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BRSM
System: ISO 9001:2008 , ISO 13485:2003
Assessment Report/Checklist
Form 009
CLIENT‐ORGANIZATION (NAME): Sanaye Felezi Pishgaman Atiyeh Sazan Salamat
Sahebzaman st. Khavaran road , 14th km. , tehran ,
PHYSICAL LOCATION(s):
Iran
Stage II Audit Date(s): 7‐8 May 2016
Stage I Audit Date(s): 8 April 2016
NAICS (or NACE) CODE MD0404, MD1109
EXCLUSIONS: 7.5.1.2.2‐7.5.1.2.3‐7.5.1.3‐7.5.2.2‐7.5.2.2.2‐ 8.2.4.2
Assessment objectives: Third party assessment of requirements of ISO 9001:2008 ,
ISO 13485:2003 , is met in companies management system,
as well as legal requirements
ASSESSMENT TEAM INFORMATION
Assessment Team Leader, ATL M. Azadmanesh
Assessor 2 M.R.Khoshgoo
Assessor 3
Assessor 4
Assessor 5
Assessor 6
Note: Adjusting the language within this form to the type of activity and nature of the organization is acceptable.
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 1 of 16
2 Scope of activities: ical hospital beds includes : CPRs , examination , gynecology , pediatric beds and baby
BRSM requires that the organization’s legal obligations and regulatory are met. Technical
Legal status supervisor is main responsible for executing and monitoring of these regulations
ok
3
Obligatory applicable standard which
organization has to follow
Moh regulations
4 Quality Management System
Scope of activities: different kind of mechanical hospital beds includes : CPRs ,
examination , gynecology , pediatric beds and baby cot , stretcher and trolly..
following document(s) has been reviewed during assessment: Document name: table
of measuring and monitoring criteria of processes ,Document ID: F‐Q3‐1/00, Revision
and Date: 001, Approved by: Ms. Mehvar. Another document reviewed : process map
, document No.: C‐M1‐2/00,Version: 001. The processes needed for QMS and their
application throughout the organization has been defined effectively. the sequence
and interaction of these processes has been Determined effectively. the criteria and
methods has been determined to ensure that both the operation and control of these
Quality Management processes are effective . Resources and information are available to support and
4.1 Ok
System monitor processes. the Organization Monitors, measures and analyses all its
processes. the organization follows actions necessary to achieve planned results and
to maintain the effectiveness of these processes. All clauses are applicable/As ample
of organization processes: next process is 'process name', with process
indicator/index: 'index', acceptance level/critteria: 'criteria', Owner of the Process:
'Owner', and 'input from' is input to this process . Output form this process is used in
'output to' .next process is 'after sales services', with process indicator/index:
'Handling time', acceptance level/criteria: '5days', Owner of the Process: 'mr.
aghakhani', and 'not defined' is input to this process.
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 2 of 16
Sample of organization processes: process 'after sales services', with process
indicator/index: ‘Handling time', acceptance level/criteria: '5days', Owner of the
Process: 'mr. aghakhani', The structure of the documentation is compatible with
standard requirements regarding size and complexity of organization. the Quality
Manual: M‐ M1‐1 is in place, Quality Objectives: F‐M1‐1/00 and Policy: T‐M1‐01
backed with documented procedures and work instructions/SoPs, control forms
Documentation requirements OK
and planning records, as well as Regulatory documents , such as; 'GMP
requirements for production of class A,B products from (MOH)' are in place.
Document control procedure was reviewed during assessment with Document ID: P‐
Q4‐1, Revision and Date: 00, 12‐DEC‐12 Approved by: MR.. Document control meets
following requirements; it provides a system to review and approve documents for
adequacy prior to issue. To review and update as necessary and re‐approve
documents it provides a method of revision status identification and prevention of
obsolete document to be used. Method of identification: ok and obsolete seal stamp.
, Obsolete documents are kept in QA ROOM. To review and update as necessary and
4.2.3 Control of Documents re‐approve documents are always available at the point of access as in procedure for OK
production has been determined the last version, QA dept. was available. All sample
reviewed documents are Legible and Readily identifiable. External documents were
identified. Applicable external documents were listed in master list code: F‐Q4‐1/00.
