Thông tư 28/2012/TT-BKHCN Quy định công bố hợp chuẩn công bố hợp quy phương thức

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;

...

...

...

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.

...

...

...

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

...

...

...

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;

...

...

...

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

...

...

...

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:

...

...

...

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);

...

...

...

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.

...

...

...

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;

...

...

...

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

...

...

...

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).

...

...

...

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);

...

...

...

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.

...

...

...

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.

...

...

...

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.

...

...

...

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:

...

...

...

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;

...

...

...

- 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;

...

...

...

- 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

...

...

...

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)

...

...

...

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

...

...

...

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.

...

...

...

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:

...

...

...

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:

...

...

...

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.

...

...

...

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.

...

...

...

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:

...

...

...

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.

...

...

...

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;

...

...

...

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.

...

...

...

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:

...

...

...

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:

...

...

...

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:

...

...

...

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:

...

...

...

- 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:

...

...

...

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:

...

...

...

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.

...

...

...

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.

...

...

...

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

...

...

...

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.

...

...

...

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

...

...

...

The recording table

Note

(1)

(2)

(3)

(4)

(5)

(6)

(7)

...

...

...

...

...

...

…………., 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: ……… ……………………………………………………………………..

...

...

...

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)

…………………………..………………………………………..………………………………………

……………………………………………………………………..……………………………………..

...

...

...

……………………………………………………..………………………………………………………

……………………………………………………..………………………………………………………

……………………………………………………..………………………………………………………

.....(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)

...

...

...

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)…………………

...

...

...

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)

...

...

...

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.

...

...

...

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

...

...

...

2

...

...

...

....

...

...

...

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

...

...

...

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: ..................................................

...

...

...

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.

...

...

...

The assessing person

 (signature and full name)

Certified by head of product owner
(signature, position, seal)