BRSM Form 009 Qms MDD Ps

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

Assessment Report/Checklist
Form 009

CLIENT‐ORGANIZATION (NAME): Paksaman Industrial Medical Group.
(SAMANASA CO. & PAKARIANAM CO.).

PHYSICAL LOCATION(s): Office: 5th floor of west block, Arian tower,
Mirdamad blvd., Tehran, Iran
Factory: Paksaman Plant, Ind. City, Zanjan,
Iran
Stage II Audit Date(s): 1,2,3 March
Stage I Audit Date(s): 3‐4 Feb 2016
NAICS (or NACE) CODE MD0103
NACE:32.5
EXCLUSIONS: 7.5.1.2.2, 7.5.1.2.3, 7.5.1.3, 7.5.2.2, 7.5.3.2.2

Assessment objectives: Attesting Company against ISO 9001:2008, IMED
REGULATION & ISO13485:2003

ASSESSMENT TEAM INFORMATION
Assessment Team Leader, ATL Milad Pourhasan
Assessor 1 Mojtaba Ramezani
Assessor 2 Shahabadi
TE MirzaHosseini
Witness Hodjat Allah Bagheri

Note: Adjusting the language within this form to the type of activity and nature of the organization is acceptable.
REFERENCE, AS
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Reference Clause Observations Verified,
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We pursuit to assure that client‐organization adheres to the protection of communities and consumers. This is to
1 follow the intent to the substitution of the word “identify” to the word “determine” as part of the importance to
the processes being capable of achieving desired outputs (including consumer’s well‐being).
Design & Product of the rehabilitation & ready orthosis including
R&D
Design
Cutting
Sewing
2 Scope of activities
Labeling
Packaging
Cartooning
Store
dispatch
BRSM requires that the organization’s legal obligations
Legal status and regulatory are met. Who are the main responsible
for executing and monitoring of these regulations?
3
No ISIRI requirements
Obligatory applicable standard which
IMED regulations 
organization has to follow
Certificate No. C02069
4 Quality Management System
GENERAL REQUIREMENTS Documentation requirements has been audited in stage
Does the organization establish, document, implement,
maintain and continually improve a Quality I and company documentation is as needs.
Management System (QMS) with due consideration Required processes has been identified such as process
given to identification of processes needed for the
QMS and their application throughout the system; ”Manaegment”
determination of sequence and interaction of these Input: such as Internal Audit report
4.1 processes, determination of criteria and methods 
required to ensure effective operation and control of Output: Management review outputs
these processes; availability of resources and
information required to support the operation and
Owner: MD
monitoring of processes; measurement, monitoring and Index: Percentage of fulfillment of Management review
analysis of the processes; implementation of action to
achieve planned results and continual improvement outputs
‐If any, are the outsourced processes are defined? For 1394, target is 80% and yield number is 100%
DOCUMENTATION REQUIREMENTS organization provided quality and safety policy in
Control of documents P102
Is there a documented quality policy and documented
quality objectives and are they appropriate? document M520 such as
Is there a documented quality manual and are there commitment to IMED regulation
documented procedures required by the standards??
Are required records for planning, acting and controlling manufacturing high quality materials
4.2 processes efficiently available? AR
Are the documents are created for every type of
Continual improvement in all processes of organization
medical device including qms requirements and product There is no backup system for R&D computers which
specifications? (4.2.3) If these documents are applicable
to manufacturing processes, are montage and service
contains drawings. SOPs, Technical files since eight
defined? month ago
Quality Manual M530 has been observed
QUALITY MANUAL Company referred to Quality Manual in section 5.3of
Does the Quality Manual include scope of QMS and
details of exclusion?
quality manual.
4.2.2 Are documented procedures reference to mandatory interaction of processes demonstrated in: annex I of 
procedures;
Is description of interaction of the processes included in quality manual such as, rejection of NC raw material
the QMS? order which is an output of QC and input of purchase
process
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 Page 2 of 20
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Has been
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In document with code L104 there are all internal and
external documents listed such as:
ISO 13485:2003, last check for new version 17 Jan 2016
CONTROL OF DOCUMENTS by Mrs. Toude as letter no ‫دا‬ – 2333 to Mr. Farzad.
Are mandatory procedures documented? Traceability records, retention ten years after
Are control conditions pertaining to mandatory
documents proper? production.
Are review, update and re‐approval situations and
changes and current review situations for documents
Shall be kept in Sales Department.
traceable? Shall be stamped with “‫”اعتبار دارد‬ in the documentation
Are the relevant documents usable, readable and
4.2.3 recognizable at concerned usage points?
Soft copy shall be back up in a portable hard drive. (as
Are outsourced documents defined? mentioned in technical file and control of document and
Are distribution of documents controlled, outdated
documents prevented from being used and appropriate control of record procedures)
definition method applied in case of being stored for Soft copy for September has been observed in Ms.
any purpose?
Toude room.
Are these subjects clear in the relevant procedure?
Procedure Customer feedback: P202
Distribution: sales, MR
Retention 5 years after being obsolete. 2 years in
current and 3 years in morgue
In document with code L104 there are all internal and
external records listed such as:
Annex ‫ب‬ of IMED Shall be kept in Technical Supervisor
CONTROL OF RECORDS Folder and Shall be stamped with “‫”اعتبار دارد‬ in the
Are documents readable, easily recognizable and stored
in available manner? documentation
4.2.4
Has a documented procedure been established and Soft copy shall be back up in a portable hard drive. (as 
applied for determination of required controls for
storage, retrieval, retention time and disposition of mentioned in technical file and control of document and
records? control of record procedures)
Has the archiving defined for at least 2 years?
Form Customer satisfaction measurement, shall be hold
2 year in current and 3 years in morgue and after that
shall be eliminated.
5 Management responsibility
MANAGEMENT COMMITTMENT
Has the top management ensured that requirement for
meeting customer conditions and legal conditions I asked Mr Farzad about his role in quality and legal
should be understood by all personnel?
conditions, he knew about recall, advisory notice,
5.1 Is a quality policy available? 
Are quality objectives available? production prevention, he knew about quality objectives
Is management review established? and quality policy.
Does the management provide required sources for
QMS?
Company uses Procedure customer feedback with code
CUSTOMER FOCUS
Does top management have methodologies to ensure P202, to ensure gathering all necessary data for customer
5.2 that customer needs and expectations are determined 
and met for increasing customer satisfaction?
expectations such as Kermanshah Retail Mohseni
Brothers which want to pay in three month conditions
QUALITY POLICY
Has top management established a Quality Policy in Quality policy set to be reviewed each year
Quality Manual
accordance with the objective of the organization?
Quality policy and objectives are related with each other
M530
Does the Quality Policy include a statement of
5.3 commitment to meeting requirements and continual through objective action plan form. AR
improvement of the QMS?
Has the Quality Policy been revised for communication, organization provided quality and safety policy in
understanding and continuous compliance within the document M530 such as
body of the Organization?
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commitment to IMED regulation
manufacturing high quality materials
QUALITY OBJECTIVES Continual improvement in all processes of organization
Are quality objectives established by top management Some of factory personnel did not know about quality
at relevant functions and levels within the organization?
Are the objectives measurable and consistent with the Policy, such as Mrs. Hashemi.
Quality Policy Objective: customer satisfaction
5.4 5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING
Has the QMS been planned by Top Management in Index: average of customer satisfaction (from 75 to 80)
order to meet the conditions and quality objectives
detailed in Section 4.1?
Action plan:
When changes are initiated, is the integrity of the QMS to recognize unsatisfactory factors through surveys
maintained during the change process?
root cause analysis
Sorting root causes regarding 20/80 rule
Planning to fulfill requirements asap
5.5 Responsibility, Authority and Communication
RESPONSIBILITY AND AUTHORITY
Based on the Organization Chart L116 and Responsibility
Has top management identified responsibility and and authority L114 all positions are defined and set to
authority and been communicated within the
5.5.1 organization? be reviewed each one year such as store responsible. 
Has top management defined responsibilities and Mr Farzad knew his exact responsibility and authority
authorizations for CE marking?
well and it was informed to him
MANAGEMENT REPRESENTATIVE
Has top management appointed a member as Mrs. Babei is technical supervisor and Mr. Farzad
Management Representative with responsibility and
authority to ensure that the processes of the QMS are appointed as MR. she performs her responsibility in
5.5.2 established, implemented and maintained; report to 
top management on the performance of the QMS,
accordance to promote the QMS and QMSMDD level in
including needs for improvement and promote the CO.
awareness of customer requirements?
Communication W101
INTERNAL COMMUNICATION For internal communication all personnel can use the
Has the top management ensured establishment of
appropriate communication processes within the telephone, fax, internet and also verbally meetings to
5.5.3 organization? Has the top management ensured 
realization of communication considering the processes
perform the processes. Such as ISO 13485:2003, last
of the QMS and their effectiveness? check for new version 17 Jan 2016 by Mrs. Toude as
letter no ‫دا‬ – 2333 to Mr. Farzad.
5.6 Management review
TOP MANAGEMENT REVIEW
Does top management review the QMS to ensure its The last management review has been held on Jan 2016
continuing suitability, adequacy and effectiveness at
regular and planned intervals? one week after internal audit.
5.6.1 Do reviews include assessing opportunities for
improvement including the need for changes to the
The inputs were as needed such as: Internal audit,
QMS, quality policy, and quality objectives? Processes analysis, Preventive and corrective actions,
Are management review records kept?
REVIEW INPUT
last IMED regulations.
Does review input include current performance and The outputs were decisions such as: 
improvement opportunities related to:
a) results of audits; Expanding Final product Store
b) customer feedback; Re‐training of factory personnel about ISO 13485:2003
5.6.2 c) process performance and product conformance;
d) status of corrective and preventive actions; Contracting with company “Toose Arad Tous” to have an
e) follow‐up action from earlier management reviews; investigation about trend of customer decrease in
f) changes that could affect the QMS,
g) recommendations for improvement Khorasan Razav
h) New or revised regulatory rules?
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REVIEW OUTPUT
Does output from management review include actions
related to improvement of the QMS and its processes,
5.6.3 improvement of product related to customer
requirements, actions and decisions relate to resource
needs?
6 Resource Management
Company uses Quality Manual M530 to be assuring that
PROVISION OF RESOURCES
Does the organization have methods to determine and resources such as humans, machines, materials are
6.1 provide resources needed to implement and improve provided. The conditions of current resources in the
the processes of the QMS and address customer
satisfaction by meeting requirements? format of reports are considered in management review
meetings.
6.2 Human Resources
Are personnel assigned with responsibilities that affect
product quality competent on the basis of applicable
Based on the Organization Chart L116 and Responsibility
6.2.1 education, training, skills, and experience? and authority L114 all positions are defined and set to
Are trainings performed for achievement of Required
Competence?
be reviewed each one year such as store responsible.
Mr Farzad knew his exact responsibility and authority
well and it was informed to him Job description for
Dispatch are:
1‐ ensuring packing list and loading items
COMPETENCE, AWARENESS, AND TRAINING
2‐ ensuring address
Has the organization identified the experience, 3‐ Calling sales department as soon as loader moved
qualifications, competencies and skills of the personnel
performing activities affecting safety and efficiency of from company.
medical devices particularly being manufactured and
provided to customer?
4‐ Checking insurance of loader 
Is training provided by the organization to satisfy the Mrs. Asna Ashari as dispatch responsible had all needed
6.2.2 competency needs?
Does the organization ensure that its employees are
properties and was assigned compatible.
aware of the relevance and importance of their The last consideration for needed training classes for
activities and how they contribute to the achievement
of quality objectives? dispatch responsible was ISO 13485:2003 requirements
Are records of education, experience, training and
qualifications maintained?
and store keeping which was on August 2016 and
September 2015.
(note: effectiveness was done after 1 months)
Effectiveness for was ISO 13485:2003 requirements is
83% and for store keeping is 100%.
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There are 243 items considered for PM for
manufacturing products.
The maintenance and repair procedure with code P503
INFRASTRUCTURE is written and PM is done in accordance with the plan.
Has manufacturing equipment been designed,
constructed, properly established and placed for proper Preventive maintenance is performed for some
operation, maintenance, adjustment and cleaning?
In case of applicability, has the organization ensured
machines monthly and for the ones with more
documentation of natural limits or permissible importance weekly such as "over lock swinger" machine
tolerances in manufacturing process and measuring and
test equipment and availability of the same for and also based on the cleaning work instruction in the
6.3
operators? beginning and end of working shifts with air compressor 
Are documented processes available for maintenance,
cleaning and control of all equipment used in and a piece of cloth wetted by 70% alcohol the " over
manufacturing process and control of work lock swinger" machine will be cleaned.
environment?
Are required adjustments and maintenance intervals Related records for “over lock swinger” for July and
identified?
Is maintenance plan placed normally on or near the October has been observed.
equipment and easily reachable?
Is maintenance realized based on the relevant plan? EM report for over lock swinger with code “1” because
of changing blade observed on 20/2/1394 and after this
EM, there is no more EM.
PM is strength point of this organization
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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  The GMP requirements in accordance with latest
product or pollution of solid particle which is stipulated
to be sterilized or could live or not live during its IMED regulations are designed and established
manufacture or utilization is important? effectively, as IMED regulation this company does
Has exclusion been applied during all manufacturing
processes for a controlled environment? As valid not need air conditioner, company uses interlock
ground of exclusion, is pollution reduced to known,
consistent and controlled level by an approved cleaning
system for entrances and loading. Temperature in
method and packaging kept at this level through control production lines and store were in control (records
process?
Have indicators been identified for a controlled for September and October has been observed. sun
environment which covers valid cleaning and packaging light shine in production lines after a UV protector.
processes including the organizations holding a valid
6.4 cleaning process? Additionally, the work instructions such as cleaning 
(Temperature, Humidity, Air Current, Filtration of Air,
Ionization of Air, Pressure differences, Lighting (along
and dressing for working in production lines with are
with its spectral content and severity), Sound, Vibration, performed (records for September and October
cleaning of Working surfaces and processes, Water
quality, number of persons in the work environment)
2015 has been observed),. Also personnel in factory
Have dressing conditions, cleaning conditions and and warehouse were under supervision with camera
health conditions for any person being in contact with
the product or the work environment including those to be performed 5S regulations.
persons who enter the area sterilized prior to use or  5S checklist for Novemebr and December 2015 has
temporarily or for a short period in terms of importance
microbiologic cleaning holds been identified? been observed.
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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Risk analysis procedure is P109, all identified risk shall be
review at least annually or in case of change in man, machine,
method and material.
There are 37 identified risk for ankle support and 32 identified risk
for Torso support with lock
Such as three below:
Bacterial and fungal infections microbial contamination
(there maybe, Pseudomonas, Staphylococcus and E. coli
PLANNING OF PRODUCT REALIZATION and Candida and Salmonella) in Raw materials item
Has the organization considered the scope of its own (lanolin), RPN is 24, control is controlling setup, QC, Post
quality management system in planning of product
realization? RPN is 12 with is in green area
Has the organization prepared required records for a
proof indicating that quality objectives and product
Bacterial and fungal infections in preservation Leather
rules, processes established, documents and product‐ microbial contamination RPN is 24, control is controlling
specific necessary resources, verification, validation,
tracking, measuring, inspection and product‐specific setup, QC, Post RPN is 12 with is in green area
test activities , realization processes and the product Bacterial and fungal infections microbial contamination
meet the rules?
In the event that inspection and test are conducted by resin, RPN is 20, control is controlling setup, QC, Post
manufacturing personnel, do inspection and test RPN is 10 with is in green area
results, processes, organization’s procedures ensure
impartiality of inspection and test results? Mis‐Use because of lack of awareness, RPN is 18,
7.1 Risk management 
Has the organization prepared a procedure containing providing information on website, VOC, qc for catalogue,
all processes of product realization for risk management
activities and realized the following?
advisory notice, post RPN is 8
Keeping the records clinical evaluations for Lock torso support from Imam
Preparation of Risk Management Plan
Determination of Risk team and its Responsibilities Khomeini Governmental Hospital has been observed on
Determination of Intended Use of Device and Safety
Characteristics of Device
letter on date 20 Feb 2016, sample sending date: July
Definition of hazards 2015, samples 10, result on Letter 884022 to IMED,
Risk Estimation for Hazards
Evaluation of Risks result OK
Risk Control Measures
Definition of Residual Risks
Evaluation of performance of same product has been
Risk/Benefit Analysis observed in a letter date 23 Feb 2016, result is Dr.
Preparation of Risk Management Report
Mohseni chief of orthopedic department of Ghods
Governmental Hospital is satisfied of result based on
mentioned letter.

For all the product types measuring and monitoring the
characteristics are performed based on SOPs of product
manufacturing and SOPs of stations. Such as over lock
swing work instruction in station No 11.
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DETERMINATION OF REQUIREMENTS RELATED TO THE
PRODUCT/SERVICE From F201, is customers order which include first call to
Has the organization defined the requirements of
customer including the requirements for the activities sending order to Customer thought ERP system.
on delivery and after delivery?
Do these requirements include the following?: Such as:
‐ regulatory and legal requirements related to the
countries and territories where the product is supplied Order No. 94-8022 contains 22 items such as:
to the market
‐ anticipated utilization, Hard Neck support L=25 Carton, Med=25 Carton,
‐ Performance expectations, Xl=10, S=10 Cartons
‐ Design factors
7.2.1 ‐ Delivery plans Wrist Support large and Med 10 Carton, S=15 carton and 
‐Unclear customer expectations
Does the organization record customer’s expectations XL= 5 cartons
related to product/service in order to revise the same?
In the event of any change in order or offer or both for Order No. 94-7922 contains 35 Items such as:
any reason whatsoever, are changes revised and an
agreement is reached on the changes as it is in original Simple back support L=5 Carton, Med=5 Carton, Xl=5,
order or offer? S=5 Cartons
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
REVIEW OF REQUIREMENTS RELATED TO THE
PRODUCT/SERVICE
Does the organization review the requirements related
to the product?
Are review records kept?
Has this review been realized prior to commitment of The company is committed to do the customer 5S logical
the organization for provision of the product to
changes to and that is indicated in the contract and by
7.2.2 customer? 
Has the organization ensured settlement of contract or the changes in the order the company receives the
order requirements which are different from previously
defined? changed order and informs it through ERP systems.
Does the organization have the ability to meet defined
requirements?
Are the results of review and subsequent follow‐up
actions recorded?
CUSTOMER COMMUNICATION
Are arrangements for communication identified and
implemented relating to product information, demands, The communication channels such as telephone, letter,
7.2.3
applications, contracts or realization of order including
amendments? fax, website and E‐mail are provided between the 
Are required arrangements identified and implemented company and the customers.
for customer feedback and communication with
customers including customer complaints?
7.3 Design and Development
DESIGN AND DEVELOPMENT PLANNING
Have the stages of design and/or development been Company has one D&D record for “Supports, Torso with lock”
identified?
Have review, verification and validation activities Inputs: R&D department gathered information from north of Iran
appropriate to each design and/or development stage, about a new need from their agency in there. On april 2015 on from
7.3.1 responsibilities and authorities been identified in design
and development planning? D&D inputs “F803”
Are design and development planning updated when
The project defined in F802, project control verified by CFT on April
planning output is appropriate and in the progress of
design and development? 2015 
DESIGN AND DEVELOPMENT INPUTS
Are inputs related to product requirements identified
Project reviewed and verified and validate as plan of this form, such
and relevant records maintained? as review on June which product has been sent to governmental
Do these inputs include functional and performance Hospitals for performance tests. (validation)
7.3.2 requirements, applicable regulatory and legal
requirements, applicable information derived from And before validation on may of 2015, CFT completed form
previous and similar designs a any other requirements “Technical information on early maps product design and
essential for design?
development” F804 for this product to ensure all desired outputs
Have the inputs been reviewed in terms of adequacy?
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DESIGN AND DEVELOPMENT OUTPUTS have been prepared by D&D team.
Are design and/or development outputs approved
before prior to release and in a manner that enables Such as OPC
verification against the design and/or development
inputs? SOPs and Master Sample
Do the design and/or development outputs meet the
7.3.3 design input requirements and Validation:
‐provide appropriate information for purchasing,
manufacture and service performance,
clinical evaluations for Lock torso support from Imam
‐ contain or reference product acceptance criteria Khomeini Governmental Hospital has been observed on
‐ define the characteristics of the product that are
essential to its safe and proper use? letter on date 20 Feb 2016, sample sending date: July
DESIGN AND DEVELOPMENT REVIEW 2015, samples 10, result on Letter 884022 to IMED,
Does the organization identify suitable stages for
systematic reviews of design and/or development? result OK
7.3.4 Are the results of review and subsequent follow‐up
Evaluation of performance of same product has been
actions recorded in order to evaluate the ability to
fulfill requirements and identify problems and observed in a letter date 23 Feb 2016, result is Dr.
propose corrective actions?
DESIGN AND DEVELOPMENT VERIFICATION
Mohseni chief of orthopedic department of Ghods
7.3.5 Does the organization in planned arrangements ensure Governmental Hospital is satisfied of result based on
that design output meets input criteria
mentioned letter.
DESIGN AND DEVELOPMENT VALIDATION
Is the design and/or development validation performed Technical file has been sent to IMED in date of 29
in accordance with planned arrangements to confirm
that final product is capable of meeting the February with No. 1394-‫ب‬-00144
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 The procedure of purchasing and suppliers assessment is
conforms to purchasing requirements? been performed and coded with M740
Are criteria for selection of suppliers defined?
Are evaluation and reevaluation of suppliers have been
defined?
The list of accepted suppliers are defined" L119" by
Has the organization defined tracking frequency of some factors such as quality, price, provision period,
supplier’s performance?
Does the organization have the proofs indicating that
distance and etc.
supplier monitoring activities, outsourced processes are
controlled and the products or services conform to the Pak Saman Uses two supplier in each items, and always
7.4.1
rules of the organization containing customer demands use one of them as main supplier.
and regulatory rules?
Have the requirements of purchasing information For the order No. 94-7922 to purchase the resin,
(containing the rules related to supplier records)
including outsourced processes been identified to supplier name is “salamat andishan” which have grade
ensure product and service quality?
Does the organization have the methodology to
"A" has been selected as the supplier. The purchase
communicate these requirements to the supplier? request issued through ERP system because of inventory
Are purchasing contracts available?
Do the type and content of the control on supplier and became less than order point, order point was 25 Liter
purchased product depend on the next product and order quantity is 200 liters. This observed in ERP
realization of purchased product or final product?
Are purchasing records retained? system of Parchakani.
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PURCHASING INFORMATION
Does purchasing information define the product to be
purchased?
The purchasing request includes the details and either
Where appropriate, does purchasing information there is a purchasing guide which has been derivative of
include product approval, procedures, requirements for
process and equipment, Personnel qualification and the purchased items before. The purchase request issued
7.4.2 requirements of Quality Management System? through ERP system because of inventory became less
How does organization ensure the adequacy of
specified requirements in the purchasing information than order point, order point was 25 Liter and order
prior to their release to the supplier? quantity is 200 liters. Purchase serial was 1009411184
Are records for the information related to purchased
product available? which means order came out from factory/ in eleventh
VERIFICATION OF PURCHASED PRODUCT
Has the organization identified a method in order to
year 1394 by system (automatically due to order point)
ensure that the product received conforms to the and number of order from factory in this year is 184 This
specifications, is finished, holds appropriate identity
and is free from any damage?
observed in ERP system of Ms. Parchakani. It has been
Do the processes include the provisions in order to verified by QC Mrs. Babei criteria is such manufacturing
verify that incoming product is provided along with
support documentation (e.g. conformity certificates, date, physical appearance, smell
7.4.3 acceptance test reports)?
Has data been provided related to analysis of previous Purchase Number 1009410123 has been observed for
acceptance inspection data, rejection history in the zips on Nov 2015, verification records has been observed
plant or customer complaints, required inspection
quantity and necessity of reevaluation of supplier? by Mrs. Babei
Has the organization identified the authorized person
for conformity approval of incoming material?
Are verification records retained?
7.5 Production and Service Provision
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Paksaman adjust production plans base on moving
average system and record of sale of same month of last
year which can be modified by sale manager and Mrs.
Naderi (factory manager) such as change requested by
Mr. Achak in neck support from 1500 to 1900 and
CONTROL OF PRODUCTION AND SERVICE PROVISION approved by Mrs. Naderi (factory manager) to
7.5.1.1 General rules
Has the organization identified control requirements for production plan in next day. Record of changing will
production and service process?
Is control quantity and control detail level
written by red color. Record has been observed by Mrs.
proportionate to criticality level of its process? Khatibi swing line manager
Has the characteristic qualities of product been
identified? When required, have documented
SOP of cutting has been asked from Mrs. Moradi, Cutting
procedures, documented rules, work instructions and operator and that was same as documented SOP.
reference materials reference materials and reference
measuring processes been made available? Quality control is done for the purchased raw material,
Has appropriate equipment been selected in the through the production and final products. The quality
manner that enables process and product specifications
to be obtained? plans which include the measurement method,
Have the documents for using appropriate equipment
been established?
conditions, tools and the other effective factors are
Has it been verified that new and/or significantly prepared in all three stages above. For the raw material
modified equipment meets purchasing/design
specifications and posses the ability to operate within
sampling method is established and implemented by
7.5.1 the limits defined and process operating limits?
Have control devices been identified?
technical supervisor as QC department and for the final 
Has a document been prepared for using control products either is done but 100% inspection is applied
devices? for the final products. For the semi‐manufactured
Have implementation and control requirements for
labeling and packaging been identified? products the production personnel do the planned tests
Are the records obtained during manufacturing process
of any product lot and facilitating traceability and
on qc tables before going to next station.
review of the manufacture of this lot retained? F302/01 is SOPs, for all production has been prepared
Do the records include the following information?
‐ When applicable, quantity of raw materials,
such as:
components and intermediate products and lot #7 for lower pregnancy Corset, Item 3, length of stick
numbers of those materials,
‐ When applicable, start and completion dates of shall be 8 Cm ± 0.5 cm
different stages of manufacture including sterilization Item 9 is packing, all items shall be inside
records,
‐ Quantity of manufactured product, Item 11 is jet print of batch on pack
‐ Signed results of all inspections and tests,
‐ Representation of production line used,
#34 for buckled Corset
‐ Any deviation from manufacturing specifications. Crystal length 18± 1.5 cms
#23 for neck support
No harsh curve on product, qc 5%, foreman 100% and
record of f301 has been checked on 30/10/1394
(December 2015)
packaging were controlled.
7.5.1.2 Control of production and service‐Special rules
Control of product cleanliness and contamination
Has the organization identified product cleanliness
rules?
Company uses online camera to monitor cleanness and
Have the materials and substances used during tidiness of factory
manufacturing process been adequately defined and
labeled in order to prevent complexity and process
Mrs. Nadri as Factory manager is in charge of cleaning,
7.5.1.2.1 faults?
Have certain medical devices been cleaned and/or
cleaning program is daily before and after work and on 
cleared of contamination so as to prevent employees Thursday disinfecting will be done such as record of 27
and other product from being exposed to any Feb 2016, QC table has been disinfected by 70%
contamination
Have cleaning and implementation requirements been alchohol by Mrs. Zandi
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 excluded
and/or calibrations?
Has the organization provided the instructions which
allow assembler to confirm proper operation of the
device?
Are the results of assembly or commissioning tests
recorded?
Service activities
In the event that functionality of products needs service
or maintenance for proper utilization of products, have
documented requirements been established for service
activity?
Has the organization identified service responsibilities
between distributors and users?
Have service activities carried out by the organization or
a separate agency been planned?
Have the design and functionality of equipment or
devices with special purpose related to manual
operation and service after assembly been validated?
7.5.1.2.3 Are measuring and test equipment used for site service excluded
and tests controlled?
Have instructions related to the lists of spare parts or
parts and for use in product service been prepared?
Has the infrastructure covering technical consultancy
and technical support, customer training and spare
parts or provision of parts been established?
Are service personnel trained?
Are specialized service personnel available?
Has the organization formed a system for receiving
customer demands so as to determine whether
customer complaints and rules are handled?
Are service records retained?
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
Are sterilization records tracked for each production lot
related to medical devices?
7.5.2 VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION
General rules
a)defined criteria for review and approval of the
process
b)approval of equipment and qualification of staff
involved
7.5.2.1 c) use of specific methods and procedures
d)records requirements
e)revalidation
documented procedure for validation of
software/computer applications, and records of excluded
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?
Have the requirements in the Article no. 7.5.2.1 been
met?
7.5.3 Identification and Traceability
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Identification is done by labels F420 for each packs and
Identification cartons, such as:
Has the organization identified and documented the
product through appropriate methods during product Crystal for bucked corset batch No on carton
7.5.3.1 realization? 50211216203446 its tracble to supplier and operators
How has the organization identified product situations
in accordance with tracing and measuring such as
requirements?
It has been celefoned on 16/8/1394 October 2015 on
first shift with operator 502, shift 1
For the order No. 94-7922 to purchase the resin,
supplier name is “salamat andishan” which have grade
"A" has been selected as the supplier. The purchase
request issued through ERP system because of inventory
became less than order point, order point was 25 Liter
and order quantity is 200 liters. This observed in ERP
TRACEABILITY
75.3.2.1 General system of Parchakani.
How is the product traced?
7.5.3.2 Has any method been documented for traceability? Identification is done by labels F420 for each packs and
Does the organization ensure traceability of the medical cartons, such as:
device during typically production and storage process
up to expiration of ownership? Crystal for bucked corset batch No on carton
50211216203446 its tracble to supplier and operators
such as
There is no record for recall
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 excluded
raw materials, changes in the works performed through
tools, new or different machine devices, changes of
process methods?
When applicable, are special personnel assigned to act
during processing medical device or each stage of
delivery traced?
Identification is done by labels F420 for each packs and
cartons, such as:
Status Identification Crystal for bucked corset batch No on carton
7.5.3.3 Organization has identified status of product with
respect to measurement and monitoring requirements
50211216203446 its traceble to supplier and operators
such as
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CUSTOMER PROPERTY
Does the organization ensure identification, verification,
protection and safety of customer property provided
for product or in the manner that it creates product
while it is under the organization’s control or being
7.5.4 used? excluded
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?
Raw Material warehouse was neat and clean
PRESERVATION OF PRODUCT I took samples to control inventory such as
Are methods and controls established to preserve
conformity of product during internal processing and 36 mg white fabrics, item code 1011-111, inventory 193
until delivery to intended destination? kg, inventory on ERP program was 193 kg too
Has the organization established documented processes
or documented work instructions for control of the Needle Item Code dv18, quantity 750, erp quantity 750
product with limited shelf life or which requires special too
7.5.5 storage?
All warehouse was Section Shelved.
Are such special storage requirements controlled and
recorded? Log of humidity and temretuer for warehouse has been
Does this preservation include definition, transport,
packaging, storage and protection of the product and observed.
the parts constituting the product? On final ware house item “bucked corset batch No on
Is there a logo on product? Is it proper to its
instructions? carton 50211216203446” inventory 5 carons, on erp it
was 5 cartons too
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 Entrance scale calibration certificate No. 941232s, has +1
requirement?
a) Be calibrated or verified at specified intervals, or
error which mentioned on scale
prior to use, against measurement standards traceable All internal meters has been verified before giving them
to international or national measurement standards;
to operators by reference meter. Such as M22, meter by
7.6 where no such standards exist, the basis used for
calibration or verification s hall be recorded; Mrs. Moradi cutting operator, has been verified on
b) Be adjusted or re‐adjusted as necessary; October 2015 by Mrs. Naderi with reference meter with
c) Be identified to enable the calibration status to be
determined; no error,
d) Be safeguarded from adjustments that would Certification for reference meter si No. 941230m
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 company measured and monitored all the processes
processes required for conformity of the product and
8.1 QMS and improvement of its efficiency? and products to be ensure of customer satisfaction and
Are measurement, analysis and improvement efficiency of QMS
processes are carried out through statistical
techniques and applicable methods?
8.2 Monitoring and Measuring
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The procedure of Customer feedback: P202 is being
performed at least two times in a year. In the last survey
the results of average of customer satisfaction were:
79%
Target was 80%
Analysis done by sale manager Mr. Achak, reason is
because price of paksaman is more than other Iranian
Made Brand because of quality and paksaman.
8.2.1 CUSTOMER SATISFACTION
Does the organization monitor the information related Company announced result online and put reason on
to customer perception in order to understand whether website.
8.2.1 customer requirements are met or not?
Has the organization determined methodologies for There are 95 customer complaints, Mr. Achak recorded
obtaining and using information on customer
satisfaction and/or dissatisfaction?
them on F207 such as:
Case 90, Mrs. Zahra Anvari complains about color of
corset, she wants pink corset, Achak reported to R&D

Case 75, from Hormozgan Retail, complaint wa about
price, Achak reported to Manager. Final act, company
approved to add one month to Hormozgan retails length
of credit (from 2 to 3 months)

The procedure of internal audit P107 is been
INTERNAL AUDIT
implemented to do the internal audit at least annually
Has a documented procedure been established that one was on (Jan 2016) 2015/11/25 and audit range was
includes responsibilities and requirements,
requirements for planning and conducting the audit, all processes and altogether there were 2 NCR and so 2
reporting the results, maintaining the records? corrective actions were defined.
Are audits planned in the form of an audit program?
Does audit programme take importance and status of Such as: corrective action 94‐23: there is no record of
8.2.2 the fields and processes to be audited including the
results of previous audits?
training for sales department new recruit Mrs. Zandi.
Do selection of auditors and implementation of audit Root cause, missing of Mrs. Taheri training Manager
ensure objectivity and impartiality of the process?
Do auditors audit their works?
Corrective action, letter from Mr. Farzad to Mrs. Taheri
Do follow‐up actions cover verification of the measures for a penalty
taken and reporting of verification results?
Correction, adjusting training course for her before end
Of march 2016
All processes are measured and monitored such as the
management index “Percentage of fulfillment of
MONITORING AND MEASUREMENT OF PROCESSES
Management review outputs” which is 100%
Does the organization implement appropriate methods MTBF is 0.01 hour which is less than excepted
for monitoring QMS processes and where applicable,
8.2.3 for measurement such WMS processes? Sales department shows decrease of sales in Khorsan so
When planned results are not achieved, is corrective in corrective action No 94‐18 it were to:
action taken for product conformity?
Contracting with company “Toose Arad Tous” to have an
investigation about trend of customer decrease in
Khorasan Razavy to understand root cause of decrease.
8.2.4 MONITORING AND MEASUREMENT OF PRODUCT
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General rules
Does the organization establish appropriate stages to
measure and monitor product characteristics?
Refer to 7.5.1
Have verification methods been documented? All samples were trace able to qc files such as:
Is this verification process realized in accordance with
the arrangements planned during appropriate stages of
record of f301 has been checked on 30/10/1394
8.2.4.1 product realization process? (December 2015) for neck support
Are conformity evidences along with acceptance criteria
maintained? F301 “bucked corset batch No on carton
Are the records approved by the authorized 50211216203446” has been checked By Mr. babaei on
person/persons in the process of product release?
Are product release and distribution of service, planned 1394/11/21 jan 2017
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 NA
personnel carrying out any inspection or test?
CONTROL OF NON‐CONFORMING PRODUCT
Does the organization have methodologies to ensure
that product that does not conform to requirements is
identified and controlled to prevent unintended use or
delivery?
Is there a documented procedure related to non‐
conforming product?
Does the organization take measures to remove non‐ There is no record for final product non-conforming as
conformity related to product? Mrs. Naderi factory manager says but there are raw
When applicable, do the processes identify the methods
authorizing the non‐conformity’s use, release or materials that Mrs. Babaie as QC rejected them such as:
8.3 acceptance in agreement with customer?
Case 102, Stain on band, order 137987 on 1394/11/09
Are required measures taken to preclude the product’s
original intended use or application? (Feb 2016) Mr. Amiri store of Band
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 All processes are measured and monitored such as the
Does the organization collect, identify and analyze
appropriate data to demonstrate efficiency and management index “Percentage of fulfillment of
appropriateness of QMS and the fields where QMS’s
efficiency can be continuously improved?
Management review outputs” which is 100%
Has a documented procedure been prepared for these MTBF is 0.01 hour which is less than excepted
analyses?
8.4 Sales department shows decrease of sales in Khorsan so

Do the characteristics and tendencies of the processes
and products including data analysis, customer in corrective action No 94‐18 it were to:
satisfaction, conformance to product requirements,
opportunities for corrective actions provide information Contracting with company “Toose Arad Tous” to have an
related to suppliers? investigation about trend of customer decrease in
Have data types for data analysis been defined?
Are data analyses recorded? Khorasan Razavy to understand root cause of decrease.
8.5 Improvement
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CONTINUAL IMPROVEMENT
Has the organization identified required changes by
using quality policy, quality objectives, audit results,
The PDCA is implemented in all processes and products.
analyses of data, corrective and preventive actions and The procedure of Customer feedback: P202 is being
management review in order to ensure and sustain
ongoing conformity and efficiency of quality
performed at least two times in a year. In the last survey
management system and does the organization the results of average of customer satisfaction were:
implement such changes?
Has the organization established written procedures in 79%
order that advisory warnings can be published and Target was 80%
implemented?
Are the records of all examinations related to customer Analysis done by sale manager Mr. Achak, reason is
complaint maintained?
Have the complaints been evaluated within the scope of
because price of paksaman is more than other Iranian
the following points?: Made Brand because of quality and paksaman.
‐ whether the organization fails to comply with its own
specifications or not,
Company announced result online and put reason on
8.5.1 ‐ whether the organization has caused problems to website.
occur despite the fact that it has complied with its own
specifications There are 95 customer complaints, Mr. Achak recorded
In the event that the activities outside the organization them on F207 such as:
are identified through examination of the contribution
of such activities to customer complaint, has the Case 90, Mrs. Zahra Anvari complains about color of
relevant information been shared among responsible
organizations?
corset, she wants pink corset, Achak reported to R&D
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
Case 75, from Hormozgan Retail, complaint wa about
and recorded? price, Achak reported to Manager. Final act, company
Has the organization established a documented
procedure for notifying adverse events and alertness approved to add one month to Hormozgan retails length
within the scope of after‐sale supervision activities? of credit (from 2 to 3 months)
Does the process comply with international guides?
(MEDDEV 2.12.1 – MEDDEV 2.12.2)
Are the notices for adverse events recorded
in corrective action No 94‐18 it were to:
8.5.2. CORRECTIVE ACTION Contracting with company “Toose Arad Tous” to have an
Is there a documented procedure for Corrective and
Preventive Action?
investigation about trend of customer decrease in
Are corrective actions taken to eliminate causes of Khorasan Razavy to understand root cause of decrease.
nonconformities effective in preventing recurrences?
Does this procedure include the requirements of
corrective action 94‐23: there is no record of training for
8.5.2 reviewing non‐conformities (including customer sales department new recruit Mrs. Zandi. Root cause,
complaints), determining the causes of non‐conformity,
evaluating the actions needed to ensure that missing of Mrs. Taheri training Manager
nonconformities do not recur, determining and Corrective action, letter from Mr. Farzad to Mrs. Taheri
implementing the corrective action needed, and review
of the results of the action initiated? for a penalty
Is adequacy of corrective‐preventive actions identified?
Correction, adjusting training course for her before end
Of march 2016
PREVENTIVE ACTION
Has the organization established a documented
procedure for preventive action with defined
requirements for identifying potential non‐conformities
and their causes; evaluating the need for action to
8.5.3 prevent occurrence; determining and implementing No record for preventive action
preventive action needed; recording results of action
taken; reviewing preventive action taken.
What are the methods for identifying the adequacy of
corrective‐preventive actions?

By exception, we indicate the specific Strengths and weakness of the organization in light of the management system, as we perceive and seen through
processes in reference to requirements of the criteria being ascribed as these apply and relate to the assessment plan and planning of the assessment.
This aspect relates to Accreditation Body as it does to the protection of consumers in the client-organization’s role within their respective supply – chain.
Disclaimers: (1) herein, we reiterate that any suggestion or opinion that the assessment team expresses does not construe to be a contractual
requirement. (2) The degree of certainty in conclusions increases by the competence of the assessment team as well as the attestation within the
assessment protocol, values, mission and vision under which we operate for the protection of consumers, still remains a certain level of uncertainty.
Strength Weakness
Preventive maintenance ‐
Cleanness of factory and final product warehouse ‐

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:
stage I: MRME -1-15: Supports, Torso with lock are a new production, clinical evaluations and/or evaluation of performance of the medical

device for this Item was not observed in technical file (this was stage I audit NC which has been removed effectively)
stage II: MRME -2-15: There is no backup system for R&D computers which contains drawings. SOPs, Technical files since eight month ago
Observation Form-018 – with uniquely specific identification:
ATL: Pourhasan DATE: 5-March 2016
END of REPORT

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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

BRSM Form 009 Qms MDD Ps

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stage I: MRME -1-15: Supports, Torso with lock are a new production, clinical evaluations and/or evaluation of performance of the medical

stage II: MRME -2-15: There is no backup system for R&D computers which contains drawings. SOPs, Technical files since eight month ago

Observation Form-018 – with uniquely specific identification:

ATL: Pourhasan DATE: 5-March 2016

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

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