3 and 7-5-2-2 and
the QMS? 7-5-3-2-2 and 8 -2-4-2 and 7-5-4
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 Page 2 of 16
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CONTROL OF DOCUMENTS
Are mandatory procedures documented?
Are control conditions pertaining to mandatory
documents proper?
Are review, update and re‐approval situations and Document control procedure MSP/00 is documented in
changes and current review situations for documents appropriate way
traceable?
Distribution of copies of the documents described in
4.2.3 Are the relevant documents usable, readable and
recognizable at concerned usage points? MSP/00 list. Review of all documents defined annually √
Are outsourced documents defined?
Are distribution of documents controlled, outdated obsolete documents are stamped on paper or omitted
documents prevented from being used and appropriate
definition method applied in case of being stored for
from the documents system.
any purpose?
Are these subjects clear in the relevant procedure?
CONTROL OF RECORDS
Are documents readable, easily recognizable and stored According to records control procedure MSP/00records
in available manner?
are kept properly, table of records (MSP‐05) was
4.2.4
Has a documented procedure been established and
applied for determination of required controls for observed. Records are kept for 2 years. √
storage, retrieval, retention time and disposition of
records?
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 Directive manager as top manager set Quality policy and
should be understood by all personnel? Objectives (MSP‐20) accompany with his team, also he
5.1 Is a quality policy available?
Are quality objectives available? approved Quality Policy and Quality manual and QMS √
Is management review established?
Does the management provide required sources for
document
QMS?
CUSTOMER FOCUS Customer requirements are determined through
5.2
Does top management have methodologies to ensure
that customer needs and expectations are determined contract review, customer satisfaction is measure √
and met for increasing customer satisfaction? periodically.
Quality Policies GH‐03 with the contexts such as finding
QUALITY POLICY acceptable and qualify contractors, Development of
Has top management established a Quality Policy in
accordance with the objective of the organization? cooperation sales representative, efficient use of staff
Does the Quality Policy include a statement of skills and provide high quality products,
5.3 commitment to meeting requirements and continual
improvement of the QMS? The last version of QP is accessible with code GH‐3/00. √
Has the Quality Policy been revised for communication,
understanding and continuous compliance within the
Quality policy is asked from two personnel, they answer
body of the Organization? shows they know the Quality policy
Version 0 annually checked, last release October 2012
Quality objectives with code MSP‐20with the relevant
QUALITY OBJECTIVES operational programs were observed. Director manager
Are quality objectives established by top management
at relevant functions and levels within the organization? approved objectives. Increasing market share in all
Are the objectives measurable and consistent with the products, increasing the Monetary volume of Safety
Quality Policy
5.4 5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING Boxes sales (4%), increasing the variety of products (up √
Has the QMS been planned by Top Management in to then)
order to meet the conditions and quality objectives
detailed in Section 4.1? Action plan was observed the quality objectives are
When changes are initiated, is the integrity of the QMS
maintained during the change process? measurable.

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5.5 Responsibility, Authority and Communication
Organizational GH04 and Responsibility and Authority
are documented ,
Responsibilities and authorities are defined in detailed.
RESPONSIBILITY AND AUTHORITY responsibilities for MR, production manager, sales
Has top management identified responsibility and
manager were checked
authority and been communicated within the
5.5.1 organization?
Directive manager has approved Organizational Chart √
Has top management defined responsibilities and
authorizations for CE marking? and responsibility and authority documents.
In accordance Iranian MOH regulation they have
technical supervisor .his responsibilities and authorities
was observed.
MANAGEMENT REPRESENTATIVE Mrs.Habibi has been appointed to management
Has top management appointed a member as
Management Representative with responsibility and representative by directive manager.
5.5.2
authority to ensure that the processes of the QMS are
established, implemented and maintained; report to Formal authority letter was observed. Her job √
top management on the performance of the QMS,
including needs for improvement and promote description is compatible with by her responsibility and
awareness of customer requirements? competence.
INTERNAL COMMUNICATION Outlook software is used for internal communication
Has the top management ensured establishment of
Internal communication method is defined in Quality
5.5.3
appropriate communication processes within the
organization? Has the top management ensured Manual properly. √
realization of communication considering the processes
of the QMS and their effectiveness? Organization Chart shows communication plan.
5.6 Management review
Management review conduct every six month.
