Академический Документы
Профессиональный Документы
Культура Документы
BRSM
System: QMS ISO 9001 (2008)‐QMSMDD ISO 13485 (2003)
Assessment Report/Checklist
Form 009
CLIENT‐ORGANIZATION (NAME): Ofogh Sanat Medisa
No.30, Golshid7 St., Nakhlestan Blvd., Shams Abad
PHYSICAL LOCATION(s):
Industrial Zone, Hassan Abad, Tehran, Iran
Stage II Audit Date(s): 10 may 2016
Stage I Audit Date(s): 30 April 2016
NAICS (or NACE) CODE MD0104, 32.5
EXCLUSIONS: 7.3 ‐ 7.5.1.3‐7.5.2.2‐7.5.3.2.2‐8.2.4.2
Assessment objectives: Third party assessment of requirements of QMS ISO 9001
(2008)‐QMSMDD ISO 13485 (2003), is met in companies
management system, as well as legal requirements
ASSESSMENT TEAM INFORMATION
Assessment Team Leader, ATL Marjan Azadmanesh
Assessor 2 Farhang Mohajer
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 15
Clause observation
We pursuit to assure that client‐organization adheres to the protection of communities and consumers. This is to follow the intent to the
1 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).
Manufacturing, sales and after sales services of Automatic Blood Pressure Monitor (CKD)
2 Scope of activities: and Blood Glucose Monitoring System (SKD)
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
IMED REGUALTION, ISIRI STANDARDS
4 Quality Management System
sample of organization processes: 'sales', with process indicator/index: 'Number of
Sold', acceptance level/criteria: '10000 in 1 year', Owner of the Process: 'sell s
manager', and 'customer' is input to this process. Output from this process is used in
'warehouse' .next process is 'warehouse', with process indicator/index: 'defect on
inventories', acceptance level/criteria: 'below 1 percent', Owner of the Process:
'Warehouse manager’ and 'qc' is input to this process. Output from this process is
Quality Management used in ‘sales and marketing' .The structure of the documentation is compatible
4.1 Ok
System with standard requirements regarding size and complexity of organization. the
Quality Manual: ma‐mr‐94 is in place, Quality Objectives: qo‐o1 and Policy: qp01
Backed with documented procedures and work instructions/Sops, control forms and
planning records, as well as Regulatory documents, such as; 'IMED GMP regulation'
is in place.
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 2 of 15
Clause observation
Document control is in place ; Document control procedure was reviewed during
assessment with Document ID: PR‐SM‐01, Revision and Date: 00, 20 MARCH 2016
Approved by: MD. It provides a system to review and approve documents for
adequacy prior to issue. It provides a system to review and approve documents for
adequacy prior to issue and re‐approve and update when in use. It provides a
method of revision status identification and prevention of obsolete document to be
used. Method of identification: approved and obsolete seal stamp. , Obsolete
documents are kept in QA Dept... Documents are always available at the point of
Control of Documents access as in QA Dept., Internal audit chek list / Fr‐Mr‐06 was available. All sample
4.2.3 OK
reviewed documents are Legible and Readily identifiable. Applicable national or local
regulations were identified. Applicable local and national documents were listed in
Master list FR‐Mr‐00. sample of applicable local and national documents listed :
IMED recall work instruction. External documents were identified. Applicable
external documents were listed in Master list FR‐Mr‐00. Sample of external
documents listed: IsO 14971. The records related to tested medical device samples
are kept for 3 years. Records of sample device tested, observed: Blood Glucose
Measurement. tested at: 2013‐10‐31
5 Management responsibility
the Top Management, Mr.Pourhasan has communicated to the organization the
importance of meeting customer as well as statutory and regulatory requirements,
Management
5.1,2 through policy, objectives and providing resources
Commitment/Customer Focus
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 3 of 15
Clause observation
Quality Objectives have been documented, with ID: qo‐o1, Version: 0 Issued:
10 Mar 2016 Approved by, MD. Quality objectives are in line with quality
policy. The objectives are SMART. Sample objectives: increase in customer
satisfaction, Time to fulfill the objective: end of march 17, Objective
indicator: Increased sales of products, Objective goal: 10% growth, another
sample objectives: decrease in RPN, Time to fulfill the objective: end of
march
17, Objective indicator: Increase staff knowledge, Objective goal: 15
man/hours training course
5.4 Quality Objectives OK
based on the evidences that top management is committed, it proves that
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
necessary to perform their tasks. As seen in O‐Chart: F55100QM01 R01, to meet
5.5.1 Responsibility and Authority
IMED regulations Mrs.Dadashpour has been appointed as Technical Supervisor. With
License number: s1/1/94872Top Management has appointed Mr.shakerias
Management representative. some of the main job duties of MR are as follows: ,
Establish and Implement processes needed for the QMS and maintained, Report to OK
top management on the performance of the quality management system and any
5.5.2 Management Representative need for improvement , promotion of awareness of regulatory and customer
requirements throughout the organization., Internal communications are mostly;
verbally, Face to Face, In writing, Via automation/email, The communication is
effective and efficient according to the complications and size of organization.
