Académique Documents
Professionnel Documents
Culture Documents
System: QMSMDD ISO 13485 (2003)
Assessment Report/Checklist
Form 009
CLIENT‐ORGANIZATION (NAME): Tajhizat Pishrafteh Darman
Block 1071, Central Blvd., Golgon Ind. City, Shahriar,
PHYSICAL LOCATION(s):
Tehran, Iran
Stage II Audit Date(s): 20 Oct 2016
Stage I Audit Date(s): 20 Sep 2016
NAICS (or NACE) CODE MD1103 MD 1302
EXCLUSIONS:
7.3‐7.5.1.3‐7.5.2.(1)‐7.5.2.2‐7.5.3.2.2‐8.2.4.2
Assessment objectives: Third party assessment of requirements of 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 Mojtaba Ramezani
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.
Clause observation
We pursuit to assure that client‐organization adheres to the protection of communities and consumers. This is to follow the intent to
1 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).
2 Scope of activities: Manufacture (SKD), sales and after sale of Defibrillator
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
IEC 60601‐1, IEC 60601‐2‐27, IEC 60601‐2‐4
4 Quality Management System
sample of organization processes: 'Improvement', with process indicator/index:
'Effective CA to all CA', acceptance level/criteria: 'over 90%', Owner of the Process:
Quality Management 'Mr. Mohebbi', and 'All processes' is input to this process. Output from this process
4.1 is used in 'all processes' .next process is 'QC', with process indicator/index: 'after OK
System
delivery complaints', acceptance level/criteria: 'below 1% of all sales', Owner of
the Process: 'Mr. Ahanian', and 'Production' is input to this process . Output from
this process is used in 'warehouse' .next process is 'Sales', with process
indicator/index: 'quantity of sales', acceptance level/criteria: ‘50 defibrillator in
first half of shamsi year', Owner of the Process: 'Mr. Ahanian', and 'customers' is
input to this process. Output from this process is used in 'customers' .The
structure of the documentation of organization has got some issues explained in
Documentation requirements more detail as follows: Quality Policy has been documented in: qm‐1‐01, Quality OK
objectives have been documented in: F‐1‐01 There is Quality Manual documented.,
Documented procedures are in place : system lacks supporting forms and plans., All
applicable regulatory documents are is in place such as : Recall work instruction
Document review was done during Stage 1 as follows: Document control is in place
; Document control procedure was reviewed during assessment with Document ID:
p01, Revision and Date: 00, 2011 Approved by: MD. it provide 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: ok and obsolete seal
stamp. , Obsolete documents are kept in OPC, FTP11. Documents are always
available at the point of access as in Assembly unit, assembly work instruction was
4.2.3 Control of Documents available. All sample reviewed documents are Legible and Readily identifiable. OK
Applicable national or local regulations were identified. Applicable local and
national documents were listed in Master list F‐6‐10. Sample of applicable local
and national documents listed: GMP. External documents were identified.
Applicable external documents were listed in Master list F‐6‐10. Sample of external
documents listed: GMP. The records related to tested medical device samples are
kept for forever. Records of sample device tested, observed: Defibrillator code
report: 323‐36. tested at: 2014
Clause observation
record control procedure was reviewed during assessment with Document ID: p02,
Revision and Date: 001, 2011, Record control has following features; method of
identification: ok and obsolete seal stamp. Method of defining distribution: form
0384 distribution table. Method of retrieving of records: backup of electronic file
each month, all records are in e:/ISO forms/. Method of disposing of records:
4.2.4 Control of Records when a new record is in place the old one is collected and torn. All samples ok
reviewed records were Legible and Readily identifiable. As evidence records of
store exit receipt seen issued at: 2016 which is kept on computer e‐records.
5 Management responsibility
the Top Management, Mr. Ahanian 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
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:FL‐1‐01, to meet IMED
5.5.1 Responsibility and Authority regulations Mohammadali Rasooli has been appointed as Technical Supervisor. With
License number: 9002011‐1452088/254517Top Management has appointed
Mohammadkazem Mohebbias Management representative. some of the main job
duties of MR are as follows: , Establish and Implement processes needed
OK
Clause observation
for the QMS and maintained, Report to top management on the performance of
5.5.2 Management Representative 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, In writing, Via
automation/email, The communication is effective and efficient according to the
5.5.3 Internal Communication complications and size of organization.
5.6 Management review
The latest management review was conducted on 16‐10‐2016 Records of
Management review minute observed, Management review was recorded
5.6.1 Management review in FL‐6‐03. Participants in the latest Management review session: Ahanian
and Rasooli and Behbudi and Mohebbi.all inputs to management review
were reviewed such as Customer feedback, product conformity, Status of
preventive and corrective actions, Follow‐up actions from previous
5.6.2 Review input management reviews, changes and improvements and regulatory updates. OK
Following items has been significant outputs of Management review:
5.6.3 Review output updating spare parts, enhancing sales. Management Review sessions are
held every 12 months.
6 Resource Management
Training and competence of staff affecting quality is directed by Training
6.1 Provision of Resources
Procedure with Document ID of W‐2, Version: 01 issued in, approved by
MD. Records of qualifications and competence needed for positions
6.2 Human Resources
affecting quality observed during audit; training plan/matrix F‐2‐02. Records
of trainings conducted for positions affecting quality observed during audit;
training plan F‐2‐02. Records of trainings evaluations for training conducted
observed during audit; Effectiveness F‐42‐02. The organization keeps the
educational records of staff affecting quality, Type of Record and Ms. Or
PHD. The organization keeps the Training records of staff affecting quality,
6.2.1 responsibilities Type of Record: effectiveness record/certificates. The organization keeps
the Experience and skills records of staff affecting quality, Type of Record:F‐
42‐02. for sample, following evidence has been reviewed during HR audit;
Name of the staff profile reviewed, Mohammad Kazem Mohebi, Position:
QA. Education record was in place: BS of Telecommunication, Ms. Of
electronics. Training planned observed during audit for Internal audit of
OK
Clause observation
,
13485, Planned in April 2016. Records of Training conducted in April 2016
Observed during audit for Internal audit of 13485. Records of Training
effectiveness evaluation done in June 2016 observed during audit for
Internal audit of 13485, evaluation result: 0.75. Name of the staff profile
reviewed, Rasooli, Position: QC, assembly. Education record was in place:
Ms. Of electronics. Training planned observed during audit for procedures
6.2.2 mcompetence, Awareness, and and work instructions, Planned in June 2016. Records of Training conducted
Training nin June 2016, observed during audit for procedures and work instructions.
Records of Training effectiveness evaluation done in October 2016,
Observed during audit for procedures and work instructions, evaluation
result: 0.8.
7.2 Customer‐Related Processes
The documented record observed during assessment for product
Requirement was; Contract No. "24‐ه ‐95 ‐ق,dated June 2016, for customer:
Heyat Omana, sample of requested product requirements: quantity 60,
delivery time 6 weeks Product requirements are reviewed and accepted
prior to next steps of the process. The company reviews the product
Review of requirements requirements through informal communications or verbally with customer.
7.2.2 OK
related to the product/service Such as contract no "24‐‐ه95‐"ق on for June 2016 for selling 60, delivery
time in six weeks for defibex 700, 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.. No case happened.
7.4 Purchasing
Clause observation
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: pr4679/01 ,
Date; 6‐3‐16. 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: 'All' every 12 months, Latest suppliers evaluation has
been done in 7 may 16. , Records of suppliers' evaluation were provided in
form 6482. Sample of criteria: distance ‐ price ‐ equipment. Suppliers’
acceptance criteria; over 80 points. Sample suppliers evaluation observed
during audit; Osato, with scope: Mother company,AG386,AH386,".Sample
7.4.1 Purchasing Process suppliers evaluation observed during OK
Audit; Jahan Ghalb, with scope: Importer, spare part supplier, results of
evaluation for this supplier: 98. Sample suppliers evaluation observed during
audit; Sadra Lab, with scope: QC, Validation, results of evaluation for this
supplier: 70. Letter of authorization from Supplier (OEM) observed. No.: Fish
No 112620027 Date: 20 June 2013. License of import authorization from
authorities (MoH) observed. No.: back of contracts no 1837 Date: 42491. .
Supplier below 50 will enter blacklist, all suppliers are evaluated annually.
7.5 Production and Service Provision
7.5.1 Production and Service Provision
Clause observation
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 D‐300 , amount
manufactured is: 3 , amount distributed is: 3. mentioned 3 manufactured D‐
300 defibrillators are sold to Hasme Abad hospital.
Servicing activities through training and technical support. Servicing personnel are competent OK
and trained for the job. as; Mr. Ahanian certificate from Osato. Sample
record of service/repair of medical device observed. . Certificate of service
and installation by OSATO company for Mr. Ahanian has been observed,
there is no service happened during last three years.
Excluded
7.5.1.3
Particular requirements for
E
sterile medical devices
7.5.2 Validation of processes for production and service provision
7.5.2.1 General requirements Excluded E
Particular requirements for Excluded
7.5.2.2 E
sterile medical devices
7.5.3 Identification and traceability
The organization has identified the product throughout product realization,
and established documented procedure. Document name: Identification
and traceability, Document code/version: W‐501, Dated: 12‐ Feb. ‐16. 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.
7.5.3.1 Identification OK
,Company assembles each product in one day, assembly and internal test
report is done in one day, and after that it will be sent to "behine sanjesh
sadra" lab for leakage test. After that (in case there is no error) will be sent
to client's site, all these can be trace through tagging or related records.
7.5.3.2 Traceability
Clause observation
The organization has established documented procedures for traceability, it
Defines the extent of product traceability and the records required.
Document name: Identification and traceability. Organization controls and
records the unique identification of the product. Sample product taken: 'D‐
300', Invoice No.: 12, Sample taken is traceable to following items: to the
customer the product has been sold to : Hashem abad hospital, to the date
it was sold, 12 June 2016 to the person released the product, : Mr. rasooli +
7.5.3.2.1 General OK
sadra test report, to the Date released : 10 June
2016, The sample is traceable to raw material, Lot Number: 950111,12 and
13. to the Date material verified: 42430, to whom verified material: Mr.
Rasooli compared to packing list, to supplier: osatu, . Its SKD, so all are
traceable to a box that have serial which can be traced to proforma
Excluded
Particular requirements for
active implantable medical
7.5.3.2.2 OK
devices and implantable
medical devices
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
system, it also includes of use of analytic statistical techniques. Documented
8.1 General procedures for implementation and control of the application of statistical OK
techniques is 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
feedback, Procedure code: w‐3‐002, Approved by: MD, Dated: 2011. Source
8.2.1 Feedback of customer requirements fulfillment monitoring: complaints. Customers can OK
follow their complaints with form f‐3‐01 or IMED website. Sample evidence
observed: Jahan Ghalb ‐ client satisfaction average is 94%.
Excluded
Particular requirement for
active implantable medical
8.2.4.2 E
devices and implantable
medical devices
8.5 Improvement
The organization has established documented procedures for the issue and
Implementation of advisory notices. Procedure name: advisory notice,
Procedure code: user Manual and service manual+ label, Approved by: Mr.
mohebbi. no need to corrective action as the records suggest that,. The
organization has established documented procedures for notification of
8.5.1 General adverse events to regulatory authorities. Adverse event documented OK
procedure: IMED recall work instruction. discharge it every three month
that is mentioned on user manual as advisory notice to ensure
performance of battery, or do not use unsterile medical pad
Clause observation
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
Expertise PMS
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: