Circular 28/2012/TT-BKHCN on Declaration of Standard and Regulation Conformity

Circular 28/2012/TT-BKHCN stipulates the declaration of standard conformity, declaration of regulation conformity, and methods for conformity assessment with standards and technical regulations issued by the Minister of the Ministry of Science and Technology (MOST) on December 12, 2012. This Circular 28 applies to organizations, individuals, and regulatory authorities involved in conformity assessment, declaration of standard conformity, and declaration of regulation conformity activities.

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Table of contents

Circular 28/2012/TT-BKHCN took effect on January 27, 2013, and replaced Decision No. 24/2007/QD-BKHCN. Accordingly, organizations and individuals that violate regulations on the declaration of standard conformity and declaration of regulation conformity will, depending on the nature and severity of the violation, be handled in accordance with current relevant laws.

1. View the full text of Circular 28/2012/TT-BKHCN

CIRCULAR

REGULATING THE DECLARATION OF STANDARD CONFORMITY, DECLARATION OF REGULATION CONFORMITY, AND METHODS FOR CONFORMITY ASSESSMENT 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 Decree No. 127/2007/ND-CP dated August 01, 2007, of the Government detailing the implementation of a number of articles of the Law on Standards and Technical Regulations;

Pursuant to Decree No. 132/2008/ND-CP dated December 31, 2008, of the Government detailing the implementation of a number of articles of the Law on Product and Goods Quality;

Pursuant to Decree No. 28/2008/ND-CP dated March 14, 2008, of the Government regulating functions, tasks, powers, and organizational structure of the Ministry of Science and Technology;

At the proposal of the Director General of the Directorate for Standards, Metrology and Quality;

The Minister of Science and Technology stipulates the declaration of standard conformity, declaration of regulation conformity, and methods for conformity assessment with standards and technical regulations.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Circular regulates the declaration of standard conformity, declaration of regulation conformity, and methods for conformity assessment with standards and technical regulations.

Article 2. Subjects of application

This Circular applies to organizations, individuals, and regulatory agencies involved in conformity assessment, declaration of standard conformity, and declaration of regulation conformity activities.

Article 3. Interpretation of terms

In this Circular, the terms below are understood as follows:

1. Declaration of standard conformity is the act of an organization or individual self-declaring that products, goods, services, processes, or the environment conform to the corresponding standards.

2. Declaration of regulation conformity is the act of an organization or individual self-declaring that products, goods, services, processes, or the environment conform to the corresponding technical regulations.

3. A certification body performing certification activities for standard conformity is an organization that has registered its field of certification activities (hereinafter referred to as a registered certification body) according to the provisions of Circular No. 08/2009/TT-BKHCN dated April 08, 2009, of the Minister of Science and Technology guiding the requirements, sequence, and procedures for registering the field of conformity assessment activities (hereinafter abbreviated as Circular No. 08/2009/TT-BKHCN) and Circular No. 10/2011/TT-BKHCN dated June 30, 2011, of the Minister of Science and Technology amending and supplementing a number of provisions of Circular No. 08/2009/TT-BKHCN (hereinafter abbreviated as Circular No. 10/2011/TT-BKHCN).

4. A certification body performing certification activities for technical regulation conformity is a certification body registered under Clause 3 of this Article and designated by a competent authority to perform certification of regulation conformity activities (hereinafter referred to as a designated certification body).

5. A testing body performing product and goods quality testing activities is an organization that has registered its field of testing activities (hereinafter referred to as a registered testing body) according to the provisions of Circular No. 08/2009/TT-BKHCN and Circular No. 10/2011/TT-BKHCN.

Article 4. Standard conformity mark and regulation conformity mark

1. Standard conformity mark and use of standard conformity mark

The registered certification body stipulates the shape, structure, presentation, and use of the standard conformity mark granted to the certified object, which must meet the following basic requirements:

a) Ensure clarity and avoid confusion with other marks;

b) Fully display the symbol of the corresponding standard used as the basis for standard conformity certification.

In cases where organizations or individuals declare standard conformity based on self-assessment results, they do not need to stipulate the shape or structure and are not permitted to use the standard conformity mark.

2. Regulation conformity mark and use of regulation conformity mark

a) The regulation conformity mark has the shape and dimensions as specified in Appendix I of this Circular;

b) The regulation conformity mark is used directly on products, goods, or packaging, or in technical documents, or on labels attached to products and goods in a visible and legible position;

c) The regulation conformity mark must be indelible and non-detachable for reuse;

d) The regulation conformity mark may be enlarged or reduced but must ensure the correct proportions and basic dimensions specified in Appendix I and be recognizable by the naked eye;

e) The regulation conformity mark must be designed and presented in a single, easily recognizable color.