Sample of external documents listed: GMP for A,B products not observed in
organization. The records related to tested medical device samples are kept for 2
years. Records of sample device tested, observed: stretchers S/N: 27452. tested at:
jan‐2013
Record control procedure was reviewed during assessment with Document ID: P04,
Revision and Date: 00, 12‐dec‐12 Approved by: imani zadeh. Record control has
following features; method of identification: ok and obsolete seal stamp. Method of
defining distribution: F‐Q5‐1/00. Method of retrieving of records: backup of electronic
4.2.4 Control of Records OK
and paper file. Method of disposing of records: according to records of QMS form: F‐
Q5‐1/00. all samples reviewed records were Legible and Readily identifiable. As
evidence records of examination beds s/N:94352 seen issued at: 23‐jan‐14 which is
kept on computer e‐records
5 Management responsibility
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 3 of 16
the Top Management, mr. vasaeli has communicated to the organization the
Management
5.1,2 importance of meeting customer as well as statutory and regulatory requirements,
Commitment/Customer Focus through policy, objectives and providing resources
Quality Policy has been documented, with ID: T‐M1‐01, Version: 3 Issued: 12‐
OK
jan‐15 Approved by, mr.vasaeli. Quality policy was communicated to staff , as
staff were asked they were aware of the policy. Staff asked;mr.imanizadeh.
5.3 Quality Policy Sample of Policy items: meeting law and regulations. The policy includes
commitment to comply with requirements and to maintain the effectiveness
of the quality management system. The policy is reviewed every 3 years, it
provides a framework for objectives
Quality Objectives have been documented, with ID: F‐M1‐1/00, Version: 1
Issued: 12‐jan‐15 Approved by, mr.vasaeli. Quality objectives are in line with
quality policy. The objectives are SMART. Sample objectives: increasing quality
of products, Time to fulfill the objective: end of 2016, Objective indicator:
number of NC products, Objective goal: less than 100 per 1000, another
Sample objectives: increasing customer satisfaction, Time to fulfill the
objective: end of march 16, Objective indicator: satisfaction rate, Objective
5.4 Quality Objectives goal: higher than 75% OK
Top management ensures that the planning of the quality management
system is carried out in order to meet the requirements given in qms
documentation system, as well as the quality objectives, and the integrity of
the quality management system is maintained when changes to the quality
management system are planned and implemented
5.5 Responsibility, Authority and Communication
Top management has defined responsibilities and authorities which are documented
and communicated within the organization. Top management has established the
interrelation of all personnel affecting quality, with independence and authority
5.5.1 Responsibility and Authority
necessary to perform their tasks. as seen in O‐Chart:oc‐39587/01, to meet IMED
regulations ms. Mehvar has been appointed as Technical Supervisor. With License
number: 323843Top Management has appointed ms.mehvaras Management
representative. some of the main job duties of MR are as follows: , Establish and OK
Implement processes needed for the QMS and maintained, Report to top
5.5.2 Management Representative management on the performance of the quality management system and any need
for improvement , promotion of awareness of regulatory and customer requirements
throughout the organization., Internal communications are mostly; verbally, Face to
Face, The communication is effective and efficient according to the complications and
5.5.3 Internal Communication size of organization.
5.6 Management review
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 4 of 16
The latest management review was conducted on 20‐ APR ‐16 Records of
5.6.1 Management review
Management review minute observed, Management review was recorded in
management review commission paper. Participants in the latest
Management review session: ms. Mehvar and mr. aghakhani and mr. vasaeli
and mr. imani zadeh .all inputs to management review were reviewed such as
5.6.2 Review input Customer feedback, product conformity, Status of preventive and corrective
OK
actions, Follow‐up actions from previous management reviews, changes and
improvements and regulatory updates. Following items has been significant
outputs of Management review: purchasing of better material and more
effectiveness supervision on outsources processes, training of personal,
5.6.3 Review output purchasing of electrical bending machine. Management Review sessions are
held every 6 months.
6 Resource Management
6.1 Provision of Resources
Training and competence of staff affecting quality is directed by Training
6.2 Human Resources procedure with Document ID of P‐A1‐1, Version: 00 issued in 1‐dec‐12,
approved by management representative. Records of qualifications and
competence needed for positions affecting quality observed during audit;
6.2.1 responsibilities identification and necessary competence F‐A2‐2. Records of trainings
conducted for positions affecting quality observed during audit; training plan
F‐A1‐4‐//. Records of trainings evaluations for training conducted observed
during audit; evaluation training effectiveness F‐A1‐06. The organization
keeps the educational records of staff affecting quality, Type of Record:
Diploma and License. The organization keeps the Training records of staff
affecting quality, Type of Record: Training Certificates. The organization
keeps the Experience and skills records of staff affecting quality, Type of OK
Record: Resumes. For sample, following evidence has been reviewed during
HR audit; Name of the staff profile reviewed, javad mousavi, Position:
welding operator. Education record was in place: diploma. Training planned
6.2.2 competence, observed during audit for welding with co2 gas
Awareness, , Planned in june‐2015. Records of Training conducted in apr‐2015, observed
during audit for safety of tools principles.
and Training
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 5 of 16
Clause observation check
Preventive maintenance of machines affecting quality is directed by
maintenance and repair procedure with Document ID of P‐P04‐1, Version:00
issued in 01‐dec‐12 , approved by management representative. Records of
Planned maintenance and services needed for Machines affecting quality
observed during audit; preventive maintenance planning. Each machine has a
record of the history of repairs and services done for it recorded in repair
records. Sample of Machines taken as evidence during audit. Name of the
machine/device reviewed: CO2 welding, Machine ID: 2w02. This
6.3 Infra structure OK
machine/device is used for welding. Planned Services considered for this
machine observed during audit: changing shutting section, Planned intervals:
every 1 Months. Records of repairs done in 10‐dec‐15, observed during
Audit: torch was changed. Name of the machine/device reviewed: bending
machine, Machine ID: 2B08. This machine/device is used for bending.
planned Services considered for this machine observed during audit:
Functional check of motor, Planned intervals: every 1 day. Records of repairs
done in 10‐jan‐16, observed during audit: contactor changing.
The company meets basic requirements by regulations.
6.4 Work Environment OK
7 Product Realization
The organization has planned and developed the processes needed for
product realization. Planning of product realization is in consistent with the
requirements of the other processes of the quality management system.
In planning product realization, the organization has determined the
following: Quality objectives and requirements for the product; processes,
documents, and resources specific to the product; required verification,
validation, monitoring, inspection and test activities specific to the product
and the criteria for product acceptance which is explained further in the
report. The output of this planning is suitable for the organization’s method
of operations. Technical file is the name of the documented requirement
established for risk management throughout product realization approved
7.1 Planning of product realization by technical supervisor, Date; 2011. Members of the Risk assessment OK
team/committee; technical supervisor, Qcmanager . according to technical
file, Risk levels have been considered as follows; Intolerable: risk level is:
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 6 of 16
Over 6, alarp Risk level is; 4 to 6 and Acceptable: risk level is: bellow
sample of risks hazards evaluated by organization: , sample 1, Hazard: No
efficient Length and width of bed , RPN / Risk Level: 6, Control Method:
control of product size, RPN / Risk Level after control: 3, sample 2, Hazard:
fracture of connections, RPN / Risk Level: 8, Control Method: welding test and
weighing test for all products , RPN / Risk Level after control: 4
The organization has determined requirements specified by the customer,
Determination of The organization has determined requirements not stated by the customer
7.2.1 requirements related to the but necessary for specified or intended use, such as Statutory and regulatory OK
product/service requirements related to the product, and any additional requirements
determined by the organization.
7.2 Customer‐Related Processes
The company reviews the product requirements through formal documented
communications with customer. The documented record observed during
assessment for product requirement was; Contract no.: 94‐11302,dated sep‐
25‐sep, for customer: bonyad , sample of requested product requirements:
3pieces bed with specification in production
Review of requirements
7.2.2 Order, and also The company review the product requirements through OK
related to the product/service
informal communications or verbally with customer. Customer can select
from items in catalogue and buys it from the company, Where product
requirements are changed, the organization properly ensures that relevant
documents are amended and that relevant personnel are made aware of the
changed requirements.
The organization effectively communicates with customers in relation to
product information, for feedback from clients and complaints, please refer
7.2.3 Customer Communication ok
to 8.2.1, for advisory notice refer to 8.5.1
7.3 Design and Development
The organization has established documented procedures for design and
development , with Document ID: P‐D1‐01/00, approved by management
reprtiveesent, Date; dec‐2011. The organization has defined following items
in the design and development planning; The design and development stages
Design and Development
7.3.1 has been defined, The review, verification, validation and design transfer OK
Planning
activities has been determined, The organization has defined clear
assignment of responsibility to manage interfaces between different people
involved in design and development to ensure effective communication.
Planning output is documented in planning design record desinp342
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 7 of 16
The organization has considered functional, performance and safety
requirements inputs, according to the intended use,, The organization has
Design and Development
7.3.2 considered applicable statutory and regulatory requirements , The OK
Inputs
organization has considered output(s) of risk management as input to design,
Records of Inputs are maintained in; in technical file.
outputs relating to product requirements have been determined and records
maintained The output Provides information for purchasing, production and
Design and Development for service provision, , The output includes product acceptance criteria , The
7.3.3 OK
Outputs output includes the characteristics of the product that are essential for its
safe and proper use , Outputs meet the input requirements for design and
development , Records of outputs are maintained in; form rd49.
Reviews of design and development has been performed , Records of reviews
Design and development
7.3.4 are maintained in; bill of materials , drawing ,…, Participants in design and OK
review
development reviews are as follows: QC manager .
Records of the results of the verification and any necessary actions are
Design and development maintained, Records of verification are maintained in; rd49, verification
7.3.5 OK
verification sample items are as follows: Hospital 3 way bed, verification is done against
ISIRI rd49.
Records of the results of the validation and any necessary actions is
maintained, Records of validation are maintained in; customer survey,
Design and development Validation is done through testing the device in real condition, validation
7.3.6 OK
validation sample items are as follows: survey from hospital, Hospital 3 way bed device
can only be validated following assembly and installation at point of use,
Records of Validation for this device observed in customer survey.
Control of design and
7.3.7 Design has not changed as a result no review of changes has been needed. OK
development changes
7.4 Purchasing
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 8 of 16
The organization has established documented procedure to ensure that
purchased product conforms to specified purchase requirements in; Purchase
and supplier evaluation procedure, with Document ID: P06, approved by QA
head, Date; dec‐2011. The organization evaluates and selects suppliers
based on their ability to supply product in accordance with the organization’s
requirements, the Criteria for selection, evaluation and re‐evaluation has
been established , The organization evaluates suppliers periodically, in this
case every 6 mounts for grade A
3 mounts for grade B month, latest suppliers evaluation has been performed
7.4.1 Purchasing Process NC
in MARCH‐16, Records of suppliers' evaluation was provided in F‐RI‐7/00.
Sample of criteria: quality ‐ on time delivery ‐ acceptance of none conform
parts ‐ provision of test report for parts ‐ . Suppliers acceptance criteria; over
70 points. Sample suppliers evaluation observed during audit; TOSHAK NOVIN
, results of evaluation for this supplier: GRADE B ‐ nikofar(plastic parts),
results of evaluation for this supplier: 91.3 ‐ abkari esmaeeli, results of
evaluation for this supplier: 93. , NC observed, grades A suppliers, and
must be evaluate every 6 mounts and grade B suppliers, every 4 mounts.
But all supplier has been evaluated every year
Purchasing information describing the product to be purchased is in place in
QMS, records of the purchase information is provided in BOM, sample of
7.4.2 Purchasing information OK
purchase data for purchased item: size: width, length, thickness of bed
mattress with following specification; size of fittings: diameter, observed.
The organization has established inspection and verifies purchased products
meet specified purchase data requirements, records of the purchase
Verification of purchased verification and controls are provided in F‐P4‐6/00, the item purchased in 10‐
7.4.3 OK
product 4‐16, was verified with following specification; size of fittings: diameter,
Purchased item wheel 12.5mm diameter, with march‐23‐16 Serial number,
observed as sample for traceability.
7.5 Production and Service Provision
7.5.1 Production and Service Provision
Information that describes the characteristics of the product, are available ,
Documented procedures, documented requirements, work instructions, and
reference materials and reference measurement procedures as necessary are
7.5.1.1 General requirements OK
available, Suitable equipment is in place , for The implementation of
monitoring and measurement please refer to 7.6, for The implementation of
monitoring and measurement please refer to 8.2.
7.5.1.2 Control of production and service provision — Specific requirements
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 9 of 16
According to production process and the nature of the product There is no
Cleanliness of product and
7.5.1.2.1 need to establish documented requirements for cleanliness of the product as OK
contamination control
none of the a to d sections of the clause are not applicable.
7.5.1.2.2
Installation activities Excluded OK
The organization has established documented requirements , as necessary,
for performing servicing activities and verifying that they meet the specified
requirements in; customer feedback procedure: , with Document ID: P‐C1‐
1/00, approved by management representative, Date; 01‐dec‐12. The
responsibility for servicing and repairs have been defined in customer
feedback procedure: , customer relationship dpt. is responsible for repairs
7.5.1.2.3
and servicing of the medical device. Servicing personnel are competent and
Servicing activities OK
trained for the job. as; training of assembling of 3 pieces beds for mr. shirazi
observed on nov.2015. Sample record of service/repair of medical device
observed. Name of the record: form: F‐CI‐8/01, name of device
serviced/repaired: stretcher (changing of connection in bedside of stretcher,
serviced/repaired at : valiasr NAJA hospital, date: 1‐Feb 2016, service
performed by mr. shirazi. The service/repair done, validated through
Feedback from customer.
7.5.2 Validation of processes for production and service provision
The organization validates any processes for production and service provision
where the resulting output cannot be verified by subsequent monitoring or
measurement Such as; welding of parts. Organization has defined criteria for
review and approval of the processes such as; Amp. And time of welding.
7.5.2.1 General requirements Organization approves equipment and qualification of personnel, as sample; OK
license of welder. Such as : mr. heydari. On jun.2015.. Organization has set
specific methods and procedures for such processes, as sample; WPS. 1.1.
These processes are revalidated, through; qc tests and recertification duration
production. Sample: for 3 pieces on march.2016.
Particular requirements for
7.5.2.2 Excluded OK
sterile medical devices
7.5.3 Identification and traceability
The organization has identified the product throughout product realization,
and established documented procedure. Document name: Manufacturing
method, Document code/version: P‐P1‐1, Approved by: MD, Dated: 01‐dec‐
7.5.3.1 Identification OK
12. The organization identifies products/parts/material by 'Tagging'. The
organization ensures that medical devices returned to the organization are
identified and distinguished from conforming product.
7.5.3.2 Traceability
The organization has established documented procedures for traceability, it
defines the extent of product traceability and the records required.
Document name: Manufacturing method, Approved by: MD. Organization
controls and records the unique identification of the product. Sample
.5.3.2. General OK
product taken: 'for stretchers with observed records of final inspection and
production order
With technical specifications.’ Serial number: S/N: 12428, Date produced: 1‐
march‐16.
Particular requirements for
active implantable medical
7.5.3.2.2 Excluded OK
devices and implantable
medical devices
The organization identifies the product status with respect to monitoring and
measurement requirements. The identification of product status is
7.5.3.3 Status identification maintained throughout whole processes to ensure that only product that has OK
passed the required inspections and tests by authorized staff is dispatched to
customers. Refer to 8.2.4
7.5.4 Customer property Excluded OK
The organization has established documented method for preserving the
conformity of product during internal processing and delivery to the intended
destination, D o c u m e n t e d Procedure name: layout instruction,
document code: W‐P3‐1/00, Approved by: management representative,
Dated: not defined. The company has following storages: Raw material, Semi
product, Final product. Preservation method does not include identification
of the product sample product: plastic parts wheels, taken from raw material.
7.5.5 Preservation of product Identification method for the sample taken: on the label tagged on bin with OK
code: F‐P3‐16, Handling method for the sample taken: by machine, Packaging
method for the sample taken: by plastic cover. Storage and protection
method for the sample taken: in cartons and closed bags to protect from
Dust. There is sufficient inventory stock of the sample taken as required in
the system. There are currently 30 boxes of plastic parts wheels in the
storage. Minimum inventory stock /order point for this product is 25. Storage
records checked in wheels.
The organization has established documented procedure procedures to
ensure that monitoring and measurement is carried out in a manner that is
consistent with the monitoring and measurement requirements. Procedure
name: maintenance , repair and calibration , Procedure code: P‐P4‐1/00,
Approved by: management representative, Dated: 1‐dec‐12. Calibration plan
is recorded/planned in: measuring equipment and calibration planning, with
document code: F‐P4‐5. Calibration status is recorded in: CALIPER , with
document code: 51456. Devices are identified for their calibration status.Type
of status identification record: calibration label. Name of the tool/device
reviewed :protractor, device ID: P02. This device is used for measuring
angles, calibration status: Calibrated. last date of calibration: may.2015.
Control of monitoring and
7.6 Planned intervals: every 6 Months. Next due date of calibration: may‐16. The NC
measuring devices
device is calibrated externally by Laksar, Calibration certificate No.51458.
Measuring device found NOT calibrated in range required by
standard/application. Evidence observed: one caliper in production line, has
not identified calibration status. Calibrations are traceable to international
applicable standards. Measuring devices are safeguarded from adjustments
that would invalidate the measurement results. Measuring devices are
protected from damage and deterioration during handling, maintenance and
storage. Evidence observed: caliper in QC department ID: 51458 have kept in
safe situation. NC observed, one caliper in production line , has not identified
calibration status such as : calibration label
8 Measurement, analysis and improvement
The organization plans and implements the monitoring, measurement,
analysis and improvement processes needed. Which includes; conformity of
8.1 General OK
the product, conformity and effectiveness of the quality management
system, it also includes of use of analytic statistical techniques.
8.2 Monitoring and measurement
The organization monitors information relating to whether the organization
has met customer requirements. The organization has established
documented procedure for feedback system Procedure name: customer
feedback, Procedure code: P‐CI‐1/00, Approved by: management
representative, Dated: 01‐dec‐12. Source of customer requirements
8.2.1 Feedback OK
fulfillment monitoring: complaints. Sample evidence observed: aria hospital
complaint about connections of bedside. Action for this complaints
Recorded in F‐CI‐3/01. . National or local regulations require the organization
to gain experience from the post‐production phase, review of this experience
is part of the feedback system.
The responsibilities and requirements for planning and conducting audits, and
reporting results and maintaining records is provided in a documented
procedure. Procedure name: internal audit, Procedure code: P‐Q6‐1/00,
Approved by: management representative, Dated: DEC‐2012. The
Organization conducts internal audits at planned intervals. Records observed
In: F‐Q6‐2. Internal audits are conducted every 6 Months. Latest internal audit
8.2.2 Internal audit OK
was conducted in 20‐march‐16. Latest internal audit was conducted by ms.
Mehvar and mr. imani zadeh. Auditors did not audit their own work. Sample
of NCs observed in the report: no accessibility of equipment card. Corrective
action followed up after the NCs raised, suitable space for installation of
equipment card. Internal audit has been recorded in: F‐Q6‐4 and checklist :F‐
Q6‐3.
The organization uses methods for monitoring and measurement of the
Monitoring and measurement
8.2.3 quality management system processes to ensure that processes reach to OK
of processes
planned results.
8.2.4 Monitoring and measurement of product
The Test criteria and quality control is documented in control plan for 3
pieces, With Document code: F03‐P04/01, Approved by: QC manager, Dated:
10‐feb‐14. As sample product QC recorded: 'uv light ' observed, Taken from
Final product qc. Control criteria: 'not broken, on and off test', Method:
'Observation'. Inspected by: 'Ali mosaffa', Date: '14‐jan‐16'. Equipment:
'Inspection light'. Number of items examined: ‘30’. Number of items
accepted: '29'. Record of disposed item, the item was disposed for: 'failed to
turn on'. As sample product QC recorded: 'm435 nuts' observed, Taken
8.2.4.1 General requirements from semi product. Control criteria: 'diameter: 9 mm‐9.3mm', Method: OK
'Measurement'. Inspected by: 'ali mostafa', Date: '13‐feb 16'. Equipment:
'calipper'., device was calibrated. Number of items examined: '25'., Number
of items accepted: '25'.As sample product QC recorded: 'filter hepa' observed
, Taken from raw material. Control criteria: 'no damage in package', Method:
'Observation'. Inspected by: 'Hoseyn kia', Date: '10‐jan‐16'., device was
calibrated. Number of items examined: '28'., Number of items accepted:
'27'. Record of disposed item, the item was disposed for: 'item was deformed
and package was torn, rejected to supplier'.
Particular requirement for
active implantable medical
8.2.4.2 Excluded OK
devices and implantable
medical devices
There is a documented procedure to identify, control and prevent unintended
use or delivery of non conforming products. Procedure name: customer
feedback, Procedure code: P‐CI‐1/00, Approved by: management
representative, Dated: DEC‐2012. Controls and related responsibilities and
authorities for dealing with nonconforming product have been defined in
procedure. QC manager is authorized to deal with non‐conforming products.
Sample non‐conforming products/records observed: failed wheels. Nature of
Non‐conformity of the product is recorded, . The non‐conforming product
observed in: 'warehouse'. The non‐conforming are identified by: non
Control of nonconforming conformity label. The non‐conforming products are properly identified
8.3 OK
product throughout the process. The organization takes actions to eliminate the
detected nonconformity and re‐verifies the product to be conforming to
requirements. The organization releases the non‐conforming product if it
meets regulatory requirements .The organization takes action to preclude
Non‐conforming product's original intended use or application if it meets
regulatory requirements. The non‐conforming products are properly released
by designated person. Released by: QC manager. When nonconforming
product is detected after delivery or use has started, the organization takes
actions appropriate to the effects, or potential effects, of the nonconformity.
Sample records of actions taken: replacement of product or repairmen.
The organization has established documented procedures to determine
collect and analyze appropriate data to demonstrate the suitability,
effectiveness and improvement of its quality management system. Procedure
name: Data analysis, Procedure code: da6823‐01, Approved by: management
representative, Dated: dec‐2011. Records of the results of the analysis of data
observed. Records observed in: management representative record. Process
8.4 Analysis of data name: 'after sales services', , Process index: 'handling time', Process criteria: OK
'5days', Process outcome/result: '3.5 days'. With comparison of characteristics
and trends of processes with previous results the system is proved to be
improving. Corrective actions have been considered for processes not meeting
their criteria requirements. Data regarding, Suppliers, Feedbacks and
conformity of products: analysis on customer feedback : fracture in
Connections of bedsides.
8.5 Improvement
The organization has established documented procedures for the issue and
implementation of advisory notices. Records of all customer complaint
investigations are maintained .Records of complaint investigation observed
8.5.1 General OK
in: customer complaint receiving and handling form. the complaint
description: connections of bedside has broken in several times.. Corrective
action taken: changing the material and design of bedside.
The organization has established a documented procedure for Corrective
action. Procedure name: corrective action, Procedure code: P‐Q1‐1/01,
Approved by: mr. imani zadeh, Dated: 7‐feb‐2013. Sample corrective
action: suitable space for installation of equipment card. Action taken was
evaluated and it was not effective, NC: NO follow up action has been
considered. Sample corrective action: according to customer complaint, has
8.5.2 Corrective action NC
happened changing the material and design of bedside. Action taken was
evaluated and it was not effective, NC: NO follow up action has been
considered. Sample corrective action:. Sample corrective action: delay in
delivery. Corrective action was recorded in: F‐Q1‐1/01. Cause of
nonconformity: no effective communication between sale and production
dept. Action taken has not been evaluated for effectiveness yet.
The organization has established a documented procedure for Preventive
action. Procedure name: preventive action, Procedure code: P‐Q1‐1/01,
8.5.3 Preventive action OK
Approved by: management representative, Dated: 7‐feb‐2013. There has
been no preventive action taken yet in the organization.
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
production documentatio
n
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:
one caliper in production line , has not identified calibration
grade A suppliers, must be evaluate every 6 mounts and grade B suppliers, every 4 mounts. But all supplier has been
evaluated every year