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THE
MINISTRY OF SCIENCE AND TECHNOLOGY
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SOCIALIST
REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
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No.:
08/2009/TT-BKHCN
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Hanoi,
April 08, 2009
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CIRCULAR
GUIDANCE ON THE REQUIREMENTS AND ORDER AND PROCEDURES FOR
REGISTRATION OF FIELD OF CONFORMITY ASSESSMENT OPERATION
Pursuant to the Law on
Quality of Products, Goods date November 21, 2007;
Pursuant to the Decree No.28/2008/ND-CP
dated March 14, 2008 of the Government defining function, tasks, powers and
organizational structure of the Ministry of Science and Technology;
Pursuant to the Decree
No.132/2008/ND-CP dated December 31, 2008 of the Government detailing the
implementation of a number of Articles of the Law on Quality of Products,
Goods;
Ministry of Science and
Technology guides generally on the requirements and order and procedures for
registration of field of conformity assessment operation as follows:
I. GENERAL
PROVISIONS
1. Scope of governing and
subjects of application
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1.2. This Circular applies to
organizations providing conformity assessment services and the state management
agencies related to activities of conformity assessment.
1.3. This Circular does not
apply to the following activities:
1.3.1. Expertise of the
measuring device on the list of measuring means subject to list of measuring
means required to calibrate under the provisions of law on measurement;
1.3.2. Testing for internal operations
of organizations; not providing the testing services to the outside.
2. General principles
2.1. Ministry of Science and
Technology is responsible for the unified State management on the operation of
conformity assessment.
2.2. The ministries of managing
branches, sectors are responsible for managing the operation of the conformity
assessment within its scope of management.
2.3. Terms and definitions of
testing, expertise, calibration, and certification are prescribed in Article 3
of the Law on Quality of Products and Goods.
2.4. Where the standards
prescribed in this Circular are amended, supplemented, or replaced, it shall
comply with the documents which are amended, supplemented, or promulgated
newly.
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1. For the certification
organizations
1.1. General requirements
Certification organizations must
meet the following requirements:
1.1.1. Established under the
provisions of law, functioning in the field of certification;
1.1.2. System of management and
operational capacity of the certification organizations must meet the
requirements specified in national standards, international standards, and
international guidelines for each following respective type:
- National standards TCVN
7457:2004 or international standards ISO/IEC Guide 65:1996 and the relevant
guidelines of the International Accreditation Forum (IAF) for the certification
operation of products and goods;
- National Standards TCVN ISO/IEC
International Standard 17021:2008 or international standards ISO/IEC 17021:2006
and the relevant guidelines of the International Accreditation Forum (IAF) for
certification operation of management system.
1.1.3. It must have at least 05
experts of assessment of the official personnel (public employees or employees
signing contract with a period of 12 months or more or the labor contract of
indefinite term) of the organizations and meet the following requirements:
- Having graduated from
university or more and professional skill consistent with the field of
certification registration;
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- Being trained on certification
of management system.
1.2. The order and procedures
for registration of certification operation
1.2.1. The certification organizations
meeting the requirements specified in point 1.1 clause 1 of this Item,
formulate the registration dossier of the field of certification operation and
send to the contact-point agency stipulated in point 1.3 clause 1, Item III of
this Circular.
1.2.2. Dossier for registration
of the field of certification operation includes:
1.2.2.1. Registration paper of
the field of certification operation in the form prescribed in Appendix II of
this Circular;
1.2.2.2. A copy of the
establishment decision, or the certificate of business registration, or the
investment license;
1.2.2.3. List of experts of
assessment meeting the requirements specified in clause 1.1.3 of this Item, in
the form prescribed in Appendix I of this Circular together with the copy of respective
training certificate;
1.2.2.4. The documents proving
the capacity of the certification operation meeting requirements specified in
point 1.1 clause 1 of this Item, specifically as follows:
- For the certification
organizations that have been assessed and granted certificates for
certification operation in Vietnam by the lawful accreditation organizations of
Vietnam or accreditation organizations as a member of the International
Accreditation Forum (IAF), The Pacific Accreditation Cooperation (PAC): Submit
a copy of the certificate attached to the scope of accreditation.
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1.2.2.5. Form of certificate
paper and seal of certification;
1.2.2.6. Results of
certification operation carried out in the field of registration of a latest
year (if any).
1.2.3. Within seven working days
after receiving complete and valid dossiers under the provisions in point
1.2.2, clause 1 of this Item, the contact-point agency stipulated in point 1.3
clause 1, Item III of this Circular conducts a review of dossiers and the grant
of certificate of registration of certification operation field in the form
prescribed in Appendix III to this Circular for the certification
organizations.