Article 5. Conformity assessment methods

1. Conformity assessment is performed according to one of the following methods:

a) Method 1: Typical sample testing;

b) Method 2: Typical sample testing and assessment of the production process; surveillance through testing of samples taken from the market;

c) Method 3: Typical sample testing and assessment of the production process; surveillance through testing of samples taken at the production site combined with assessment of the production process;

d) Method 4: Typical sample testing and assessment of the production process; surveillance through testing of samples taken at the production site and from the market combined with assessment of the production process;

e) Method 5: Typical sample testing and assessment of the production process; surveillance through testing of samples taken at the production site or from the market combined with assessment of the production process;

f) Method 6: Assessment and surveillance of the management system;

h) Method 7: Testing and assessment of a lot of products and goods;

i) Method 8: Testing or inspection of the entire batch of products and goods.

2. The content, sequence, and principles for using conformity assessment methods are specified in Appendix II of this Circular.

Article 6. Application of conformity assessment methods

1. The method for assessing standard conformity for each specific type of product, goods, service, process, or environment is selected by the standard conformity certification body or the declaring organization/individual according to the methods specified in Article 5 of this Circular. The selected method must be appropriate for the object being assessed to ensure the reliability of the results.

2. The method for assessing technical regulation conformity for specific products, goods, services, processes, or environments is specified in the corresponding technical regulation.

3. The conformity assessment method must be specifically recorded on the certificate of technical regulation conformity.

Chapter II

DECLARATION OF STANDARD CONFORMITY

Article 7. Principles of declaration of standard conformity

1. Subjects of declaration of standard conformity are products, goods, services, processes, and the environment specified in the corresponding standards. Declaration of standard conformity is a voluntary activity.

2. The declaration of conformity with the corresponding standards is based on:

a) Results of standard conformity certification performed by a registered certification body; or

b) Results of self-assessment of conformity by the organization or individual declaring standard conformity.

Testing serving standard conformity assessment must be performed at a registered testing body.

Article 8. Sequence of declaration of standard conformity

The declaration of standard conformity is performed according to the following steps:

1. Step 1: Assess the conformity of the subject of declaration of standard conformity with the corresponding standard (hereinafter abbreviated as standard conformity assessment).

a) Standard conformity assessment is performed by a registered certification body (third party) or by the organization/individual declaring standard conformity (first party).

Standard conformity assessment is performed according to the conformity assessment methods specified in Clause 1, Article 6 of this Circular;

b) The results of standard conformity assessment specified in Point a, Clause 1 of this Article serve as the basis for the organization or individual to declare standard conformity.

2. Step 2: Register the declaration of standard conformity dossier at the Department of Standards, Metrology and Quality of the province or central-affiliated city where the manufacturing organization or individual has registered their business or household business (hereinafter abbreviated as the Department).

Article 9. Registration dossier for declaration of standard conformity

The organization or individual declaring standard conformity shall prepare 02 (two) sets of declaration of standard conformity dossiers, of which 01 (one) set is submitted directly or sent by mail to the Department and 01 (one) set is kept by the organization or individual. The components of the dossier are regulated as follows:

1. In case the declaration of standard conformity is based on the results of standard conformity certification by a registered certification body (third party), the dossier includes:

a) Declaration of standard conformity (according to Form 2. CBHC/HQ specified in Appendix III of this Circular);

b) A certified copy of documents proving the production and business activities of the organization or individual declaring standard conformity (Business Registration Certificate or Enterprise Registration Certificate or Household Business Registration Certificate or Investment Certificate or Establishment Decision or other documents as prescribed by law);

c) A certified copy of the standard used as the basis for declaration;

d) A certified copy of the Certificate of Standard Conformity issued by a registered certification body, accompanied by the standard conformity mark sample.

During the dossier review process, if necessary, the original will be reviewed for comparison or a certified copy will be requested.

2. In case the declaration of standard conformity is based on the self-assessment results of the manufacturing or business organization or individual (first party), the dossier includes:

a) Declaration of standard conformity (according to Form 2. CBHC/HQ specified in Appendix III of this Circular);

c) A certified copy of the standard used as the basis for declaration;

d) In case the organization or individual declaring standard conformity has not been issued a certificate for a management system (ISO 9001, ISO 22000, HACCP…) by a registered certification body, the dossier must include a production process accompanied by a quality control plan (according to Form 1. KHKSCL specified in Appendix III of this Circular) and a management system surveillance plan;

e) In case the organization or individual declaring standard conformity has been issued a certificate for a management system (ISO 9001, ISO 22000, HACCP…) by a registered certification body, the dossier must include a certified copy of the valid management system certificate;

f) Standard conformity assessment report (according to Form 5. BCĐG specified in Appendix III of this Circular) accompanied by a certified copy of the test report for samples tested within 12 months up to the time of submission from a registered testing body.

During the dossier review process, if necessary, the original will be reviewed for comparison or a certified copy will be requested.

Article 10. Processing of declaration of standard conformity dossiers

Dossiers sent to the Department are processed as follows:

1. For incomplete dossiers as specified in Article 9 of this Circular, within 03 (three) working days from the date of receipt, the Department shall notify in writing requesting supplementation of documents according to Article 9. If the dossier is not supplemented within 15 (fifteen) working days from the request date, the Department has the right to cancel the processing of the dossier.

2. For complete dossiers as specified in Article 9 of this Circular, within 05 (five) working days from the date of receipt, the Department must inspect the validity of the dossier to process as follows:

a) If the dossier is complete and valid, the Department issues a Notice of Acceptance of the declaration of standard conformity dossier (according to Form 3. TBTNHS specified in Appendix III of this Circular). This Notice is valid according to the validity of the certificate issued by the registered certification body or for 03 (three) years from the date the organization/individual leader signs the assessment report (for self-assessment cases).

b) If the dossier is complete but invalid, the Department shall notify the organization or individual in writing of the reasons for non-acceptance.

Article 11. Responsibilities of organizations and individuals declaring standard conformity

1. Select a conformity assessment method appropriate to the subject of declaration to ensure the reliability of results.

2. Continuously maintain and take responsibility for the conformity of the registered products, goods, services, processes, and environment; maintain quality control, testing, and periodic surveillance at the facility.

3. Upon detecting non-conformity of declared products during circulation or use, the entity must:

a) Suspend shipment and recall non-conforming products from the market if they pose a high risk to user safety; stop operations of related processes, services, or environment when necessary;

b) Implement corrective actions;

c) Notify the Department in writing of the results of corrective actions before resuming use, circulation, exploitation, or business.

4. Establish and maintain declaration of standard conformity dossiers as follows:

a) For third-party certification: Keep originals and copies of documents specified in Clause 1, Article 9 and surveillance records from the registered certification body;

b) For first-party self-assessment: Keep originals and copies of documents specified in Clause 2, Article 9 and self-surveillance records according to the plan.

5. Provide documents proving conformity with the corresponding standard upon request by the Regulatory Authority.

6. Provide certified copies of the Notice of Acceptance to organizations or individuals trading the products, goods, services, processes, or environment.

7. Perform re-declaration upon any changes to the registered dossier content or changes in features, functions, or characteristics of the declared products, goods, or services.

Chapter III

DECLARATION OF REGULATION CONFORMITY

Article 12. Principles of declaration of regulation conformity

1. Subjects of declaration of regulation conformity are products, goods, services, processes, and the environment specified in national technical regulations issued by line ministries or specified in local technical regulations issued by People’s Committees of provinces or central-affiliated cities. Declaration of regulation conformity is a mandatory activity.

2. The declaration of conformity with technical regulations is based on one of the two following cases:

a) Results of certification of regulation conformity according to the provisions of the corresponding technical regulation and performed by a designated certification body;

b) Results of self-assessment of conformity by the organization or individual declaring regulation conformity.

Testing serving regulation conformity assessment is performed at a registered testing body.

3. In case products or goods are managed by multiple different technical regulations, the organization or individual must perform registration for the declaration of regulation conformity at the corresponding specialized agencies, and the regulation conformity mark is only used when those products or goods have fully implemented the management measures specified in the corresponding technical regulations.

Article 13. Sequence of declaration of regulation conformity

The declaration of regulation conformity is performed according to the following steps:

1. Step 1: Assess the conformity of the subject of declaration of regulation conformity with the corresponding technical regulation (hereinafter abbreviated as regulation conformity assessment).

a) Regulation conformity assessment may be performed by a designated certification body (third party) or by the organization/individual declaring regulation conformity (first party).

Regulation conformity assessment is performed according to the conformity assessment method specified in the corresponding technical regulation.

In case the results of conformity assessment from a foreign conformity assessment organization are used, the foreign conformity assessment organization must be recognized according to the provisions of law or designated by a competent state management agency;

b) The results of regulation conformity assessment serve as the basis for the organization or individual to declare regulation conformity.

2. Step 2: Register the declaration of regulation conformity at the specialized agency designated by the line ministry or the People’s Committee of the province or central-affiliated city (hereinafter abbreviated as the specialized agency).

Article 14. Registration dossier for declaration of regulation conformity

The organization or individual declaring regulation conformity shall prepare 02 (two) sets of declaration of regulation conformity dossiers, of which 01 (one) set is submitted directly or sent by mail to the specialized agency and 01 (one) set is kept by the organization or individual. The components of the dossier are regulated as follows:

1. In case the declaration of regulation conformity is based on the results of certification of regulation conformity by a designated certification body (third party), the dossier includes:

a) Declaration of regulation conformity (according to Form 2. CBHC/HQ specified in Appendix III of this Circular);

b) A certified copy of documents proving the production and business activities of the organization or individual declaring regulation conformity (Enterprise Registration Certificate or Business Registration Certificate or Household Business Registration or Investment Certificate or Establishment Decision or other documents as prescribed by law);

c) A certified copy of the certificate of conformity with the corresponding technical regulation issued by the designated certification body, accompanied by the regulation conformity mark sample issued by the designated certification body to the organization or individual.

During the dossier review process, if necessary, the original will be reviewed for comparison or a certified copy will be requested;

2. In case the declaration of regulation conformity is based on the self-assessment results of the manufacturing or business organization or individual (first party), the dossier includes:

a) Declaration of regulation conformity (according to Form 2. CBHC/HQ specified in Appendix III of this Circular);

c) In case the organization or individual declaring regulation conformity has not been issued a certificate for a management system (ISO 9001, ISO 22000, HACCP…) by a registered certification body, the dossier must include a production process accompanied by a quality control plan (according to Form 1. KHKSCL specified in Appendix III of this Circular) and a management system surveillance plan;

d) In case the organization or individual declaring regulation conformity has been issued a certificate for a management system (ISO 9001, ISO 22000, HACCP…) by a registered certification body, the dossier must include a certified copy of the valid management system certificate;

e) A certified copy of the test report for samples tested within 12 months up to the time of submission from a registered testing body;

f) Regulation conformity assessment report (according to Form 5. BCĐG specified in Appendix III of this Circular) accompanied by the regulation conformity mark sample and relevant documents;

During the dossier review process, if necessary, the original will be reviewed for comparison or a certified copy will be requested.

Article 15. Processing of declaration of regulation conformity dossiers

Dossiers sent to the specialized agency are processed as follows:

1. For incomplete dossiers as specified in Article 14 of this Circular, within 03 (three) working days from the date of receipt, the specialized agency shall notify in writing requesting supplementation of documents. If the dossier is not supplemented within 15 (fifteen) working days from the request date, the specialized agency has the right to cancel the processing of the dossier.

2. For complete dossiers as specified in Article 14 of this Circular, within 05 (five) working days from the date of receipt, the specialized agency organizes an inspection of the validity of the dossier:

a) If the dossier is complete and valid, the specialized agency issues a Notice of Acceptance of the declaration of regulation conformity dossier (according to Form 3. TBTNHS specified in Appendix III of this Circular).

The Notice of Acceptance is valid according to the validity of the certificate of regulation conformity issued by the designated certification body or for three (03) years from the date the organization/individual leader signs the assessment report (for self-assessment cases);

b) If the dossier is complete but invalid, the specialized agency shall notify the organization or individual in writing of the reasons for non-acceptance.

Article 16. Responsibilities of organizations and individuals declaring regulation conformity

1. Announce through appropriate information media about their declaration of regulation conformity to ensure easy access for product users.

3. Use the regulation conformity mark for products and goods that have been declared for regulation conformity as specified in Clause 2, Article 4 of this Circular before market circulation. Maintain a tracking log and report annually on the use of the regulation conformity mark to the designated certification body.

4. Upon detecting non-conformity of declared products during circulation or use, the entity must:

a) Promptly notify the specialized agency in writing about the non-conformity;

b) Suspend shipment and recall non-conforming products from the market if they pose a high risk to user safety; stop operations of related processes, services, or environment when necessary;

c) Implement corrective actions;

d) Notify the specialized agency in writing of the results of corrective actions before resuming use, circulation, exploitation, or business.

5. Establish and maintain declaration of regulation conformity dossiers as a basis for inspection and examination by state management agencies as follows:

a) For third-party certification: Keep originals and copies of documents specified in Clause 1, Article 14 and surveillance records from the designated certification body;

b) For first-party self-assessment: Keep originals and copies of documents specified in Clause 2, Article 14 and self-surveillance records according to the plan.

6. Provide documents proving conformity with the corresponding technical regulation upon request by the Regulatory Authority.

7. Provide certified copies of the certificate of regulation conformity and the Notice of Acceptance to organizations or individuals trading the products, goods, services, processes, or environment.

8. Perform re-declaration upon any changes to the registered dossier content or changes in features, functions, or characteristics of the declared products, goods, or services.

Chapter IV

ORGANIZATION OF IMPLEMENTATION

Article 17. Responsibilities of regulatory agencies

1. Responsibilities of line ministries and People’s Committees of provinces and central-affiliated cities:

a) Direct the declaration of regulation conformity activities according to the provisions of this Circular when issuing corresponding technical regulations for management;

b) Designate a focal agency responsible for managing declaration of regulation conformity activities within the assigned field; notify the list of focal agencies to relevant organizations and individuals for implementation and send it to the Ministry of Science and Technology for coordination and management;

c) Assign the responsibility of receiving declaration of regulation conformity dossiers to specialized agencies;

d) Annually, summarize the situation of designating conformity assessment organizations and notify the Ministry of Science and Technology for coordinated management; unexpectedly, upon request, summarize and report the situation of declaration of regulation conformity to the Ministry of Science and Technology for summarizing and reporting to the Prime Minister.