5.5.3 Internal Communication
5.6 Management review
The latest management review was conducted on 10 April 2016Records of
Management review minute observed, Management review was recorded
5.6.1 Management review in 1. Participants in the latest Management review session: Mr. Pourhasan
and Mr. shakeri and Mrs. Dadashpour.all inputs to management review
were reviewed such as Customer feedback, product conformity, Status of
preventive and corrective actions, Follow‐up actions from previous
management reviews, changes and improvements and regulatory updates.
5.6.2 Review input OK
following items has been significant outputs of Management review:
Producing new products, hiring new staffs, reduction in costs. Management
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 4 of 15
Clause observation
Review sessions are held every 1 month.
5.6.3 Review output
6 Resource Management
Training and competence of staff affecting quality is directed by Training
6.1 Provision of Resources
procedure with Document ID of TR‐MA‐01, Version: 01 issued in 03/2016.
records of qualifications and competence needed for positions affecting
6.2 Human Resources
quality observed during audit; Job Identification for R&D F55100QM02 R00.
records of trainings conducted for positions affecting
Quality observed during audit; training calendar F62200TR02 R01. Records
of trainings evaluations for training conducted observed during audit;
evaluation training form F62200TR07 R01. The organization keeps the
educational records of staff affecting quality, Type of Record: Copies of origin
6.2.1 responsibilities licenses. The organization keeps the Training records of staff affecting
quality, Type of Record: Training Certificates/training effectiveness. The
organization keeps the Experience and skills records of staff affecting
Quality, Type of Record: Resumes. For sample, following evidence has been
reviewed during HR audit; Name of the staff profile reviewed, Mr. Nejati,
Position: manufacturing manager. Education record was in place: BS
Chemical engineering. Training planned observed during audit for ISIRI 3572
course, Planned in 3 august 2016. Name of the staff profile reviewed, Ms.
Torkaman, Position: R&D. Education record was in place: BS Chemical
engineering. Training planned observed during audit for Internal audit of OK
QMS, Planned in 2 march 2016. Records of Training conducted in
2016/05/18, observed during audit for Internal audit of QMS. Records of
Training effectiveness evaluation done in 6 March 2016, observed during
audit for Internal audit of QMS, evaluation result: 88. Name of the staff
profile reviewed ,Ms... Torkaman, Position: R&D. Education record was in
place: BS Chemical engineering. Training planned observed during audit for
GMP, Planned in Jan 2016. Records of Training conducted in 20jan 2016,
6.2.2 Competence, n
Observed during audit for GMP. Records of Training effectiveness evaluation
Awareness, and Training
Done in April 2016 observed during audit for GMP, evaluation result: 100.
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 5 of 15
Clause observation
Preventive maintenance of machines affecting quality is directed by
Preventive Maintenance procedure with Document ID of Wl‐p‐04, Version:
00 issued in 10 Mar 2016, approved by MD. Records of Planned
maintenance and services needed for Machines affecting quality observed
during audit; PM PLAN FR‐Mr‐11. Each machine has a record of the history
of repairs and services done for it recorded in Paper. Each machine is
identified when out of work is recorded in Paper. Sample of Machines taken
6.3 Infra structure as evidence during audit. Name of the machine/device reviewed: calibrator, OK
Machine ID: C01. This machine/device is used for Calibration of medical
Device in lab. Planned Services considered for this machine observed during
audit: checking grips, Planned intervals: every 50 calibration. Machine ID:
FS006.