In case of refusal to grant a
certificate, the contact-point agency must send written reply of the reasons
therefore to the certification organization applied for registration.
1.3. When the certification
organizations signed up the certification operation field have the needs of
change, supplementation of operation fields which have been registered, they
must perform the registration of changes and supplementation as prescribed in
point 1.2, clause 1 of this Item.
Written request for change,
supplementation of operation fields specified in Appendix IV of this Circular.
2. For the testing
organizations
2.1. General requirements
Testing organizations must meet
the following requirements:
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2.1.2. Having capacity of
testing meeting requirements specified in national standards TCVN ISO/IEC
17025:2007 or international standards ISO/IEC 17025:2005;
2.1.3. It must have at least 01
qualified tester in accordance with the field of testing registration.
In the case of having national
standards or international standards on quality management system for the
specialized testing organization, the specialized testing organization must
meet the requirements of such standards.
2.2. The order and procedures
for registration of testing operation
2.2.1. Testing organizations meeting
the requirements specified in point 2.1 clause 2 of this Item, make dossier for
registration of field of testing operation and submit to the contact-point
agency as specified in point 1.3, clause I Item III of this Circular.
2.2.2. Registration dossier for
testing operation field includes:
2.2.2.1. Written registration
for testing operation field in the form is prescribed in Appendix II of this
Circular;
2.2.2.2. A copy of the
establishment decision or certificate of business registration or investment
license;
2.2.2.3. List of testers
corresponding to the registration field for testing attached to a copy of the
certificate of professional training.
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- For the testing organizations
that have been assessed and granted accreditation certificates for testing
operation in Vietnam by the lawful accreditation organizations of Vietnam or foreign
accreditation organizations as a member participating in signing Agreement on
mutual recognition of the Association of International Laboratory Accreditation
(ILAC), Association of Laboratory Accreditation in Asia - Pacific (APLAC-Asian
Pacific Laboratory Accreditation Cooperation): Submit a copy of the
accreditation certificate attached to the accredited scope.
- For the testing organizations
that have not been accredited: Submit documents, procedures, assessment
procedures and other concerned documents to demonstrate the operational
capacity in accordance with the requirements of respective standards specified
in point 2.1, clause 2 of this Item.
2.2.2.5. Form of the testing
results;
2.2.2.6. The testing results
conducted in the field of registration of a latest year (if any).
2.2.3. Within seven working days
after receiving complete and valid dossiers under the provisions in point
2.2.2, clause 2 of this Item, the contact-point agency stipulated in point 1.3
clause 1, Item III of this Circular conducts a review of dossiers and the grant
of certificate of registration of testing operation field in the form
prescribed in Appendix III to this Circular for the testing organizations.
In case of refusal to grant a
certificate, the contact-point agency must send written reply of the reasons
therefore to the testing organization applied for registration.
2.2.4. When the testing
organizations signed up the testing operation field have the needs of change,
supplementation of operation fields which have been registered, they must
perform the registration of changes and supplementation as prescribed in point
2.2, clause 2 of this Item.
Written request for change,
supplementation of operation fields is specified in Appendix IV of this
Circular.
3. For expertise organizations,
calibration organizations
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3.1.1. For expertise
organizations
Expertise organizations must
meet the following requirements:
3.1.1.1. Established in
accordance with law regulations;
3.1.1.2. It must have capacity
of appraisal meeting requirements specified in national standards TCVN ISO/IEC
17020: 2001 or International Standard ISO/IEC 17020:1998;
3.1.1.3. It must have qualified
expertise experts under the provisions of the Commercial Law.
3.1.2. For calibration organizations
Calibration organizations must
meet the following requirements:
3.1.2.1. Established in
accordance with law regulations;
3.1.2.2. It must have
laboratories meeting requirements specified in national standards TCVN ISO/IEC
17025:2007 or international standard ISO/IE 17025:2005;
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3.2. The order and procedures
for registration of operation fields of expertise, calibration
3.2.1 For the expertise
organizations
3.2.1.1. The order and
procedures for registration of the expertise operation field are made under the
provisions of the Commercial Law and other guiding documents: the Decree
No.20/2006/ND-CP dated 20/02/2006 of the Government, Circular No.06/2006/TT-BTM
dated 11/04/2006 of Ministry of Commerce (now the Ministry of Industry and
Trade).
3.2.1.2. On the conditions,
expertise organizations must meet the requirements specified in point 3.1.1
clause 3 of this Item.
3.2.2. For calibration
organizations
3.2.2.1 The order and procedures
for registration of calibration operation shall comply with the provisions of
the ministries of managing branches, sectors for products and goods of its
scope of management.
3.2.2.2. On the conditions,
calibration organizations must meet the requirements specified in point 3.1.2
clause 3 of this Item.
III.
RESPONSIBILITY OF MANAGEMENT AGENCIES AND ORGANIZATIONS OF CONFORMITY
ASSESSMENT
1. The responsibilities of
the ministries of managing branches, sectors
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1.2. The ministries of managing
branches, sectors appoint the contact-point agency to take responsibility for
quality expertise operation management of products and goods of the field
assigned management and inform on the mass media to the organizations,
individuals, and inform the Ministry of Science and Technology for coordinating
the management.
1.3. Ministry of Science and
Technology appoints the following agencies as the contact-point agencies:
1.3.1. Directorate for
Standards, Metrology and Quality is the contact-point agency to take
responsibility for management of conformity certification operation, testing of
quality of products and goods in the whole country and operation of conformity
assessment for products and goods on the management responsibilities of the
Ministry of Science and Technology (except for products related to safety of
nuclear radiation).
1.3.2. Department of Radiation
Safety and Nuclear is the contact-point agency to take responsibility for
management of the conformity assessment operation for products related to
nuclear radiation.
2. Responsibilities of the
contact-point agencies appointed
2.1. To receive, process
registration documents and grant registration certificates of fields of
conformity assessment operation for organizations of conformity assessment.
2.2. Manage and inspect
operations of conformity assessment of the conformity assessment organizations
that have been granted certificates of registration of operation fields. Take
measures of warning, temporary suspension of validity or cancellation of the
certificate of registration of operation fields as organizations of conformity
assessment violate the provisions of this Circular or the provisions of Article
20 of the Law on Quality of products and goods.
2.3. To sum up the list of
organizations of conformity assessment that have been granted certificates of
registration of operation fields together with the field of conformity
assessment and organizations of conformity assessment registered operation
fields but have been warned, temporarily suspended or cancelled certificates of
registration; notify publicly on the website of the Ministry of managing
branches, sectors to the organizations and individuals and inform the Ministry
of Science and Technology (Directorate for Standards, Metrology and Quality)
for general synthesis.
2.4. Every six months and
irregularly when required, the contact-point agencies shall review the
situation, the operation results of organizations of conformity assessment that
have been granted certificates of registration of operation fields, report to
Ministry of managing branches, sectors and inform the Ministry of Science and
Technology (Directorate for Standards, Metrology and Quality) for coordinating
the management.
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3.1. Exercise the rights and
perform obligations as stipulated in Article 19 and Article 20 of the Law on
Quality of Products and goods. In case of violation of the provisions of this
Circular or the provisions of Article 20 of the Law on Quality of Products,
Goods, depending on the nature, extent, it shall be warned or temporarily
suspended its validity or cancelled certificates of registration of operation
fields of conformity assessment.
3.2. Every six months and
irregularly when required, report according to the prescribed form in Appendix
V of this Circular on the results of the assessment operation of conformity
signed up, particularly for the certification organizations, it is reported by
prescribed form in Appendix VI of this Circular on the results of certification
operation; and also notify the Ministry of Science and Technology (Directorate
for Standards, Metrology and Quality) for synthesis and report to the Prime
Minister.
3.3. Notify the contact-point
agencies specified in clause 1, Item III of this Circular on the changes that
affect the operational capacity of conformity assessment signed up within
fifteen days from the date of the change.
IV.
ORGANIZATION OF IMPLEMENTATION
1. The ministries managing
fields, sectors are responsible for guiding the implementation of this Circular
within its scope of management. Based on the guidance in this Circular,
building requirements; order, procedures of registration for specific operation
field for the calibration, expertise organizations within its scope of
management.
2. Directorate for Standards,
Metrology and Quality is responsible for monitoring and urging the
implementation of this Circular.
3. This Circular takes effect 45
days from the date of its signing and replaces the regulations on the
registration of standards conformity certification operation specified in Article
8 and Article 9 of the Regulation on standards conformity certification, rules
conformity certification and publication of standards conformity, rules
conformity, issued together with Decision No.24/2007/QĐ-BKHCN dated 28/09/2007
of the Minister of Science and Technology.
4. After 6 months from the
effective date of this Circular, the standards conformity certification
organizations that have been granted certificates of registration of standards
conformity certification operation in accordance with provisions in the
Decision No.24/2007/QD-BKHCN dated 28/09/2007 of the Minister of Science and
Technology must complete the additional documents, diplomas and certificates
prescribed in clause 1.2.2 of Item I to be converted the certificates of
registration of certification operation field in accordance with provisions of
this Circular.
5. After 6 months from the
effective date of this Circular, the organizations of conformity assessment
must register the operation fields as specified in this Circular. If it violates,
depending on the nature and seriousness of the violation, it will be handled
according to the law regulations.
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FOR
MINISTER
DEPUTY MINISTER
Tran Quoc Thang
APPENDIX I
FORM OF LIST OF ASSESSMENT EXPERTS OF ORGANIZATIONS
OF CONFORMITY ASSESSMENT
(Issued together with Circular No.08/2009/TT-BKHCN dated April 08, 2009 by
the Minister of Science and Technology)
ORGANIZATION’S NAME:……………
LIST
OF ASSESSMENT EXPERTS OF ORGANIZATIONS OF CONFORMITY ASSESSMENT REGISTERING THE
OPERATION FIELDS
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Full
name
Professional
certificate
Certificate
training management system
Assessment
of capability of experts
Levels
of experts (assessment head /assessment/ technician…)
Assessment
experience
Types
of labor contract signed
Note
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8
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9
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…….
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……..
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…….,
Date …..month…..year …….
Organization’s representative....
(Full name, Signature, seal)
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APPENDIX II
REGISTRATION PAPER FORM OF OPERATION FIELDS OF
CONFORMITY ASSESSMENT
(Issued together with Circular No.08/2009/TT-BKHCN dated April 08, 2009 by
the Minister of Science and Technology)
SOCIALIST
REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
-------------------
………..,
Date …..month…..2000…….
REGISTRATION
PAPER
FIELD
OF TESTING/ CERTIFICATION OPERATIONS
To:
…..(Name of the contact-point agency appointed by the Ministry of Science
and Technology)
1. Organization’s
name:.....................................................................................................
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Tel:
........................................... Fax:
............................... E-mail:......................................
3.
Establishment decision (if any) / Certificate of business
registration/investment license No. ... ... ...., Issued by: ... ... ... ...
... issued on ... ... .. at.......................................
4. After studying
the provisions of Decree No.132/2008/ND-CP of December 31, 2008 of the
Government detailing the implementation of some Articles of the Law on Quality
of Products and Goods, Circular No.08/2009/TT-BKHCN April 08, 2009 by the
Minister of Science and Technology guiding on the requirements, order,
procedures for registration of operation field of conformity assessment, we
found that we may meet the operating conditions in the testing/certification
for the field (name of specialized domain).
5. Form of
testing results/certificates, certification seal attached.
Request ...
... ... ....(Name of the contact-point agency appointed by the Ministry of
Science and Technology) to consider and grant certificates of registration of
testing/certification operation in the field as listed above.
We commit to
comply with the regulations on conformity assessment operation and the relevant
provisions of law./.
Organization’s
representative....
(Full name, Signature, seal)
...
...
...
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Note: Registration
for a certain field of operation, then state name of such field.
APPENDIX III
CERTIFICATE FORM OF REGISTRATION OF FIELD OF
CONFORMITY ASSESSMENT
(Issued together with Circular No.08/2009/TT-BKHCN dated April 08, 2009 by the
Minister of Science and Technology)
……………………………………
(Name of the contact-point agency appointed by the Ministry of Science and
Technology)
-------------
No.: …………………….
SOCIALIST
REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
-------------------
Hanoi,
date …….month….. 200…..
CERTIFICATE
OF
...
...
...
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Pursuant to
Decision No.... .....defining functions, tasks, powers and organizational
structure of the ... ... ... ... (name of the contact-point agency appointed by
the Ministry of Science and Technology);
Pursuant to
Decree No.132/2008/ND-CP of December 31, 2008 of the Government detailing the
implementation of some Articles of the Law on Quality of Products and Goods;
Pursuant to
Circular No.08/2009/TT-BKHCN dated April 08, 2009 by the Minister of Science
and Technology guiding the requirements, order, procedures for registration of
operation of conformity assessment;
At the
proposal of ... ... ... ... ... ... .. (Name of units of the contact-point
agency tasked dossier calibration), it is certified that:
1. …………( Name
of the conformity assessment organization).....................................
Address:
..........................................................................................................................
Phone:
........................................... Fax:
............................... E-mail:............................
Already
registered operation fields of testing/certification for the following areas:
- .........................................................
(name of specialized field)....................................
...
...
...
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3.
Certificate is granted for: ........ (first, second …)
4. This
certificate is valid from the signing date./.
Recipients:
- Name of the organization in Item 1;
- Minitry of Science and Technology (report);
- Directorate for Standards, Metrology and Quality (for knowing);
- Archiving,…
NAME
OF THE CONTACT-POINT AGENCY APPOINTED BY THE MINISTRY OF SCIENCE AND
TECHNOLOGY
Note: Issuance
for registration certificate for a certain field of operation, then state name
of such field.
...
...
...
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FORM OF REGISTRATION PAPER FOR AMENDMENT,
SUPPLEMENTATION OF FIELD OF CONFORMITY ASSESSMENT
(Issued together with Circular No.08/2009/TT-BKHCN dated April 08, 2009
by the Minister of Science and Technology)
SOCIALIST
REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
-------------------
………..,
date …….month….. 200…..
REGISTRATION
CERTIFICATE FOR AMENDMENT, SUPPLEMENTATION OF FIELD OF TESTING/CERTIFICATION
To:
…..(Name of the contact-point agency appointed by the Ministry of Science
and Technology)
1. Name of
organization:.................................................................................................
2. Address:
.....................................................................................................................
Phone:
........................................... Fax: ...............................
E-mail:.............................
...
...
...
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4. Field of
testing/certification operation proposed for changes and
supplements:............
Request
................................ (Name of the contact-point agency appointed
by the Ministry of Science and Technology) to review and grant registration
of changes, supplements of field of testing/certification operation mentioned
above.
It is
committed by us to comply with the regulations on conformity assessment in the
field of registration of changes and supplements./.
Organization’s
representative....
(Full name, Signature, seal)
Note: Additional
registration for a certain field of operation, then state name of such field.
...
...
...
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REPORT FORM ON OPERATION SITUATION OF CONFORMITY
ASSESSMENT
(Issued together with Circular No.08/2009/TT-BKHCN dated April 08, 2009
by the Minister of Science and Technology)
(Name
of the governing agency)
(Name of the organization of conformity assessment)
SOCIALIST
REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
-------------------
Date
…….month….. 200…..
REPORT
ON OPERATION SITUATION OF TESTING/EXPERTISE/CALIBRATION
(From...../…./200…
to ……/…./200….)
To:
- …….( Name of the
contact-point agency appointed by the Ministry of managing Branch)
- Directorate for Standards, Metrology and Quality (Ministry of Science and
Technology)
...
...
...
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1. Name of
Organization of conformity
assessment:.....................................................
2. Address:
......................................................................................................................
3. Phone:
....................................... Fax: ...............................
E-mail:............................
4. Operation
situation
…………..(Name
of Organization of the conformity assessment) report on the
operation situation of conformity assessment from...../…./200… to ……/…./200….as
follows:
- Name of the
specialized field
- The
quantity and content of work assessed the conformity
5. Proposals
and recommendations
a) The
problems arising in the process of conformity assessment
...
...
...
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.........................................................................................................................................
.........................................................................................................................................
b)
Recommendations and proposals for competent state agencies to improve the
conformity assessment operation
.........................................................................................................................................
.........................................................................................................................................
.........................................................................................................................................
………( Name
of Organization of the conformity assessment) report for …..(name
of the contact-point agency of Ministry of managing branch, sector) and
Directorate for Standards, Metrology and Quality./.
...
...
...
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Note: Report for a
certain field of operation, then state name of such field.
APPENDIX VI
REPORT FORM ON OPERATION SITUATION OF CERTIFICATION
(Issued together with Circular No.08/2009/TT-BKHCN dated April 08, 2009
by the Minister of Science and Technology)
(Name
of the governing agency)
(Name of the organization of conformity assessment)
SOCIALIST
REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
-------------------
Date
…….month….. 200…..
...
...
...
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ON
THE SITUATION OF CERTIFICATION OPERATION
(From...../…./200…
to ……/…./200….)
To:
Directorate for Standards,
Metrology and Quality (Ministry of Science and Technology)
1. Name of Organization of conformity
assessment:......................................... .............
2. Address:
3. Phone: ....................................... Fax:
............................... E-mail :............................
4. Operation situation
... ... ... ... .. (Name of Organization of the conformity assessment) report
on the activities of conformity assessment from...../ ... ./200 ... ... to... /
... ./200 ... . as follows:
a) Units that are certified in the report period
No.
Unit’s
name
Address
(stating place name of province/city)
...
...
...
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Applicable
standards
Time/Validity
of Certificate of certification (stating the year of expiry)
Note
...
...
...
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b) Units had certificates but are
revoked or expired (if any) during the report period
No.
Unit’s
name
Address
(stating place name of province/city)
Field/object
Applicable
standards
Time/Validity
of Certificate of certification (stating the year of expiry)
Note
...
...
...
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5. Proposals
and recommendations (if any)
... ... ...
(Name of organization of conformity certification) report to Directorate for
Standards, Metrology and Quality./.
...
...
...
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