Decision No. 2424/2000/QĐ-BKHCNMT on the issuance of the "Provisional Regulations on the Announcement of Goods Meeting Standards"

DECISION OF THE MINISTER
MINISTRY OF SCIENCE, TECHNOLOGY AND ENVIRONMENT

Regarding the issuance of the "Provisional Regulations on Announcing Goods Compliant with Standards"

THE MINISTER

MINISTRY OF SCIENCE AND TECHNOLOGY AND ENVIRONMENT

Pursuant to the Quality of Goods Ordinance dated December 24, 1999;

Pursuant to Decree No. 22/CP dated May 22, 1993 of the Government on the tasks, powers, and organizational structure of the Ministry of Science, Technology, and Environment;

Pursuant to the opinion of the Prime Minister in the letter dated month year 2000 regarding the provisional issuance of certain regulations guiding the implementation of the Quality of Goods Ordinance;

At the proposal of the General Director of the Standardization, Measurement, and Quality Control Administration;

DECISION:

Article 1.Issued herewith are the "Provisional Regulations on Announcing Goods Compliant with Standards".

Article 2. The Standardization, Measurement, and Quality Control Administration and relevant State agencies shall organize, guide, and inspect the implementation of this Decision.

Article 3. The General Director of the Standardization, Measurement, and Quality Control Administration and related organizations and individuals shall be responsible for implementing this Decision.

Article 4.This Decision takes effect from January 1, 2001.

Provisional Regulations

On Announcing Goods Compliant with Standards

(issued together with Decision No. / 2000/QĐ-BKHCNMT

dated / 12/ 2000 of the Minister of Science and Technology and Environment)

I. General Provisions

1. This document specifies the conditions and procedures for announcing goods compliant with standards according to Articles 11, 12, and 13 of the Quality of Goods Ordinance.

2. Announcing goods compliant with standards is the act of a business entity declaring its goods to be in compliance with corresponding standards.

The announcement of goods compliant with standards shall be based on one of the following grounds:

a) the results of quality certification by a quality certification organization regarding the compliance of goods with corresponding standards;

b) the self-assessment results of the business entity regarding the compliance of goods with corresponding standards.

3. Methods of announcing goods compliant with standards include:

a) Voluntary announcement

Voluntary announcement applies generally to all goods except those specified in point b below;

b) Mandatory announcement

Mandatory announcement applies to:

Goods listed in the "Catalogue of Goods Required to Apply Vietnam National Standards" prescribed by the Ministry of Science and Technology and Environment;

Goods listed in the "Catalogue of Goods Required to Apply Industry Standards" prescribed by the specialized management ministry.

4. Goods listed in points 1.3 (b) may only be allowed to circulate in the market after being announced by the business entity as compliant with standards.

II. Content and Form of Announcement

1. Content of Announcement

The content of the announcement includes information set forth in Appendix 1.

Additional information as provided in Appendix 1 includes:

The name and address of the testing laboratory that tested the sample or the certification organization that certified the goods of the business entity;

Reference to the certificate of goods compliance with standards issued by the aforementioned organizations;

Reference to the certificate of the quality management system of the business entity;

Reference to the accreditation certificate of the testing laboratory of the business entity.

2. Forms of Announcement Include:

a) Declaration of Compliance;

b) Conformity Mark;

c) The conformity mark can be displayed directly on the goods and/or packaging, in catalogs, or user manuals.

3. The form of the Conformity Mark is stipulated in Vietnam National Standard TCVN 5680:2000.

Depending on the size of the goods or packaging, the Conformity Mark may be enlarged or reduced, but it must be clear, visible, and durable. The color of the Conformity Mark is chosen by the business entity.

III. Content, Evaluation Procedure, and Announcement

1. Evaluation and Announcement Based on Certification Results of a Third-Party Certification Organization:

In this case, the business entity announces its goods as compliant with corresponding standards after being evaluated and certified by a third-party certification organization.

The certification process by the certification organization is carried out according to the provisions of the Ministry of Science and Technology and Environment in another document.

2. Evaluation and Announcement Based on Self-Assessment Results of the Business Entity:

The self-assessment by the business entity regarding the compliance of goods with corresponding standards must be based on the quality assurance conditions of the business entity and the test results of typical samples of the goods; and is conducted by the business entity in accordance with the following procedure:

2.1 Preparation for Assessment

a) Establishing or completing the Technical File as set forth in Appendix 2 and implementing measures to ensure the compliance of goods with standards during production and related processes;

b) Determining the testing capability according to the requirements and criteria of the corresponding standard. For criteria that cannot be tested internally, the business entity should consider selecting a testing laboratory capable of testing these criteria (priority given to accredited laboratories);

c) Developing a sampling plan and testing typical samples according to the standard's provisions;

d) Establishing an internal assessment team consisting of individuals knowledgeable about production technology and product quality;

e) Developing an assessment plan including: plans to review technical documentation systems and measures to ensure compliance of goods with standards.

2.2 Conducting the Assessment

a) Assessing quality assurance conditions and measures to ensure compliance according to the established assessment plan;

b) Conducting sampling and testing according to the established assessment plan;

c) Preparing an assessment report, including:

Relevant technical files directly related to the goods;

The assessment plan and testing of typical samples;

Reports on the assessment results of quality assurance conditions and testing of typical samples;

Reports on non-conformities and corrective actions;

Summary report of the assessment results;

Post-announcement monitoring and compliance assurance plan;

Quality Management System Certification or Accreditation Certificate of Testing Laboratory (if applicable).

If the business entity has been certified for a quality management system such as ISO 9000, HACCP, GMP, or the Vietnam Quality Award, it does not need to implement the quality assurance condition assessment tasks specified in points 3.2.1 (a, d, e); instead, it provides the certification file and the quality management system certification already issued.

2.3 Announcing Compliance

After the assessment, if the goods are concluded to be compliant with standards, the business entity shall announce compliance with the content and form specified in Section 2 of these Regulations.

Within seven days from the date of formal announcement, the business entity must submit the Declaration of Compliance to the following authorities:

The Standardization, Measurement and Quality Control Office where the Enterprise has its principal office;

The focal agency designated by the relevant Ministries under Point 5.1 below for specific goods subject to specialized management;

IV. Responsibilities of the Enterprise with respect to goods that have been declared compliant with standards

4.1The Enterprise shall not declare goods as compliant with standards if such goods only meet some of the provisions of the corresponding standard, except in cases where there are other regulations from competent state agencies.

4.2During the production or circulation of goods, if the Enterprise fails to ensure the conditions for producing goods that comply with the declared content or if the goods are found to no longer comply with the corresponding standard, the Enterprise must immediately report to the relevant authorities and take the following measures:

For voluntary declarations

Temporarily cease using the Conformity Mark;

Take corrective actions for non-compliance.

For mandatory declarations

Temporarily halt the release and circulation of non-compliant goods;

Take corrective actions for non-compliance;

4.3After correcting the non-compliance, the Enterprise may continue to use the Conformity Mark and circulate the goods normally; at the same time, notify the agencies mentioned in Point 3.2.3.

4.4The Enterprise is responsible for retaining all documentation related to goods declared compliant with standards and submitting it for review by competent authorities upon request.

V. Guidance on Implementation

1.In accordance with the division of responsibilities stipulated in Decree No. 86/CP dated December 8, 1995 of the Government regarding the division of responsibilities for state management of product quality, the relevant Ministries shall direct the activities of declaring goods compliant with standards according to this Regulation; designate focal agencies responsible for managing the declaration of goods compliant with standards at both central and local levels; and inform enterprises and the Ministry of Science, Technology and Environment of the list of these focal agencies.

2.The General Department of Standardization, Measurement and Quality Control and the focal agencies at the central level under the relevant Ministries shall be responsible for urging and guiding the implementation of the declaration of goods compliant with standards according to this Regulation.

The Standardization, Measurement and Quality Control Offices shall manage goods, excluding specific goods within the scope of specialized management by the relevant Ministries; and coordinate with the focal agencies designated locally in managing the activities of enterprises declaring goods compliant with standards.

3.Quarterly, the agencies designated in Points 5.1, 5.2 and 5.3 within their respective areas of responsibility shall compile the situation of implementing the declaration of goods compliant with standards and report it to the relevant Ministries and the Ministry of Science, Technology and Environment.

VI. Inspection, Audit and Handling of Violations

1.State agencies with authority will conduct inspections, audits and handle violations concerning the declaration of goods compliant with standards according to this Regulation and other current regulations related thereto.

6.2Organizations and individuals violating the regulations on the declaration of goods compliant with standards shall be dealt with according to the law, depending on the nature and degree of violation.

ANNEX 1

MODEL DECLARATION OF COMPLIANCE WITH STANDARDS

DECLARATION OF COMPLIANCE WITH STANDARDS

Number …

(Attached to the letter No. of the Department of Information and Communications [province/city]) (name of enterprisetelephone number)    

Currency Exchange Agent No. 3 .....................................................................................

fax,

email ....................................................................................

DECLARATION:

Goods

(name, type, model, code of goods) Comply with standard        

(standard number and name):Additional information (if necessary)

.....................................................................................................................

If the enterprise deems it necessarySample conformity mark ..., date ..., month ..., year ...):

Representative of the enterprise           

                                                                                                 (name, position)

             TECHNICAL DOCUMENTATION FILE

ANNEX 2

The technical documentation file includes:

 1. Directly related standards (Vietnamese standards, industry standards and other standards); other technical regulations;

2. General description of the goods (features, functions);

3. Design drawings, manufacturing drawings and diagrams of component parts, assemblies and details;

4. Design calculation results, research and development and testing results;

5. Production process and quality control procedures.

5. Production process and quality control procedure.