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BRSM
QMSMDD ISO 13485 (2003)
Assessment Report/Checklist
Form 009
CLIENT‐ORGANIZATION (NAME): Teb Karan Iranian
PHYSICAL LOCATION(s): No.12 , Arghavan st. , Farkhondeh Ave. , Sanat
Blvd , Parand industrial town , tehran‐saveh road
, Iran
Stage II Audit Date(s): 06&07 April 2016
Stage I Audit Date(s): 17 March 2016
NAICS (or NACE) CODE MD1109
EXCLUSIONS: 7.5.1.3/7.5.1.2.2/7.5.2.2/7.5.3.2.2/8.2.4.2/7.3
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 Ms. Azadmanesh
Assessor 2 Mr. Pourhasan
Note: Adjusting the language within this form to the type of activity and nature of the organization is acceptable.
REFERENCE, AS
This Clause
APPLICABLE1
Has been
Reference Clause Observations Verified,
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We pursuit to assure that client‐organization adheres to the protection of communities and consumers. This is to
1 follow the intent to 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).
manufacture and after sale services of skin , hair , ophth examination
2 Scope of activities
beds and gynecologicalental surgery and examination beds
BRSM requires that the organization’s legal obligations
Legal status and regulatory are met. Who are the main responsible
3 for executing and monitoring of these regulations?
Obligatory applicable standard which ISIRI 3368 and Good manufacturing practice for C
organization has to follow medical device products from MOH.
4 Quality Management System
GENERAL REQUIREMENTS
Does the organization establish, document, implement,
maintain and continually improve a Quality
Management System (QMS) with due consideration
given to identification of processes needed for the Processes are: management, analysis of data, sale,
QMS and their application throughout the system;
determination of sequence and interaction of these procurement, production, aftersales services, quality
4.1 processes, determination of criteria and methods
required to ensure effective operation and control of
control, storage, preventive maintenance.
these processes; availability of resources and Acceptance criteria has determined in F01-P12.
information required to support the operation and
monitoring of processes; measurement, monitoring and
analysis of the processes; implementation of action to
achieve planned results and continual improvement
‐If any, are the outsourced processes are defined?
DOCUMENTATION REQUIREMENTS
Is there a documented quality policy and documented
quality objectives and are they appropriate?
Is there a documented quality manual and are there
documented procedures required by the standards?? Documentation process was checked in stage I
4.2
Are required records for planning, acting and controlling
processes efficiently available? Quality manual QM/02 , Quality policy: QP/01 edited on
Are the documents are created for every type of march 2015 and all required procedures has documented.
medical device including qms requirements and product
specifications? (4.2.3) If these documents are applicable
to manufacturing processes, are montage and service
defined?
QUALITY MANUAL
Does the Quality Manual include, scope of QMS and Quality manual QM/02 observed. Identified procedures
details of exclusion?
and instructions that organization has implemented.
4.2.2 Are documented procedures reference to mandatory
procedures; Scope of activities and QMS is determined in this
Is description of interaction of the processes included in document.
the QMS?
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5.5 Responsibility, Authority and Communication
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RESPONSIBILITY AND AUTHORITY
Has top management identified responsibility and
Job description for production operator Also for
5.5.1
authority and been communicated within the
organization?
quality control manager observed in F02-P10.
Has top management defined responsibilities and
authorizations for CE marking?
MANAGEMENT REPRESENTATIVE
Has top management appointed a member as
Management Representative with responsibility and
Factory manager is management representative. He is
5.5.2
authority to ensure that the processes of the QMS are
established, implemented and maintained; report to
aware about his responsibilities.
top management on the performance of the QMS,
including needs for improvement and promote
awareness of customer requirements?
INTERNAL COMMUNICATION
Has the top management ensured establishment of
Internal communication is implemented by: tel., face
5.5.3
appropriate communication processes within the
organization? Has the top management ensured
to face ,letter, internal committee.
realization of communication considering the processes
of the QMS and their effectiveness?
5.6 Management review
TOP MANAGEMENT REVIEW
Does top management review the QMS to ensure its
continuing suitability, adequacy and effectiveness at
Management review has planned on quality manual
5.6.1
regular and planned intervals?
Do reviews include assessing opportunities for annually and has held on feb.2016.
improvement including the need for changes to the
QMS, quality policy, and quality objectives?
Are management review records kept?
REVIEW INPUT
Does review input include current performance and
improvement opportunities related to:
a) results of audits;
b) customer feedback;
All inputs has reviewed .such as : internal audit result ,
5.6.2 c) process performance and product conformance;
d) status of corrective and preventive actions; customer feedback , …
e) follow‐up action from earlier management reviews;
f) changes that could affect the QMS,
g) recommendations for improvement
h) New or revised regulatory rules?
REVIEW OUTPUT
Does output from management review include actions
Some Outputs for improvement of product quality and
needed sources are; provision of LASER cut equipment
5.6.3
related to improvement of the QMS and its processes,
improvement of product related to customer
and thickness meter tool , …. Also for improvement of
requirements, actions and decisions relate to resource
needs? processes determined new method.
6 Resource Management
PROVISION OF RESOURCES
Does the organization have methods to determine and
Human resources, infrastructure provided for support of
6.1 provide resources needed to implement and improve
the processes of the QMS and address customer processes.
satisfaction by meeting requirements?
6.2 Human Resources
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WORK ENVIRONMENT
Does the organization identify and manage required
work environment needed to achieve conformity of
product?
Are the following factors which could affect product
quality in the work environment identified?
‐ Process equipment,
‐ Work environment,
‐ Personnel in this work environment
Are qualified and quantified limit values of the work
environment identified for a desired quality of the work
environment?
Are pollution levels of microbial and solid particles
controlled during product manufacturing where sterile
product or pollution of solid particle which is stipulated
to be sterilized or could live or not live during its
manufacture or utilization is important?
Has exclusion been applied during all manufacturing
processes for a controlled environment? As valid
ground of exclusion, is pollution reduced to known,
consistent and controlled level by an approved cleaning
method and packaging kept at this level through control
process? According to monitoring and control of work
Have indicators been identified for a controlled
environment which covers valid cleaning and packaging
environment procedure: P11, work environment controls
processes including the organizations holding a valid about cleaning weekly. This procedure, meets legal
6.4 cleaning process?
requirements about GMP for A, B medical devices .
(Temperature, Humidity, Air Current, Filtration of Air,
Ionization of Air, Pressure differences, Lighting (along For example: cleaning of warehouse. Checklist of Jun
with its spectral content and severity), Sound, Vibration,
cleaning of Working surfaces and processes, Water 2015 was observed.
quality, number of persons in the work environment)
Have dressing conditions, cleaning conditions and
health conditions for any person being in contact with
the product or the work environment including those
persons who enter the area sterilized prior to use or
temporarily or for a short period in terms of importance
microbiologic cleaning holds been identified?
Are personnel to work in special work conditions or a
controlled environment provided with special training
and/or supervision? In the event that any personnel
including temporary and trained personnel for
performance of special tasks in a controlled
environment are assigned for performance of the works
such as production, maintenance, cleaning or repair, are
such personnel supervised by an appropriately trained
person? Have the procedures for product introduction,
product polluted or being likely to be polluted, manual
working for working surfaces or personnel, cleaning or
removal of contamination in order to prevent cross
pollution of product, work environment or personnel?
Are the records indicating appropriateness for all
conditions kept?
7 Product Realization
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7.2 Customer‐Related Processes
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DESIGN AND DEVELOPMENT VALIDATION
Is the design and/or development validation performed
in accordance with planned arrangements to confirm
that final product is capable of meeting the
requirements of intended use or application
7.3.6 requirements defined? excluded
Is verification completed (if applicable) prior to delivery
or implementation of product? Ara relevant records
maintained?
Are results of review and required actions recorded?
CONTROL OF DESIGN AND DEVELOPMENT CHANGES
Have design and development changes been identified
and recorded?
Have design and development changes been reviewed,
verified, validated and approved prior to
implementation?
7.3.7 Does the review of design and development changes excluded
include evaluation of the effect of changes on
previously delivered product and the parts constituting
the product?
Are the results of review of changes and subsequent
follow‐up actions documented?
7.4 Purchasing
Purchasing Process; Has the organization prepared
documented process to ensure that purchased product
conforms to purchasing requirements?
Are criteria for selection of suppliers defined?
Are evaluation and reevaluation of suppliers have been
defined?
Has the organization defined tracking frequency of
supplier’s performance?
Does the organization have the proofs indicating that
supplier monitoring activities, outsourced processes are
Records of suppliers evaluation for chromium
controlled and the products or services conform to the electroplating parts observed based on: records of
7.4.1
rules of the organization containing customer demands
and regulatory rules?
activity, price, quality of service, distance from factory.
Have the requirements of purchasing information Score was 69 and grade: B.
(containing the rules related to supplier records)
including outsourced processes been identified to
ensure product and service quality?
Does the organization have the methodology to
communicate these requirements to the supplier?
Are purchasing contracts available?
Do the type and content of the control on supplier and
purchased product depend on the next product
realization of purchased product or final product?
Are purchasing records retained?
PURCHASING INFORMATION
Does purchasing information define the product to be
purchased?
Where appropriate, does purchasing information Purchasing data for row material determined in BOM in
include product approval, procedures, requirements for
technical file.
7.4.2
process and equipment, Personnel qualification and the
requirements of Quality Management System?
How does organization ensure the adequacy of On dec.2015 purchase order no.: 364 observed for foam
specified requirements in the purchasing information 60*180 . this order is accordant with BOM.
prior to their release to the supplier?
Are records for the information related to purchased
product available?
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VERIFICATION OF PURCHASED PRODUCT
Has the organization identified a method in order to
ensure that the product received conforms to the
specifications, is finished, holds appropriate identity
and is free from any damage? One cromium electroplating part on jan.2016 purchased
Do the processes include the provisions in order to from supplier. 10 number testes based on instruction
verify that incoming product is provided along with
(strength and humidity test) and verified.
7.4.3
support documentation (e.g. conformity certificates,
acceptance test reports)?
Has data been provided related to analysis of previous On jan.2016 , trans 24v purchased from supplier and
acceptance inspection data, rejection history in the tested based on amper of trans and verified. Records of
plant or customer complaints, required inspection
quantity and necessity of reevaluation of supplier? this verification observed on F01-P04.
Has the organization identified the authorized person
for conformity approval of incoming material?
Are verification records retained?
7.5 Production and Service Provision
CONTROL OF PRODUCTION AND SERVICE PROVISION
7.5.1.1 General rules
Has the organization identified control requirements for
production and service process?
Is control quantity and control detail level
proportionate to criticality level of its process?
Has the characteristic qualities of product been
identified? When required, have documented
procedures, documented rules, work instructions and
reference materials reference materials and reference
measuring processes been made available?
Has appropriate equipment been selected in the
manner that enables process and product specifications
to be obtained?
Have the documents for using appropriate equipment After receiving order , communicated to warehouse ,
been established? assemble , manufacture of body . such as , order no: 2325
Has it been verified that new and/or significantly
modified equipment meets purchasing/design for genycology bed with 2 motors and code : GM2.N .
specifications and posses the ability to operate within
7.5.1 the limits defined and process operating limits?
Have control devices been identified?
Control duration production according to form F02-P04
on jan.2015 observed. Such as : for measuring and
Has a document been prepared for using control
devices? cutting of parts , welding of frame and skelet ,
Have implementation and control requirements for assembling and painting . this controls has done based on
labeling and packaging been identified?
Are the records obtained during manufacturing process quality control plan.
of any product lot and facilitating traceability and
review of the manufacture of this lot retained?
Do the records include the following information?
‐ When applicable, quantity of raw materials,
components and intermediate products and lot
numbers of those materials,
‐ When applicable, start and completion dates of
different stages of manufacture including sterilization
records,
‐ Quantity of manufactured product,
‐ Signed results of all inspections and tests,
‐ Representation of production line used,
‐ Any deviation from manufacturing specifications.
7.5.1.2 Control of production and service‐Special rules
Control of product cleanliness and contamination
Has the organization identified product cleanliness
rules?
Have the materials and substances used during
manufacturing process been adequately defined and
labeled in order to prevent complexity and process
After all steps of production , products cleans by and
7.5.1.2.1 faults?
Have certain medical devices been cleaned and/or also after welding , welded parts , cleans by antox gel.
cleared of contamination so as to prevent employees
and other product from being exposed to any
contamination
Have cleaning and implementation requirements been
documented?
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Assembly activities
Have assembly activities and responsibility for medical
device been identified?
In the event that any medical device should be
assembled and mounted in the location where the user
is present, have guiding instructions been prepared by
7.5.1.2.2 the organization for accurate assembly, montage, tests excluded
and/or calibrations?
Has the organization provided the instructions which
allow assembler to confirm proper operation of the
device?
Are the results of assembly or commissioning tests
recorded?
Service activities
In the event that functionality of products needs service
or maintenance for proper utilization of products, have
documented requirements been established for service
activity?
Has the organization identified service responsibilities
between distributors and users?
Have service activities carried out by the organization or
a separate agency been planned?
Have the design and functionality of equipment or One sample for aftersales services request on jan.2015
devices with special purpose related to manual
operation and service after assembly been validated? observed. About failoure in function of remote control of
7.5.1.2.3 Are measuring and test equipment used for site service
and tests controlled?
beds. Records includes : failure description , result of
Have instructions related to the lists of spare parts or actions and customer satisfaction observed in form F05-
parts and for use in product service been prepared? W01. Action was changing of remote board.
Has the infrastructure covering technical consultancy
and technical support, customer training and spare
parts or provision of parts been established?
Are service personnel trained?
Are specialized service personnel available?
Has the organization formed a system for receiving
customer demands so as to determine whether
customer complaints and rules are handled?
Are service records retained?
Special rules for sterile devices
Does the organization record process parameters
related to sterilization process and used for each
7.5.1.3 sterilization lot? exluded
Are sterilization records tracked for each production lot
related to medical devices?
7.5.2 VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION
W01
involved
validation of welding operation observed in training
7.5.2.1 c) use of specific methods and procedures
d)records requirements records of operator. Records of validation of chromium
AR
e)revalidation
documented procedure for validation of
electroplating operation observed for purchased material
software/computer applications, and records of such as on jan.2016. For painting operation , records of
validation
parameters controls has not recorded.
Special rules for sterile medical devices
Have sterilization processes been validated prior to
use?
7.5.2.2 Have the standards used for validation of sterilization excluded
process been identified and implemented?
Have the requirements in the Article no. 7.5.2.1 been
met?
7.5.3 Identification and Traceability
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Identification
Has the organization identified and documented the
product through appropriate methods during product
All beds in assemble line have S/N and lable includes
7.5.3.1 realization?
How has the organization identified product situations name and model of product . such as : S/N: 9412012.
in accordance with tracing and measuring
requirements?
TRACEABILITY For skin exaination bed with S/N: 9412006 for order no.:
75.3.2.1 General
How is the product traced? 2456 , traceability and control of produced productions
7.5.3.2 Has any method been documented for traceability?
Does the organization ensure traceability of the medical
observed. S/N recorded in that. Specifications of parts
device during typically production and storage process such as : upper motor , electronic board , wheels ,… .type
up to expiration of ownership? of motor identified in that.
Special rules related to active implantable medical
devices and implantable medical devices
Does the organization ensure traceability in inspection
and stock records for the changes of the personnel
performing a work traceability of which belongs to an
7.5.3.2.2 introductory (e.g. serial number, data code, lot code,
party number) special to operation source, changes in excluded
raw materials, changes in the works performed through
tools, new or different machine devices, changes of
process methods?
When applicable, are special personnel assigned to act
during processing medical device or each stage of
delivery traced?
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CONTROL OF MONITORING AND MEASURING DEVICES
Has the organization identified the measurements to be
made and the measuring and monitoring devices
required to ensure conformity of product to specified Caliper code vc02 in size: 30cm in quality control unit
requirement?
a) Be calibrated or verified at specified intervals, or and has not identified for calibration status and according
prior to use, against measurement standards traceable to calibration planning, not observed calibration records.
to international or national measurement standards;
P05
7.6 where no such standards exist, the basis used for
calibration or verification s hall be recorded;
Caliper VC01 is calibrated and certificate No. is AR
934853ب194 calibration is valid before September 2016
b) Be adjusted or re‐adjusted as necessary;
c) Be identified to enable the calibration status to be Coating film calibration certificate is 934857ب194
determined;
d) Be safeguarded from adjustments that would calibration is valid before September 2017
invalidate the measurement result;
e) Be protected from damage and deterioration during
handling, maintenance and storage.
8 Measurement, Analysis and Improvement
General
Does the organization plan to implement the
monitoring, measurement, analysis, and improvement Statistic technique and analysis of data P12, internal
processes required for conformity of the product and
8.1 QMS and improvement of its efficiency? audit , customer feedback handling procedure
Are measurement, analysis and improvement documented.
processes are carried out through statistical
techniques and applicable methods?
8.2 Monitoring and Measuring
8.2.1 CUSTOMER SATISFACTION
Does the organization monitor the information related Score of customer satisfaction was 92.84% . this score
to customer perception in order to understand whether
has improved 10% from last year.
8.2.1 customer requirements are met or not?
Has the organization determined methodologies for No complaint from interested parties
obtaining and using information on customer No recall
satisfaction and/or dissatisfaction?
Internal audit procedure: P03.
INTERNAL AUDIT
Has a documented procedure been established that Interval for internal audit is annual. Records observed
includes responsibilities and requirements, on feb.2016.
requirements for planning and conducting the audit,
reporting the results, maintaining the records? they have issued 6 NCR’s (such as not evaluation
Are audits planned in the form of an audit program? training effectiveness about storage method) and
8.2.2
Does audit programme take importance and status of
the fields and processes to be audited including the related corrective action. All determined corrective
results of previous audits? actions have been closed and their effectiveness have
Do selection of auditors and implementation of audit
ensure objectivity and impartiality of the process? been evaluated by the management representative.
Do auditors audit their works? As mentioned above, for non conformities, has issued
Do follow‐up actions cover verification of the measures
taken and reporting of verification results?
corrective actions. Some actions have finished and
effectiveness of them has evaluated.
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DATA ANALYSIS
Does the organization collect, identify and analyze
appropriate data to demonstrate efficiency and
appropriateness of QMS and the fields where QMS’s
efficiency can be continuously improved?
Has a documented procedure been prepared for these By improvement of parts quality with better quality
8.4
analyses?
parts , customer satisfaction has got better 10%
Do the characteristics and tendencies of the processes
and products including data analysis, customer comparing last year.
satisfaction, conformance to product requirements,
opportunities for corrective actions provide information
related to suppliers?
Have data types for data analysis been defined?
Are data analyses recorded?
8.5 Improvement
CONTINUAL IMPROVEMENT
Has the organization identified required changes by
using quality policy, quality objectives, audit results,
analyses of data, corrective and preventive actions and
management review in order to ensure and sustain
ongoing conformity and efficiency of quality
management system and does the organization
implement such changes?
Has the organization established written procedures in
order that advisory warnings can be published and
implemented?
Are the records of all examinations related to customer
complaint maintained?
Have the complaints been evaluated within the scope of
the following points?:
‐ whether the organization fails to comply with its own Improvement planning were: installation of painting line,
specifications or not,
improvement of electrical panel of beds.
8.5.1 ‐ whether the organization has caused problems to
occur despite the fact that it has complied with its own These plans are based on quality policy and customer
specifications feedbacks.
In the event that the activities outside the organization
are identified through examination of the contribution
of such activities to customer complaint, has the
relevant information been shared among responsible
organizations?
In the event that any customer complaint is not
followed up through a corrective and/or preventive
action, has the reason of this failure been confirmed
and recorded?
Has the organization established a documented
procedure for notifying adverse events and alertness
within the scope of after‐sale supervision activities?
Does the process comply with international guides?
(MEDDEV 2.12.1 – MEDDEV 2.12.2)
Are the notices for adverse events recorded
8.5.2. CORRECTIVE ACTION
Is there a documented procedure for Corrective and
Preventive Action?
Are corrective actions taken to eliminate causes of
Corrective actions about result of internal audit , was
nonconformities effective in preventing recurrences? checked. All root causes has detected and actions are
Does this procedure include the requirements of
based on root causes. For example some semi-products
8.5.2 reviewing non‐conformities (including customer
complaints), determining the causes of non‐conformity, had not been labeled ,rout cause : the operator of who
evaluating the actions needed to ensure that was in charge was on vacation and his responsibility was
nonconformities do not recur, determining and
implementing the corrective action needed, and review not allocate to other staff.
of the results of the action initiated?
Is adequacy of corrective‐preventive actions identified?
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PREVENTIVE ACTION
Has the organization established a documented
procedure for preventive action with defined
requirements for identifying potential non‐conformities
8.5.3
and their causes; evaluating the need for action to
prevent occurrence; determining and implementing No preventive actions has issued.
preventive action needed; recording results of action
taken; reviewing preventive action taken.
What are the methods for identifying the adequacy of
corrective‐preventive actions?
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
cleaness
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:NA
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:
1. Caliper in size: 30cm in quality control unit has not identified for calibration status and according to calibration
planning, not observed calibration records.
2. For painting operation, records of parameters controls have not recorded.
END of REPORT
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