Work environment work instruction with Document ID of W‐p‐06, Version:
10 Mar 2016 issued in 10 Mar 2016, approved by MD, is in place to set
requirements for health, cleanliness and clothing of personnel to prevent the
contact between such personnel and the product which adversely affect the
quality of the product, the measures prevent contamination through; weekly
checklist of PRP. Work environment work instruction with
Document ID of W‐p‐06, Version:00 issued in 10 Mar 2016 , approved by
6.4 Work Environment MD is in place to set requirements for the work environment conditions to OK
monitor and control and prevent these work environment conditions
adversely affect the quality of the product, the measures prevent
contamination through; weekly checklist of PRP. NC observed:
7 Product Realization
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 6 of 15
Clause observation
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. Risk management procedure is the name of the documented
requirement established for risk management throughout product
realization, With Document code/Version; Pr‐Mr‐05 approved by MD, Date;
10 march
2015. Members of the Risk assessment team/committee; Mr. Pourhasan,
7.1 Planning of product realization Mrs. Dadashpour, Mr. shakeri. according to Risk management procedure, OK
Risk levels have been considered as follows; Intolerable: risk level is: over
90, ALARP: Risk level is; n/a and Acceptable: risk level is: bellow 90. sample
of risks hazards evaluated by organization: , sample 1, Hazard: Put the strips
in high moisture place, RPN / Risk Level: 350, Control Method: manual, RPN
/ Risk Level after control: 40, sample 2, Hazard: Testing with blood that has
uric acid concentrations more than 9 milligrams per deciliter, RPN / Risk
Level: 540, Control Method: Internal control, RPN / Risk Level after control:
60
The organization has determined requirements specified by the customer,
The organization has determined requirements not stated by the customer
Determination of but necessary for specified or intended use, such as Statutory and regulatory
7.2.1 requirements related to the requirements related to the product, and any additional requirements OK
product/service determined by the organization.
7.2 Customer‐Related Processes
The company reviews the product requirements through informal
communications or verbally with customer. Customer can select from items
in catalogue/website and buys it from the company, Where product
Review of requirements requirements are changed, the organization properly ensures that relevant OK
7.2.2
related to the product/service documents are amended and that relevant personnel are made aware of the
changed requirements.
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 7 of 15
Clause observation
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
Excluded
Design and Development
7.3.1 E
Planning
Design and Development Excluded
7.3.2 E
Inputs
Excluded
Design and Development
7.3.3 E
Outputs
Design and development Excluded
7.3.4 E
review
Excluded
Design and development
7.3.5 E
verification
Design and development Excluded
7.3.6 E
validation
Excluded
Control of design and
7.3.7 E
development changes
7.4 Purchasing
The organization has established documented procedure to ensure that
purchased product conforms to specified purchase requirements in;
internal and External purchasing procedure, with Document ID: Pr‐Com‐
01/Pr‐com‐02, approved by MD, Date; 10 March 2016. 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, for grade: 'A' every 12 months, and
suppliers, in grade: 'B' every 6 months. , Records of suppliers' evaluation
7.4.1 Purchasing Process were provided in form f74100pu03R00. Sample of criteria: distance ‐ price ‐ OK
equipment ‐ Quality ‐ packaging. Supplier’s acceptance criteria; 90‐100.
Sample suppliers evaluation observed during audit; Bionime, results of
evaluation for this supplier: Grade: 'a', 89. Sample observed; KMT, results of
evaluation for this supplier: Grade: 'a', 98. Sample observed; MIB, results of
evaluation for this supplier: Grade: 'a', 93.