2. Responsibilities of the Directorate for Standards, Metrology and Quality as the designated focal agency according to Point b, Clause 1 of this Article:

a) Assist the Ministry of Science and Technology in the unified management and guidance of conformity assessment, declaration of standard conformity, and declaration of regulation conformity activities;

b) Coordinate with central focal agencies under line ministries and Departments of Science and Technology of provinces and central-affiliated cities in urging and guiding the implementation of declaration of standard conformity and declaration of regulation conformity according to this Circular;

c) Monitor the situation of declaration of standard conformity and declaration of regulation conformity for products, goods, services, processes, and the environment under the management responsibility of the Ministry of Science and Technology based on reports from the Departments of Standards, Metrology and Quality; monitor the designations made by line ministries regarding conformity assessment activities.

3. Responsibilities of the designated focal agencies under line ministries and People’s Committees of provinces and central-affiliated cities according to Point b, Clause 1 of this Article:

a) Monitor and manage the registration of declaration of regulation conformity by specialized agencies; coordinate with the Directorate for Standards, Metrology and Quality in managing declaration of regulation conformity activities; annually, summarize and report to the relevant line ministries and People’s Committees on the situation of designating conformity assessment organizations, and simultaneously send the report to the Directorate for Standards, Metrology and Quality for coordinated management;

b) Summarize the situation of declaration of regulation conformity activities of specialized agencies and report annually or unexpectedly upon request to the relevant line ministries and People’s Committees.

4. Responsibilities of specialized agencies designated by line ministries and People’s Committees of provinces and central-affiliated cities:

a) Receive registration dossiers and manage declaration of regulation conformity dossiers; cancel or suspend the results of receiving declaration of regulation conformity dossiers for products, goods, services, processes, and the environment managed by national technical regulations issued by line ministries and local technical regulations related to assigned management fields;

b) Publicly announce on their websites the situation of declaration of regulation conformity with the following contents:

– Name of the organization or individual declaring regulation conformity;

– Products and goods declared for regulation conformity;

– Number of the technical regulation;

– Type of assessment: First-party (name of the organization/individual) or third-party (name of the designated certification body).

c) Coordinate with the local Department of Standards, Metrology and Quality in providing information on declaration of regulation conformity to facilitate product and goods quality inspection;

d) Annually, or unexpectedly upon request, summarize and report to the focal agency the list of products, goods, services, processes, and the environment registered for declaration of regulation conformity (according to Form 4. BCTNHS specified in Appendix III of this Circular).

5. Responsibilities of the Department of Standards, Metrology and Quality under the Departments of Science and Technology of provinces and central-affiliated cities:

a) Receive registration and manage declaration of standard conformity dossiers; cancel or suspend the results of receiving declaration of standard conformity dossiers of local manufacturing and business organizations/individuals and publicly announce the situation of declaration of standard conformity on the website of the Department of Science and Technology or the local Department of Standards, Metrology and Quality;

b) Receive registration and manage declaration of regulation conformity dossiers; cancel or suspend the results of receiving declaration of regulation conformity dossiers for products, goods, services, processes, and the environment managed by national technical regulations issued by the Ministry of Science and Technology and local technical regulations related to assigned management fields; publicly announce on the website of the Department of Science and Technology or the local Department of Standards, Metrology and Quality the situation of declaration of regulation conformity with the following contents:

– Name of the organization or individual declaring regulation conformity;

– Products and goods declared for regulation conformity;

– Number of the technical regulation;

– Type of assessment: First-party (name of the organization/individual) or third-party (name of the designated certification body).

c) Coordinate with local specialized agencies in providing information on declaration of standard conformity to facilitate product and goods quality inspection;

d) Annually, or unexpectedly upon request, summarize and report to the Directorate for Standards, Metrology and Quality on the situation of receiving declaration of standard conformity and declaration of regulation conformity dossiers (according to Form 4. BCTNHS specified in Appendix III of this Circular) as specified in Points a and b of this Clause.

Article 18. Inspection, examination, and handling of violations

1. Competent state management agencies shall perform inspection, examination, and handling of legal violations in declaration of standard conformity and declaration of regulation conformity activities according to the provisions of this Circular and other relevant current regulations.

2. Organizations and individuals violating regulations on declaration of standard conformity and declaration of regulation conformity shall, depending on the nature and severity of the violation, be handled in accordance with current relevant laws.

Article 19. Implementation provisions

This Circular takes effect from January 27, 2013, and replaces Decision No. 24/2007/QD-BKHCN dated September 28, 2007, of the Minister of Science and Technology on issuing regulations on certification of standard conformity, certification of regulation conformity, and declaration of standard conformity, declaration of regulation conformity.

Article 20. Organization of implementation

1. Ministers, Heads of ministerial-level agencies, and Chairpersons of People’s Committees of provinces and central-affiliated cities are responsible for organizing the implementation of this Circular.

2. The Director General of the Directorate for Standards, Metrology and Quality is responsible for guiding and organizing the implementation of this Circular.

3. During the implementation process, if any problems or difficulties arise, organizations and individuals should promptly reflect them in writing to the Ministry of Science and Technology for study, amendment, and supplementation./.

APPENDIX I

SHAPE AND DIMENSIONS OF THE REGULATION CONFORMITY MARK

(Issued together with Circular No. 28/2012/TT-BKHCN dated December 12, 2012, of the Minister of Science and Technology)

SHAPE AND DIMENSIONS OF THE REGULATION CONFORMITY MARK

1. The shape of the regulation conformity mark is described in Figure 1.

2. Basic dimensions for designing the regulation conformity mark are specified in Figure 2.

Note:

H = 1,5 a
h = 0,5 H
C = 7,5 H

APPENDIX II

CONTENT, SEQUENCE, AND PRINCIPLES FOR USING CONFORMITY ASSESSMENT METHODS

(Issued together with Circular No. 28/2012/TT-BKHCN dated December 12, 2012, of the Minister of Science and Technology)

CONTENT, SEQUENCE, AND PRINCIPLES FOR USING CONFORMITY ASSESSMENT METHODS

I. Method 1: Typical sample testing

Method 1 tests typical samples of products and goods to conclude on conformity. The conclusion on conformity is valid for the type and category of products and goods from which the test samples were taken.

1. The content and sequence of main activities in Method 1 include:

1.1. Sampling:

Conduct sampling of typical samples for products and goods. A typical sample of a product or good is a sample representing a specific type or category of product or good manufactured according to the same design, under the same conditions, and using the same types of raw materials.

The quantity of samples must be sufficient for testing and storage.

1.2. Conformity assessment of the test sample:

Product and goods samples are tested at a testing body registered in the field of testing activities according to the provisions of law, which may include the manufacturer’s laboratory. Priority is given to using designated and accredited testing bodies.

The characteristics of the products and goods to be tested and the testing methods are specified in the corresponding standards and technical regulations.

1.3. Processing of conformity assessment results:

Review the characteristics of the products and goods through the sample test results compared with the requirements of the corresponding standards and technical regulations.

1.4. Conclusion on conformity:

Conclude on the conformity of the products and goods compared with the requirements of the corresponding standards and technical regulations. Products and goods are considered conforming if all indicators of the test samples conform to the levels specified in the corresponding standards and technical regulations.

2. Principles for using Method 1:

Method 1 is used to assess the conformity of products and goods under the following conditions:

a) The design of the products and goods allows for clear identification of the products and goods by specific type and category;

b) No review of requirements to ensure the maintenance of stable quality is conducted.

II. Method 2: Typical sample testing and assessment of the production process; surveillance through testing of samples taken from the market

Method 2 is based on typical sample test results and assessment of the production process to conclude on the conformity of products and goods. Subsequent surveillance assessment is performed through testing of product and goods samples taken from the market.

1. The content and sequence of main activities in Method 2 include:

1.1. Sampling:

Proceed as specified in Section 1.1 of Method 1.

1.2. Conformity assessment of the test sample:

Proceed as specified in Section 1.2 of Method 1.

1.3. Assessment of the conformity of the production process:

The assessment of the production process must fully consider the manufacturer’s control conditions related to product formation to ensure the maintenance of stable quality for products and goods. Control conditions include:

a) Control of technical dossiers of the product (design documents, technical standards of the product);

b) Control of the entire production process from input, through intermediate stages, until the product is formed, including the process of packaging, handling, warehousing, and transportation;

c) Quality control of raw materials, semi-finished products, and finished products;

d) Control of technological equipment and measuring, inspection, and testing equipment;

đ) Control of the skill levels of workers and technical staff;

e) Other necessary technical contents.

In cases where the manufacturer has a quality management system certificate from a certification body registered in the field of certification or recognized for the specific production field of the products and goods being assessed, assessment of the production process is not required. However, if there is evidence of failure to maintain the effectiveness of the QMS, the certification body must conduct an assessment of the production process and report to the Directorate for Standards, Metrology and Quality.

1.4. Processing of conformity assessment results:

Review the characteristics of the products and goods through the sample test results compared with the requirements of the corresponding standards and technical regulations.

Review the conformity of the production process compared with the requirements specified in Section 1.3 of this method.

1.5. Conclusion on conformity:

a) All indicators of the test samples conform to the levels specified in the corresponding standards and technical regulations;

b) The production process assessment results meet the requirements.

The conclusion on conformity of products and goods has a maximum validity of 3 years, provided that the products and goods undergo surveillance assessment.

1.6. Surveillance:

During the validity period of the conclusion on conformity, products and goods must be assessed and monitored through testing of samples taken from the market. The frequency of surveillance assessment must ensure it does not exceed once every 12 months.

The testing of product and goods samples is performed as specified in Sections 1.1, 1.2, and 1.3 of Method 1.

Surveillance assessment results will be used as the basis to decide on the maintenance, suspension, or cancellation of the conclusion on conformity.

2. Principles for using Method 2:

Method 2 is used to assess the conformity of products and goods under the following conditions:

a) Products and goods are in the category of having low safety, health, and environmental risk levels;

b) The design of the products and goods allows for clear identification of the products and goods by specific type and category;

c) Attention is required regarding the maintenance of stable quality characteristics of products and goods during the production process;

d) The quality of products and goods is likely to change during distribution and circulation on the market;

đ) The organization or individual manufacturing or trading the products and goods has effective measures to recall products and goods from the market upon discovering non-conforming products during the surveillance process.

