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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: 28/2012/TT-BKHCN
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Hanoi, December 12, 2012
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CIRCULAR
PROVIDING FOR DECLARATION OF STANDARD CONFORMITY
AND DECLARATION OF TECHNICAL-REGULATION CONFORMITY AND METHOD TO ASSESS
CONFORMITY WITH STANDARDS AND TECHNICAL REGULATIONS
Pursuant to the Law on Standards and Technical
Regulations dated June 29, 2006;
Pursuant to the Law on product and goods
quality dated November 21, 2007;
Pursuant to the
Government’s Decree No.127/2007/ND-CP dated August 01, 2007, detailing
implementation of a number of Articles of Law on Standards and Technical
Regulations;
Pursuant to the
Government’s Decree No.132/2008/ND-CP dated December 31, 2008, detailing
implementation of a number of Articles of Law on product and goods
quality;
Pursuant to the
Government’s Decree No.28/2008/ND-CP dated March 14, 2008, defining the
functions, tasks, powers and organizational structure of the Ministry of
science and technology;
At the proposal of
General Director of Directorate for Standards, Metrology and Quality;
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Chapter 1.
GENERAL PROVISIONS
Article 1. Scope of
regulation
This Circular provides
for declaration of standard conformity and declaration of technical-regulation
conformity and method to assess the conformity with standards and technical
regulations.
Article 2. Subjects of
application
This Circular applies to
organizations, individuals and regulatory bodies related to assessment of the
conformity, declaration of standard conformity and declaration of
technical-regulation conformity.
Article 3.
Interpretation of terms
1. Declaration of
standard conformity means the self-declaration made by an organization or
individual whose products, goods, services, process, environment are
conformable to respective standards.
2. Declaration of
technical-regulation conformity means the self-declaration made by an
organization or individual whose products, goods, services, process,
environment are conformable to respective technical regulations.
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4. The appointed
certifying organization means the organization that already registered as
prescribed in Clause 3 of this Article and appointed by competent agencies to certify
technical-regulation conformity .
5. The registered testing
organization means the organization that already registered the testing operation
as prescribed in the Circular No. 08/2009/TT-BKHCN and Circular No.
10/2011/TT-BKHCN.
Article 4. Standard
conformity marking and technical-regulation conformity marking
1. Standard conformity
marking and use of standard conformity marking
The registered
certifying organization may prescribe the standard conformity marking including
form, structure, and expression and use the standard conformity marking to
issue to objects certified standard conformity and must satisfy the following
basic requirements:
a) It must clear, not
confuse with other markings;
b) It must express full
signs of respective standard used as basis for certifying the standard
conformity.
In case where the
declaration of standard conformity is made on the basis of assessment results
produced by the declarant, it not required to provide for form, structure,
expression and the standard conformity marking is not allowed using.
2. Technical-regulation
conformity marking and use of technical-regulation conformity marking
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b) The
technical-regulation conformity marking is used directly on products, goods or
packages or in technical documents or on labels stuck on products, goods at apparent
and readable positions;
c) The
technical-regulation conformity marking must be ensured to not be erased easily
and not be able to take it off then stick again;
d) The
technical-regulation conformity marking may be enlarged or shrunk but the basic
proportion and size of the technical-regulation conformity marking must be
complied with provision in Annex I of this Circular and may be recognizable
with naked eyes;
dd) The
technical-regulation conformity marking must be designed and expressed in a
same color and recognizable.
Article 5. Methods to
assess the conformity
1. The conformity
assessment is conducted according to one of the following methods:
a) Method 1: test on
typical sample;
b) Method 2: test on
typical sample and assess the manufacture process; supervise through testing on
sample collected from market;
c) Method 3: test on
typical sample and assess the manufacture process; supervise through testing on
sample collected from manufacture area in association with assessment of the
manufacture process;
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dd) Method 5: test on
typical sample and assess the manufacture process; supervise through testing on
sample collected from manufacture area or the market in association with assessment
of the manufacture process;
e) Method 6: assess and
supervise the management system;
g) Method 7: test on and
assess a batch of products, goods
h) Method 8: test or
verify all products, goods
2. Content, orders and
principle of using the methods to assess the conformity are prescribed in the
Annex II of this Circular.
Article 6. Applying
methods to assess the conformity
1. Methods to assess the
standard conformity area applied to each kind of specific product, goods,
service, the process, environment which are selected by organizations
certifying the standard conformity or the organization or individual that makes
the declaration of standard conformity according to the methods to assess the
conformity specified in Article 5 of this Circular. The selected method to
assess the conformity must be suitable to the assessed object so as to ensure
the reliability of the result of assessment of conformity.
2.
The methods to assess
the technical-regulation conformity applicable to specific products, goods,
services, process, and environment are prescribed in the respective technical
regulations
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Chapter 2.
DECLARATION OF STANDARD CONFORMITY
Article 7. Principles
for declaration of standard conformity
1. Objects of declaration
of standard conformity include products, goods, services, process, environment
specified in the respective standards. Declaration of standard conformity is a
voluntary operation.
2. Declaration of
conformity with respective standard is based on:
a) Result of certifying
the standard conformity which is performed by the registered certifying
organization or:
b) Result of self-assessment
by the organization or individual that makes the declaration of standard
conformity.
Article 8. Orders of declaration of standard
conformity
Declaration of standard
conformity is conducted according to the following steps:
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a) The registered
certifying organizations (third party) or the organization or individual that
makes the declaration of standard conformity (first party) shall assess the
standard conformity.
The assessment of
conformity shall comply with methods of assessing the conformity specified in
clause 1 article 6 of this Circular;
b) The result of
assessment of standard conformity specified in point a Clause 1 of this Article
is basis for making declarations of standard conformity.
2. Step 2: Applications
for registration of the declaration of standard conformity are registered at
the Sub-Departments for Standards, Metrology and Quality in provinces or central-affiliated
cities where the manufacturer is registered (hereinafter abbreviated to
Sub-Departments).
Article 9. Application for
registration of the declaration of standard conformity
The product owner shall
make 02 (two) sets of application for registration of the declaration of
standard conformity, in which 01 (one) application shall be submitted directly
or through post office to the Sub-Departments and 01 (one) application shall be
kept by the product owner. An application includes documents as follows:
1. In case of
declaration of standard conformity based on result of certifying the standard
conformity of the registered certifying organizations (the third party), application
for registration of the declaration of standard conformity includes:
a) Declaration of
standard conformity (made according to Form 2. CBHC/HQ specified in Annex III
of this Circular);
b) Original copies of
documentary evidences about business operation of the product owner (written
enterprise registration or the Business registration certificate or Business
household registration certificate or investment certificate or decision on
establishment or other papers as prescribed by law);
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While processing the
application, if it is necessary, the copies may be considered or compared with
the originals or the authenticated copies may be required for supplementation.
2. In case of
declaration of standard conformity based on result of self assessment of the first
party, application for registration of the declaration of standard conformity
includes:
a) Declaration of
standard conformity (made according to Form 2. CBHC/HQ specified in Annex III
of this Circular);
b) Original copies of
documentary evidences about business operation of the product owner (written
enterprise registration or the Business registration certificate or Business
household registration certificate or investment certificate or decision on
establishment or other papers as prescribed by law);
c) Original copy of the
applied standard;
d) In case where the
product owner has not yet been granted the certificate of standard conformity
about management system (ISO 9001, ISO 22000, HACCP...) by the registered
certifying organizations, the application must include the production process
enclosed with plan on quality control formulated and applied (according to form
1. KHKSCL specified in Annex III of this Circular) and plan on supervising the
management system;
dd) In case where the
product owner has been granted the certificate of standard conformity about
management system (ISO 9001, ISO 22000, HACCP...) by the registered certifying
organizations, the application must include copy of valid original of
certificate of conforming standards about management system;
e) Report on assessing
the standard conformity (made according to form 5. BCDG specified in Annex III
of this Circular), enclosed with original copy of the test result of sample
within 12 months calculated to time of submitting application for registration
of the declaration of standard conformity made by the registered testing
organizations.
While processing the
application, if it is necessary, the copies may be considered or compared with
the originals or the authenticated copies may be required for supplementation.
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Application for
registration of the declaration of standard conformity send to the
Sub-Department is proccessed as follows:
1. If the application
for registration of the declaration of standard conformity fail to be
sufficient as prescribed in Article 9 of this Circular, within 03 (three)
working days after receiving application for registration of the declaration of
standard conformity, Sub-Departments shall notify in writing to request for
supplementation of kinds of papers as prescribed in Article 9 of this Circular
to The product owner. Within 15 (fifteen) working days after Sub-Departments
send the written request, if the application for registration of the
declaration of standard conformity are not supplemented fully as prescribed,
the Sub-Departments have right to stop processing such application.
2. If the application
for registration of the declaration of standard conformity are sufficient as
prescribed in Article 9 of this Circular, within 05 (five) working days after
receiving application for registration of the declaration of standard
conformity, Sub-Departments shall examine the validity of applications for
registration of the declaration of standard conformity to solve as follows:
a) If application for
registration of the declaration of standard conformity is sufficient and valid,
the Sub-Department shall issue a notification of receipt of the application for
registration of the declaration of standard conformity to the applicant (made
according to Form 3. TBTNHS specified in Annex III of this Circular). The notification
of receipt of the application for registration of the declaration of standard
conformity is valid according to value of certificate of standard conformity
which is issued by the registered certifying organizations or it will be valid
in 03 (three) years after head of the product owner has signed for certifying
the report of assessing the standard conformity (in case of self-assessment).
b) If application for
registration of the declaration of standard conformity is sufficient but
invalid, the Sub-Department shall issue a written notice to the applicant about
reason for rejection of the application.
Article 11.
Responsibilities of the product owner
2. To maintain
continuously and take responsibility for the conformity of products, goods,
services, process and environment as registered for declaration of standard
conformity; maintain the quality control, testing and supervision on a
periodical basis at the premises of the product owner.
3. When detecting the
non-conformity of products, goods, services, process, and environment having
the declaration of standard conformity, during the circulation and use, the product
owner must:
a) Temporarily stop
ex-warehousing and conduct recall of unconformable products and goods
circulating on the market in case such unconformable products and goods have high
risks of causing danger for users; stop the operation, exploitation of relevant
process, services and environment as necessary;
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c) To inform in writing
to Sub-Departments about result of overcoming the non-conformity before
continue putting the products, goods, services, process, environment into use,
circulation, exploitation, and business.
4. To make and store applications
for registration of the declaration of standard conformity as follows:
a) In case of
declaration of standard conformity based on result of certifying the standard
conformity of the registered certifying organizations (the third party), a
stored application for registration of the declaration of standard conformity
includes originals, copies of papers as prescribed in Clause 1 Article 6 and documents
about assessment and supervision by the registered certifying organizations;
b) In case of
declaration of standard conformity based on result of self-assessment by the
product owner (first party), a stored application for registration of the
declaration of standard conformity includes originals, copies of papers as
prescribed in Clause 2 Article 9 and documents about self-assessment by the product
owner under the supervision plan.
5. To provide documents
to prove assurance of conformity of products, goods, services, process and
environment with the respective standard as required by competent state
agencies.
6. To provide original
copy of notice on receiving application for registration of the declaration of
standard conformity to the product owner business in products, goods, services,
process and environment.
7. To make another
declaration when there is any change about content of the registered application
for registration of the declaration of standard conformity or any change about
feature, utility, characteristic of products, goods, or services having the
declaration of standard conformity.
Chapter 3.
DECLARATION OF TECHNICAL-REGULATION CONFORMITY
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1. Objects of declaration
of technical-regulation conformity include products, goods, services, process,
environment specified in the national technical regulations promulgated by
Ministries managing sectors and fields or specified in the local technical
regulations promulgated by People’s Committees of provinces and
central-affiliated cities. Declaration of technical-regulation conformity is a
compulsory operation.
2. Declaration of
conformity with technical regulations is based on one of two following cases:
a) Result of certifying
the technical-regulation conformity as prescribed in the respective technical
regulations and performed by the appointed certifying organizations;
b) Result of self-assessment
by the organization or individual that makes the declaration of
technical-regulation conformity.
The test in serve for
assessing the technical-regulation conformity must be conducted at the
registered testing organizations.
3. In case where
products and goods is managed by many different technical regulations, the declaration
of technical-regulation conformity must be registered at respective receiving
authorities and only permitted to use technical-regulation conformity marking when
such products and goods have been implemented fully measures of management as
prescribed in the respective technical regulations.
Article 13. Orders of declaration of
technical-regulation conformity
Declaration of
technical-regulation conformity is conducted according to the following steps:
1. Step 1: Assessing the
object conformity of declaration of technical-regulation conformity with the
respective technical regulations (hereinafter abbreviated to assessing the
technical-regulation conformity).
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The assessment of
technical-regulation conformity shall comply with methods of assessing the
conformity specified in the respective technical regulations.
In case of using the
result of assessment of conformity made by a foreign organization of assessing
the conformity, the foreign organization of assessing the conformity must be
recognized as prescribed by law or appointed by competent state regulatory
bodies;
b) The result of assessment
of technical-regulation conformity will be basis for the organization or
individual making the declaration of technical-regulation conformity.
2. Step 2: Register the declaration
of technical-regulation conformity at receiving authorities which are appointed
by Ministries managing sectors, fields and People’s Committees of provinces and
central-affiliated cities (hereinafter abbreviated to the receiving authorities).
Article 14. Application for
registration of the declaration of technical-regulation conformity
The product owner shall
make 02 (two) sets of application for registration of the declaration of
technical-regulation conformity, in which 01 (one) application shall be
submitted directly or through post office to the receiving authorities and 01
(one) application shall be kept by the product owner. An application includes
documents as follows:
1. In case of
declaration of technical-regulation conformity based on result of certifying
the technical-regulation conformity of the appointed certifying organizations
(the third party), application for registration of the declaration of
technical-regulation conformity includes:
a) Declaration of
technical-regulation conformity (made according to Form 2. CBHC/HQ specified in
Annex III of this Circular);
b) Original copies of
documentary evidences about business operation of the product owner (written
enterprise registration or the Business registration certificate or Business
household registration certificate or investment certificate or decision on
establishment or other papers as prescribed by law);
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While processing the
application, if it is necessary, the copies may be considered or compared with
the originals or the notarized copies may be required for supplementation;
2. In case of
declaration of standard conformity based on result of self assessment of the the
first party, application for registration of the declaration of
technical-regulation conformity includes:
a) Declaration of
technical-regulation conformity (made according to Form 2. CBHC/HQ specified in
Annex III of this Circular);
b) Original copies of
documentary evidences about business operation of the product owner (written
enterprise registration or the Business registration certificate or Business
household registration certificate or investment certificate or decision on
establishment or other papers as prescribed by law);
c) In case where the
product owner has not yet been granted the certificate of conforming with
standards about management system (ISO 9001, ISO 22000, HACCP...) by the
registered certifying organizations, the application must include the
production process enclosed with plan on quality control formulated and applied
(according to form 1. KHKSCL specified in Annex III of this Circular) and plan
on supervising the management system;
d) In case where the
product owner has been granted the certificate of conforming with standards
about management system (ISO 9001, ISO 22000, HACCP...) by the registered
certifying organizations, the application must include the copy of valid
original of certificate of conforming standards about management system;
dd) Original copy of the
test result of sample within 12 months calculated to time of submitting application
for registration of the declaration of technical-regulation conformity made by
the registered testing organizations;
e) Report on assessing
the technical-regulation conformity (made according to Form 5. BCDG specified
in Annex III of this Circular) enclosed with marking specimen of
technical-regulation conformity and relevant documents;
While processing the
application, if it is necessary, the copies may be considered or compared with
the originals or the notarized copies may be required for supplementation.
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Application for
registration of the declaration of technical-regulation conformity send to the
Sub-Department is proccessed as follows:
1. If the application
for registration of the declaration of technical-regulation conformity fail to
be sufficient as prescribed in Article 14 of this Circular, within 03 (three)
working days after receiving application for registration of the declaration of
standard conformity, the receiving authorities shall notify in writing to
request for supplementation of kinds of papers as prescribed to the product
owner. Within 15 (fifteen) working days after the receiving authorities send
the written request, if the application for registration of the declaration of
technical-regulation conformity are not supplemented fully as prescribed, the receiving
authorities have right to stop processing such application.
2. If the application
for registration of the declaration of technical-regulation conformity are
sufficient as prescribed in Article 14 of this Circular, within 05 (five)
working days after receiving application for registration of the declaration of
technical-regulation conformity, the receiving authorities shall examine the
validity of applications for registration of the declaration of standard
conformity:
a) If application for
registration of the declaration of standard conformity is sufficient and valid,
the receiving authorities shall issue a notification of receipt of the application
for registration of the declaration of technical-regulation conformity to the product
owner (made according to Form 3. TBTNHS specified in Annex III of this
Circular).
The notification of
receipt of the application for registration of the declaration of
technical-regulation conformity is valid according to value of certificate of
technical-regulation conformity which is issued by the appointed certifying
organizations or it will be valid in 03 (three) years after the head of the product
owner has signed for certifying the report of assessing the
technical-regulation conformity (in case of self-assessment);
b) If application for
registration of the declaration of technical-regulation conformity is
sufficient but invalid, the receiving authorities shall issue a written notice
to the product owner about reason for rejection of the application.
Article 16.
Responsibilities of the product owner
1. To inform on suitable
media about their declaration of technical-regulation conformity to ensure that
persons using such products and goods can access to information easily.
2. To maintain
continuously and take responsibility for the conformity of products, goods,
services, process and environment whose conformity with technical regulation
has been declared; maintain the quality control, testing and supervision on a
periodical basis.
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4. When detecting the
non-conformity of products, goods, services, process, and environment having
the declaration of technical-regulation conformity, during the circulation and
use, the product owner must:
a) Timely inform in
writing about the non-conformity to the receiving authorities;
b) Temporarily stop
ex-warehousing and conduct recall of unconformable products and goods
circulating on the market in case such unconformable products and goods have
high risks of causing danger for users; stop the operation, exploitation of
relevant process, services and environment as necessary;
c) To conduct measures to
overcome the non-conformity;
d) To inform in writing
to the receiving authorities about result of overcoming the non-conformity
before continue putting the products, goods, services, process, environment
into use, circulation, exploitation, and business.
5. To make and store applications
for registration of the declaration of technical-regulation conformity to do as
basis for examination, inspection of the state regulatory bodies as follows:
a) In case of
declaration of technical-regulation conformity based on result of certifying
the technical-regulation conformity of the appointed certifying organizations
(the third party), a stored application for registration of the declaration of
technical-regulation conformity includes originals, copies of papers as
prescribed in Clause 1 Article 14 and documents assessment and supervision by the
appointed certifying organizations;
b) In case of
declaration of technical-regulation conformity based on result of
self-assessment by the product owner (first party), a stored application for
registration of the declaration of technical-regulation conformity includes
originals, copies of papers as prescribed in Clause 2 Article 14 and documents
about self-assessment by the product owner under the supervision plan.
7. To provide original
copy of certificate of technical-regulation conformity, notice on receiving application
for registration of the declaration of technical-regulation conformity to the product
owner.
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Chapter 4.
ORGANIZATION OF IMPLEMENTATION
Article 17. Responsibilities
of regulatory bodies
1. Responsibilities of
Ministries managing sectors and fields, and People’s Committees of provinces,
central-affiliated cities:
a) To direct activities
involving declaration of technical-regulation conformity as prescribed in this
Circular when promulgating respective technical regulations for management;
b) To direct focal
agencies in charge of managing activities in declaration of
technical-regulation conformity in the assigned fields; notify list of focal
agencies for the relevant organizations and individuals for implementation and
send list to the Ministry of science and technology for coordination and
management;
c) To assign duty for
receiving application for registration of the declaration of
technical-regulation conformity to the receiving authorities;
d) Annually, to sum up
situation of appointing the organizations for assessing the conformity, notify
the Ministry of Science and Technology for coordination in management; or
irregularly, as required, to sum up and report on receipt of declarations of
technical-regulation conformity to the Ministry of Science and Technology for
summing up and reporting to the Prime Minister.
2. Responsibility of the
Directorate for Standards, Metrology and Quality shall act as an appointed
focal agency as prescribed in point b Clause 1 of this Article:
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b) To coordinate with
focal agencies at Central level under Ministries managing sectors and fields,
the Departments of science and technology in provinces and central-affiliated
cities, in urging, guiding implementation of declaration of standard conformity,
declaration of technical-regulation conformity as prescribed in this Circular;
c) To monitor receipt of
declarations of standard conformity and declaration of technical-regulation
conformity for products, goods, services, process, environment under management
responsibility of Ministry of science and technology on the basis of reports of
Sub-Departments of Standard, Metrology and Quality; to monitor the appointment
of Ministries managing sectors, fields about activities of assessing the
conformity.
3. Responsibilities of
the appointed focal agencies, as prescribed in point b Clause 1 of this
Article, and under Ministries managing sectors and fields, and People’s
Committees of provinces, central-affiliated cities:
a) Monitoring and
managing activities of registration for declaration of technical-regulation
conformity conducted by the receiving authorities; coordinating with the
Directorate for Standards, Metrology and Quality in managing activities of declaration
of technical-regulation conformity; annually, summing up and reporting to send
to Ministries managing sectors, fields and People’s Committees of provinces,
central-affiliated cities, involving situation of appointment of assessing the
conformity, concurrently sending them to the Directorate for Standards,
Metrology and Quality for coordination in management;
b) Summing up receipt of
declarations of technical-regulation conformity conducted by the receiving
authorities and annually, or irregularly as required, reporting to the relevant
Ministries managing sectors, fields and People’s Committees of provinces and
central-affiliated cities.
4. Responsibilities of
the receiving authorities which are appointed by the Ministries managing
sectors and fields, and People’s Committees of provinces, central-affiliated
cities:
a) Receiving and
managing applications for registration of declaration of technical-regulation
conformity; cancelling, suspending results of receiving applications for
registration of the declaration of technical-regulation conformity for
products, goods, services, process, environment managed by the national
technical regulations which are promulgated by Ministries managing sectors and
fields and the local technical regulations related to fields under their
management;
b) To post publicly on
their websites about receipt of declarations of technical-regulation conformity
with the following contents:
- Name of the
organization or individual making the declaration of technical-regulation
conformity;
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- Number of technical
regulations;
- Assessment type: The
first party (name of the product owner) or third party (name of the appointed
certifying organizations).
c) To coordinate with
the Sub-Department of Standards, Metrology and Quality;
d) Annually or
irregularly as required, to sum up and report to the focal agencies about list
of products, goods, services, process and environment which have been
registered for declaration of technical-regulation conformity (made according
to Form 4. BCTNHS specified in Annex III of this Circular).
5. Responsibilities of
Sub-Departments of Standards, Metrology and Quality, under Departments of
science and technology in provinces and central-affiliated cities:
a) To receive
registration and management of applications for registration of declaration of
standard conformity; cancel, suspend results of receiving applications for declaration
of standard conformity in localities and post publicly on websites of
Departments of science and technology or Sub-Departments of Standards,
Metrology and Quality about receipt of declarations of standard conformity;
b) To receive applications
for registration and manage applications for registration of declaration of
technical-regulation conformity; cancel, suspend results of receiving applications
for registration of the declaration of technical-regulation conformity for
products, goods, services, process, environment managed by the national
technical regulations which are promulgated by the Ministry of Science and
Technology and the local technical regulations related to fields under their
management; post publicly on websites of Departments of science and technology
or Sub-Departments of Standards, Metrology and Quality on localities about receipt
of declarations of technical-regulation conformity with the following contents:
- Name of the
organization or individual making the declaration of technical-regulation
conformity;
- Products and goods having
the declaration of technical-regulation conformity;
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- Assessment type: The
first party (name of the product owner) or third party (name of the appointed
certifying organizations).
c) To coordinate with
the receiving authorities in localities in providing information about declaration
of standard conformity to facilitate for examination on quality of products and
goods;
d) Annually or
irregularly as required, to sum up and report to the Directorate for Standards,
Metrology and Quality about receipt of applications for registration of
declaration of standard conformity, declaration of technical-regulation
conformity (made according to Form 4. BCTNHS specified in Annex III of this
Circular) as prescribed in point a, b this Clause.
Article 18. Examination,
inspection and handling of violations
1. The competent state regulatory
bodies shall conduct examination, inspection and handling of violations in declaration
of standard conformity and declaration of technical-regulation conformity as
prescribed in this Circular and other relevant current regulations.
2. Organizations and
individuals infringing regulations on declaration of standard conformity and declaration
of technical-regulation conformity, depend on nature and seriousness of violations
shall be handled as prescribed by relevant current law.
Article 19. Provisions
of implementation
This Circular takes
effect on January 27, 2013, and replaces the Decision No. 24/2007/QD-BKHCN
dated September 28, 2007, of the Minister of science and technology, on
promulgating regulation on certifying standard conformity, certifying
technical-regulation conformity and declaration of standard conformity, declaration
of technical-regulation conformity.
Article 20. Organization
of implementation
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2. The General Director
of Directorate for Standards, Metrology and Quality shall guide and organize
implementation of this Circular.
3. In the course of
implementation, any arising problems should be reported timely in writing to
the Ministry of science and technology for research, amendment and
supplementation.
FOR THE MINISTER OF SCIENCE AND TECHNOLOGY
DEPUTY MINISTER
Tran Viet Thanh
ANNEX I
SHAPE AND SIZE OF TECHNICAL-REGULATION
CONFORMITY MARKING (Enclosed with the Circular No. 28/2012/TT-BKHCN dated
December 12, 2012, of the Minister of Science and Technology)
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1. Technical-regulation
conformity marking has the shape as described at picture 1.
Picture 1. Shape of technical-regulation conformity marking
2. The basic size for designing
technical-regulation conformity marking specified in picture 2.
Picture 2. The basic size of technical-regulation conformity
marking
Notes:
H = 1.5 a
h = 0.5 H
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ANNEX II
CONTENT, ORDER AND PRINCIPLE OF USING METHODS TO
ASSESS THE CONFORMITY (Enclosed with the Circular No. 28/2012/TT-BKHCN dated
December 12, 2012, of the Minister of Science and Technology)
CONTENT, ORDERS AND PRINCIPLE OF USING THE METHODS TO ASSESS THE
CONFORMITY
I. Method 1: test on
typical sample
Method 1 by test on
typical sample of products and goods to conclude about the conformity. Conclusion
about the conformity is valid for model, type of products and goods which are
taken sample for test.
1. Content and order of
implementing the main activities in Method 1 include:
Taking sample:
Taking typical samples
for products and goods. Typical sample of products and goods is sample
representing for a specific model or type of products or goods produced
according to a same design, in a same condition and made of same raw materials.
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1.2. Assessing the
conformity of the testing sample:
Samples of products and
goods are conducted test at laboratory already registered for operational
sector of testing as prescribed by law, may include laboratory of producers. To
prioritize for using of laboratory already appointed and recognized.
Characteristics of
products, goods for testing and method of testing shall be stipulated in the
respective standards and technical regulations.
1.3. Processing of
results of assessing the conformity
To consider
characteristics of products, goods through result of testing samples in
comparison with requirements of the respective standards and technical
regulations.
1.4. Conclusion about
the conformity
To conclude about the
conformity of products and goods in comparison with requirements of the
respective standards and technical regulations. Products and goods will be
considered as conformable if all criteria of the testing sample are conformable
with the prescribed level of the respective standards and technical
regulations.
2. Principle of using
the method 1
Method 1 is used to
assess the conformity of products and goods with the following conditions:
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b) Fail to consider
requirements to ensure maintenance of quality stability.
II. Method 2: Test on
typical samples and assessment on the production process; supervision through
testing samples taken on the market
Method 2 bases on result
of test on typical samples and assessment of the manufacture process to
conclude about the conformity of products and goods. Assessment of supervision
is conducted after that and conducted through test on samples of products and
goods taken on the market.
1. Content and order of
implementing the main activities in Method 2 include:
Taking sample:
Conducting as prescribed
in item 1.1 of method 1.
1.2. Assessing the
conformity of the testing sample:
Conducting as prescribed
in item 1.2 of method 1.
1.3. Assessing the
conformity of the production process:
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a) Control of technical
dossiers of products (design documents, technical standards of products);
b) Control of all
production process from input, through intermediate stages, till as finishing
products included process of packing, loading and unloading, storage in
warehouses and transport of products;
c) Control of quality of
raw materials, semi-products and finished products;
d) Control of
technological equipment and equipment for metrology, examination and testing;
dd) Control of
professional skill qualification of workers and technical officers;
e) Other necessary
technical contents.
In case where producers
have gotten certificate of quality control system of the certifying
organizations registered in sector of certifying or recognized for sector of
producing products and goods which are assessed, It is not required to assess
the process of production. However, if there is proof about failing to maintain
validity of quality control system, the certifying organizations should conduct
assessment of the production process, concurrently report to the Directorate
for Standards, Metrology and Quality.
1.4. Processing of
results of assessing the conformity:
To consider
characteristics of products, goods through result of testing samples in
comparison with requirements of the respective standards and technical
regulations.
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1.5. Conclusion about
the conformity
To conclude about the
conformity of products and goods in comparison with requirements of the
respective standards and technical regulations. Products and goods shall be
considered as conformable if they ensure full two following conditions:
a) All criteria of the
testing sample are conformable to the prescribed level of the respective
standards and technical regulations.
b) The result of
assessment of production process is conformable to requirement.
Conclusion about the
conformity of products and goods will be valid maximally in 3 years, and
provided that such products and goods are assessed supervision.
1.6. Supervision:
During valid time of
conclusion about the conformity, products and goods must be assessed and
supervised through test of samples taken on the market. Frequency of assessment
and supervision must ensure not exceeding 12 months once.
The test of samples of
products and goods is conducted as prescribed in items 1.1, 1.2 and 1.3 of
method 1.
Result of assessing supervision
will be used as basis for deciding on maintenance, suspension or cancellation
of conclusion about the conformity.
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Method 2 is used to
assess the conformity of products and goods with the following conditions:
a) Products and goods
under subject of having risks involving safety, health and environment at low
level.
b) Design of products
and goods allow defining clearly products and goods according to each typical
model, type;
c) The maintenance of
stability and quality characteristics of products and goods should be paid
attention during the production;
d) Quality of products
and goods able to be changed during course of distribution and circulation on
the market;
dd) Organizations and
individuals producing and trading in products and goods have effective measures
to recall products and goods from the market when detecting unconformable
products and goods during supervision.
III. Method 3: test on
typical samples and assess the manufacture process; supervise through testing
on samples collected from manufacture area in association with assessment of
the manufacture process
Method 3 bases on result
of test on typical samples and assessment of production process to conclude
about the conformity. Assessment of supervision will be conducted through test
of samples of products and goods taken from manufacture area in association
with assessment of the manufacture process.
1. Content and order of
implementing the basic activities in Method 3 include:
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Conducting as prescribed
in item 1.1 of method 1.
1.2. Assessing the
conformity of the testing sample:
Conducting as prescribed
in item 1.2 of method 1.
1.3. Assessing the
conformity of the production process:
Conducting as prescribed
in item 1.3 of method 2.
1.4. Processing of
results of assessing the conformity:
Conducting as prescribed
in item 1.4 of method 2.
1.5. Conclusion about
the conformity
Conducting as prescribed
in item 1.5 of method 2.
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The test of samples of
products and goods is conducted as prescribed in items 1.1, 1.2 and 1.3 of
method 1.
The assessment of the
production process is conducted as prescribed in items 1.3 of method 2.
Result of assessing
supervision will be used as basis for deciding on maintenance, suspension or
cancellation of conclusion about the conformity.
2. Principle of using
the method 3
Method 3 is used to
assess the conformity of products and goods with the following conditions:
a) Products and goods
under subject of having risks causing loss of safety, health and environment at
a level higher than products and goods assessed under the method 2;
b) Design of products
and goods allow defining clearly products and goods according to each typical
model, type;
c) The maintenance of
stability and quality characteristics of products and goods should be paid
attention during the production;
d) Quality of products
and goods, on nature, is not changed or changed a little during distribution
and circulation on the market;
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IV. Method 4: test on
typical sample and assess the manufacture process; supervise through testing on
sample collected from manufacture area and the market in association with
assessment of the manufacture process
Method 4 bases on result
of test on typical samples and assessment of production process to conclude
about the conformity. Assessment of supervision after that will be conducted
through test of samples of products and goods taken from manufacture area and
market in association with assessment of the manufacture process.
1. Content and order of
implementing the basic activities in the Method include:
Taking sample:
Conducting as prescribed
in item 1.1 of Method 1.
1.2. Assessing the
conformity of the testing samples:
Conducting as prescribed
in item 1.2 of Method 1.
1.3. Assessing the
conformity of the production process:
Conducting as prescribed
in item 1.3 of Method 2.
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Conducting as prescribed
in item 1.4 of Method 2.
1.5. Conclusion about
the conformity
Conducting as prescribed
in item 1.5 of Method 2.
1.6. Supervision:
During valid time of notice
about the conformity, products and goods must be assessed and supervised
through test of samples taken at the production area and market in association
with assessment of the production process. Frequency of assessment and
supervision must ensure not exceeding 12 months once.
The test of samples of
products and goods is conducted as prescribed in items 1.1, 1.2 and 1.3 of
method 1.
The assessment of the
production process is conducted as prescribed in items 1.3 of method 2.
Result of assessing
supervision will be used as basis for deciding on maintenance, suspension or
cancellation of conclusion about the conformity.
2. Principle of using
the method 4:
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a) Products and goods
under subject of having risks causing loss of safety, health and environment at
a level higher than products and goods assessed under the method 3;
b) Design of products
and goods allow defining clearly products and goods according to each typical
model, type;
c) The maintenance of
stability and quality characteristics of products and goods should be paid
attention during the production;
d) Quality of products
and goods is able to lose stability during production, and able to be changed
during distribution and circulation on the market;
dd) There are measures
allowing recall of products and goods from the market when detecting
unconformable products and goods during supervision.
V. Method 5: test on
typical sample and assess the manufacture process; supervise through testing on
sample collected from manufacture area or the market in association with assessment
of the manufacture process.
Method 5 based on result
of test on typical samples and assessment of production process to conclude
about the conformity. The assessment of supervision is conducted through test
on samples taken at production area or on market in association with assessment
of the manufacture process.
1. Content and order of
implementing the basic activities in Method 5 include:
Taking sample:
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1.2. Assessing the
conformity of the testing samples:
Conducting as prescribed
in item 1.2 of Method 1.
1.3. Assessing the
conformity of the production process:
Conducting as prescribed
in item 1.3 of Method 2.
1.4. Processing of
results of assessing the conformity:
Conducting as prescribed
in item 1.4 of Method 2.
1.5. Conclusion about
the conformity
Conducting as prescribed
in item 1.5 of Method 2.
1.6. Supervision:
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The assessment of the
production process is conducted as prescribed in items 1.3 of method 2.
Result of assessing supervision
will be used as basis for deciding on maintenance, suspension or cancellation
of notice about the conformity.
2. Principle of using
the method 5:
Method 5 is used to
assess the conformity of products and goods with the following conditions:
a) It is necessary to
use a method with high reliability as method 4, but it is allowed to be
flexible in using supervision measures to cut down costs;
b) It is necessary to
use a method which is applied popularly aiming to direct to mutual recognition
of results of assessing the conformity.
VI. Method 6: Assessing
and supervising the management system
Method 6 bases on
assessment of the management system to conclude about the conformity of
management system with the respective standards and technical regulations.
1. Content and order of
implementing the main activities in Method 6 include:
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- The management system
is assessed under the respective standards and technical regulations.
- Report on result of
assessment in comparison with the respective standards and technical
regulations.
1.2. Conclusion about
the conformity
Base on result of
assessment, conclusion about the conformity of management system with the
respective standards and technical regulations.
Conclusion about the
conformity of management system which is valid maximally 3 years, and provided
that management system is assessed and supervised.
1.3. Supervision of
management system.
- Supervision through
assessment of management system with frequency of assessment and supervision
must ensure not exceeding 12 months once.
- Result of assessment
is basis for deciding on further maintenance, suspension, cancellation of the
conformity of management system.
2. Principle of using
the method 6:
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VII. Method 7: test on
and assess a batch of products, goods
The method 7 bases on
result of test on samples of products and goods which are taken according to
method of statistical probability for a batch of products and goods to give out
conclusion about the conformity of batches. Conclusion about the conformity
will be valid for the specific batch of products and goods, and it is not
required to conduct the following supervision measures.
1. Content and order of
implementing the main activities in Method 7 include:
Taking sample:
The test sample is
sample taken under method of statistical probability, ensures the
representative nature for all batch.
Quantity of samples must
be full for testing and storing sample.
1.2. Assessing the
conformity of the testing samples:
Conducting as prescribed
in item 1.2 of Method 1.
1.3. Processing of
results of assessing the conformity:
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1.4. Conclusion about
the conformity:
The batch of products
and goods will be considered as conformable if quantity of the testing samples
with result of non-conformity is in the allowed limitation.
The batch of products
and goods will be considered as unconformable with regulations if quantity of
the testing samples with result of non-conformity exceeds the allowed
limitation.
2. Principle of using
the method 7:
The method 7 is used to
assess the conformity of products and goods with the following conditions:
a) Products and goods
are divided under identical batches;
b) Fail to consider
requirements to ensure maintenance of quality stability.
VIII. Method 8: test or
verify all products, goods
Method 8 bases on result
of testing or verifying all products, goods to conclude the conformity before
putting into circulation and use. Conclusion about the conformity will be valid
for each single product or goods, and it is not required to conduct the
following supervision measures.
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1.1. Defining the
products, goods which need to be tested or verified;
1.2. Assessing the
conformity of products, goods:
a) Testing or verifying
products and goods is conducted by laboratories, the verifying rooms which have
been registered for the capable operational sector at production place, installment
place, use place or laboratories, the verifying rooms.
To prioritize for using
of laboratories, the verifying rooms already recognized.
b) Characteristics of
products, goods which need to be tested, verified, and method of testing,
verifying shall be stipulated in the respective standards and technical
regulations.
1.3. Processing of
results of assessing the conformity:
Consider characteristics
of products and goods through result of testing or result of verifying in
comparison with requirement.
1.4. Conclusion about
the conformity:
Products and goods will
be considered as conformable if all criteria of the tested or verified products
and goods are conformable with the prescribed level of the respective standards
and technical regulations.
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The method 8 is used to
assess the conformity of products, goods with strict requirements on safety
before putting into circulation and use.
ANNEX III
THE FORMS USED IN DECLARATION OF STANDARD
CONFORMITY AND DECLARATION OF TECHNICAL-REGULATION CONFORMITY
(Enclosed with the Circular No. 28/2012/TT-BKHCN dated December 12, 2012, of
the Minister of Science and Technology)
1. Plan on quality
control:
Form 1. KHKSCL
28/2012/TT-BKHCN.
2. Declaration of
conformity:
Form 2. CBHC/HQ
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3. Notification of
receipt of the application for registration of the declaration of conformity:
Form 3. TBTNHS
28/2012/TT-BKHCN.
4. Report on receipt of applications
for registration of declaration of conformity:
Form 4. BCTNHS
28/2012/TT-BKHCN.
5. Report on assessing
the standard conformity and technical-regulation conformity:
Form 5. BCDS
28/2012/TT-BKHCN.
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Form 1. KHKSCL
28/2012/TT-BKHCN
PLAN ON QUALITY CONTROL
Products/goods/services/process/environment:
……………………………….
The specific production
processes
Plan on quality control
Criteria of supervision
and control
Standards/ technical
regulations
Frequency of taking
sample/ size of sample
Equipment for
testing/examination
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The recording table
Note
(1)
(2)
(3)
(4)
(5)
(6)
(7)
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…………., date........month........year ..….
Representative of organization
(signature, seal)
Form 2. CBHC/HQ
28/2012/TT-BKHCN
SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
----------------
DECLARATION OF CONFORMITY
No. …………………………..
Name of product owner:
……… ……………………………………………………………………..
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Telephone number: …………………………..
Facsimile: …………………………………………
E-mail:
……………………………………………………..……………………………………………
HEREBY DECLARES THAT:
Products, goods,
process, services, environment (name, model, type, label, technical
characteristic,… )
…………………………..………………………………………..………………………………………
……………………………………………………………………..…………………………………….
conforming to
standard/technical regulations (number, sign, name)
…………………………..………………………………………..………………………………………
……………………………………………………………………..……………………………………..
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……………………………………………………..………………………………………………………
……………………………………………………..………………………………………………………
……………………………………………………..………………………………………………………
.....(Name of product
owner) …….. hereby commits and takes responsibility for the conformity of……….
(products, goods, process, services, environment)… which are produced,
traded, preserved, transported, used and exploited by it/him/her.
…………., date........month........year ….
Representative of product owner
(Signature, position, seal)
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Form 3. TBTNHS
28/2012/TT-BKHCN
NAME OF SUPERIOR REGULATORY BODY
NAME OF RECEIVING AUTHORITY
--------
SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
----------------
No.: …….../TB-……
………, date........month........year …..
NOTICE
OF
RECEIVING APPLICATION FOR REGISTRATION OF THE DECLARATION OF CONFORMITY
……. (Name of receiving
authority)……….. certifies that application for registration of the declaration
of standard conformity/ the technical-regulation conformity No. ......... dated
........... of ............. (name of product owner)…………………
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has been received.
For products, goods,
process, services, environment (name, model, type, label, technical
characteristic,…): ………………………………………………………………
conforming to standard
(number, sign, name of standard) /technical regulations (number, sign, name of
technical regulations) and be valid till date ……………….. (or state: Be valid in 3
years from date ……………..).
This notice records the
commitment of product owner. This notice has no value to certify that products,
goods, services, process, environment are conformable to the respective
standards/ technical regulations.
(Name of product owner)
…………must entirely be responsible for the conformity of products, goods,
process, services, and environment, which are produced, traded, preserved,
transported, used and exploited by it/him/her.
Receivers:
-
Product owner;
- The superior regulatory body (for report);
- Save: the receiving authority.
Competent representative of receiving authority
(signature,
position, seal)
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Form 4. BCTNHS
28/2012/TT-BKHCN
NAME OF SUPERIOR REGULATORY BODY
NAME OF RECEIVING AUTHORITY
--------
SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
----------------
No.: …….../TB-……
………, date........month........year …..
REPORT
OF
RECEIVING APPLICATION FOR REGISTRATION OF THE DECLARATION OF CONFORMITY
(From date ….. month …….. year ……… to date ….. month …….. year
………)
No.
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Name of product owner
Name of products, goods, process, services, environment
Standards/ technical regulations
Assessment type
Note
The first party (name of the registered/apointed certifying
organization
The third party (self assessment)
1
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2
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Total applications for
registration of declaration of conformity already received: …………………………………………………………
Receivers:
-
Directorate for Standards, Metrology and Quality;
- The superior regulatory body (for report);
- Save: the receiving authority.
Competent representative of receiving authority
(signature,
position, seal)
Form 5. BCDG
28/2012/TT-BKHCN
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SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
----------------
No.: ……...……
………, date........month........year …..
REPORT
ON
ASSESSING THE STANDARD CONFORMITY AND TECHNICAL-REGULATION CONFORMITY
1. Assessment date:
.........................................................................................................
2. Assessment place:
.......................................................................................................
3. Product name:
..............................................................................................................
4. Number of standards /
technical regulations applied:
..................................................
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6. Assessment on result
of testing according to the applied standards / technical regulations and the
effectiveness of application, implementation of the production process:
.............................................................................
....................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
7. Other content (if
any): .................................... ....................................
........................
8. Conclusion:
Product conforms to
standard/technical regulations.
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The assessing person
(signature and full name)
Certified by head of product owner
(signature,
position, seal)