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 8 of 15
Clause observation
Purchasing information describing the product to be purchased is in place in
QMS, records of the purchase information is provided in Fr‐Mr‐07, sample of
7.4.2 Purchasing information purchase data for purchased item: connector with following specification; OK
Gold connector, ce marked, observed
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 available, Suitable equipment is in place , for The implementation of
monitoring and measurement please refer to 7.6 and 8.2, The
7.5.1.1 General requirements implementation of release, delivery and post‐delivery activities, is explained OK
further in the report. The labeling record provides data on amount
manufactured and amount distributed. as for Digital Barometer , amount
manufactured is: 200
7.5.1.2 Control of production and service provision — Specific requirements
According to production process and the nature of the product , product is
cleaned by the organization prior to sterilization and/or its use, product is
supplied non‐sterile to be subjected to a cleaning process prior to
sterilization and/or its use, product is supplied to be used non‐sterile and its
cleanliness is of significance in use As cleaning and contamination control of
the product is part of the production system, organization requires to
Cleanliness of product and establish documented requirements for cleanliness of the product. The
7.5.1.2.1 OK
contamination control organization has established documented requirements for Cleanliness of
product and contamination control in IMED GMP , with Document ID: pr‐mr‐
04, approved by MD, Date; 20 march 2016.
7.5.1 7.5.
Installation activities Excluded E
Servicing activities Excluded E
7.5.2 Validation of processes for production and service provision
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 9 of 15
Clause observation
Excluded
Particular requirements for
7.5.2.2 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: PR‐MR‐04,
Document code/version: 4, Approved by: MD, Dated: 10 March 2016. The
organization identifies products/parts/material by 'Tagging, Marking'. The
7.5.3.1 Identification organization ensures that medical devices returned to the organization are OK
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: PR‐MR‐04, Approved by: MD. Organization controls and
records the unique identification of the product. Sample product taken:
7.5.3.2.1 General 'Blood Glucose Measurement', Serial number: 95020050, Date produced: OK
10 March 2016. Final product is traceable to following items: operation,
Purchased Material, shift, for the sample taken it is tracked to shift: 1,
Excluded
Particular requirements for
active implantable medical
7.5.3.2.2 OK
devices and implantable
medical devices
Clause observation
The organization has established documented method for preserving the
conformity of product during internal processing and delivery to the
intended destination, Documented Work Instruction name: Warehousing,
document code: pr‐mr‐07, Approved by: MD, Dated: 10 March 2016. The
company has following storages: Raw material, Semi product, Final product.
Preservation method includes: Identification, Handling, Packaging, Storage
and protection. Sample product: Barometer, taken from Final Product ware
house. Identification method for the sample taken: Labeling, Handling
method for the sample taken: Manual, Packaging method for the sample
taken: 1 in box and 5 box in a cartoon. Storage and protection method for
7.5.5 Preservation of product the sample taken: in cartons and closed bags to protect from dust. There is OK
sufficient inventory stock of the sample taken as required in the system.
There are currently 200 each product of Barometer in the storage.
Minimum inventory stock /order point for this product is 50. Storage records
checked in Warehouse software. , Documented Work Instruction
Warehousing also provides the control of product with a limited shelf‐life or
requiring special storage conditions.
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: monitoring and measuring device master list, Procedure code: PR‐
MR‐
09, Approved by: MD, Dated: 10 Mar 16. Calibration plan is
recorded/planned in: monitoring and measuring device master list, with
document code: FR‐mr‐20. Calibration status is recorded in: monitoring and
measuring device master list, with document code: FR‐mr‐20. Devices are
identified for their calibration status. Type of status identification record:
calibration label. Name of the tool/device reviewed: Ohm Meter, device ID:
A12. This device is used for measurement of electricity flow, calibration
status: Calibrated. Last date of calibration: march 2016. Planned intervals:
every 12 Months. Next due date of calibration: march 2016. The device is
calibrated externally by Rasa, Calibration certificate No.Naci‐lab‐401. All
measuring devices observed have been calibrated in range required by
standard and application. Calibrations are traceable to international
Control of monitoring and applicable standards. Measuring devices are safeguarded from adjustments OK
7.6
measuring devices that would invalidate the measurement results. Measuring devices are
protected from damage and deterioration during handling, maintenance and
storage. When equipment is found out of calibration, all previous
measurements are called invalid and they get verified again. The
Organization takes appropriate action on the equipment and any product
affected by out of calibration measuring device. The organization confirms
and makes sure that any computer software used in measurements satisfy
the intended application requirements. This has been undertaken prior to
initial use. After 1 more samples taken all were calibrated. Name of the
d i l l i C lib i C lib d C lib i
FORM‐009_V4_QMS MDD Issued: July 9, 2003 Revised: March 2013 11 of 15
Clause observation
Certification No.: 95/0124. Calibration status: Calibrated.
8 Measurement, analysis and improvement
The organization plans and implements the monitoring, measurement,
analysis and improvement processes needed. Which includes; conformity of
the product, conformity and effectiveness of the quality management
8.1 General system, it also includes of use of analytic statistical techniques. Documented OK
procedures for implementation and control of the application of statistical
techniques are in place.
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
8.2.1 Feedback feedback, Procedure code: fr‐mr‐07, Approved by: MD, Dated: 10 Mar 2016. OK
Source of customer requirements fulfillment monitoring: complaints,
customer feedback forms.
The responsibilities and requirements for planning and conducting audits,
and reporting results and maintaining records are provided in a documented
procedure. Procedure name: internal audit, Procedure code: PR‐MR‐01,
Approved by: MD, Dated: 10 Mar 2016. The organization conducts internal
audits at planned intervals. Records observed in: audit pan FR‐MR‐08‐1.
Internal audits are conducted every 12 Months. Latest internal audit was
conducted in 1 march 2016. Latest internal audit was conducted by Mr.
8.2.2 Internal audit OK
shaker Mrs. Dadashpour. Auditors did not audit their own work. Sample of
NCs observed in the report: Product risk analysis is not complete. Corrective
action followed up after the NCs rose, Increasing the knowledge of team.
Internal audit has been recorded in: internal audit report form FR‐MR‐08.
8.2.4 Monitoring and measurement of product
Excluded
Particular requirement for
active implantable medical
8.2.4.2 E
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: fr‐mr‐07, Approved by: Mehran
Pourhasn, Dated: 10‐Mar‐2015. Controls and related responsibilities and
authorities for dealing with nonconforming product has been defined in
procedure.Dadashpour are authorized to deal with non‐conforming
products. Nature of Non‐conformity of the product is recorded; the non‐
conforming products are properly identified throughout the process. The
organization takes actions to eliminate the detected nonconformity and re‐
Control of nonconforming verifies the product to be conforming to requirements. The organization
8.3 releases the non‐conforming product if it meets regulatory requirements OK
product
.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.
When product needs to be reworked, the has organization documents the
rework process in a work instruction, with determination of any adverse
effects.
Clause observation
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: PR‐MR‐03, Dated: 10‐feb
2016. Records of the results of the analysis of data observed. Records
observed in: data analysis report. Process name: 'sales', Process index:
'Number of sold', Process criteria: '10000 in 1 year', Process
outcome/result: '0'. Process name: 'warehouse', , Process index: 'defect on
inventories', Process criteria: 'below 1 percent', Process outcome/result:
'0%'. With comparison of characteristics and trends of processes with
previous results the system is proved to be improving. Corrective actions
8.4 Analysis of data have been considered for processes not meeting their criteria requirements. NC
Data regarding, Suppliers, Feedbacks and conformity of products: sales
process: as company did not receive sales permit from IMED and sales
permit need ISO 13485 certificate, so company cannot sales productions.
NC observed, Purchase process with criteria of deviation from index is (5%),
the result was 6% but they have not analyzed the situation.
8.5 Improvement
The organization has established documented procedures for the issue and
implementation of advisory notices. Procedure name: advisory notice and
complaints, Procedure code: PR‐MR‐05, Approved by: Pourhasn, Dated: 10
8.5.1 General mar15. No need to corrective action as the records suggest that,. OK
The organization has established a documented procedure for Corrective
action. Procedure name: corrective action, Procedure code: fr‐mr‐05,
Approved by: shakeri, Dated: 10 mar15. Sample corrective action: Increasing
8.5.2 Corrective action the knowledge of team. Action taken was evaluated and it was effective. OK
The organization has established a documented procedure for Preventive
action. Procedure name: preventive action, Procedure code: fr‐mr‐05,
8.5.3 Preventive action Approved by: shakeri, Dated: 10 mar15. OK
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 research ‐‐
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: