Documentos de Académico
Documentos de Profesional
Documentos de Cultura
System: QMSMDD ISO 13485 (2003)
Assessment Report/Checklist
Form 009
CLIENT‐ORGANIZATION (NAME): Fonoun Teb Fartak
No. 5, Salahi Dead End, First Kowsar St., Sattarkhan
PHYSICAL LOCATION(s):
St.., Tehran. Iran
Stage II Audit Date(s): 28 & 29 Sep 2016
Stage I Audit Date(s): 10 & 11 Sep 2016
NAICS (or NACE) CODE MD1104, MD1109, IVD0108
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 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.
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).
Manufacture and after sale services of air mattress and surgical suction and Import and
2 Scope of activities:
after sale services of electrolyte and blood gas analysis
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/ISIRI 3368 seriesISIRI 4592
4 Quality Management System
sample of organization processes: 'management', with process indicator/index:
'Fulfillment of management review outputs', acceptance level/criteria: 'over 70',
Quality Management Owner of the Process: 'Ahari', and 'all processes' is input to this process. Output
4.1 from this process is used in 'all processes' .next process is 'QA', with process Ok
System
indicator/index: 'customer satisfaction average', acceptance level/criteria: 'over
75%', Owner of the Process: 'Keshavarz', and 'all processes' is input to this process.
Output from this process is used in 'all processes' .The structure of the
documentation is compatible with standard requirements regarding size and
complexity of organization. the Quality Manual: FTF‐QM is in place, Quality
Documentation requirements Objectives: FTF‐QO and Policy: FTF‐QP backed with documented procedures and OK
work instructions/SoPs, control forms and planning records, as well as
Regulatory documents , such as; 'regulation for technical supervisor / GMP' are
in place.
5 Management responsibility
the Top Management, Mr. shahab ahari has communicated to the organization the
Management importance of meeting customer as well as statutory and regulatory requirements,
5.1,2
Commitment/Customer Focus through policy, objectives and providing resources
5.5 Responsibility, Authority and Communication
Clause observation
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:FTF‐OC, to meet
5.5.1 Responsibility and Authority
IMED regulations Hanieh Amin Shahidi has been appointed as Technical Supervisor.
With License number: 9105011‐1452088Top Management has appointed Ali
Keshavarzas Management representative. some of the main job duties of MR are as
follows:, Establish and Implement processes needed for the QMS and maintained, OK
Report to top management on the performance of the quality management system
5.5.2 Management Representative 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, T h e 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 Aug 2016Records of
5.6.1 Management review
Management review minute observed, all inputs to management review
were reviewed such as Customer feedback, product conformity, Status of
5.6.2 Review input preventive and corrective actions, Follow‐up actions from previous
management reviews, changes and improvements and regulatory updates. OK
Following items has been significant outputs of Management review:
finalizing. Management Review sessions are held every 12 months.
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 FTF‐p02, Version: 00 issued in April 2016,
approved by MD. Records of qualifications and competence needed for
6.2 Human Resources
positions affecting quality observed during audit; training plan/matrix FTF‐
JD. Records of trainings conducted for positions affecting quality observed
during audit; training plan P02‐F02. Records of trainings evaluations for
training conducted observed during audit; evaluation training form p02‐f05.
The organization keeps the educational records of staff affecting quality,
Type of Record: Diploma and License. The organization keeps the Training
6.2.1 responsibilities records of staff affecting quality, Type of Record: Training Certificates. 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
7 Product Realization
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. sample of organization products: Mattress, UMDNS: 18147,
Silence valid till:novmebr 2016.electolyte analyzer, UMDNS: 16818.blood
gas analyzer, UMDNS: 18619.surgery suction, UMDNS: 10217.Sample of
Technical file review observations: BoM observed; with document ID: F03‐
P04. Quality Plan observed; with document ID: P04‐F01 raw material CP, p04‐
f03 for final product CP. Technical Drawing(s) observed; with document ID:
Technical files. Clinical Evaluation observed; with document ID: Payamber
azam Kerman letter. External Test(s) observed; with document ID: d‐1294‐
640 march 2016. Technical symbols observed on label; such as: Serial
Number, Class I electrical medical device. Intended use is documented in
Technical file. Sucking liquids while surgery. Risk management procedure is
7.1 Planning of product realization the name of the documented requirement established for risk management OK
throughout product realization, With Document code/Version; FTF‐p05
approved by MD, Date; April 2016. Members of the Risk assessment
team/committee; Modarres, Keshavarz, MD, Technical supervisor. According
to Risk management procedure, Risk levels have been considered as follows;
Intolerable risk level is: over 50, and Acceptable risk level is: below 50.
sample of risks hazards evaluated by organization: , sample 1, Hazard:
entering liquids to vacuum point , RPN / Risk Level: 63, Control Method:
putting control sensor, RPN / Risk Level after control: 27, sample 2,
Hazard: operator miss, RPN / Risk Level: 56, Control Method: PMS,
Technical Support, Catalogue, RPN / Risk Level after control: 32, sample 3,
Hazard: Inappropriate Cell material, RPN / Risk Level: 63, Control Method:
supplier management, validation, PMSRPN / Risk Level after control: 18
Clause observation
The organization has determined requirements specified by the customer,
The organization has determined requirements not stated by the customer
but necessary for specified or intended use, such as Statutory and regulatory
requirements related to the product, and any additional requirements
Determination of determined by the organization.
7.2.1 requirements related to the OK
product/service
7.2 Customer‐Related Processes
The documented record observed during assessment for product
Requirement was; Invoice 1610, dated April 2016, for customer: Valiasr
Hospital Birjand, sample of requested product requirements: HD‐Dual
D18Product requirements are reviewed and accepted prior to next steps of
the process. The company reviews the product requirements through
Review of requirements informal communications or verbally with customer. Customer can select
7.2.2 OK
related to the product/service from items in cataloged 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.
7.4 Purchasing
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: FTF‐p03,
approved by MD, Date; 2016. The organization evaluates and selects
suppliers to import based on their ability to supply product in accordance
with the organizations and legal requirements, Latest suppliers evaluation
has been done in 7 may 16. . Supplier’s acceptance criteria; over 80 points.
Sample suppliers evaluation observed during audit; air kinetic, with License:
7.4.1 Purchasing Process CE, Mattress, AG386, AH386,".Sample suppliers evaluation observed during OK
audit; 0.84, with License: Electrolyte analyze. Letter of authorization from
Supplier (OEM) observed. No.: 13071763 Date: April 2017. License of import
authorization from authorities (MoH) observed. No.: Invoice IS160722 Date:
42578. IMED Evaluation observed:9527896401‐31/5/95.
Clause observation
Purchasing information describing the product to be purchased is in place in
QMS, records of the purchase information is provided in IS160722, sample of
purchase data for purchased item: I‐smart 30 cartridge with following
7.4.2 Purchasing information specification; 150 test, for electrolyte anayzer,#6902, observed.. other OK
example of purchase product 8ich matters base ,Contolparameter visual also
COA of supplier was received
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, for The implementation of monitoring and measurement
7.5.1.1 General requirements please refer to 7.6 and 8.2. The labeling record provides data on amount OK
manufactured and amount distributed. as for Mattress ‐ 51595010490 ,
amount manufactured is: 1 , amount distributed is: 1
documented requirements , as necessary, for performing servicing activities
Installation activities OK
and verifying that they meet the specified requirements in; Installation and
after sale services procedure All test and measuring devices used in service
and repairs activities were calibrated., such as; same case in 7.5.1.2.2.
Sample record of service/repair of medical device observed. Name of the
form/record: p12‐f01, name of device installed: mattress and PUMP,
installed in: birjand hospital, date: 12/2/1394 April 2015, installed by Mr.
Behnam Jariani. The installation has been approved by customer. by technical
supervisor, Ms. Riasi
Servicing activities through training and technical support. Servicing personnel are competent OK
and trained for the job. as; Mr. Arman Fakhravar is competent, trained by
Ms. Modarres. Sample record of service/repair of medical device observed.
Name of the record: p12‐f10, name of device serviced/repaired: mattress
and PUMP(the Pump chenched), serviced/repaired at : birjand hospital,
date: 11/4/1395 June 2016, service performed by Mr. arman
FakhravarThe Service provided has been approved by customer. By technical
supervisor, Ms. Riasi.
7.5.3 Identification and traceability
The organization has identified the product throughout product realization,
And established documented procedure. Document name: Identification and
tractability, Document code/version: P08, Approved by: MD, Dated: April
7.5.3.1 Identification 2016. The organization identifies products/parts/material by 'Tagging'. The OK
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: Identification and tractability, Approved by: MD.
Organization controls and records the unique identification of the product.
Invoice No.: Invoice 1610, Sample taken is traceable to following items: to
the customer the product has been sold to : Birjand Hospital, to the date it
7.5.3.2.1 General was sold, 9/2/1395 April 2016 to the person released the product, : OK
Modarres, to the Date released : 27/12/1394 march 2016, The sample is
traceable to raw material, Lot Number: lot number pump 52094120106‐
108. To the Date material verified, to whom verified material, Sample
taken lacks traceable to following items: the product is not traceable to
supplier.
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
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
Relation, Procedure code: FTF‐p14, Approved by: MD, Dated: April 2016.
Source of customer requirements fulfillment monitoring: Feedbacks. Interval
meeting is organization key marketing and relation to customers. Sample
8.2.1 Feedback evidence observed: Brigand hospital grade is not traceable, name of hospital OK
is not mentioned because of confidentiality. 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.
8.2.4 Monitoring and measurement of product
The Test criteria and quality control is documented in QC, With Document
Code: FTF‐p04, Approved by: MD, Dated: april 2016. As sample product QC
recorded: 'mattress cell ' observed, Taken from semi product. Control
criteria: 'as CP', Method: 'visual'. Inspected by: 'Mr. fakhravar', Date: '1394‐
10‐5'. Equipment: ‘visual’. device was calibrated. Number of items
examined: ‘1’. Number of items accepted: '1'. As sample product QC
8.2.4.1 General requirements recorded: 'mattress 8 inch n‐TPU' observed, Taken from Final product. OK
Control criteria: 'debi', Method: 'flow meter'. Inspected by: 'Modarres', Date:
'12/6/2016'. Equipment: 'flow meter’. device was calibrated. Number of
Items examined: ‘1’. Number of items accepted: '1'., device was calibrated.
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 and
complaints, Procedure code: pr03‐04, Approved by: abdullah, Dated: 12‐jan‐
14. Records of all customer complaint investigations are maintained .Records
of complaint investigation observed in: form 3420. The complaint description:
device failed to work after 1 week. Corrective action taken: changing the
8.5.1 General on/off key. advisory notice mentioned in user manual as procedure pr03‐ OK
04such as: Disposable jars should be use in product batch
51595010495 on may 2016 there was couple of short hose that replace with
standard ones and Qc by Msr.Amin Shahidi that recorded in f01‐p17 recall is
done base on IMED work instruction, there was no recall happened
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.
Clause observation
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
organizational knowledge
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: