NCQM — National Committee for Quality Management

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Center for International Standards Research

Vietnam: Requirements and Standards

Research on defined product requirements and the use of standards in Vietnam. Each record identifies its scope, source and practical evidence questions.

Market scope

TCVN, QCVN and drafts differ; fresh 2025/2026 legal checks required.

The records below examine specific provisions and standards relationships. They do not combine different products or regulatory roles into one approval route.

Requirements at a glance

  1. Match conformity assessment to the current product risk category Article 5(2)–(5), consolidated in 156/VBHN-VPQH
  2. Traceability obligations depend on the high risk product rollout Article 6d(1)–(3)
  3. Production controls and quality records before market circulation Article 28(1)(a)–(d) and (đ); Article 28(2)
  4. Product information and complaint controls on digital marketplaces Article 34b(2) and (3)
  5. Accurate consumer information, instructions and replacement part availability Article 21(1), (2), (4) and (5)
  6. Defective product recall and authority reporting Article 32(1) and Article 33(1)–(4)

Standards and their use

These records distinguish adoption, legal incorporation, designation and programme recognition. A standard’s use is assessed within the specific relationship recorded.

Standards relationship · VN-R01

TCVN ISO 9001:2015 is an identical adoption of ISO 9001:2015

TCVN ISO 9001:2015 — Quality management systems — Requirements · Official catalogue equivalence, status and publication decision

The national catalogue identifies TCVN ISO 9001:2015 as identical to ISO 9001:2015 and lists it as active, replacing the 2008 national edition. This supplies a verified national designation for document and certificate reviews. The intended legal, procurement or certification use must still be established separately, including any applicable amendments and the actual activities covered by a claimed certificate.

Scope, actions and official sources
Issuer
Vietnamese Ministry of Science and Technology; catalogue maintained by VSQI
Status and context
Listed as active in the official national catalogue on the review date.
Edition or text examined
2015
Relationship
National adoption
Legal character
Voluntary reference
Source check
2026-10-20

Applies to

Organizations selecting a Vietnamese national quality management system reference.

Scope and conditions

National adoption and active catalogue status do not create universal product certification or a blanket legal duty to certify the system.

Actions

  • Record the national designation and catalogue status.
  • Check the document set and certificate scope required for the intended use.

Evidence identified by the source

  • No certification is conferred by the catalogue adoption record itself.

Materials for the research review

  • Licensed document and amendment register.
  • Certificate scope, sites and current status where certification is claimed.

Dates and application

Published
2015-12-31

Official sources

VSQI national standards catalogue: TCVN ISO 9001:2015

Equivalent to ISO 9001:2015, IDT; active; decision 4109/QD-BKHCN dated 31 December 2015 · Official source (Vietnamese and English) · Checked 2026-10-20

Standards relationship · VN-R02

TCVN ISO IEC 17025:2017 adopts the international laboratory competence standard

TCVN ISO IEC 17025:2017 — General requirements for the competence of testing and calibration laboratories · Official catalogue equivalence and publication announcement

The official catalogue records TCVN ISO IEC 17025:2017 as an identical adoption of ISO/IEC 17025:2017 and identifies replacement of the 2007 national edition. The national standards authority’s publication announcement corroborates its establishment. A report review should next check the laboratory’s current competence scope and any required regulatory designation for the actual method; national publication alone supplies neither of those permissions.

Scope, actions and official sources
Issuer
Vietnamese Ministry of Science and Technology; catalogue maintained by VSQI
Status and context
Listed as active in the official national catalogue on the review date.
Edition or text examined
2017
Relationship
National adoption
Legal character
Voluntary reference
Source check
2026-10-20

Applies to

Laboratories and users identifying the Vietnamese national laboratory competence document.

Scope and conditions

A laboratory’s use of this standard is distinct from accreditation, regulatory designation and acceptance of a particular report.

Actions

  • Use the verified national designation when comparing requirements.
  • Check laboratory accreditation and regulatory designation separately where required.

Evidence identified by the source

  • No laboratory accreditation or designation follows solely from national adoption.

Materials for the research review

  • Current laboratory certificate and detailed scope.
  • Report-to-method and sample configuration mapping.

Dates and application

Published
2017-12-29

Official sources

VSQI national standards catalogue: TCVN ISO IEC 17025:2017

ISO/IEC 17025:2017 IDT; active status · Official source (Vietnamese and English) · Checked 2026-10-20

National standards authority publication announcement

Decision 3981/QD-BKHCN of 29 December 2017 · Official source (Vietnamese) · Checked 2026-10-20

Standards relationship · VN-R03

TCVN ISO 13485:2017 adopts ISO 13485:2016

TCVN ISO 13485:2017 — Medical devices — Quality management systems — Requirements for regulatory purposes · Official catalogue equivalence and replaced documents

Vietnam’s national designation uses the year 2017 while the equivalent ISO document is ISO 13485:2016. The official catalogue expressly identifies the relationship as identical and records replacement of the earlier national medical device quality documents. A reviewer should preserve both designations accurately, then check whether the claimed system certification and the separate device regulatory evidence cover the actual manufacturer, site and activities.

Scope, actions and official sources
Issuer
Vietnamese Ministry of Science and Technology; catalogue maintained by VSQI
Status and context
Listed as active in the official national catalogue on the review date.
Edition or text examined
TCVN 2017 edition; identical to ISO 13485:2016
Relationship
National adoption
Legal character
Voluntary reference
Source check
2026-10-20

Applies to

Organizations working with medical device quality management systems and suppliers comparing national and international document identities.

Scope and conditions

The national adoption record is not medical device authorization and does not certify any manufacturer or device.

Actions

  • Record both the TCVN and ISO designation years accurately.
  • Match any claimed certificate to the device lifecycle activities and sites.

Evidence identified by the source

  • No manufacturer certificate or device approval is conferred by publication of this standard.

Materials for the research review

  • Controlled national and international document references.
  • System certificate scope and independent device regulatory records if required.

Dates and application

Published
2017-12-29

Official sources

VSQI national standards catalogue: TCVN ISO 13485:2017

ISO 13485:2016 IDT; active; replaces TCVN ISO 13485:2004 and TCVN 8331:2010 · Official source (Vietnamese and English) · Checked 2026-10-20

National standards authority publication announcement

Decision 3979/QD-BKHCN of 29 December 2017 · Official source (Vietnamese) · Checked 2026-10-20

Standards relationship · VN-R04

TCVN 5699-1:2010 adopts the identified IEC appliance safety edition

TCVN 5699-1:2010 — Household and similar electrical appliances — Safety — Part 1: General requirements · Official catalogue equivalence and revision history

The official catalogue identifies TCVN 5699-1:2010 as identical to IEC 60335-1:2010 and lists the 2004 national edition as replaced. This edition-specific relationship helps compare appliance test reports and national document references. The applicable particular part and any compulsory technical regulation must be examined separately; neither a later IEC report nor an active general standard automatically establishes compliance with every Vietnamese appliance requirement.

Scope, actions and official sources
Issuer
Vietnamese Ministry of Science and Technology; catalogue maintained by VSQI
Status and context
Listed as active in the official national catalogue on the review date.
Edition or text examined
2010; identical to IEC 60335-1:2010
Relationship
National adoption
Legal character
Voluntary reference
Source check
2026-10-20

Applies to

Household and similar electrical appliances within the standard’s scope.

Scope and conditions

The national catalogue’s active status does not determine which appliances are subject to a particular QCVN or which test edition a regulator accepts.

Actions

  • Identify the appliance category and applicable general and particular documents.
  • Check the actual QCVN or scheme reference and accepted editions.

Evidence identified by the source

  • No universal appliance certificate is required merely by this national adoption record.

Materials for the research review

  • Licensed national standard and selected particular part.
  • Report edition mapping and regulatory acceptance evidence where relevant.

Dates and application

Published
2010-12-30

Official sources

VSQI national standards catalogue: TCVN 5699-1:2010

IEC 60335-1:2010 IDT; active; replaces TCVN 5699-1:2004; decision 2923/QD-BKHCN dated 30 December 2010 · Official source (Vietnamese and English) · Checked 2026-10-20

Authorities and source systems

Research sources and interpretation

The linked official sources establish the provisions, document identities or relationships examined. NCQM supplies original English analysis. Where an official source is in another language, the English explanation is not an official translation. Source-check dates, effective dates and adopted editions are kept separate.

The research review materials help organize an assessment. They are distinguished from evidence expressly identified by the source. International standards remain subject to their publishers’ access and rights conditions.

Research enquiries

Ask a research question or request a correction identifying the record, relevant passage and supporting source.