Chương 3 Thông tư 28/2012/TT-BKHCN: Công bố hợp quy

Chapter 3.

DECLARATION OF TECHNICAL-REGULATION CONFORMITY

Article 12. Principles for 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).

a) The registered certifying organizations (third party) or the organization or individual that makes the declaration of technical-regulation conformity (first party) shall assess 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);

c) Original copy of certificate of conforming to the respective technical regulations issued by the appointed certifying organization, enclosed with marking specimen of technical-regulation conformity which is issued to the product owner by the appointed certifying organizations;

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.

Article 15. Processing of application for registration of the declaration of technical-regulation conformity

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.

3. To use technical-regulation conformity marking for products and goods whose conformity with technical regulation has been declared as prescribed in clause 2 Article 4 of this Circular before putting them into circulation on market. To make logbook and annually report use of technical-regulation conformity marking to the appointed certifying organizations.

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.

6. To provide documents to prove assurance of conformity of products, goods, services, process and environment with the respective technical regulations as required by competent state agencies.

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.

8. To make another declaration when there is any change about content of the registered application for registration of the declaration of technical-regulation conformity or any change about feature, utility, characteristic of products, goods, or services having the declaration of technical-regulation conformity.