Assessment Report/Checklist: Isfahan, Iran

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

Assessment Report/Checklist
Form 009

CLIENT‐ORGANIZATION (NAME): SEPAHAN BEHBOOD PARSA CO.
PHYSICAL LOCATION(s): No.127, No.9 St., No.1 AVE., JEY Ind. Town,
ISFAHAN, IRAN
Phase II Audit Date(s): 14, 15 Jun 2015
Phase I Audit Date(s): 6 Jun 2015
NAICS (or NACE) CODE 32.5
EXCLUSIONS: 7-3, 7-5-1-2-2, 7-5-1-2-3, 7-5-2-1, 7-5-3-2-2,8-2-

4-2

Assessment objectives: Attesting that the requirements of ISO
13485,9001 have been met in client’s system to
protect consumers and meet legal requirements

ASSESSMENT TEAM INFORMATION
Assessment Team Leader, ATL MarjanAzadmanesh
Assessor 2 YasamanZehtab
Assessor 3 Hodjat Bagheri as observer
Assessor 4
Assessor 5
Assessor 6

Note: Adjusting the language within this form to the type of activity and nature of the organization is acceptable.
REFERENCE, AS
This Clause
APPLICABLE1
Has been
Reference Clause Observations Verified,
please Tick
mark √

We pursuit to assure that client‐organization adheres to the protection of communities and consumers. This is to
1 follow the intent to the substitution of the word “identify” to the word “determine” as part of the importance to
the processes being capable of achieving desired outputs (including consumer’s well‐being).
Production of Sterile & Non-Sterile Medical Gauzes & Bandages and
2 Scope of activities provision of EOG sterilization
BRSM requires that the organization’s legal obligations

Legal status and regulatory are met. 
3 All products have license from MoH valid till June 2016
Obligatory applicable standard which SIRI 3061,ISIRI 583,ISIRI 11032 , ISIRI 3001-1, ISIRI

organization has to follow 5557 , ISIRI 3949
4 Quality Management System
The organization established needed documents in accordance
with ISO 9001:2008 And ISO 13485:2003
GENERAL REQUIREMENTS
Quality Manual SO-MA001 is established.
Does the organization establish, document, In accordance with quality manual (SO-MA001), the products
implement, maintain and continually improve a
Quality Management System (QMS) with due
in QMS Scope are as follows;
consideration given to identification of processes Simple Wound bandage, 16 layers cotton gauze (with or
needed for the QMS and their application throughout
the system; determination of sequence and
without Barium thread), 8 layers cotton gauze (with or without
barium), gauze sterile .long gauze, Vaseline gauze that use for
4.1
interaction of these processes, determination of
criteria and methods required to ensure effective skin burns. √
operation and control of these processes; availability
of resources and information required to support the Communication between processes in has been identified a
operation and monitoring of processes; measurement,
monitoring and analysis of the processes;
process map.( CH- MA001)
implementation of action to achieve planned results Data analysis procedure and required Forms are designed.
and continual improvement The documentation structure includes Manual, Procedures,
‐If any, are the outsourced processes are defined?
None of main activities which affect production process has not

been outsourced
DOCUMENTATION REQUIREMENTS
Is there a documented quality policy and documented
Quality Manual SO-MA001, Quality policy FO-MA010 and
quality objectives and are they appropriate? Quality objectives FO-MA011are documented in appropriated.
Is there a documented quality manual and are there
documented procedures required by the standards??
standard Licenses and permits production
4.2
Are required records for planning, acting and the master list form observed and checked, the errors from √
controlling processes efficiently available?
Are the documents are created for every type of document review had been all resolved
medical device including qms requirements and
product specifications? (4.2.3) If these documents are
applicable to manufacturing processes, are montage
and service defined?
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 Page 2 of 19
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

Quality Manual SO-MA001 is established. clauses

QUALITY MANUAL
7-3, 7-5-1-2-2, 7-5-1-2-3, 7-5-2-1,7-5-3-2-2,8-2-4-2 are
Does the Quality Manual include, scope of QMS and excluded
details of exclusion?
Documented mandatory procedures Are referenced to in √
4.2.2 Are documented procedures reference to mandatory
procedures; Manual,
Is description of interaction of the processes included
in the QMS?
Communication between processes in has been identified a
process map.( CH- MA001)
Number of revision is 01 at 2012
CONTROL OF DOCUMENTS
Are mandatory procedures documented?
Are control conditions pertaining to mandatory
documents proper? All mandatory procedure are documented
Are review, update and re‐approval situations and
changes and current review situations for documents
Document Control procedure WP‐QA001 is established. The
traceable? method of approval documents is defined in this procedure,
Are the relevant documents usable, readable and
4.2.3 recognizable at concerned usage points? documents are coded and classified base on Document Control √
Are outsourced documents defined? procedure.
Are distribution of documents controlled, outdated
documents prevented from being used and List of documents observed that including the distribute
appropriate definition method applied in case of being documents.
stored for any purpose?
Are these subjects clear in the relevant procedure?
Record control procedure WP‐QA‐002 is established.

CONTROL OF RECORDS
Are documents readable, easily recognizable and Storage, retrieval, retention time is 3 years for obsolete
stored in available manner? documents and disposition of records has been defined in the
Has a documented procedure been established and
4.2.4 applied for determination of required controls for procedure, the electric documents are copied every 6 months to √
storage, retrieval, retention time and disposition of back ups
records?
Has the archiving defined for at least 2 years? Also the tests samples as part of Quality system saved for 3
years in laboratory.
5 Management responsibility
MANAGEMENT COMMITTMENT
Has the top management ensured that requirement
for meeting customer conditions and legal conditions Management has approved Quality Policy, Quality manual and
should be understood by all personnel?
Quality Objectives.
5.1 Is a quality policy available?
Are quality objectives available? Management commitment is proved through Sources √
Is management review established?
Does the management provide required sources for
assignment For QMS/QMSMDD.
QMS?
CUSTOMER FOCUS
5.2
Does top management have methodologies to ensure
that customer needs and expectations are determined relate to 7.2.1 and 8.2.1 √
and met for increasing customer satisfaction?
Quality policy principle (FO-MA010)was established in
QUALITY POLICY
Has top management established a Quality Policy in
2015(94/6/24):
accordance with the objective of the organization? Provide safe and high quality products at the level of national
Does the Quality Policy include a statement of
and international standards, increase customer satisfaction
5.3 commitment to meeting requirements and continual √
improvement of the QMS? levels and the interested parties ,to reduce consumption of non-
Has the Quality Policy been revised for
communication, understanding and continuous
renewable energy sources, reduce environmental pollution,
compliance within the body of the Organization? compliance processes, and products with legal regulations,
provide timely delivery of goods
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

The quality objective FO-MA011 has been established.

Reducing waste, preserving the effectiveness of the quality
management system, increasing staff awareness and ability.
As an example:

policy Target targ plan
indicator et
Improve quality Receiving

production Long
gauze and
sterile
gauze
license
Increased levels of customer 93 Timely

customer satisfactio to supply of
satisfaction and n score 95 raw
interested parties material
QUALITY OBJECTIVES s for
Are quality objectives established by top management producti
at relevant functions and levels within the
on
organization? Are the objectives measurable and
consistent with the Quality Policy
5.4 5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING Reduce waste The 5% Personn √
Has the QMS been planned by Top Management in amount of to el
order to meet the conditions and quality objectives 2% training
detailed in Section 4.1?
waste
When changes are initiated, is the integrity of the and
QMS maintained during the change process? mechani
sms
designe
d to
convert
waste
into gas
fabric or
graph
Reduce the Productio 0.1 Turning

consumption of n/electric % off the
non-renewable power to air
energy sources consumpti 0.0 condition
on ratio 5% ing and
lights
after
work is
done

5.5 Responsibility, Authority and Communication
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

Job description, job skills (WI-FA001 ) and organization

chart are defined appropriately, Job Description Forms
RESPONSIBILITY AND AUTHORITY
Has top management identified responsibility and for MR and QC Manager was observed.
authority and been communicated within the
5.5.1 organization? Management approved job description and Organization √
Has top management defined responsibilities and chart.
authorizations for CE marking?
The technical supervisor and management representative
responsibility observed
MANAGEMENT REPRESENTATIVE
Has top management appointed a member as
Management Representative with responsibility and
Director manager has appointed Mrs. Sttar Zadehas MR to
5.5.2
authority to ensure that the processes of the QMS are establish, implement, and maintain the QMS,QMS MDD √
established, implemented and maintained; report to
top management on the performance of the QMS,
and to report the performance of the QMS ,QMS MDD and
including needs for improvement and promote promote awareness .
awareness of customer requirements?
Internal communication is done properly verbally and

INTERNAL COMMUNICATION through email and written correspondence, no records
Has the top management ensured establishment of
appropriate communication processes within the resulting of ineffective communication have been seen so
5.5.3 organization? Has the top management ensured this shows the effectiveness of communications √
realization of communication considering the processes
of the QMS and their effectiveness? As sample the legal requirement about sterile device
packaging observed.
5.6 Management review
TOP MANAGEMENT REVIEW Management Review meeting was conducted in
Does top management review the QMS to ensure its
continuing suitability, adequacy and effectiveness at
accordance with plan and management review procedure
regular and planned intervals? PO-MA001.
5.6.1 √
Do reviews include assessing opportunities for
improvement including the need for changes to the
Management review meeting is held every six month
QMS, quality policy, and quality objectives? and last meeting was on 94/03/30( May2015)
Are management review records kept?
REVIEW INPUT
Does review input include current performance and All relevant inputs are discussed in the meeting for
improvement opportunities related to:
a) results of audits; examples changes that could affect the QMS such as
b) customer feedback; changing clean rooms ventilator in March 2015,(for
5.6.2 c) process performance and product conformance;
ensuring the performance of new ventilator check list √
d) status of corrective and preventive actions;
e) follow‐up action from earlier management reviews; was filled out one a week in April 2015 by PM unit),
f) changes that could affect the QMS,
g) recommendations for improvement
h) New or revised regulatory rules?
Following decisions were made in the meeting:
REVIEW OUTPUT Make effort to receive elastic bandage standard license
Does output from management review include actions
related to improvement of the QMS and its processes,
from standard organization - training new personnel-
5.6.3 improvement of product related to customer inventory control through continuous production-launch √
requirements, actions and decisions relate to resource
needs?
all medical gas station -reduced, FIFO…

6 Resource Management
PROVISION OF RESOURCES
Does the organization have methods to determine and
6.1 provide resources needed to implement and improve Refer to 6.2 and 7.4 √
the processes of the QMS and address customer
satisfaction by meeting requirements?
6.2 Human Resources
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

Are personnel assigned with responsibilities that affect
product quality competent on the basis of applicable
Training procedure is documented.
6.2.1 education, training, skills, and experience? Courses that are planned in the first half of 94 are as √
Are trainings performed for achievement of Required
Competence?
follows: methods of production and control
characteristics associated with the production (2/28/94)
COMPETENCE, AWARENESS, AND TRAINING
Has the organization identified the experience,
risks associated with the production (03/27/94) - GMP
qualifications, competencies and skills of the personnel and quality policy (03/15/94).
performing activities affecting safety and efficiency of
medical devices particularly being manufactured and
The courses were held timely.
provided to customer? The Cutting station operator score of GMP and quality
6.2.2
Is training provided by the organization to satisfy the
competency needs?
policy (conducted on 2 May 2015(03/12/94) was 80%. √
Does the organization ensure that its employees are
aware of the relevance and importance of their The effectiveness of the courses was evaluated. The
activities and how they contribute to the achievement
of quality objectives? evaluation records of GMP and quality policy for
Are records of education, experience, training and production staff was observed. Cutting station operator
qualifications maintained?
evaluation score was 75%
Manufacturing equipment have been designed,
constructed, properly established and placed for proper
operation.
INFRASTRUCTURE
Has manufacturing equipment been designed, To ensure the proper functioning of air conditioner filters
constructed, properly established and placed for proper (HEPA) in the clean room, particle tests and periodic
operation, maintenance, adjustment and cleaning?
In case of applicability, has the organization ensured tests have been conducted annually.
documentation of natural limits or permissible
tolerances in manufacturing process and measuring and
Maintenance program (in accordance with repair and
test equipment and availability of the same for maintenance procedure WP-TE001) of heating and
6.3
operators?
Are documented processes available for maintenance,
cooling air conditioner and sterile chamber were √
cleaning and control of all equipment used in observed.
manufacturing process and control of work
environment? In this program and related checklists, items such as
Are required adjustments and maintenance intervals control of 3-phase motor, belts, filters, bearings, water
identified?
Is maintenance plan placed normally on or near the pumps, heating boiling were checked.
equipment and easily reachable?
Is maintenance realized based on the relevant plan?
The form of maintenance activities (FO-TE004) of
production salon air conditioner was observed. Also
profile of air conditioner (FO-TE001), device code
DS031 was observed.
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

WORK ENVIRONMENT
Does the organization identify and manage required
work environment needed to achieve conformity of
product?
Are the following factors which could affect product
quality in the work environment identified?
‐ Process equipment,
‐ Work environment,
‐ Personnel in this work environment
Are qualified and quantified limit values of the work
environment identified for a desired quality of the work
environment?
Are pollution levels of microbial and solid particles
controlled during product manufacturing where sterile
product or pollution of solid particle which is stipulated
to be sterilized or could live or not live during its
manufacture or utilization is important? The overall work environment of company is decent.
Has exclusion been applied during all manufacturing
processes for a controlled environment? As valid
Cleaning check list for folding machine were observed.
ground of exclusion, is pollution reduced to known, GMP principle and requirements is implementing. Just in
consistent and controlled level by an approved cleaning
method and packaging kept at this level through control one case there is a nonconformities the storage Pallet is
GMP requirements
process? wooden.
Have indicators been identified for a controlled
environment which covers valid cleaning and packaging Periodic health care examinations of staff that are in
processes including the organizations holding a valid
direct contact with the products have been conducted by 2
6.4 cleaning process?
(Temperature, Humidity, Air Current, Filtration of Air, the Provincial Health Center. Health cards of production AR
Ionization of Air, Pressure differences, Lighting (along
with its spectral content and severity), Sound, Vibration,
personnel in the clean room were issued on
cleaning of Working surfaces and processes, Water 12/25/93(March 2015).
quality, number of persons in the work environment)
Have dressing conditions, cleaning conditions and
health conditions for any person being in contact with The record of Particle counting test (according to class 8
the product or the work environment including those
persons who enter the area sterilized prior to use or of ISO 14644-1) was not seen during assessment
temporarily or for a short period in terms of importance
microbiologic cleaning holds been identified?
Are personnel to work in special work conditions or a
controlled environment provided with special training
and/or supervision? In the event that any personnel
including temporary and trained personnel for
performance of special tasks in a controlled
environment are assigned for performance of the works
such as production, maintenance, cleaning or repair, are
such personnel supervised by an appropriately trained
person? Have the procedures for product introduction,
product polluted or being likely to be polluted, manual
working for working surfaces or personnel, cleaning or
removal of contamination in order to prevent cross
pollution of product, work environment or personnel?
Are the records indicating appropriateness for all
conditions kept?
7 Product Realization
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

All necessary procedures are established to planning

product realization.
Example
Description of operations of elastic bandage is
documented. 1. Preparation of Poly 2- weaving 3-
cutting 4- industrial over locks 5- rolling. 6. Cellophane
PLANNING OF PRODUCT REALIZATION packaging 6-carton packaging
Has the organization considered the scope of its own Risk analysis of the products was evaluated.
quality management system in planning of product
realization? Elastic bandage analysis risk:
Has the organization prepared required records for a
proof indicating that quality objectives and product risk severity probability Detectability Risk
rules, processes established, documents and product‐ degree
specific necessary resources, verification, validation,
tracking, measuring, inspection and product‐specific
test activities , realization processes and the product
meet the rules? Lack of proper 7 3 1 21
In the event that inspection and test are conducted by
stretching
manufacturing personnel, do inspection and test
results, processes, organization’s procedures ensure during use
impartiality of inspection and test results?
7.1 Risk management Improper width 7 2 1 14 √
Has the organization prepared a procedure containing and length of
all processes of product realization for risk management bandage
activities and realized the following?
Keeping the records
Preparation of Risk Management Plan
Determination of Risk team and its Responsibilities
Determination of Intended Use of Device and Safety
Characteristics of Device The risk assessment method was FMEA and the limited
Definition of hazards risk degree was 50 (RPN)
Risk Estimation for Hazards
Evaluation of Risks Appropriate controls have been identified according to
Risk Control Measures the elastic specification of this product. Records of
Definition of Residual Risks
Risk/Benefit Analysis Identification and assessment risks Such as, use of the
Preparation of Risk Management Report expired product, packaging damage, Failure to insert the
correct expiration date, unsanitary disposal of used
bandage were observed. Also the residual risks were in
labeling.
7.2 Customer‐Related Processes
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

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? In determining the product requirements, has the
Do these requirements include the following?:
‐ regulatory and legal requirements related to the organization considered Customer specific requirements
countries and territories where the product is supplied
to the market
The products is delivered at the point of production to
‐ anticipated utilization, client and has no post delivery services to clients by
‐ Performance expectations,
‐ Design factors
contracts
7.2.1 ‐ Delivery plans As the client selects the products already produced so the √
‐Unclear customer expectations
Does the organization record customer’s expectations client accepts the specification of the product. The orders
related to product/service in order to revise the same? are usually the numbers of the products ordered, with the
In the event of any change in order or offer or both for
any reason whatsoever, are changes revised and an routine specifications. As example the record of razavi
agreement is reached on the changes as it is in original hospital observed. In that order: 120 box long gauze
order or offer?
In the event that changes are accepted, are all needed and the delivery time was observed.
personnel being affected by the changes within the
organization informed?
Are relevant documents affected by these changes
amended?
REVIEW OF REQUIREMENTS RELATED TO THE Purchase unit accompany with QC review product-
PRODUCT/SERVICE
Does the organization review the requirements related related requirements from client, before committing to
to the product? accept the order, the organization ensures that can meet
Are review records kept?
the product requirements, check any requirements
Has this review been realized prior to commitment of
the organization for provision of the product to differing from routine products , through the process if
7.2.2 customer?
any requirement is changed this is communicated in √
Has the organization ensured settlement of contract or
order requirements which are different from previously written to managers/supervisors and then verbally to
defined?
Does the organization have the ability to meet defined
operational staff, in arrangement with production and the
requirements? storage raw materials available.
Are the results of review and subsequent follow‐up
actions recorded? As example the record of razavi hospital observed
CUSTOMER COMMUNICATION means for the organization communicating with the
Are arrangements for communication identified and
implemented relating to product information, demands,
customer are as follows: Telephone calls, emails, catalog
applications, contracts or realization of order including and letters,
7.2.3 √
amendments?
Are required arrangements identified and implemented
Specific Forms are design to records client orders.
for customer feedback and communication with The records of sold products are kept in case of advisory
customers including customer complaints? notices.
7.3 Design and Development are excuded
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 ‐‐‐ N/A
and development planning?
Are design and development planning updated when
planning output is appropriate and in the progress of
design and development?
DESIGN AND DEVELOPMENT INPUTS
Are inputs related to product requirements identified
and relevant records maintained?
Do these inputs include functional and performance
7.3.2 requirements, applicable regulatory and legal ‐‐‐‐ N/A
requirements, applicable information derived from
previous and similar designs a any other requirements
essential for design?
Have the inputs been reviewed in terms of adequacy?
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

DESIGN AND DEVELOPMENT OUTPUTS
Are design and/or development outputs approved
before prior to release and in a manner that enables
verification against the design and/or development
inputs?
Do the design and/or development outputs meet the
7.3.3 design input requirements and ‐‐‐‐ N/A
‐provide appropriate information for purchasing,
manufacture and service performance,
‐ contain or reference product acceptance criteria
‐ define the characteristics of the product that are
essential to its safe and proper use?
DESIGN AND DEVELOPMENT REVIEW
Does the organization identify suitable stages for
systematic reviews of design and/or development?
7.3.4 Are the results of review and subsequent follow‐up ‐‐‐‐ N/A
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 ‐‐‐‐‐ N/A
that design output meets input criteria
DESIGN AND DEVELOPMENT VALIDATION
Is the design and/or development validation performed
in accordance with planned arrangements to confirm
that final product is capable of meeting the
requirements of intended use or application
7.3.6 requirements defined? ‐‐‐‐‐ N/A
Is verification completed (if applicable) prior to delivery
or implementation of product? Ara relevant records
maintained?
Are results of review and required actions recorded?
CONTROL OF DESIGN AND DEVELOPMENT CHANGES
Have design and development changes been identified
and recorded?
Have design and development changes been reviewed,
verified, validated and approved prior to
implementation?
7.3.7 Does the review of design and development changes ‐‐‐‐‐‐ N/A
include evaluation of the effect of changes on
previously delivered product and the parts constituting
the product?
Are the results of review of changes and subsequent
follow‐up actions documented?

REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

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? Purchase procedure has been developed. When a supplier is
Has the organization defined tracking frequency of
supplier’s performance? selected, necessary work permits will receive. For example
Does the organization have the proofs indicating that technical documents (standard license) were received from
supplier monitoring activities, outsourced processes are
controlled and the products or services conform to the
Vaseline (soft paraffin) suppliers. Standard license been
7.4.1
rules of the organization containing customer demands issued in accordance with the national standard 3949 and is √
and regulatory rules?
Have the requirements of purchasing information
valid until 08/02/95(April 2016). Examples soft paraffin
(containing the rules related to supplier records) test report (dated June / 2015 batch number IPW94-51 )
including outsourced processes been identified to
ensure product and service quality?
received from suppliers was observed:
Does the organization have the methodology to
communicate these requirements to the supplier? TEST RESUL STANDARD
Are purchasing contracts available?
Do the type and content of the control on supplier and T
purchased product depend on the next product
realization of purchased product or final product? Penetration at 25ºc 144 ASTM –D937
Are purchasing records retained?
PURCHASING INFORMATION
Does purchasing information define the product to be Kinematic viscosity at 100ºc 5.8CST ASTM-D455
purchased?
Where appropriate, does purchasing information
Organic acid Passed ISIRI 3949
include product approval, procedures, requirements for
process and equipment, Personnel qualification and the
7.4.2 requirements of Quality Management System? Sulfure & sulfide Passed ISIRI 3949 √
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?
List of acceptable supplier includes 18 supplier was
VERIFICATION OF PURCHASED PRODUCT observed.
Has the organization identified a method in order to Also filled out evaluation check list for supplier were
ensure that the product received conforms to the
specifications, is finished, holds appropriate identity observed: carton Spadan with 71% score, cargo company
and is free from any damage? (JiTarabar) with 76%, Laksar calibration company with
Do the processes include the provisions in order to
verify that incoming product is provided along with 80%, textile of Arak with 84% were observed.
7.4.3
support documentation (e.g. conformity certificates, The purchasing info provided in BOM and purchasing √
acceptance test reports)?
Has data been provided related to analysis of previous order. As sample the textile purchasing order observed.
acceptance inspection data, rejection history in the And in qc record we observed the purchase verification.
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
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

characteristic qualities of products been identified and

CONTROL OF PRODUCTION AND SERVICE PROVISION documented
7.5.1.1 General rules
Has the organization identified control requirements for
examples:
production and service process? -The results of gauze sterile quality control with Barium
Is control quantity and control detail level
proportionate to criticality level of its process?
yarn (dimension 10*10, batch production 9404/6 on
Has the characteristic qualities of product been production date: 94/4/22(June 2015)) in bleaching stage
identified? When required, have documented
procedures, documented rules, work instructions and
were Observed. Two of the tests include testing the PH and
reference materials reference materials and reference Active surface material were mentioned in quality control
measuring processes been made available?
Has appropriate equipment been selected in the
records. PH: 6.92 (standard: up to 8) and there was not
manner that enables process and product specifications Active surface material.
to be obtained?
Have the documents for using appropriate equipment
been established? -Test report of elastic Bandage is issued on 17/06/93 by the
Has it been verified that new and/or significantly external laboratory.
modified equipment meets purchasing/design
specifications and posses the ability to operate within
7.5.1 the limits defined and process operating limits? √
Have control devices been identified?
Has a document been prepared for using control
Acceptable range result Checked
devices?
Have implementation and control requirements for due to standard items
labeling and packaging been identified?
Are the records obtained during manufacturing process ±2% poly %89 Material
of any product lot and facilitating traceability and
%11 ‫ و‬ester of
review of the manufacture of this lot retained?
Do the records include the following information? bandage
Lakra
‐ When applicable, quantity of raw materials,
components and intermediate products and lot
numbers of those materials, ±5% 386cm Stretched
‐ When applicable, start and completion dates of
different stages of manufacture including sterilization
records,
‐ Quantity of manufactured product,
‐ Signed results of all inspections and tests,
‐ Representation of production line used, The result of this report was failure to comply with the
‐ Any deviation from manufacturing specifications. standard. The appropriate corrective Action was taken.

7.5.1.2 Control of production and service‐Special rules
Cleanness of environment procedureWI-QA005is

established.
Cleaning checklist of clean rooms was observed.
Control of product cleanliness and contamination The material used for covering floor and walls are cleanable
Has the organization identified product cleanliness
rules? and do not absorb dusts, the entrance of staff is completely
Have the materials and substances used during isolated and in 2 stages staff change the cloths
manufacturing process been adequately defined and
labeled in order to prevent complexity and process The hygiene of personnel is at acceptable level and all staff
7.5.1.2.1 faults? have health examination cards from province health office √
Have certain medical devices been cleaned and/or
cleared of contamination so as to prevent employees The hygienic work instructions are based on control
and other product from being exposed to any checklists, staff do not use jewelry or cell-phones in
contamination
Have cleaning and implementation requirements been production line
documented? All products are produced in clean room and packaged and
transferred thru production to storage by pass box,
The services and cloakrooms are clean and in good situation
No wooden or cloth is found in clean room
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

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 the organization for accurate assembly, montage, tests
7.5.1.2.2
and/or calibrations? excluded N/A
Has the organization provided the instructions which allow assembler to confirm proper operation of the
device?
Are the results of assembly or commissioning tests recorded?
Service activities
In the event that functionality of products needs service or maintenance for proper utilization of products,
have documented requirements been established for service activity?
Has the organization identified service responsibilities between distributors and users?
Have service activities carried out by the organization or a separate agency been planned?
Have the design and functionality of equipment or devices with special purpose related to manual operation
and service after assembly been validated?
Are measuring and test equipment used for site service and tests controlled?
7.5.1.2.3 Have instructions related to the lists of spare parts or parts and for use in product service been prepared? excluded N/A
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?

the organization record process parameters related to sterilization process
and used for each sterilization lot
graft Gas sterile size 50 x 60, 4 layers, made from yarn 20 (batch number
930 960),production date 11/09/93 was observed records of sterilization
is issued on March 2015 Sterile report as follows:
Special rules for sterile devices
Following specifications are related to Indicator tape for ethylene oxide
Does the organization record with: LOT NO. : F48 / G415, class 5,
process parameters related to
sterilization process and used for
The color of tape changes to green. Sterilization process was verified
√

7.5.1.3 each sterilization lot? The amount The

Are sterilization records tracked for the end of the start of The duration Quantity of
of gas pressure Start time vacuum
each production lot related to fumigation fumigation of injection vacuum
consumed drop
medical devices? 5kg 10:5 9.55 0 9.45 780 9:25
The
The loss
The duration Since the The end of number of
he duration of after The duration of the
of the opening of air air
venting exposure presence of gas
quarantine the chamber injection injection
to gas
and refine
72 hours 16:12 16:10 3 times 15 0 5 hours
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
validation
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

In direct Microbial culture and of Microbial culture test

filter method, the result was negative.
The verification method is by use of Vials containing
Microbes, after sterilization, the vial is broken and if the
color changes it means that the sterilization is not ok, results
for 94/3/27(June 2015) observed.
The last report of remaining etalon oxide gas (in long gauze,
sterile) was issued in 94/3/27(June 2015)
Record of the emission of etilen Oxaide gauze (137-carton
Special rules for sterile medical devices and product number 16511005) was observed. Serial
Have sterilization processes been validated prior to
use? numbers from 23144 to 23280 was chose. Microbiology lab
7.5.2.2 Have the standards used for validation of sterilization results were observed in the series. 10 samples were tested. √
process been identified and implemented?
Have the requirements in the Article no. 7.5.2.1 been The tests include total count of bacteria and mold and yeast,
met? The number of bacteria, mold and yeast were 100.
Validation of process was documented for sterilization.
Sample of Microbial culture test filter method on sterile by
external Lab Harir Novin Sepahan for grafts gauze
(production date 94/03/25(June 2015),batch number
940403/2.) is as following :
Mesophilic aerobic bacteria: negative
Anaerobic bacteria: negative
Fungus-positive, as the result was positive sampling was
repeated.
7.5.3 Identification and Traceability
Identification
Has the organization identified and documented the
Instruction of trace and identify the product WI-PR001were
product through appropriate methods during product documented. And there is a place for rejected products to
7.5.3.1 realization? identified. √
How has the organization identified product situations
in accordance with tracing and measuring A gauze sterile with Barium yarn (dimension 10*10), batch
requirements? number 9404/6, production date: 94/4/22(June 2015)
sampled.
TRACEABILITY Records of sterilization of this product were observed
75.3.2.1 General
How is the product traced? including venting time: 55 minutes.
7.5.3.2 Has any method been documented for traceability? The completed ID card (number 7351) related to this √
Does the organization ensure traceability of the medical
device during typically production and storage process product With this card, the quality of raw material and test
up to expiration of ownership? results on the textile bleaching has been kept.

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
7.5.3.2.2 personnel performing a work traceability of which belongs to an introductory (e.g. serial number, data

code, lot code, party number) special to operation source, changes in raw materials, changes in the excluded n/a
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 procedure has been established.
Status Identification Non‐conforming products and all semi products are labeled according to
7.5.3.3 Organization has identified status of product with identification procedure.
respect to measurement and monitoring requirements We observed some product waiting for sterile process.

REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

CUSTOMER PROPERTY
Does the organization ensure identification, verification,
protection and safety of customer property provided
for product or in the manner that it creates product
Customer Property procedure WI-QA007 is established just
in case. there is no customer property in organization.
7.5.4
while it is under the organization’s control or being
used? As sample the “Pooshesh Teb Mani” order to sterile process √
Does the process ensure that occurrence of any
customer property that is lost, damaged or otherwise for 85 box as customer property at Feb 2015 observed.
found to be unsuitable for use are recorded and
reported to the customer?
methods and controls established to preserve conformity of
PRESERVATION OF PRODUCT
Are methods and controls established to preserve
product during internal processing and until delivery to
conformity of product during internal processing and intended destination
until delivery to intended destination?
Has the organization established documented processes
following were evaluated:
or documented work instructions for control of the Storage of bleaching textile was clean and textile was
product with limited shelf life or which requires special
covered by plastic .all batches have ID cart.
7.5.5 storage?
Are such special storage requirements controlled and Identification and traceability is possible √
recorded?
Does this preservation include definition, transport,
Inventory storage l is recorded appropriately as an example
packaging, storage and protection of the product and inventory of packaging nylon was 70 kg.
the parts constituting the product? Items are entered and exited in FIFO
Is there a logo on product? Is it proper to its
instructions? Storage general condition is appropriate with sterile product,
in case of temperature and moisture, 27c with 32% humidity
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 Laboratory equipment has been sent to calibration
requirement?
a) Be calibrated or verified at specified intervals, or
laboratories in accordance with calibration schedule.
prior to use, against measurement standards traceable Equipment calibration records for the previous period were
to international or national measurement standards;
observed. Measurement equipment Sterilizer devices such
7.6 where no such standards exist, the basis used for
calibration or verification s hall be recorded; as Autoclave and Laminar Hood, including pressure gauge
√
b) Be adjusted or re‐adjusted as necessary;
c) Be identified to enable the calibration status to be
is calibrated by Laksar on26/01/94.(15 April 2015)
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
organization implement the monitoring, measurement,
analysis, and improvement processes required for
General
Does the organization plan to implement the conformity of the product and QMS and QMS,MDD and
monitoring, measurement, analysis, and improvement improvement of its efficiency
8.1
processes required for conformity of the product and
QMS and improvement of its efficiency? Monitoring and measurement of the final product procedure √
Are measurement, analysis and improvement PO-QA004. Data analysis procedure WP-MA002) have
processes are carried out through statistical
techniques and applicable methods?
been established. And data analysis is carried out through
statistical techniques and applicable methods

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

Customer complaints procedure has been developed. Upon

receipt of the complaint by the head of sales, He will
determine which unit has to follow up the complaints. The
head of unit determines the cause of complaints in order to
achieve customer satisfaction. Then corrective action is
taken to resolve the root causes of complaint.
8.2.1 feedback
For example: One of the complaints was related to improper
Does the organization monitor the information related packaging 8 layers non-sterile gauze.
to customer perception in order to understand whether To fulfill customer satisfaction, the product with new
8.2.1 customer requirements are met or not?
Has the organization determined methodologies for packaging has been posted for client. Corrective action in √
obtaining and using information on customer this case, was retraining the staff.
satisfaction and/or dissatisfaction?
Records of satisfaction customer evaluation were observed

such as:
Customer - Mr. Riaziayn – wale edge bandage- Score 90%
Customer - Mr. Nik behavior - simple bandage - Score 81%
Customer - Mr. KargarRezaei– sterile gauze- rating 94%

INTERNAL AUDIT Internal audit procedure is documented (WPQA004) internal
Has a documented procedure been established that
includes responsibilities and requirements,
audit is done Every 6 months, audit criteria is defined base
requirements for planning and conducting the audit, on standard clauses, audit team includes technical supervisor
reporting the results, maintaining the records?
Are audits planned in the form of an audit program?
and quality control supervisor.
It is done on 94/3/20(may 2015), records are documented, 4
8.2.2
Does audit programme take importance and status of
the fields and processes to be audited including the non-conformities are recorded: the door of production salon √
results of previous audits?
Do selection of auditors and implementation of audit was open, production personnel wear ring, and some
ensure objectivity and impartiality of the process? machine was unclean after it was repaired. Effective and
Do auditors audit their works?
Do follow‐up actions cover verification of the measures appropriate corrective actions were taken.
taken and reporting of verification results?
Process indices are determined where the results of process measures
are shown in data analysis table and if the Acceptance criteria is not met,
corrective action is taken.
Measuring Results of production and training a process as follows:
MONITORING AND MEASUREMENT OF PROCESSES process Measuring Acceptance target result

Does the organization implement appropriate methods Indicator criteria
8.2.3
for monitoring QMS processes and where applicable,
for measurement such WMS processes? production The percentage 1% 0.02% 0.035%
√
When planned results are not achieved, is corrective
of waste
action taken for product conformity?
training Per capita 60 80 65

man/hour man/hour man/hour

8.2.4 MONITORING AND MEASUREMENT OF PRODUCT
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

(PO-QA004 )control and measure of products and (PO-

QA003) control and measure of row material Procedure are
establish in order to measure and monitor product
characteristic, row material, semi products and finished
products,
General rules Form FO-QA001 is filled out when the row material is enter
Does the organization establish appropriate stages to
measure and monitor product characteristics? to factory then QC controls the row materials in accordance
Have verification methods been documented? the Quality Plan and purchase information, if row material is
Is this verification process realized in accordance with
the arrangements planned during appropriate stages of acceptable QC will approved it.
8.2.4.1 product realization process?
Are conformity evidences along with acceptance criteria
Form FQ-QA001was filled out for Textile was received in √
maintained? 02April 2015. The textile specifications such as Thickness
Are the records approved by the authorized of yarn, color of textile, type of yarn were in acceptable
person/persons in the process of product release?
Are product release and distribution of service, planned criteria.
regulations (Article 7.1) completed satisfactorily? The qc of Barium thread in long Gauze was checked it was
approximately 0.55 in length to be detected in x-ray device
The sterility of product, packing (seal, labeling, expiration
date, advisory notices on label, compliance of product with
label) are as sample taken for control of quality of final
product with No. 94026/9 observed
Special rules related to active implantable medical
devices and implantable medical devices
8.2.4.2 Does the organization record the identity of the Excluded N/A
personnel carrying out any inspection or test?
CONTROL OF NON‐CONFORMING PRODUCT
Does the organization have methodologies to ensure
that product that does not conform to requirements is
identified and controlled to prevent unintended use or
delivery?
Is there a documented procedure related to non‐
conforming product?
Does the organization take measures to remove non‐
conformity related to product? In The inspection and test procedures, the methods of
When applicable, do the processes identify the methods detection and determination and responsibility to deal with
8.3
authorizing the non‐conformity’s use, release or
acceptance in agreement with customer? non-conforming product are documented. There is no non- √
Are required measures taken to preclude the product’s conforming product in the recent period.
original intended use or application?
Are records related to the nature of nonconformities
and the measures taken later maintained?
Is corrected nonconforming product subject to re‐
verification to demonstrate conformity to the
requirements?
Do the processes ensure that appropriate corrective
action is initiated when non‐conforming product is
detected after delivery or use has started?
DATA ANALYSIS
Does the organization collect, identify and analyze Data analysis procedure WP-MA002 is established,
appropriate data to demonstrate efficiency and Purchase must be made at specified intervals between the
appropriateness of QMS and the fields where QMS’s
efficiency can be continuously improved? time the storage staff sent request to purchase unit till the
Has a documented procedure been prepared for these material is receive in factory The acceptable deviation from
8.4
analyses?
the specified criteria is 5% . √

Do the characteristics and tendencies of the processes
and products including data analysis, customer The result of data analysis in 6 month shows 2% deviation
satisfaction, conformance to product requirements,
opportunities for corrective actions provide information which is acceptable.
related to suppliers? And supply evaluation was analyzed and that was good for
Have data types for data analysis been defined?
Are data analyses recorded?
company.
8.5 Improvement
REFERENCE, AS
This Clause
APPLICABLE1
Has been
please Tick
mark √

CONTINUAL IMPROVEMENT
Has the organization identified required changes by
using quality policy, quality objectives, audit results,
analyses of data, corrective and preventive actions and
management review in order to ensure and sustain
ongoing conformity and efficiency of quality
management system and does the organization
implement such changes?
Has the organization established written procedures in
order that advisory warnings can be published and
implemented? Continual improvement procedure is established PO‐MA002,
Are the records of all examinations related to customer based on this procedure The organization determined new
complaint maintained?
Have the complaints been evaluated within the scope of acceptable criteria to improve quality and accept of raw
the following points?: materials input.
‐ whether the organization fails to comply with its own
specifications or not,
8.5.1 ‐ whether the organization has caused problems to
occur despite the fact that it has complied with its own
Information and specifications of products listed on the √
specifications carton and original packing. This information is listed to
In the event that the activities outside the organization alert the consumer to the product. Including the date of
are identified through examination of the contribution
of such activities to customer complaint, has the production and expiry and sterile technique and etc
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
Is there a documented procedure for Corrective and
Preventive Action?
Are corrective actions taken to eliminate causes of
Corrective and preventive action procedure WP-QA003 is
nonconformities effective in preventing recurrences? documented.
Does this procedure include the requirements of
8.5.2 reviewing non‐conformities (including customer
complaints), determining the causes of non‐conformity, The records of corrective action where observed , √
evaluating the actions needed to ensure that As an example records of training production Staff to not
nonconformities do not recur, determining and
implementing the corrective action needed, and review wearing Ring or accessories during working with machines.
of the results of the action initiated?
Is adequacy of corrective‐preventive actions identified?
PREVENTIVE ACTION
Has the organization established a documented Corrective and preventive action procedure WP-QA003 is
procedure for preventive action with defined
requirements for identifying potential non‐conformities
documented. one corrective action has been taken in recent
period. It is decided the Blade of Cutting Machine be
8.5.3
and their causes; evaluating the need for action to
prevent occurrence; determining and implementing change every Six month in order to prevent Stop production √
preventive action needed; recording results of action
taken; reviewing preventive action taken. Line.
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
Market share Storage equipment

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:
1-The storage Pallets are wooden.

2-The record of Particle counting test was not seen during assessment.
Observation Form-018 – with uniquely specific identification:
ATL: Marjan Azadmanesh DATE: 15 Jun 2015
END of REPORT
FORM-014 – Opening Meeting Checklist FORM-009 – MS Reporting,

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

Assessment Report/Checklist: Isfahan, Iran

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Assessment Report/Checklist: Isfahan, Iran

Uploaded by

Copyright:

Available Formats

EXCLUSIONS: 7-3, 7-5-1-2-2, 7-5-1-2-3, 7-5-2-1, 7-5-3-2-2,8-2-

BRSM requires that the organization’s legal obligations

None of main activities which affect production process has not

Quality Manual SO-MA001 is established. clauses

Record control procedure WP‐QA‐002 is established.

The quality objective FO-MA011 has been established.

Improve quality Receiving

Increased levels of customer 93 Timely

Reduce the Productio 0.1 Turning

Job description, job skills (WI-FA001 ) and organization

Internal communication is done properly verbally and

All necessary procedures are established to planning

characteristic qualities of products been identified and

Cleanness of environment procedureWI-QA005is

7.5.1.3 each sterilization lot? The amount The

72 hours 16:12 16:10 3 times 15 0 5 hours

In direct Microbial culture and of Microbial culture test

Customer complaints procedure has been developed. Upon

Records of satisfaction customer evaluation were observed

MONITORING AND MEASUREMENT OF PROCESSES process Measuring Acceptance target result

training Per capita 60 80 65

(PO-QA004 )control and measure of products and (PO-

Market share Storage equipment

1-The storage Pallets are wooden.

Observation Form-018 – with uniquely specific identification:

ATL: Marjan Azadmanesh DATE: 15 Jun 2015

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

You might also like