Beruflich Dokumente
Kultur Dokumente
System: QMS ISO 9001 (2008)‐QMSMDD ISO 13485 (2003)
Assessment Report/Checklist
Form 009
CLIENT‐ORGANIZATION (NAME): ADEL NOVIN SEPAHAN
No. 27, Phase II, Soroush Baderan Ind. Town, Isfahan,
PHYSICAL LOCATION(s):
Iran
Stage II Audit Date(s): 13,14 August 2016
Stage I Audit Date(s): 9 July 2016
NAICS (or NACE) CODE Manufactuer of bandages and Sterile & non‐sterile
gauze
EXCLUSIONS:
7.3 ,7.5.1.2.2 &7.5.1.2.3
&7.5.3.2.2 & 8.2.4.2
2 Scope of activities: Manufacture of bandages and Sterile & non‐sterile gauze
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 Regulation
4 Quality Management System
sample of organization processes: 'Customer Communication', with process
indicator/index: 'Average of customer satisfaction', acceptance level/criteria: 'Over
Quality Management 60', Owner of the Process: 'Emsaeili', and 'customer surveys' is input to this process
4.1 . Output from this process is used in 'improvements' .next process is 'Purchasing', Ok
System
with process indicator/index: 'average of supplier grades', acceptance
level/criteria: 'over 75', Owner of the Process: 'Arablou’ and 'warehouse' is input
to this process. Output from this process is used in 'qc' .next process is
'Improvement', with process indicator/index: 'effectiveness of corrective actions',
Acceptance level/criteria: '90', Owner of the Process: 'Safarpour', and 'all
processes' is input to this process. Output from this process is used in 'all
processes' .next process is 'Manufacturing', with process indicator/index: 'PPM',
acceptance level/criteria: 'less than 5 %', Owner of the Process: 'Arablou', and
Documentation requirements 'Sales' is input to this process. Output from this process is used in 'warehouse' .The OK
structure of the documentation is compatible with standard requirements regarding
size and complexity of organization. the Quality Manual: M‐0‐01‐01 is in place,
Quality Objectives: M‐3‐02 and Policy: M‐6‐02 backed with documented procedures
and work instructions/SoPs, control forms and planning records, as well as
Regulatory documents, such as; 'GMP' are in place.
Clause observation
record control procedure was reviewed during assessment with Document ID: A‐1‐
03, Revision and Date: 002, 40513 Approved by: MD. 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. Method of disposing of records: when a new record is in place the
4.2.4 Control of Records OK
old one is collected and torn. All samples reviewed records were Legible and
Readily identifiable. As evidence records of Batch 950404, Sterile gauze seen issued
at:
4/4/94 (June 2016) which is kept Test Report Folder in the lab.
5 Management responsibility
the Top Management, Mohammad Ali Enayati has communicated to the
Management organization
5.1,2
Commitment/Customer Focus the importance of meeting customer as well as statutory and regulatory
requirements, through policy, objectives and providing resources
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: C01‐00, to meet
5.5.1 Responsibility and Authority
IMED regulations Elahe Safarpour has been appointed as Technical Supervisor. With
License number: 9303041‐1452088 Top Management has appointed Ms.
Safarpouras Management representative. some of the main job duties of MR are as
follows: , Establish and Implement processes needed for the QMS and maintained, OK
Clause observation
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; verbaly, Face to Face, In writing, The communication is effective and
efficient according to the complicatons and size of organization.
5.5.3 Internal Communication
5.6 Management review
The latest management review was conducted on Feb 2016Records of
Management review minutee observed,Management review was recorded
5.6.1 Management review in M‐3‐05. Participants in the latest Management review session: Mr.
Enayati and Ms. Safarpour.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,
OK
5.6.2 Review input changes and improvements and regulatory updates. following items has
been significant outputs of Management review: 1‐ Recruiting marketing
personnel 2‐Change Test computer 3‐updating IMED certificate.
Management Review sessions are held every 6 months.
5.6.3 Review output
6 Resource Management
Trining and competence of staff affecting quality is directed by Training
procedure with Document ID of F‐1‐01, Version:002 issued in 40513 ,
approved by MD. records of qualifications and competence needed for
6.1 Provision of Resources positions affecting quality observed during audit; Training Need Assesment f‐
3‐16. records of trainings conducted for positions affecting quality observed
during audit; training plan f‐3‐04. records of trainings evaluations for
training conducted observed during audit; evaluation training form F‐1‐05.
The organization keeps the educational records of staff affecting quality,
Type of Record:Diploma and Licence. The organization keeps the Training
records of staff affecting quality, Type of Record:Training Certificates. The
6.2 Human Resources 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 ,Safarpour, Position:
Technical supervisor. Education record was in place: BS Cehmical industries.
Training planned observed during audit for ISIRI 3001, Planned in July 2016.
ISIRI 3001 Training was planned but no record was provided that the training
has been conducted in the planned dates. Records of Training effectiveness
evaluation done in 42522 observed during audit for ISIRI 3001, evaluation
6.2.1 responsibilities OK
result: Good. Name of the staff profile reviewed ,Safarpour, Position:
Technical supervisor. Education record was in place: BS computer science.
Training planned observed during audit for Risk assesment (re‐training),
Planned in March 2016. Records of Training conducted in 42430, observed
During audit for Risk assessment (re‐training). Records of Training
Clause observation
Effectiveness evaluation done in 42461, observed during audit for Risk
assessment (re‐training), evaluation result: very good. Name of the staff
profile reviewed, Ms. Shookati, Position: bandage Packaging. Education
record was in place: Diploma general. Training planned observed during
audit for Quality policy, Planned in August 2016. Records of Training
Competence, Awareness, and conducted in 42339, observed during audit for ISO 13485. Records of
6.2.2 Training effectiveness evaluation done in 42461 observed during audit for
Training
ISO 13485, evaluation result: 75.
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. Risk management procedure is the name of the documented
requirement established for risk management throughout product
realization, With Document code/Version; Q‐2‐01 approved by MD, Date;
40513. Members of the Risk assessment team/committee; Mohsen, Nima
goudarzi, jahanshahi, Mirzahoseini. according to Risk management
procedure, Risk levels have been considered as follows; Intolerable risk level
7.1 Planning of product realization is: over 60 and/or severity more than 8, ALARP Risk level is: 40 to 60 and NC
Acceptable
Risk level is: bellow 40. sample of risks hazards evaluated by organization: ,
sample 1, Hazard: Sterilization (fail in sterile), RPN / Risk Level: 30, Control
Method: Test report of supplier, validation test by reference lab , RPN / Risk
Level after control: 30, sample 2, Hazard: Physical object in gauze, RPN /
Risk Level: 40, Control Method: GMP, Final Check, RPN / Risk Level after
control:
10, sample 3, Hazard: lack of performance because of absorbance , RPN / Risk
Level: 40, Control Method: Incoming QC check RPN / Risk Level after control:
15. NC observed: Risk of High Humidity is not identified (ISIRI requirement)
7.2 Customer‐Related Processes
Clause observation
The company reviews the product requirements through formal
Documented communications with customer. The documented record
observed during assessment for product requirement was; B‐3‐06,dated
29/4/1395 July 2015, for customer: Mr. Sharifi, sample of requested product
Requirements: 8 ply, simple Gauze, and also The company reviews the
product requirements through informal communications or verbally with
Review of requirements
7.2.2 customer. Customer expect to have order on same date, # 408 (tracing code) OK
related to the product/service
regarding same contract has been sent to customer same date on F‐3‐12,
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.
Design and Development Excluded
7.3.2 E
Inputs
Design and Development Excluded
7.3.3 E
Outputs
Design and development Excluded
7.3.4 E
review
Design and development Excluded
7.3.5 E
verification
Design and development Excluded
7.3.6 E
validation
Control of design and Excluded
7.3.7 E
development changes
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: B‐1‐01 & B‐
2‐01, approved by MD, Date; 40513. 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 4 months, Latest suppliers evaluation has
7.4.1 Purchasing Process been done in 7 may 16. , Records of suppliers' evaluation were provided. OK
Sample of criteria: distance ‐ price ‐ equipment. Supplier’s acceptance
criteria; over 80 points. Sample suppliers evaluation observed during audit;
Rajabi, results of evaluation for this supplier: Grade: 'a', 94. Sample observed
; Sima Far, results of evaluation for this supplier: Grade: 'a',
96. Sample observed; najaf abadi, results of evaluation for this supplier:
Grade: 'c', 60.
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 OK
please refer to 7.6 and 8.2. The labeling record provides data on amount
manufactured and amount distributed. as for Bandage , amount
manufactured is: 2 cartons , amount distributed is: 0
Clause observation
According to production process and the nature of the product , 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, process agents are to be removed from
Cleanliness of product and product during manufacture. As cleaning and contamination control of the
product is part of the production system, organization requires establishing OK
7.5.1.2.1
contamination control
documented requirements for cleanliness of the product... The cleanliness of
product is validated by: Ms. Safarpour. , Validation parameters:
Microbiological Test
7.5.1.2.3 7.5.1.2.2
Excluded
Installation activities E
Excluded
Servicing activities E
Excluded
7.5.1.3
Particular requirements for
E
sterile medical devices
7.5.2 Validation of processes for production and service provision
Excluded
7.5.2.1 General requirements E
The organization has established documented Procedure for validation of
Sterilization processes: Purchasing, with Document ID: B‐1‐01, approved by
Particular requirements for md, Date; December 2015, Sample of records of sterilization process
7.5.2.2
sterile medical devices observed in; QA Folder, record of sterilization for #408 has been observed in OK
Sterilization processes is validated prior to initial use.
7.5.3 Identification and traceability
The organization has identified the product throughout product realization,
And established documented procedure. Document name: p‐1‐02,
Document code/version: 0, Approved by: md, Dated: 40513. The
7.5.3.1 Identification organization identifies products/parts/material by 'Tagging/ warehouse OK
layout'. 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: p‐1‐02, Approved by: md. Organization controls and
records the unique identification of the product. Sample product taken:
7.5.3.2.1 General 'Simple sterile gauze', Serial number: 408, Date produced: in two days after OK
receiving textile (referee to 7.4). Final product is traceable to following
items: operation, time produced, Purchased Material, for the sample taken
it is tracked to Purchased Material: Textile ,
Clause observation
Particular requirements for Excluded
active implantable medical
7.5.3.2.2 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
maintained throughout whole processes to ensure that only product that has
7.5.3.3 Status identification passed the required inspections and tests by authorized staff is dispatched OK
To customers. Refer to 8.2.4
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: B‐2‐02, Approved by: md, Dated: 40513. Source OK
of customer requirements fulfillment monitoring: sales communication.
Sample evidence observed: Shane saz 92.5 %.
8.2.4 Monitoring and measurement of product
Clause observation
The Test criteria and quality control is documented in QC, With Document
Code: Q‐1‐01, Approved by: md. As sample product QC recorded: 'Simple
sterile gauze' observed, Taken from sales department. Control criteria:
'absorption', Method: 'ISIRI 3061'. Inspected by: 'Safarpour', Date: '42826'.
Equipment: ‘Chronometer’. device was calibrated. Number of items
examined: ‘1’. Number of items accepted: '1'. As sample product
QC recorded: 'Simple sterile gauze' observed, Taken from sales department.
Control criteria: 'pH', Method: 'ISIRI 3061'. Inspected by: 'Safarpour'.
8.2.4.1 General requirements OK
Equipment: 'pH meter’. device was calibrated. Number of items
examined: '1'., Number of items accepted: '1'.As sample product QC
Recorded: 'Bandage' observed, Taken from Warehouse. Control criteria:
'Density', Method: 'counting'. Inspected by: 'Safarpour', Date: 'May 2016'.
Equipment: 'Visual, Ruler’. device was calibrated. Number of items
examined: ‘1’. Number of items accepted: '1'.
Excluded
Particular requirement for
active implantable medical
8.2.4.2 E
devices and implantable
medical devices
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: A‐1‐02, Approved by: md,
Dated: 40513. Records of the results of the analysis of data observed.
Records observed in: data analysis report. Process name: 'Customer
Communication', Process index: 'Average of customer satisfaction', Process
criteria: 'Over 60', Process outcome/result: '92.5'. Process name:
8.4 Analysis of data 'Purchasing', , Process index: 'average of supplier grades', Process criteria: OK
'Over 75', Process outcome/result: '95.16'. Process name: 'Improvement',
Process index: 'effectiveness of corrective actions', Process criteria: '90',
Process outcome/result: '100%'. Process name: 'Manufacturing', Process
index: 'PPM', Process criteria: 'less than 5 %', Process outcome/result: '0.05'.
With comparison of characteristics and trends of processes with previous
results the system is proved to be improving.
8.5 Improvement
The organization has established documented procedures for the issue and
Implementation of advisory notices. Procedure name: Customer complaints,
8.5.1 General OK
Procedure code: b‐2‐03, Approved by: quality manual, Dated: dec 2016.
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.
Clause observation
Strength Weakness
Brand Marketing
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:
* Risk of High Humidity is not identified (ISIRI requirement)