BRSM Form 009 VRM

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

Assessment Report/Checklist
Form 009

CLIENT‐ORGANIZATION (NAME): Varesan_e_ rahe_e_ melal (VERMELL)
PHYSICAL LOCATION(s): No.158 , 159 – kharazmi sq.-mamouniyeh

industrial town-zarandiyeh-iran
Stage II Audit Date(s): 25 to 28 Nov.2015(4days)
Stage I Audit Date(s): 8 to 9 Nov.2015(2days)
NAICS (or NACE) CODE BRSM MDD Code: MD0102
EXCLUSIONS: lauses :7.3/7.5.1.2.2 / 7.5.1.2.3/7.5.3.2.2/7.5.4

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

ASSESSMENT TEAM INFORMATION
Assessment Team Leader, ATL Mr. Pourhassan
Assessor 2
Assessor 3
Assessor 4
Assessor 5
Technical Expert

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).
production of single use medical devices for blood transfusion includes : plasma
pheresis set , transfer bag , RBC washing set , blood letting bag and different kinds
of blood containers .
2 Scope of activities
Conventional blood collection bag , blood collection bags with BSA (single ,
double , triple , quadruple) , triple and quadruple blood collection bag with in line
filter and infant blood bag produced by OBL.
BRSM requires that the organization’s legal obligations and
regulatory are met. Who are the main responsible for executing
Legal status and monitoring of these regulations 
3 MoH Licence: has not yet recieved
ISIRI 4638-4 , MOH GMP requirements about A,B
Obligatory applicable standard which
organization has to follow
products 
4 Quality Management System
GENERAL REQUIREMENTS Interaction between processes is specified in VFQA17 and
Does the organization establish, document, implement, sequence of processes in VFQA18 determined. Criteria of
maintain and continually improve a Quality monitoring and measuring of processes is determined and be
Management System (QMS) with due consideration
given to identification of processes needed for the done.
QMS and their application throughout the system; Processes are: purchasing-sale-quality control-warehousing-
determination of sequence and interaction of these
maintenance and repairing of infrastructures-training and
4.1 processes, determination of criteria and methods
required to ensure effective operation and control of management processes are: analysis of data and continus 
these processes; availability of resources and improvement
information required to support the operation and
monitoring of processes; measurement, monitoring and
For control of performance of contractors producer of parts of
analysis of the processes; implementation of action to blood bag , is documented instruction of supervision of parts
achieve planned results and continual improvement producing :VWQC03.checkllist for control of contractors is
‐If any, are the outsourced processes are defined?
specified.
The Quality Manual (QM) was observed. All required
DOCUMENTATION REQUIREMENTS standards clauses have been mentioned.
Is there a documented quality policy and documented
quality objectives and are they appropriate?
They have developed quality policy (QP) by determining main
Is there a documented quality manual and are there targets including movement toward customer satisfaction,
documented procedures required by the standards?? focusing on product innovation, effective training for staff,
4.2
Are required records for planning, acting and controlling
processes efficiently available? increasing market share by increasing production & sales rate. 
Are the documents are created for every type of Quality Objectives (QO) have been determined according to
medical device including qms requirements and product the main targets of quality policy.
specifications? (4.2.3) If these documents are applicable
to manufacturing processes, are montage and service As sample, sales process’s index is customer satisfaction
defined? average and shall be calculated every six month.
Inputs are customer needs and output is installed products.
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 Page 2 of 17
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According to VQMQA02 : production of single use medical

devices for blood transfusion includes : plasmapheresis set ,
transfer bag , RBC washing set , blood letting bag and different
kinds of blood containers .
Conventionl blood collection bag , blood collection bags with
QUALITY MANUAL BSA (single , double , triple , quadruple) , triple and quadruple
Does the Quality Manual include, scope of QMS and blood collection bag with in line filter and infant blood bag
details of exclusion?
produced by OBL.
4.2.2 Are documented procedures reference to mandatory
procedures; production satages for OBL (Own Brand Labling) products are 
Is description of interaction of the processes included in : labling , visual chack , azot vacuum and cartooning.also blood
the QMS?
bags without anticoagolusion includes : transfer bags , plasma
pheresis , RBC washing set are produced
independently.Products of organization in new brand are not
yet received license of product from MOH and therefore can
not sales them. Old brand products that produced in old site
sold.
CONTROL OF DOCUMENTS
Are mandatory procedures documented?
Are control conditions pertaining to mandatory
documents proper?
Are review, update and re‐approval situations and
changes and current review situations for documents
traceable? Control of records procedure: VPQA05. Records are kept in
Are the relevant documents usable, readable and
4.2.3 recognizable at concerned usage points?
related archives. Such as records of final product qc should
Are outsourced documents defined? kept 3 years in current folder and 7 more years in Morgue
Are distribution of documents controlled, outdated folders.
documents prevented from being used and appropriate
definition method applied in case of being stored for
Back up interval is weekly, monthly. Seasonally and annually 
any purpose? in different situation. Such as communication records with
Are these subjects clear in the relevant procedure? IMED’s back up are weekly, back up for last two weeks has
CONTROL OF RECORDS been checked on Server, responsible is Mr sheykhi.
Are documents readable, easily recognizable and stored
in available manner?
Has a documented procedure been established and
4.2.4 applied for determination of required controls for
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
should be understood by all personnel?
Quality policy is available and management review is
5.1 Is a quality policy available?
Are quality objectives available? established. 
Is management review established?
Does the management provide required sources for
QMS?
CUSTOMER FOCUS
5.2
Does top management have methodologies to ensure
that customer needs and expectations are determined System for gathering of costumer feedback is established. 
and met for increasing customer satisfaction?
QUALITY POLICY
Has top management established a Quality Policy in Quality policy is approved by top management and
accordance with the objective of the organization? communicated is to staff and factory.
Does the Quality Policy include a statement of
Observance of pre requierments of GMP- increasing market
5.3 commitment to meeting requirements and continual
improvement of the QMS? share-increasing products and quality and productivity- 
Has the Quality Policy been revised for communication, development of applied research.
understanding and continuous compliance within the
body of the Organization?
Quality policy are reviewed annual.
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QUALITY OBJECTIVES
Are quality objectives established by top management
at relevant functions and levels within the organization?
Are the objectives measurable and consistent with the Organization objectives are approved 94.04.06. objectives are :
Quality Policy
20man/hours training for personnal – production of transfer
5.4 5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING
Has the QMS been planned by Top Management in blood bags 120000 – production of 2 new products – ontime 
order to meet the conditions and quality objectives delivery up to 3 days. Access time of objectives is specified.
detailed in Section 4.1?
When changes are initiated, is the integrity of the QMS
maintained during the change process?
5.5 Responsibility, Authority and Communication
Organization duties are documented. Technical supervisor and
RESPONSIBILITY AND AUTHORITY
Has top management identified responsibility and quality control manager is the same and are Responsible for
product release.
5.5.1
authority and been communicated within the
organization? 
Has top management defined responsibilities and
authorizations for CE marking?
MANAGEMENT REPRESENTATIVE Management representative is Dr. Sebt_e_ nabi

Has top management appointed a member as
Management Representative with responsibility and
5.5.2
authority to ensure that the processes of the QMS are
established, implemented and maintained; report to 
top management on the performance of the QMS,
including needs for improvement and promote
awareness of customer requirements?
internal phone and official letter & information board are the
INTERNAL COMMUNICATION
Has the top management ensured establishment of main methods for internal communication. Also the interaction
between job positions for making communication are
5.5.3
appropriate communication processes within the
organization? Has the top management ensured determined in procedures, work instructions and organization 
realization of communication considering the processes
of the QMS and their effectiveness? chart. A guideline code by MoH was available at aftersale
services and it was effectely documented
5.6 Management review
TOP MANAGEMENT REVIEW
Does top management review the QMS to ensure its
continuing suitability, adequacy and effectiveness at
regular and planned intervals?
5.6.1 Do reviews include assessing opportunities for
improvement including the need for changes to the
QMS, quality policy, and quality objectives?
Quality manual : VQMQA02

Are management review records kept?
REVIEW INPUT Management review commission was stablished on 94.08.06.
Does review input include current performance and Top management , management representative , factory
improvement opportunities related to: manager and trading manager are in commission.
a) results of audits;
b) customer feedback; Some of inputs was not observed such as: result of internal
5.6.2 c) process performance and product conformance; audit , result of corrective and preventive action and AR
d) status of corrective and preventive actions; improvement suggestion .
e) follow‐up action from earlier management reviews;
f) changes that could affect the QMS, Outputs of commission are: 20man/hours training , analysis of
g) recommendations for improvement data about costumer feedback to 1 year later and determining
h) New or revised regulatory rules?
of production objectives.
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
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PROVISION OF RESOURCES
Does the organization have methods to determine and
6.1 provide resources needed to implement and improve
the processes of the QMS and address customer
Resource needed to implement of processes are determined. 
satisfaction by meeting requirements?
6.2 Human Resources
Are personnel assigned with responsibilities that affect The job qualification are defined . Needed Skills are:
product quality competent on the basis of applicable
6.2.1 education, training, skills, and experience? awareness about GMPs-how to operate mashines producing of
Are trainings performed for achievement of Required products-
Competence? Education : at least diploma and 2 years work experience
Qualifying for technical supervisor : mastery of standards ,
education in one discipline of medical engineering ,
microbiology , pharmacy or polimer chemical and 5 years
work experience.
Qualifying for physics laboratory tests are: awareness af
equipments and related standards. Education is at least BS in
COMPETENCE, AWARENESS, AND TRAINING physics or chemistry or mechanics and 2 years work
Has the organization identified the experience, experience.
qualifications, competencies and skills of the personnel
performing activities affecting safety and efficiency of
Qualifying for head od microbial lab. : at least BS in
medical devices particularly being manufactured and microbiology or laboratory sciences. Skills are awareness 
provided to customer? about GMPs , sampling methods and microbial tests.
Is training provided by the organization to satisfy the
6.2.2 competency needs? Training records for head of physic laboratory observed .
Does the organization ensure that its employees are education is master of analytical chemistry , records of training
aware of the relevance and importance of their before recruitment : HPLC and training after that: ISO 13485.
activities and how they contribute to the achievement
of quality objectives? Records of training for head of microbial lab. are GMP , ISO
Are records of education, experience, training and 13485.
qualifications maintained? Certificate of internal audit for ms. Reza zadeh one of internal
auditors observed.
Training schedule for 1394 observed. For example : standards
of environmental standards for clean room 94.09.05
Effectiveness of training evaluation about ISO13485 for
production manager observed. Training course was effective
Check of For Nitrogen Vacuum packaging machine for v-pack

and primary packaging of blood bag is includes of: checking of
oil , setting of machine , vacuum pressure . records of this
INFRASTRUCTURE checking observed in 26th week of this year.
Has manufacturing equipment been designed, Schedule of preventive maintenance for lamin air hood in clean
constructed, properly established and placed for proper
operation, maintenance, adjustment and cleaning?
room to make suitable environment for primary packaging of
In case of applicability, has the organization ensured blood bag by aseptic method includes of : check of
documentation of natural limits or permissible electromotor about performance , shake , validation of hood is
tolerances in manufacturing process and measuring and
test equipment and availability of the same for planed annual and replacement of filter must be done every
2000 hours.
6.3
operators?
Are documented processes available for maintenance, Records for repair of air shower was observed. Action was : 
cleaning and control of all equipment used in
manufacturing process and control of work set of sysem.
environment? Approval of microbial safety cabinet (class 100) in production
Are required adjustments and maintenance intervals line according to BS EN12469 , ISO 14644-1 , FED STD
identified?
Is maintenance plan placed normally on or near the 209E was received 94.08.16. cabin is in grade of class 100 and
equipment and easily reachable? this report is valid to 12 mounts later. According to standard
Is maintenance realized based on the relevant plan? microbial count mist be up to 3 colony per M3 and results
shows that no colony.
Particle counting test result: no parts with size of 0.5um.
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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 Report of microbial limitation related to different places of
controlled during product manufacturing where sterile production line in 94.08.13 observed. This operation is done
Monitoring and measuring of environment procedure

product or pollution of solid particle which is stipulated
to be sterilized or could live or not live during its
after cleaning and disinfection. Some places was sampled such
manufacture or utilization is important? as: under hood. No colony observed , SDA:0.
Has exclusion been applied during all manufacturing Acceptance level of colony is not specified.
processes for a controlled environment? As valid
ground of exclusion, is pollution reduced to known,
Cleanroom operational qualification protocol ,
consistent and controlled level by an approved cleaning date:31.october.2015 , according to : standard : ISO 14644-3
method and packaging kept at this level through control Test result :
process?
Have indicators been identified for a controlled GMP Grade: calss D
environment which covers valid cleaning and packaging Differential pressure test: desired differential pressure(Pa) :
processes including the organizations holding a valid 7.5-15Pa , measured : 15Pa
6.4 cleaning process?
Temperature &relative humidity test result: AR
(Temperature, Humidity, Air Current, Filtration of Air,
Ionization of Air, Pressure differences, Lighting (along Desired (T): 22±2 c , measured : (in H1 ZONE): 22.3In place
with its spectral content and severity), Sound, Vibration, of one of filters in clean room , reported one bug. Corrective
cleaning of Working surfaces and processes, Water
quality, number of persons in the work environment) action was: correction of filter box and installation of new
Have dressing conditions, cleaning conditions and filter. Factory manager told provided this action be done 2
health conditions for any person being in contact with mounts later.
the product or the work environment including those
persons who enter the area sterilized prior to use or Before start of production , for every series production , status
temporarily or for a short period in terms of importance of production line must be checked for example: cleaning of
microbiologic cleaning holds been identified? salon , pressure of salon , cover staff , cleaning machines .
Are personnel to work in special work conditions or a
controlled environment provided with special training records for 94.09.02 before production of series production
and/or supervision? In the event that any personnel TSB9409021 observed.
including temporary and trained personnel for
performance of special tasks in a controlled
environment are assigned for performance of the works
such as production, maintenance, cleaning or repair, are
such personnel supervised by an appropriately trained
person? Have the procedures for product introduction,
product polluted or being likely to be polluted, manual
working for working surfaces or personnel, cleaning or
removal of contamination in order to prevent cross
pollution of product, work environment or personnel?
Are the records indicating appropriateness for all
conditions kept?
7 Product Realization
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PLANNING OF PRODUCT REALIZATION
Has the organization considered the scope of its own RBC washing set is produced from soft PVC according to
quality management system in planning of product American and uropean pharmacopoeia. Reference standard is
realization?
Has the organization prepared required records for a ISO 3826
proof indicating that quality objectives and product Risk analysis of RBC washing set :
rules, processes established, documents and product‐ Hazard1: leakage of bag. Consequence is contamination to
specific necessary resources, verification, validation,
tracking, measuring, inspection and product‐specific operator and environment. Risk level is 108. Control method :
Risk management instruction

test activities , realization processes and the product leakage test, strength test , centrifuge test.
meet the rules?
Hazard2: obstruction of hose. Consequence: error performance.
In the event that inspection and test are conducted by
manufacturing personnel, do inspection and test Risk level: 144. Control method: pressure release test.
results, processes, organization’s procedures ensure Risk analysis of blood bag with anticoagulant solusion (produced
impartiality of inspection and test results?
by OBL) is not observed.
7.1 Risk management
Reference standard for Bloog bag for collection and evanescence
AR
Has the organization prepared a procedure containing
all processes of product realization for risk management of blood from patient with poly cythemia : ISO 3826-1
activities and realized the following?
Keeping the records
Risk analysis for this product observed. This product produced
Preparation of Risk Management Plan by aseptic method . blood bag has already been prodeuced and
Determination of Risk team and its Responsibilities have expired date , in clean room re-packaged. Risks of this
Determination of Intended Use of Device and Safety
Characteristics of Device
products are the same of other blood bags.
Definition of hazards Risk analysis of plasma pheresis observed. Hazard1: obstruction
Risk Estimation for Hazards of cords. Consequence: error in performance. Risk level is 135.
Evaluation of Risks
Risk Control Measures
Control method: discharge under pressure.
Definition of Residual Risks Risk analysis of transfer blood bag observed. Hazard: using of
Risk/Benefit Analysis inappropriate material . consequence is skin allergy.
Preparation of Risk Management Report
DETERMINATION OF REQUIREMENTS RELATED TO THE
PRODUCT/SERVICE
Has the organization defined the requirements of
customer including the requirements for the activities
on delivery and after delivery?
Do these requirements include the following?:
‐ regulatory and legal requirements related to the Technical supervisor told new products in new brand is produced
countries and territories where the product is supplied
in new site . Products of organization in new brand are not yet
to the market
‐ anticipated utilization, received license of product from MOH and therefore can not
‐ Performance expectations, sales them. Old brand products that produced in old site sold.
‐ Design factors
Costumer order :
7.2.1 ‐ Delivery plans
Specified some blood bag with anticoagulant solution (sodium

‐Unclear customer expectations
Does the organization record customer’s expectations citrate 4%) is documented in sale department. After receiving of
related to product/service in order to revise the same?
In the event of any change in order or offer or both for
order sale expert checked inventory and was enough and
any reason whatsoever, are changes revised and an delivered to costumer.
agreement is reached on the changes as it is in original
order or offer?
In the event that changes are accepted, are all
personnel being affected by the changes within the
organization informed?
Are relevant documents affected by these changes
amended?
7.2 Customer‐Related Processes
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REVIEW OF REQUIREMENTS RELATED TO THE

PRODUCT/SERVICE
Does the organization review the requirements related
to the product?
Are review records kept?
Has this review been realized prior to commitment of
Review of orders is done after reciving of orders to ensure is
the organization for provision of the product to enough. Also time delivery check and be announced in
7.2.2 customer?
Has the organization ensured settlement of contract or
proforma . about order no. 3827 time delivery was 20 days 
order requirements which are different from previously
after order.
defined?
Does the organization have the ability to meet defined
requirements?
Are the results of review and subsequent follow‐up
actions recorded?
Products produced by OBL have lable consist of : name and
CUSTOMER COMMUNICATION address of main producer , lot no. , production date , expiry
Are arrangements for communication identified and
implemented relating to product information, demands, date , disposable , sterility method , instruction for use , name
of local producer , storage temperature and humidity
7.2.3
applications, contracts or realization of order including
amendments? Instruction for RBC washing set : VFQA19. Includes of : 
Are required arrangements identified and implemented
for customer feedback and communication with disposable , instruction for use , opening of packaging ,
customers including customer complaints? connection of parts.
7.3 Design and Development
DESIGN AND DEVELOPMENT PLANNING
Have the stages of design and/or development been
identified?
Have review, verification and validation activities
appropriate to each design and/or development stage,
7.3.1 responsibilities and authorities been identified in design
and development planning?
Are design and development planning updated when
planning output is appropriate and in the progress of
design and development?
DESIGN AND DEVELOPMENT INPUTS
Are inputs related to product requirements identified
and relevant records maintained?
Do these inputs include functional and performance
7.3.2 requirements, applicable regulatory and legal
requirements, applicable information derived from
previous and similar designs a any other requirements
essential for design?
Have the inputs been reviewed in terms of adequacy?
DESIGN AND DEVELOPMENT OUTPUTS
Are design and/or development outputs approved Excluded
before prior to release and in a manner that enables
verification against the design and/or development
inputs?
Do the design and/or development outputs meet the
7.3.3 design input requirements and
‐provide appropriate information for purchasing,
manufacture and service performance,
‐ contain or reference product acceptance criteria
‐ define the characteristics of the product that are
essential to its safe and proper use?
DESIGN AND DEVELOPMENT REVIEW
Does the organization identify suitable stages for
systematic reviews of design and/or development?
7.3.4 Are the results of review and subsequent follow‐up
actions recorded in order to evaluate the ability to
fulfill requirements and identify problems and
propose corrective actions?
DESIGN AND DEVELOPMENT VERIFICATION
7.3.5 Does the organization in planned arrangements ensure
that design output meets input criteria
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DESIGN AND DEVELOPMENT VALIDATION
Is the design and/or development validation performed
in accordance with planned arrangements to confirm
that final product is capable of meeting the
requirements of intended use or application
7.3.6 requirements defined?
Is verification completed (if applicable) prior to delivery
or implementation of product? Ara relevant records
maintained?
Are results of review and required actions recorded?
CONTROL OF DESIGN AND DEVELOPMENT CHANGES
Have design and development changes been identified
and recorded?
Have design and development changes been reviewed,
verified, validated and approved prior to
implementation?
7.3.7 Does the review of design and development changes
include evaluation of the effect of changes on
previously delivered product and the parts constituting
the product?
Are the results of review of changes and subsequent
follow‐up actions documented?
7.4 Purchasing
Purchasing Process; Has the organization prepared
documented process to ensure that purchased product
conforms to purchasing requirements?
Are criteria for selection of suppliers defined?
Are evaluation and reevaluation of suppliers have been
defined?
Purchasing procedure: VPBT01. About production produced
Has the organization defined tracking frequency of by OBL method , received data sheet of product and
supplier’s performance? anticoagulant solution and plastic material from main producer
Does the organization have the proofs indicating that
supplier monitoring activities, outsourced processes are
and until supplier no changes , that documents are enough.2
suppliers evaluated for purchasing of one of production
VWBT01
controlled and the products or services conform to the
mashine.Evaluation criteria are : to have certification of
7.4.1
rules of the organization containing customer demands
and regulatory rules?
product and license , ontime delivery.
AR
Have the requirements of purchasing information
(containing the rules related to supplier records) license for sterilization by supplier has not seen.
including outsourced processes been identified to Approval of import for supplier of lower lock female
ensure product and service quality?
Does the organization have the methodology to
observed.Import approval of blood bag with anticoagulant
communicate these requirements to the supplier? from MOH observed. This approval is traceable to lot no.
Are purchasing contracts available? Repack blood bags that used for production of transfer bag
Do the type and content of the control on supplier and
purchased product depend on the next product batch no. MRBB940901 and identification no. SRBB940830 ,
realization of purchased product or final product? purchased based on specification in FPR24-TB-030 and test
Are purchasing records retained? result of that on 94.09.01 observed. Tests are includes of: no
PURCHASING INFORMATION
Does purchasing information define the product to be
colony count and negative gram bacteri observed.
purchased?
Where appropriate, does purchasing information
Also test result of material includes : leakage test according to
include product approval, procedures, requirements for ISIRI 4638-4 not observed. blood bag imported only tested
based on dimention .
7.4.2
process and equipment, Personnel qualification and the
requirements of Quality Management System? 
How does organization ensure the adequacy of
specified requirements in the purchasing information
prior to their release to the supplier?
Are records for the information related to purchased
product available?
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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
and is free from any damage?
Do the processes include the provisions in order to
verify that incoming product is provided along with
support documentation (e.g. conformity certificates,
7.4.3 acceptance test reports)?
Has data been provided related to analysis of previous
acceptance inspection data, rejection history in the
plant or customer complaints, required inspection
quantity and necessity of reevaluation of supplier?
Has the organization identified the authorized person
for conformity approval of incoming material?
Are verification records retained?
7.5 Production and Service Provision
CONTROL OF PRODUCTION AND SERVICE PROVISION
7.5.1.1 General rules
Has the organization identified control requirements for
production and service process? The Production Work Instruction (WI01) has been developed.
Is control quantity and control detail level Production planning (FR01-WI01), parts needed request from
proportionate to criticality level of its process?
Has the characteristic qualities of product been storage (FR02-WI01) have been prepared.
identified? When required, have documented For example the records of production of Extreme-RS with
procedures, documented rules, work instructions and serial number of RS-131206 for “Dr. Khosravani clinic” in
reference materials reference materials and reference
measuring processes been made available? Tabriz city in 8-Jan-15 was observed.
Has appropriate equipment been selected in the Software with name of “FEEL DRCS” validation in report of
manner that enables process and product specifications STD-SW-01 was observed.
to be obtained?
Have the documents for using appropriate equipment Mechanical assembly of the device is executed in accordance
been established? with the instructions contained in the installation manual for
Has it been verified that new and/or significantly
modified equipment meets purchasing/design
the device.
specifications and posses the ability to operate within The methods of Calibration and setup for tubes and generators,
7.5.1 the limits defined and process operating limits?
Have control devices been identified?
detectors, have been determined according to the technical 
Has a document been prepared for using control
data from the equipment manufacturer.
devices? According to the Traceability & Identification Procedure
Have implementation and control requirements for (PR07), in final assembly after quality control of the finished
labeling and packaging been identified?
Are the records obtained during manufacturing process
product, the quality control responsible will assign a serial
of any product lot and facilitating traceability and number to the product and register it in FR01-PR07. For
review of the manufacture of this lot retained? example the registered serial number for Extreme - CS (Ceiling
Do the records include the following information?
‐ When applicable, quantity of raw materials,
Suspension) as CS-930501for “Milad Hospital” in Tehran was
components and intermediate products and lot observed. The product serial number is registered in invoice for
numbers of those materials, recall situation. Delivery of the product from this contract has
‐ When applicable, start and completion dates of
different stages of manufacture including sterilization
been done by “abi bar co.”.
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 According to Production procedure VPPR03 control duration
manufacturing process been adequately defined and production for TSB9409021 observed. This control involves :
labeled in order to prevent complexity and process
labling – primary assembling – second assembling – packaging
7.5.1.2.1 faults?
Have certain medical devices been cleaned and/or In first assembling : connections of blood bag was checked. 
cleared of contamination so as to prevent employees In second assembling visual check was done.
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 
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 
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?
Production produced by OBL (Own Brand Labling) , imported
sterilized . sterilization of blood collection bags with BSA ,is
done by approved supplier . blood letting bag is produced by
aseptic method . SOP for aseptic method is documented.
parameters of this process are acceptance criteria for colony
Special rules for sterile devices
count and air pressure under laminar hood. Report of
VPQC03
Does the organization record process parameters
environment monitoring duration of aseptic is not recorded.
7.5.1.3
related to sterilization process and used for each
sterilization lot? after this operation , production tested microbial. In this AR
Are sterilization records tracked for each production lot
related to medical devices? method production packaged in clean room with class 100 and
then tested microbial. If test result be positive , production
sent to another company to sterilization with thermal method.
for other productions installed sterilization machine . but this
machine is not yet runed and Temporarily sent to other
company for sterilization.
7.5.2 VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION
General rules
a)defined criteria for review and approval of the Validation must be done only for sterilization process. This
process
b)approval of equipment and qualification of staff
process for OBL productions be done by main producer and for
involved production with BSA is outsourced which is approved by
7.5.2.1 c) use of specific methods and procedures
d)records requirements
IMED. For other production Temporarily also is outsourced . 
e)revalidation
Contract between organization and supplier for sterilization
documented procedure for validation of process observed.according to this contract , doing tests of
software/computer applications, and records of microbial and endotoxin.
validation
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Special rules for sterile medical devices
Have sterilization processes been validated prior to
Procedure of sterilization validation VPQC03 is documented .
use? Result of sterilization test batch no.: VBL 9408231 on 94.08.23
7.5.2.2 Have the standards used for validation of sterilization
process been identified and implemented?
observed. This product produced by aseptic method. Calture 
Have the requirements in the Article no. 7.5.2.1 been
media for this test was T.G.B and growth of microbs observed
met? and this product identified non conform product.
7.5.3 Identification and Traceability
Identification
Has the organization identified and documented the
product through appropriate methods during product
7.5.3.1 realization?
How has the organization identified product situations
in accordance with tracing and measuring Production order for transfer blood bag on 94.09.01 observed.
requirements? Batch no: tsb9409021 and batch no. of material is recorded in
TRACEABILITY this. repacked blood bag with batch no. MRBB940901 , also 
75.3.2.1 General
How is the product traced? report of visual check .
7.5.3.2 Has any method been documented for traceability?
Does the organization ensure traceability of the medical
device during typically production and storage process
up to expiration of ownership?
Special rules related to active implantable medical
devices and implantable medical devices
Does the organization ensure traceability in inspection
and stock records for the changes of the personnel
performing a work traceability of which belongs to an
7.5.3.2.2 introductory (e.g. serial number, data code, lot code,
party number) special to operation source, changes in 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?
Status Identification
Non conforming product in final production warehouse has
7.5.3.3 Organization has identified status of product with
respect to measurement and monitoring requirements lable for status identification 
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?
PRESERVATION OF PRODUCT
Are methods and controls established to preserve
conformity of product during internal processing and
until delivery to intended destination? Warehouse , layout and handling procedure: vpsr01.
Has the organization established documented processes
or documented work instructions for control of the
Temperature of blood bag storate is 35ºc and must be keeped
product with limited shelf life or which requires special away from sunlight .
7.5.5 storage?
Are such special storage requirements controlled and
In primary material , material have main cover and have 
recorded?
identification lable with : lot no. , name , application ,
Does this preservation include definition, transport, temperature of storage .ax.: tube of blood bag must be kept in
packaging, storage and protection of the product and 1-30ºc and temperature of warehouse was 16ºc.
the parts constituting the product?
Is there a logo on product? Is it proper to its
instructions?
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CONTROL OF MONITORING AND MEASURING DEVICES
Has the organization identified the measurements to be
made and the measuring and monitoring devices
required to ensure conformity of product to specified
requirement?
a) Be calibrated or verified at specified intervals, or Control of monitoring and measuring devices procedure:
prior to use, against measurement standards traceable VPCA01. Calibration certificate for incubator x01017799
to international or national measurement standards;
issued in 94.07.01 and is valid to 1 year later.
7.6 where no such standards exist, the basis used for
calibration or verification s hall be recorded; This device id used for microbial tests. 
b) Be adjusted or re‐adjusted as necessary;
c) Be identified to enable the calibration status to be
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 Analysis of data procedure is documented. Mechanism of
8.1
processes required for conformity of the product and
QMS and improvement of its efficiency? customer feedback and analysis of data specified in this 
Are measurement, analysis and improvement procedure.
processes are carried out through statistical
techniques and applicable methods?
8.2 Monitoring and Measuring
8.2.1 CUSTOMER SATISFACTION No new brand production has saled. Because they have not
Does the organization monitor the information related
to customer perception in order to understand whether license from MOH. organization customer feedback, average is
8.2.1 customer requirements are met or not? 86%, and there is objective 90% for next year. Analisys of data 
Has the organization determined methodologies for is reviews by Mr Sebtonabbi on 20 Oct 2015.
obtaining and using information on customer
satisfaction and/or dissatisfaction?
INTERNAL AUDIT Planning of internal audit observed. Processes and units
Has a documented procedure been established that
includes responsibilities and requirements, audited are management-trading-training-safety and health-
requirements for planning and conducting the audit, warehouse-production-quality assurance.
reporting the results, maintaining the records? Observations of internal audit recorded in checklist. Subjects
VQIA01
Are audits planned in the form of an audit program?
about infrastructure , traceability , and sterilization is not
8.2.2
Does audit programme take importance and status of
the fields and processes to be audited including the completely recorded. AR
results of previous audits? About nonconformities has done corrective actions.
Do selection of auditors and implementation of audit
ensure objectivity and impartiality of the process?
Do auditors audit their works?
Do follow‐up actions cover verification of the measures
taken and reporting of verification results?
MONITORING AND MEASUREMENT OF PROCESSES
Does the organization implement appropriate methods Acceptance level for production process is according to
objectives. Some processes for example production is not yet
8.2.3
for monitoring QMS processes and where applicable,
for measurement such WMS processes? run completely and there for there is no enough data for 
When planned results are not achieved, is corrective
action taken for product conformity? measuring of process.
8.2.4 MONITORING AND MEASUREMENT OF PRODUCT
General rules
Does the organization establish appropriate stages to There is final product monitoring and measurment records by
measure and monitor product characteristics?
Have verification methods been documented? MR with batch VBL 9408231, microbiological test before and
Is this verification process realized in accordance with after sterilization has been observed reviewd by MR which is
the arrangements planned during appropriate stages of
technical supervisor of Iranian MOH representative on 16 Oct
8.2.4.1 product realization process?
Are conformity evidences along with acceptance criteria 2015. 
maintained? Controls during production is done according to quality plan.
Are the records approved by the authorized
person/persons in the process of product release?
Acceptance criteria for final product is specified in quality
Are product release and distribution of service, planned certificate blood bag
regulations (Article 7.1) completed satisfactorily?
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Special rules related to active implantable medical As Nature of the organization’s scope this clause is not

devices and implantable medical devices
8.2.4.2 Does the organization record the identity of the applicable.
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‐
In warehouse observed one sample nonconform product. For
conformity related to product? example: blood bag with batch no.: VBL 9408231 on 14 Oct
When applicable, do the processes identify the methods 2015 because of positive result of microbial test. Lable of non
8.3
authorizing the non‐conformity’s use, release or
acceptance in agreement with customer? conform product is on carton and must be sterilized under 
Are required measures taken to preclude the product’s temperature 90ºc in 1 hour. The production is sterilized on 16
original intended use or application? oct 2015 and grwoth is negative. NC has been reviews by MR
Are records related to the nature of nonconformities
and the measures taken later maintained? on 20th of Oct 2015.
Is corrected nonconforming product subject to re‐
verification to demonstrate conformity to the
requirements?
Do the processes ensure that appropriate corrective
action is initiated when non‐conforming product is
detected after delivery or use has started?
DATA ANALYSIS
Does the organization collect, identify and analyze
appropriate data to demonstrate efficiency and
appropriateness of QMS and the fields where QMS’s Records of data analysis has been observed as planned, about
efficiency can be continuously improved?
Has a documented procedure been prepared for these quality control process was observed. Criteria was ppm,
planned ppm is less than 150, and caculated PPM is 78 for first
8.4
analyses?


Do the characteristics and tendencies of the processes nine month of current year. All other data analysis has been
and products including data analysis, customer
satisfaction, conformance to product requirements, observed.
opportunities for corrective actions provide information
related to suppliers?
Have data types for data analysis been defined?
Are data analyses recorded?
8.5 Improvement
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CONTINUAL IMPROVEMENT
Has the organization identified required changes by
using quality policy, quality objectives, audit results,
analyses of data, corrective and preventive actions and
management review in order to ensure and sustain
ongoing conformity and efficiency of quality
management system and does the organization
implement such changes?
Has the organization established written procedures in
order that advisory warnings can be published and
implemented?
Are the records of all examinations related to customer
complaint maintained?
Have the complaints been evaluated within the scope of
the following points?: Improvement plan observed in records of management review
‐ whether the organization fails to comply with its own about increase of production’s quality, for that organization has
specifications or not,
a gantt chart and some actions such as: decreasing PPM with
8.5.1 ‐ whether the organization has caused problems to
occur despite the fact that it has complied with its own high accuracy raw material qc, verification of set up of press 
specifications systems every hour by qc 4 more items.
In the event that the activities outside the organization
are identified through examination of the contribution
of such activities to customer complaint, has the
relevant information been shared among responsible
organizations?
In the event that any customer complaint is not
followed up through a corrective and/or preventive
action, has the reason of this failure been confirmed
and recorded?
Has the organization established a documented
procedure for notifying adverse events and alertness
within the scope of after‐sale supervision activities?
Does the process comply with international guides?
(MEDDEV 2.12.1 – MEDDEV 2.12.2)
Are the notices for adverse events recorded
8.5.2. CORRECTIVE ACTION
Corrective and preventive

Is there a documented procedure for Corrective and
Preventive Action?
action procedure
Are corrective actions taken to eliminate causes of
nonconformities effective in preventing recurrences?
Does this procedure include the requirements of
8.5.2 reviewing non‐conformities (including customer
complaints), determining the causes of non‐conformity,
evaluating the actions needed to ensure that
nonconformities do not recur, determining and
According to validation report of clean room about filters ,
implementing the corrective action needed, and review there is no records of corrective action.
of the results of the action initiated?
Is adequacy of corrective‐preventive actions identified?
As MR said, there were no corrective action record because AR
PREVENTIVE ACTION
system is newly installed.
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
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
The awareness of identifying suppliers who affect on

Staff knowledge and skils
organization services quality.

action Request Type I Form-008 – as we indicate and that each of the RA addresses the basic four (4) questions
as seen in Form-008: N/A
action Request Type II Form-008 – as we indicate and that each of the AR addresses the basic four (4) questions
as seen in Form-008:
1‐some inputs(analysis) in management review was not recorded completely.
2‐records of corrective action about filters in clean room according to report 31.Oct.2015
3‐risk analysis for blood bag with anticoagulant solution was not seen
4‐acceptance level for colony count in microbial assessment of clean room is not specified
5‐ license for sterilization by supplier has not seen.
6‐ Report of environment monitoring duration of aseptic is not recorded.
7‐there is not complete records for Internal audit of some clauses of standard. Ex.: traceability and identification requirements.
Observation Form-018 – with uniquely specific identification: N/A
ATL: Mr. Pourhassan DATE: 28.Nov.2015
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

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PHYSICAL LOCATION(s): No.158 , 159 – kharazmi sq.-mamouniyeh

NAICS (or NACE) CODE BRSM MDD Code: MD0102

According to VQMQA02 : production of single use medical

MANAGEMENT REPRESENTATIVE Management representative is Dr. Sebt_e_ nabi

Quality manual : VQMQA02

Check of For Nitrogen Vacuum packaging machine for v-pack

Monitoring and measuring of environment procedure

Risk management instruction

REVIEW OF REQUIREMENTS RELATED TO THE

Special rules related to active implantable medical As Nature of the organization’s scope this clause is not

Corrective and preventive

The awareness of identifying suppliers who affect on

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

ATL: Mr. Pourhassan DATE: 28.Nov.2015

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

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