TOP MANAGEMENT REVIEW
Does top management review the QMS to ensure its
The last Management review has been done on
continuing suitability, adequacy and effectiveness at 01/12/93(20 Feb 2015)All Inputs have been discussed.
5.6.1
regular and planned intervals?
Do reviews include assessing opportunities for At the meeting, Managing Director, representative of √
improvement including the need for changes to the management, production manager, quality control
QMS, quality policy, and quality objectives?
Are management review records kept? manager and the technical supervisor of the
organization were present.
REVIEW INPUT
Results of audit, Customer feedback, Status of process
Does review input include current performance and performance and product performance, Status of
improvement opportunities related to:
a) results of audits; corrective actions, Status of preventive actions, Follow‐
b) customer feedback; up action from previous reviews, Changes that affect the
5.6.2 c) process performance and product conformance;
d) status of corrective and preventive actions; QMS and Recommendations for improvement had been √
e) follow‐up action from earlier management reviews; discussed.
f) changes that could affect the QMS,
g) recommendations for improvement
h) New or revised regulatory rules?
The minute of Meeting dated 20 Feb 2015 was
observed.
REVIEW OUTPUT Important outputs are: improvement of handling
Does output from management review include actions
system, Contract agreement with the Iranian Red
5.6.3
related to improvement of the QMS and its processes,
improvement of product related to customer
Crescent , complete injection molds for12 liter Safety
√
requirements, actions and decisions relate to resource
needs? Boxes and increasing sale staff
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6 Resource Management
PROVISION OF RESOURCES
Does the organization have methods to determine and The organization has methods to determine and provide resources
6.1 provide resources needed to implement and improve
the processes of the QMS and address customer
needed to implement and improve the processes of the QMS and √
QMS MDD.
satisfaction by meeting requirements?
6.2 Human Resources
Are personnel assigned with responsibilities that affect According to training procedure (MSP/00) personal ID (FGh‐05) for
product quality competent on the basis of applicable
Mrs. Habibi, Mrs.Mirzayee observed. The training program (code
6.2.1 education, training, skills, and experience?
Are trainings performed for achievement of Required MSP ‐11) has been developed for 2015 ,such as safety injection √
Competence? system, the principles of GMP, principles and concepts of risk
COMPETENCE, AWARENESS, AND TRAINING management, the principles of calibration, quality control
Has the organization identified the experience, procedures. Records of safety training course to operate the machine
qualifications, competencies and skills of the personnel injection conducted in (May 2015) dated 09/2/94 was observed. And
performing activities affecting safety and efficiency of
medical devices particularly being manufactured and
effectiveness evaluation records of this course(MSP12) for Mr.
provided to customer? Goudarzi with a score of 95%, Mr. mahani with a score of 88%(in
6.2.2
Is training provided by the organization to satisfy the
competency needs?
April 2015)were observed .Effectiveness evaluation record of control
methods course for Ms. Fadakchyan(dated Jun 2015) with a score of
√
Does the organization ensure that its employees are
aware of the relevance and importance of their 84% was observed.
activities and how they contribute to the achievement The initial mandatory training of staff are completely recorded
of quality objectives?
Are records of education, experience, training and The training records are established in accordance personnel
qualifications maintained? competency requirements.
INFRASTRUCTURE
Has manufacturing equipment been designed, Manufacturing equipment been designed, constructed, properly
constructed, properly established and placed for proper established and placed for proper operation, maintenance,
operation, maintenance, adjustment and cleaning?
In case of applicability, has the organization ensured adjustment and cleaning.
Booklet PRM/00
documentation of natural limits or permissible In accordance with maintenance and repair procedure, profile ID of
tolerances in manufacturing process and measuring and
test equipment and availability of the same for
Number 5 injection Machine in the form PRP‐20and its maintenance
program in Form PRP‐47, were Observed.
6.3
operators?
Are documented processes available for maintenance,
Repair Record of Number 3 injection device in the PRP‐48form
AR
cleaning and control of all equipment used in
manufacturing process and control of work (94/12/05)(Feb 2015) was observed .
environment? Cleaning Check (PRP‐48)List were observed
Are required adjustments and maintenance intervals
identified? AR: Form of repairing the molding machine code (13) on
Is maintenance plan placed normally on or near the
equipment and easily reachable? April 2015 wasn’t filled out.
Is maintenance realized based on the relevant plan?
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WORK ENVIRONMENT
Does the organization identify and manage required
work environment needed to achieve conformity of
product?
Are the following factors which could affect product
quality in the work environment identified?
‐ Process equipment,
‐ Work environment,
‐ Personnel in this work environment
Are qualified and quantified limit values of the work
environment identified for a desired quality of the work
environment?
Are pollution levels of microbial and solid particles
controlled during product manufacturing where sterile
product or pollution of solid particle which is stipulated
to be sterilized or could live or not live during its
manufacture or utilization is important?
Has exclusion been applied during all manufacturing
processes for a controlled environment? As valid
ground of exclusion, is pollution reduced to known,
consistent and controlled level by an approved cleaning
method and packaging kept at this level through control 5S system has been implemented correctly in the organization. GMP
process? is compatible with products and Places for production
Have indicators been identified for a controlled
environment which covers valid cleaning and packaging according to Iranian regulations the GMP requirements are the basic
processes including the organizations holding a valid work environment that needs to be clean AND IN suitable package
6.4 cleaning process?
(Temperature, Humidity, Air Current, Filtration of Air,
as the product is in no contact with patient , it does not need √
Ionization of Air, Pressure differences, Lighting (along intensive hygienic controls such as particle limits, sterility, or
with its spectral content and severity), Sound, Vibration, bioburden tests and clean room
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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All needed procedure and documents such as production procedure,
Quality control Procedure, risk management procedure and BOM
,OPC and IFU etc. are documented .records related to this procedure
are fill out.

PLANNING OF PRODUCT REALIZATION Production plan provides plan and development for product and it is
Has the organization considered the scope of its own defined annually in line with Quality objectives and requirements for
quality management system in planning of product the product then divided into intervals of a month.
realization?
Has the organization prepared required records for a For each production station production instruction are design, time
proof indicating that quality objectives and product sheet are specified.
rules, processes established, documents and product‐
specific necessary resources, verification, validation, Time studies of production line are done.
tracking, measuring, inspection and product‐specific
test activities , realization processes and the product
Risk management team is qualified.
meet the rules? Risk management instruction W25/00, were observed. FMEA issued
In the event that inspection and test are conducted by as a risk analysis method. Checklist of basic requirements with form
manufacturing personnel, do inspection and test
results, processes, organization’s procedures ensure FW25/01 and risk assessment table code FW25/02 for all products
impartiality of inspection and test results? was observed.
7.1 Risk management
Has the organization prepared a procedure containing
For example Safety Boxes risk of storage and ampoule opener, the √
all processes of product realization for risk management
type of fault: inappropriate setting and sorting in storage, inaccurate
activities and realized the following? and insufficient information printed on the package, causes of fault:
Keeping the records limited storage space and Warehouse personnel are not properly
Preparation of Risk Management Plan trained, the fault effect: damage of product.
Determination of Risk team and its Responsibilities
Determination of Intended Use of Device and Safety
Characteristics of Device . Also on injection stage
Definition of hazards type of fault: hole on Safety Boxes causes of fault: increased
Risk Estimation for Hazards
Evaluation of Risks
temperature ,fault effect: contaminating the surrounding
Risk Control Measures environment
Definition of Residual Risks Severity: 8 occurrence : 3 , recognition: 5
Risk/Benefit Analysis RPN: 120
Preparation of Risk Management Report
If RPN over 70 Control actions are taken to reduce RPN
Detection method controlling is done first and end of production and
on finished product.
.in this case the product is contro100%. RPN dropped to 50.so it has
not residual risk
DETERMINATION OF REQUIREMENTS RELATED TO THE
PRODUCT/SERVICE
Has the organization defined the requirements of
customer including the requirements for the activities
on delivery and after delivery?
Do these requirements include the following?: In determining the product requirements, the organization has
‐ regulatory and legal requirements related to the considered Customer specific requirements and legal regulations.
countries and territories where the product is supplied
to the market
When a production manager receive clients Orders from sale unit, He
‐ anticipated utilization, will checked the requirements, and compare the customer
‐ Performance expectations, requirements with OPC And production and QC procedure.
‐ Design factors
If any changes needed after client approved the changes, the
7.2.1 ‐ Delivery plans
‐Unclear customer expectations production manager informs Quality manager and production staff. √
Does the organization record customer’s expectations Record of approving client order (PRP100/0, in march 2015) was
related to product/service in order to revise the same? Observed.
In the event of any change in order or offer or both for
any reason whatsoever, are changes revised and an
Also In Client order Form Delivery time is mentioned.
agreement is reached on the changes as it is in original Records of client order (Firs Aid Kit, client Mrs. Bavand) was
order or offer? observed.
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?
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7.2 Customer‐Related Processes
REVIEW OF REQUIREMENTS RELATED TO THE
PRODUCT/SERVICE before committing to accept the order, the organization
Does the organization review the requirements related reviewing product‐related requirements from client to
to the product?
Are review records kept?
ensures that can meet the product requirements, check any
Has this review been realized prior to commitment of requirements differing from routine products , if they able to
the organization for provision of the product to
meet client requirements , they sign contract
7.2.2 customer?
Has the organization ensured settlement of contract or
√
if any requirement is changed
order requirements which are different from previously
defined? First confirm by client then this is communicated in written to
Does the organization have the ability to meet defined
requirements? managers and operational staff.
Are the results of review and subsequent follow‐up
actions recorded?
CUSTOMER COMMUNICATION Means for the organization communicating with the customer
Are arrangements for communication identified and are as follows: Telephone calls, emails and letters, in such
implemented relating to product information, demands,
communications information regarding Product information is
7.2.3
applications, contracts or realization of order including
amendments? transferred and Customer responses, opinions. √
Are required arrangements identified and implemented
for customer feedback and communication with Also Advisory notices are defined in IFU.
customers including customer complaints?
Complaints refer to 8.2.1
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 excluded N/A
and development planning?
Are design and development planning updated when
planning output is appropriate and in the progress of
design and development?
DESIGN AND DEVELOPMENT INPUTS
Are inputs related to product requirements identified
and relevant records maintained?
Do these inputs include functional and performance
7.3.2 requirements, applicable regulatory and legal excluded N/A
requirements, applicable information derived from
previous and similar designs a any other requirements
essential for design?
Have the inputs been reviewed in terms of adequacy?
DESIGN AND DEVELOPMENT OUTPUTS
Are design and/or development outputs approved
before prior to release and in a manner that enables
verification against the design and/or development
inputs?
Do the design and/or development outputs meet the
7.3.3 design input requirements and excluded N/A
‐provide appropriate information for purchasing,
manufacture and service performance,
‐ contain or reference product acceptance criteria
‐ define the characteristics of the product that are
essential to its safe and proper use?
DESIGN AND DEVELOPMENT REVIEW
Does the organization identify suitable stages for
systematic reviews of design and/or development?
7.3.4 Are the results of review and subsequent follow‐up excluded N/A
actions recorded in order to evaluate the ability to
fulfill requirements and identify problems and
propose corrective actions?
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DESIGN AND DEVELOPMENT VERIFICATION
7.3.5 Does the organization in planned arrangements ensure excluded N/A
that design output meets input criteria
DESIGN AND DEVELOPMENT VALIDATION
Is the design and/or development validation performed
in accordance with planned arrangements to confirm
that final product is capable of meeting the
requirements of intended use or application
7.3.6 requirements defined? excluded N/A
Is verification completed (if applicable) prior to delivery
or implementation of product? Ara relevant records
maintained?
Are results of review and required actions recorded?
CONTROL OF DESIGN AND DEVELOPMENT CHANGES
Have design and development changes been identified
and recorded?
Have design and development changes been reviewed,
verified, validated and approved prior to
implementation?
7.3.7 Does the review of design and development changes excluded N/A
include evaluation of the effect of changes on
previously delivered product and the parts constituting
the product?
Are the results of review of changes and subsequent
follow‐up actions documented?
7.4 Purchasing
Purchasing Process; Has the organization prepared
documented process to ensure that purchased product There are documented process to ensure that purchased
conforms to purchasing requirements? product conforms to purchasing requirements
Are criteria for selection of suppliers defined?
Are evaluation and reevaluation of suppliers have been According to procedure of purchase and supplier evaluation, ,
defined?
Has the organization defined tracking frequency of depend on the effects that the purchased product have on
supplier’s performance? production realization an quality of finished
Does the organization have the proofs indicating that
supplier monitoring activities, outsourced processes are
products(According to with quality plans) type, Frequency
controlled and the products or services conform to the and scope of controls on suppliers and subcontractors, as well
7.4.1
rules of the organization containing customer demands
and regulatory rules?
as products will be determined .List of acceptable suppliers √
Have the requirements of purchasing information with form code PRP52 contains 19 supplier, supplier
(containing the rules related to supplier records) evaluation recordsFPRP52 fill out in December 2015 for
including outsourced processes been identified to
ensure product and service quality? Bandar Imam Petrochemical with a score of 79%, Basir
Does the organization have the methodology to transport services with a score of 75%, Sanat Yaran
communicate these requirements to the supplier?
Are purchasing contracts available?
80%Laksar, with a score of 75% were observed.
Do the type and content of the control on supplier and
purchased product depend on the next product
realization of purchased product or final product?
Are purchasing records retained?
PURCHASING INFORMATION
Does purchasing information define the product to be
purchased?
Where appropriate, does purchasing information
include product approval, procedures, requirements for Purchasing information is accordance with Quality Controlin
7.4.2
process and equipment, Personnel qualification and the
requirements of Quality Management System? dicator and BOM. Purchase order Forms and letter for PP √
How does organization ensure the adequacy of (poly propene) on 3may 2015 were observed.
specified requirements in the purchasing information
prior to their release to the supplier?
Are records for the information related to purchased
product available?
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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 Qc unit checked specification of purchased product in
and is free from any damage? accordance with Quality plan. Once the QC approved the
PR13 / 02/02
Do the processes include the provisions in order to
verify that incoming product is provided along with quality of purchased product, and quality supervisor or
7.4.3
support documentation (e.g. conformity certificates,
acceptance test reports)?
manager sign the Receipt
√
Has data been provided related to analysis of previous Records of checking of purchased PP (poly propene) on 29
acceptance inspection data, rejection history in the
plant or customer complaints, required inspection
may 2015 were observed.
quantity and necessity of reevaluation of supplier?
Has the organization identified the authorized person The COA of PP reviewed.
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 All working instructions, maintenance and repair instructions
Has the organization identified control requirements for
production and service process?
of machines based on production processes for semi‐finished
Is control quantity and control detail level products and finished products are available and have been
proportionate to criticality level of its process?
Has the characteristic qualities of product been
installed on the machine. Part of the quality controls are done
identified? When required, have documented by the operator during production on production stations and
procedures, documented rules, work instructions and part of the controls are done by quality control experts.
reference materials reference materials and reference
measuring processes been made available? Production procedures were observed and all production and
Has appropriate equipment been selected in the operation forms filled out of and at the end of the day and are
manner that enables process and product specifications
to be obtained?
checked by supervisors.
Have the documents for using appropriate equipment
been established?
Also all products have BOM (F18).
Has it been verified that new and/or significantly
modified equipment meets purchasing/design
F18 of Rotator Stand was observed.
specifications and posses the ability to operate within
Production plan (PRP‐14), weekly production Plan PRP‐15 (20
7.5.1 the limits defined and process operating limits?
Have control devices been identified? to 25 April 2015), Daily production plan PRP‐16 on 20 April √
Has a document been prepared for using control 2015 were observed.
devices?
Have implementation and control requirements for The safety Boxed produced on 20 April 2015 was chose,
labeling and packaging been identified?
Are the records obtained during manufacturing process during production Quality Control from MMP‐15, And final
of any product lot and facilitating traceability and Quality Control Form MMP‐27 were checked.
review of the manufacture of this lot retained?
Do the records include the following information? This product labeling is done in accordance with EN 980.
‐ When applicable, quantity of raw materials,
components and intermediate products and lot
numbers of those materials,
‐ When applicable, start and completion dates of The records of release and delivery products produced in 10
different stages of manufacture including sterilization April 2015 was observed.
records,
‐ Quantity of manufactured product,
‐ Signed results of all inspections and tests,
‐ Representation of production line used,
‐ Any deviation from manufacturing specifications.
7.5.1.2 Control of production and service‐Special rules
Control of product cleanliness and contamination
Has the organization identified product cleanliness
rules?
Have the materials and substances used during
manufacturing process been adequately defined and Records of cleaning machine were observed
labeled in order to prevent complexity and process There are Separate boxes for keeping tools, each boxed are
7.5.1.2.1 faults?
Have certain medical devices been cleaned and/or labeled. √
cleared of contamination so as to prevent employees
and other product from being exposed to any
contamination
Have cleaning and implementation requirements been
documented?
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Assembly activities
Have assembly activities and responsibility for medical
device been identified?
In the event that any medical device should be
assembled and mounted in the location where the user
is present, have guiding instructions been prepared by
7.5.1.2.2 the organization for accurate assembly, montage, tests
and/or calibrations?
excluded N/A
Has the organization provided the instructions which
allow assembler to confirm proper operation of the
device?
Are the results of assembly or commissioning tests
recorded?
Service activities
In the event that functionality of products needs service
or maintenance for proper utilization of products, have
documented requirements been established for service
activity?
Has the organization identified service responsibilities
between distributors and users?
Have service activities carried out by the organization or
a separate agency been planned?
Have the design and functionality of equipment or
devices with special purpose related to manual
operation and service after assembly been validated?
7.5.1.2.3 Are measuring and test equipment used for site service
and tests controlled?
excluded N/A
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? excluded N/A
Are sterilization records tracked for each production lot
related to medical devices?
7.5.2 VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION
General rules
a)defined criteria for review and approval of the Injection process is validated. So
process SOP is available. Validation process is defined in accordance
b)approval of equipment and qualification of staff
involved products requirements.
7.5.2.1 c) use of specific methods and procedures
d)records requirements
Production staff are qualified, machine and equipment are 
e)revalidation
under control. QC processes are done completely.
documented procedure for validation of Temperature in injection machine is monitored and calibrated
software/computer applications, and records of Temp.log was observed
validation
Special rules for sterile medical devices
Have sterilization processes been validated prior to
use?
7.5.2.2 Have the standards used for validation of sterilization
process been identified and implemented?
excluded N/A
Have the requirements in the Article no. 7.5.2.1 been
met?
7.5.3 Identification and Traceability
REFERENCE, AS
This Clause
APPLICABLE1
Has been
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Identification
Organization identified and documented the product through
Has the organization identified and documented the appropriate methods during product realization.
product through appropriate methods during product In production process, row material storage, Semi products,
7.5.3.1 realization?
How has the organization identified product situations final products storage are labeled to identify. √
in accordance with tracing and measuring Example: safety box semi product during production
requirements?
As well as rejected products
TRACEABILITY
75.3.2.1 General
Bach number of product contain 5 cell,
How is the product traced? First cell is number storage receipt, second one, machine code. Day
7.5.3.2 Has any method been documented for traceability?
Does the organization ensure traceability of the medical
of production, third: month of production, forth: Operator Code. √
The safety box with Bach number 12‐02‐25‐01‐13 choose and the
device during typically production and storage process
up to expiration of ownership? processes and related forms where checked.
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
excluded N/A
tools, new or different machine devices, changes of
process methods?
When applicable, are special personnel assigned to act
during processing medical device or each stage of
delivery traced?
Status Identification Semi products, final products are labeled to identify.
7.5.3.3 Organization has identified status of product with
respect to measurement and monitoring requirements Nonconformities products has red label.
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? excluded N/A
Does the process ensure that occurrence of any
customer property that is lost, damaged or otherwise
found to be unsuitable for use are recorded and
reported to the customer?
PRESERVATION OF PRODUCT
Are methods and controls established to preserve
conformity of product during internal processing and
until delivery to intended destination?
The environment of storage is clean and organized.
Has the organization established documented processes Piling is done based on storage instruction. Storage is divided in 3
or documented work instructions for control of the parts. Raw material, semi product and finished product. For
product with limited shelf life or which requires special controlling storage Ham Karan software system is used. FIFO is used
7.5.5 storage?
Are such special storage requirements controlled and properly. √
recorded? As sample inventory of PP raw material was checked the order point
Does this preservation include definition, transport, 250 kg the inventory was 3200 kg, bags were piled on plastic pallets.
packaging, storage and protection of the product and
the parts constituting the product? Environmental condition was according to MSDS of PP.
Is there a logo on product? Is it proper to its
instructions?
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

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 List of calibrate equipment (PRP‐34) were checked. All equipment’s
requirement? are sent to Laksar company which has ISO 17025 certificate from
a) Be calibrated or verified at specified intervals, or
NACI to calibrate.
prior to use, against measurement standards traceable
to international or national measurement standards; Table of frequency of calibration (PRP‐35) that is defined annually
7.6 where no such standards exist, the basis used for
calibration or verification s hall be recorded;
was observed. √
Calibration certificates of digital scale (code LK‐647460N‐PP)and
b) Be adjusted or re‐adjusted as necessary;
c) Be identified to enable the calibration status to be
Thermometer (code LK‐647464N‐PP)on Feb 2015 were observed.
determined;
d) Be safeguarded from adjustments that would
invalidate the measurement result;
e) Be protected from damage and deterioration during
handling, maintenance and storage.
8 Measurement, Analysis and Improvement
General
Does the organization plan to implement the
monitoring, measurement, analysis, and improvement the organization plan to implement the monitoring,
8.1
processes required for conformity of the product and
QMS and improvement of its efficiency? measurement, analysis, and improvement processes √
Are measurement, analysis and improvement required for conformity of the product and
processes are carried out through statistical
techniques and applicable methods?
8.2 Monitoring and Measuring
According to customer satisfaction evaluation and feedback
Feedback procedure, evaluation Results forms (MMP‐03) Tehran Milad
Does the organization monitor the information related
to customer perception in order to understand whether with a score 77%, Tehran Rasool Hospital with a score 80%,
8.2.1 customer requirements are met or not?
Has the organization determined methodologies for
Imam Ali Hospital in Arak with a score 79%, Razavi Hospital √
obtaining and using information on customer
Mashhad with a score 87% was observed. in recent years,
satisfaction and/or dissatisfaction? complaint has not been received

Internal audit is conduct every six month.
INTERNAL AUDIT
According to the internal audit procedures internal audit was
Has a documented procedure been established that conducted on 01/03/94(May 2015). Internal audit program
includes responsibilities and requirements, (MMP‐04) and internal audit Check list MMP‐05 were
requirements for planning and conducting the audit,
reporting the results, maintaining the records? observed. 8 cases of non‐compliance have been issued and for
Are audits planned in the form of an audit program? all of the corrective action has been issued (. 5 cases of non‐
8.2.2
Does audit programme take importance and status of
the fields and processes to be audited including the conformities are related to the quality management system √
results of previous audits? records and 3 cases are related to improper placement of
Do selection of auditors and implementation of audit
ensure objectivity and impartiality of the process?
items on a production line and warehouse, which all of them
Do auditors audit their works? solved.
Do follow‐up actions cover verification of the measures There is two Internal audit Auditors who have ISO 13485 and
taken and reporting of verification results?
ISO 9001 internal audit certificate, and the audit unrelated
process.
MONITORING AND MEASUREMENT OF PROCESSES
Does the organization implement appropriate methods
Evaluation procedure (MMP/00) is established. the indicator
for training process is 85 the data analysis result is 93.5,
8.2.3
for monitoring QMS processes and where applicable,
for measurement such WMS processes? Production process waste indicator is 1% the result if data √
When planned results are not achieved, is corrective
action taken for product conformity? analysis is 0.73%.
8.2.4 MONITORING AND MEASUREMENT OF PRODUCT
REFERENCE, AS
This Clause
APPLICABLE1
Has been
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mark √

General rules In accordance with Quality control procedure, quality control
Does the organization establish appropriate stages to
measure and monitor product characteristics? plan for raw materials (code F34), semi‐finished and finished
Have verification methods been documented? product (code F35), were observed. F39 form dated and
Is this verification process realized in accordance with
the arrangements planned during appropriate stages of assessment evaluation records of packaging Nylon 5/02/94(
8.2.4.1 product realization process?
Are conformity evidences along with acceptance criteria
25 April 2015) the finished product evaluation records (Safety √
maintained?
Boxes) 27/02/94 were observed.
Are the records approved by the authorized Specification such as Dimension, color, assembly conformity,
person/persons in the process of product release? packaging, labeling, and etc were checked
Are product release and distribution of service, planned
regulations (Article 7.1) completed satisfactorily?
Special rules related to active implantable medical
devices and implantable medical devices
8.2.4.2 Does the organization record the identity of the excluded
personnel carrying out any inspection or test?
CONTROL OF NON‐CONFORMING PRODUCT
Does the organization have methodologies to ensure
that product that does not conform to requirements is
identified and controlled to prevent unintended use or
delivery?
Is there a documented procedure related to non‐
conforming product?
Does the organization take measures to remove non‐
conformity related to product?
When applicable, do the processes identify the methods
Control of nonconforming product procedure is defined. no
8.3
authorizing the non‐conformity’s use, release or
acceptance in agreement with customer? records for recent period. √
Are required measures taken to preclude the product’s
original intended use or application?
Are records related to the nature of nonconformities
and the measures taken later maintained?
Is corrected nonconforming product subject to re‐
verification to demonstrate conformity to the
requirements?
Do the processes ensure that appropriate corrective
action is initiated when non‐conforming product is
detected after delivery or use has started?
DATA ANALYSIS
According to the data analysis procedure monitoring
processes were observed. Organization collect, identify and
Data analysis procedure MMP
Does the organization collect, identify and analyze
appropriate data to demonstrate efficiency and analyze appropriate data to demonstrate efficiency.
appropriateness of QMS and the fields where QMS’s
efficiency can be continuously improved? For example indicators of the delay in the purchase of raw
Has a documented procedure been prepared for these materials is a weak delay the result of data analysis was 4
8.4
analyses?
Do the characteristics and tendencies of the processes days, the indicators of the number release or acceptance AR
and products including data analysis, customer under concession is 10 in three months the result is 3in three
satisfaction, conformance to product requirements,
opportunities for corrective actions provide information
months, the indicators of production waste is 20 kg at 6
related to suppliers? months the result 14 kg at 6 months,.
Have data types for data analysis been defined? The data analysis for PM process isn’t done in accordance with
Are data analyses recorded?
Data analysis procedure, the result are incorrect.
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
order that advisory warnings can be published and
implemented?
Are the records of all examinations related to customer The organization identified required changes by using quality
complaint maintained?
Have the complaints been evaluated within the scope of policy, quality objectives, audit results, analyses of data,
the following points?: corrective and preventive actions and management review in
‐ whether the organization fails to comply with its own
specifications or not, order to ensure and sustain ongoing conformity.
8.5.1 ‐ whether the organization has caused problems to
occur despite the fact that it has complied with its own
Stop time and downtime is monitor continually in order to √
specifications
decreasing them.
In the event that the activities outside the organization In last 6 Month they decrease the downtime 5%.
are identified through examination of the contribution Also they sent sale staff to Marketing seminar in order to
of such activities to customer complaint, has the
relevant information been shared among responsible improve their ability to deal better with customer.
organizations?
In the event that any customer complaint is not
followed up through a corrective and/or preventive
action, has the reason of this failure been confirmed
and recorded?
Has the organization established a documented
procedure for notifying adverse events and alertness
within the scope of after‐sale supervision activities?
Does the process comply with international guides?
(MEDDEV 2.12.1 – MEDDEV 2.12.2)
Are the notices for adverse events recorded
8.5.2. CORRECTIVE ACTION Corrective and preventive action procedure is established .the
Is there a documented procedure for Corrective and
Preventive Action? records for NCs were observed. The descent correctives
Are corrective actions taken to eliminate causes of actions were taken. The evaluation training course principles
nonconformities effective in preventing recurrences?
Does this procedure include the requirements of and concepts of risk management at first wasn’t done. The
8.5.2 reviewing non‐conformities (including customer
complaints), determining the causes of non‐conformity,
tacking action records has been completed the evaluation has √
evaluating the actions needed to ensure that
been done, it was decided and training unit must evaluate
nonconformities do not recur, determining and courses with
implementing the corrective action needed, and review 2 weeks.
of the results of the action initiated?
Is adequacy of corrective‐preventive actions identified?
PREVENTIVE ACTION
Has the organization established a documented
procedure for preventive action with defined
requirements for identifying potential non‐conformities Corrective and preventive action procedure established. no
8.5.3
and their causes; evaluating the need for action to
prevent occurrence; determining and implementing
records for recent period. √
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
Storage and cleaning of organization Completing the records in PM unit

action Request Type I Form-008 – as we indicate and that each of the RA addresses the basic four (4) questions
as seen in Form-008:
action Request Type II Form-008 – as we indicate and that each of the AR addresses the basic four (4) questions
as seen in Form-008:
The data analysis for PM process isn’t done in accordance with statistical techniques procedure, the result are
incomplete.
Form of repairing the molding machine code (13) on April 2015 wasn’t filled out.
Observation Form-018 – with uniquely specific identification:
ATL:MiladPourhasan DATE: 12 July 2015
END of REPORT

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

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

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EXCLUSIONS: 7-3, 7-5-1-3 and 7-5-1-2-2 and 7-5-1-2-3 and 7-

Observation Form-018 – with uniquely specific identification:

ATL:MiladPourhasan DATE: 12 July 2015

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

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