III. Method 3: Typical sample testing and assessment of the production process; surveillance through testing of samples taken at the place of production combined with assessment of the production process

Method 3 is based on typical sample test results and assessment of the production process to conclude on conformity. Surveillance assessment is performed through testing of product and goods samples taken from the place of production combined with an assessment of the production process.

1. The content and sequence of basic activities in Method 3 include:

1.1. Sampling: Proceed as specified in Section 1.1 of Method 1.

1.2. Conformity assessment of the test sample: Proceed as specified in Section 1.2 of Method 1.

1.3. Assessment of the conformity of the production process: Proceed as specified in Section 1.3 of Method 2.

1.4. Processing of conformity assessment results: Proceed as specified in Section 1.4 of Method 2.

1.5. Conclusion on conformity: Proceed as specified in Section 1.5 of Method 2.

1.6. Surveillance: During the validity period of the conclusion on conformity, products and goods must be assessed and monitored through testing of samples taken at the place of production combined with an assessment of the production process. The frequency of surveillance assessment must ensure it does not exceed once every 12 months.

The testing of product and goods samples is performed as specified in Sections 1.1, 1.2, and 1.3 of Method 1.

The assessment of the production process is performed as specified in Section 1.3 of Method 2.

Surveillance assessment results will be used as the basis to decide on the maintenance, suspension, or cancellation of the conclusion on conformity.

2. Principles for using Method 3:

Method 3 is used to assess the conformity of products and goods under the following conditions:

a) Products and goods are in the category of having higher safety, health, and environmental risk levels compared to products and goods assessed according to Method 2;

b) The design of the products and goods allows for clear identification of the products and goods by specific type and category;

c) Attention is required regarding the maintenance of stable quality characteristics of products and goods during the production process;

d) The quality of products and goods inherently undergoes little or no change during distribution and circulation on the market;

e) It is difficult to implement effective measures to recall products and goods from the market upon discovering non-conforming products during the surveillance process.

IV. Method 4: Typical sample testing and assessment of the production process; surveillance through testing of samples taken at the place of production and on the market combined with assessment of the production process

Method 4 is based on typical sample test results and assessment of the production process to conclude on conformity. Surveillance assessment is subsequently performed through testing of product and goods samples taken from the place of production and on the market combined with an assessment of the production process.

1. The content and sequence of basic activities in the Method include:

1.1. Sampling: Proceed as specified in Section 1.1 of Method 1.

1.2. Evaluation of conformity of the test sample: Proceed as specified in Section 1.2 of Method 1.

1.3. Assessment of the conformity of the production process: Proceed as specified in Section 1.3 of Method 2.

1.4. Processing of conformity assessment results: Proceed as specified in Section 1.4 of Method 2.

1.5. Conclusion on conformity: Proceed as specified in Section 1.5 of Method 2.

1.6. Surveillance: During the validity period of the notice of conformity, products and goods must be assessed and monitored through testing of samples taken at the place of production and on the market combined with an assessment of the production process. The frequency of surveillance assessment must ensure it does not exceed once every 12 months.

The testing of product and goods samples is performed as specified in Sections 1.1, 1.2, and 1.3 of Method 1.

The assessment of the production process is performed as specified in Section 1.3 of Method 2.

Surveillance assessment results will be used as the basis to decide on the maintenance, suspension, or cancellation of the conclusion on conformity.

2. Principles for using Method 4:

Method 4 is used to assess the conformity of products and goods under the following conditions:

a) Products and goods are in the category of having higher safety, health, and environmental risk levels compared to products and goods whose conformity is assessed according to Method 3;

b) The design of the products and goods allows for clear identification of the products and goods by specific type and category;

c) Attention is required regarding the maintenance of stable quality characteristics of products and goods during the production process;

d) The quality of products and goods is likely to be unstable during the production process and changed during distribution and circulation on the market;

e) There are measures allowing for the recall of products and goods from the market upon discovering non-conforming products during the surveillance process.

V. Method 5: Typical sample testing and assessment of the production process; surveillance through testing of samples taken at the place of production or on the market combined with assessment of the production process

Method 5 is based on typical sample test results and assessment of the production process to conclude on conformity. Surveillance assessment is performed through testing of samples taken at the place of production or samples taken on the market combined with an assessment of the production process.

1. The content and sequence of basic activities in Method 5 include:

1.1. Sampling: Proceed as specified in Section 1.1 of Method 1.

1.2. Conformity assessment of the test sample: Proceed as specified in Section 1.2 of Method 1.

1.3. Assessment of the conformity of the production process: Proceed as specified in Section 1.3 of Method 2.

1.4. Processing of conformity assessment results: Proceed as specified in Section 1.4 of Method 2.

1.5. Conclusion on conformity: Proceed as specified in Section 1.5 of Method 2.

1.6. Surveillance: During the validity period of the conclusion on conformity, products and goods must be assessed and monitored through testing of samples taken at the place of production or taken on the market combined with an assessment of the production process. The frequency of surveillance assessment must ensure it does not exceed once every 12 months.

The testing of product and goods samples is performed as specified in Sections 1.1, 1.2, and 1.3 of Method 1.

The assessment of the production process is performed as specified in Section 1.3 of Method 2.

Surveillance assessment results will be used as the basis to decide on the maintenance, suspension, or cancellation of the notice of conformity.

2. Principles for using Method 5:

Method 5 is used to assess the conformity of products and goods under the following conditions:

a) It is necessary to use a method with high reliability such as Method 4, but allowing flexibility in the use of surveillance measures to reduce costs;

b) It is necessary to use a commonly applied method aimed at the mutual recognition of conformity assessment results.

VI. Method 6: Assessment and surveillance of the management system

Method 6 is based on the assessment of the management system to conclude on the conformity of the management system with the provisions of the corresponding standards and technical regulations.

1. The content and sequence of main activities in Method 6 include:

1.1. Conformity assessment of the management system:

The management system is assessed according to the provisions of the corresponding standards and technical regulations.

The assessment result report is compared with the provisions of the corresponding standards and technical regulations.

1.2. Conclusion on conformity:

Based on the assessment result report, conclude on the conformity of the management system with the provisions of the corresponding standards and technical regulations.

The conclusion on the conformity of the management system has a maximum validity of 3 years, provided that the management system undergoes surveillance assessment.

1.3. Surveillance of the management system:

Surveillance through the assessment of the management system with a surveillance assessment frequency ensuring it does not exceed once every 12 months.

Surveillance results serve as the basis to decide on the continued maintenance, suspension, or cancellation of the conformity of the management system.

2. Principles for using Method 6:

Method 6 is used to assess the conformity of processes, services, and environments that have a management system according to the provisions of the corresponding standards and technical regulations.

VII. Method 7: Testing and evaluation of a lot of products and goods

Method 7 is based on the test results of product and goods samples taken according to statistical probability methods for a lot of products and goods to conclude on the conformity of the lot. The conclusion on conformity is only valid for a specific lot of products and goods and does not require subsequent surveillance measures.

1. The content and sequence of main activities in Method 7 include:

1.1. Sampling:

Test samples are taken according to statistical probability methods, ensuring representation for the entire lot.

The quantity of samples must be sufficient for testing and storage.

1.2. Conformity assessment of the test sample:

Proceed as specified in Section 1.2 of Method 1.

1.3. Processing of conformity assessment results:

Review the characteristics of the products and goods through the sample test results against the provisions of the corresponding standards and technical regulations.

1.4. Conclusion on conformity:

The lot of products and goods is considered conforming to the regulations if the number of test samples with non-conforming results is within the allowable limits.

The lot of products and goods is considered non-conforming to the regulations if the number of test samples with non-conforming results exceeds the allowable limits.

2. Principles for using Method 7:

Method 7 is used to assess the conformity of products and goods under the following conditions:

a) Products and goods are identified by uniform lots;

b) No review of requirements to ensure the maintenance of stable quality is conducted.

VIII. Method 8: Testing or inspection of all products and goods

Method 8 is based on the results of testing or inspection of all products and goods to conclude on conformity before they are put into circulation or use. The conclusion on conformity is only valid for each individual product or good and does not require subsequent surveillance measures.

1. The content and sequence of main activities in Method 8 include:

1.1. Identification of products and goods requiring testing or inspection;

1.2. Conformity assessment of the products and goods:

a) The testing or inspection of products and goods is conducted by a testing or inspection laboratory registered in the field of activity with sufficient capacity at the place of production, installation, use, or at the testing/inspection laboratory.

Priority is given to using accredited testing or inspection laboratories.

b) The characteristics of the products and goods to be tested or inspected and the testing/inspection methods are specified in the corresponding standards and technical regulations.

1.3. Processing of conformity assessment results:

Review the characteristics of the products and goods through the test results or inspection results compared with the requirements.

1.4. Conclusion on conformity:

Products and goods are considered conforming if all indicators of the tested or inspected products and goods conform to the levels specified in the corresponding standards and technical regulations.

2. Principles for using Method 8:

Method 8 is used to assess the conformity of products and goods with strict safety requirements before they are put into circulation or use./.

APPENDIX III

FORMS USED IN THE DECLARATION OF STANDARD CONFORMITY AND DECLARATION OF REGULATION CONFORMITY

(Issued together with Circular No. 28/2012/TT-BKHCN dated December 12, 2012, of the Minister of Science and Technology)

1. Quality control plan:

Form 1. KHKSCL

28/2012/TT-BKHCN.

2. Declaration of standard conformity/declaration of regulation conformity:

Form 2. CBHC/HQ

28/2012/TT-BKHCN.

3. Notice of acceptance of the declaration of standard conformity/declaration of regulation conformity dossier: