CONFORMITY CERTIFICATION: CONCEPT, LEGAL BASIS, AND IMPLEMENTATION PROCESS
Conformity certification is a form of conformity assessment aimed at confirming that subjects within the scope of technical regulations meet the requirements of the corresponding technical regulations. This activity is an integral part of the quality and safety management mechanism for products, goods, services, and related subjects before and during circulation and use.Whether conformity certification is required, which scheme to apply, and how to utilize the certification results must be determined based on the technical regulations, the risk level of the products or goods, and the corresponding specialized legal regulations.
1. What is Conformity Certification?
According to the laws on standards and technical regulations, conformity certification is the confirmation that subjects of activities in the field of technical regulations comply with the corresponding technical regulations.
Subjects of conformity certification are not limited to products and goods but may also include:
- Products and goods;
- Services;
- Processes;
- Environments;
- Other subjects in socio-economic activities specified in technical regulations.
Conformity certification only confirms conformity with the requirements, technical indicators, and scope specified in the technical regulation, the certificate, and the applied assessment scheme. The certification result is not an absolute guarantee for all quality characteristics of the subject and does not replace the responsibilities of the manufacturing, importing, or trading organizations and individuals.
2. Distinguishing Conformity Certification and Declaration of Conformity
Conformity certification and declaration of conformity are two related but distinct activities:
| Conformity Certification | Declaration of Conformity | |
| Nature | A certification body assesses and confirms conformity. | Organizations/individuals take responsibility for the subject registered for conformity declaration. |
| Result | Certificate of Conformity. | Registration form for declaration of conformity and confirmation of registration completion. |
| Performing Subject | Certification bodies with competent capacity and appropriate scope of operation. | Manufacturing, importing, or trading organizations and individuals. |
| Basis | Testing results and assessment activities according to prescribed schemes. | Can be based on certification results, self-assessment results, or recognized results, depending on the case. |
| Mandatory Nature | Depends on technical regulations, risk levels, and specialized laws. | Mandatory for subjects subject to conformity declaration, unless exempted. |
- Certification results from a designated certification body;
- Certification results from an accredited certification body;
- Self-assessment results based on testing results from an accredited or designated testing organization;
- Conformity assessment results from recognized international, regional, or foreign organizations as prescribed.
3. When is Conformity Certification Required?
Before proceeding, organizations and enterprises must fully determine:
- Whether the subject falls under the scope of any QCVN or QCĐP;
- Whether that technical regulation is still in effect and mandates conformity certification;
- The classified risk level of the products and goods;
- The permissible bases for the declaration of conformity;
- The certification scheme or conformity assessment scheme;
- Specific requirements for domestically produced goods, imported goods, or individual shipments;
- Additional management requirements under specialized laws.
- For products and goods with a medium risk level, the declaration of conformity can be based on the certification results of an accredited certification body or self-assessment results based on testing by an accredited or designated organization, according to specific QCVN regulations.
- For products and goods with a high risk level, the declaration of conformity is fundamentally based on the certification results of a designated certification body.
- If the products and goods have already been granted a circulation license or applied a corresponding quality management measure under specialized laws, the specialized regulations shall apply.
- Some subjects may be exempted from the declaration of conformity but must still comply with relevant quality and safety management requirements.
4. Conformity Certification Schemes
Circular 14/2026/TT-BKHCN stipulates eight schemes for assessing conformity:
- Scheme 1: Type testing (testing a representative sample of the product/goods type).
- Scheme 2: Type testing; surveillance through testing samples taken from the market.
- Scheme 3: Type testing and production process assessment; surveillance through testing samples taken at the production site and production process assessment.
- Scheme 4: Type testing and production process assessment; surveillance through testing samples taken at the production site, on the market, or both, combined with production process assessment.
- Scheme 5: Type testing and assessment of the production process or management system; surveillance through sample testing and assessment of the production process or management system.
- Scheme 6: Assessment and surveillance of the management system.
- Scheme 7: Testing and assessment of a batch of products/goods.
- Scheme 8: 100% testing or inspection of all products/goods.
Not all schemes require an on-site assessment at the production facility or periodic surveillance. For example, Scheme 7 applies to specific batches; Scheme 8 evaluates the entire product/goods; while Schemes 2 through 6 may include post-certification surveillance activities.
5. Conformity Certification Process
Depending on the applied scheme, the conformity certification process typically includes the following main steps:
Step 1. Determine applicable requirements
Identify the subject, technical regulations, risk level, required indicators for assessment, certification scheme, and requirements of specialized laws. This is a crucial step to avoid applying the wrong QCVN, missing testing indicators, or selecting a certification body with the wrong scope.
Step 2. Select a certification body
The certification body must be registered to operate in the appropriate field. If regulations require results from an accredited or designated body, further verify the scope of accreditation, scope of designation, and validity period of corresponding documents.
Step 3. Registration and document review
The dossier may include:
- Legal information of the organization/enterprise;
- Name, brand, type, and technical characteristics of the product;
- Production process and quality control plan;
- Design documents, labels, packaging, and user manuals;
- Batch documentation for imported goods or batch certification;
- Existing test results and management system certificates, if applicable.
Step 4. Sampling and testing
Sampling must ensure representativeness according to technical regulations, sampling standards, or relevant legal regulations. Samples for conformity certification are tested at an accredited or designated testing organization as prescribed. Indicators and testing methods must comply with the corresponding QCVN.
Step 5. Production process or management system assessment
This step is performed when required by the certification scheme. Assessment contents may include:
- Control of raw materials and suppliers;
- Control of the production process;
- Product inspection and testing;
- Control of measuring and testing equipment;
- Product identification and traceability;
- Control of nonconforming products;
- Corrective actions;
- Maintenance of the quality management system.
The certification body reviews the testing results, assessment results, and corrective evidence. Correcting nonconformities may need to be confirmed through records, additional assessments, or re-testing.
Step 7. Certification decision
The Certificate of Conformity is issued when there is sufficient evidence proving the subject meets the technical regulations and the requirements of the certification scheme. The scope, duration, and conditions for maintaining the certificate depend on the QCVN, certification scheme, and applied certification program.
Step 8. Declaration of conformity and maintaining conformity
When subject to a mandatory declaration of conformity, organizations and individuals must register on the National Database on Standards, Metrology, and Quality. If the system is incomplete or encounters an error, registration is carried out via alternative schemes prescribed by law.
After completing the relevant procedures, organizations and individuals must use the conformity mark correctly, maintain quality control, conduct periodic surveillance or testing, and retain records for inspection and audit activities.
6. Post-Certification and Declaration Responsibilities
Organizations and individuals are responsible for the conformity of the subject throughout the production, import, circulation, and usage processes, including:
- Continuously maintaining conformity with technical regulations;
- Conducting quality control, testing, and surveillance as prescribed;
- Using the certificate and conformity mark within the correct scope;
- Not using the conformity mark when the subject does not fully meet the applicable technical regulations;
- Retaining certification and conformity declaration records;
- Providing evidence of conformity upon request by competent authorities;
- Handling, recalling, or temporarily suspending the provision of nonconforming subjects;
- Re-declaring when there is a change in technical regulations, registered contents, or characteristics of the subject.
7. Significance of Conformity Certification
When applied to the correct subject and through the appropriate scheme, conformity certification helps to:
- Provide objective evidence of meeting mandatory technical requirements;
- Support organizations and enterprises in fulfilling conditions to bring products and goods to market;
- Enhance the capability to control the production process and product consistency;
- Create a basis for conformity declaration activities, use of conformity marks, and quality inspection;
- Contribute to protecting human health, animals, plants, property, the environment, and consumer rights.
8. Main Legal Basis
Conformity certification activities are governed by the legal system on standards, technical regulations, product and goods quality, and specialized management regulations. When determining certification requirements for a specific subject, one must simultaneously consider general legal documents, corresponding technical regulations, and regulations of managing ministries and sectors. Current key legal bases include:
- Law on Standards and Technical Regulations No. 68/2006/QH11, amended and supplemented by Law No. 70/2025/QH15, effective January 1, 2026;
- Law on Product and Goods Quality No. 05/2007/QH12, amended and supplemented by Law No. 78/2025/QH15, có hiệu lực từ ngày 1/1/2026;
- Decree No. 22/2026/NĐ-CP detailing certain articles and measures to organize and guide the implementation of the Law on Standards and Technical Regulations;
- Decree No. 37/2026/NĐ-CP detailing certain articles and measures to organize and guide the implementation of the Law on Product and Goods Quality;
- Circular No. 14/2026/TT-BKHCN on declaration of standard conformity, declaration of technical regulation conformity, and conformity assessment schemes;
- QCVN, QCĐP, lists of products and goods by risk level, and specialized regulations applicable to each specific subject.
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