Conformity certification method 7 (per-lot approval)

During the consultation process with businesses, we have received many inquiries about compliance certification according to Method 7. In fact, many companies have incorrectly followed the procedure for Method 7 compliance certification, resulting in test results not being accepted for conformity assessment. This article will provide you with an overview and delve into the specifics of the definition, process, benefits, and limitations of Method 7 compliance certification, as well as important points to note.

Definition of Conformity Certification by Method 7

Based on Circular No. 28/2012/TT-BKHCN on regulations for the declaration of conformity and methods of assessing conformity with standards and technical regulations, the definition of conformity certification by method 7 (also known as batch certification) can be provided as follows:

>>> Learn more: Overview of Conformity Certification and Certification Methods

Definition of a Batch of Products or Goods

Circular No. 30/2011/TT-BTTTT defines "a batch of products as a set of a single type of goods determined by quantity, having the same name, use, brand, type, technical characteristics, from the same production facility, origin, and belonging to the same import dossier."

However, according to ExtendMax's viewpoint:

• Certification by batch can also be applied to domestically produced products and goods (which do not have an import dossier).
• The Law on Product and Goods Quality has separate definitions for "products" and "goods". Also, according to the Law on Product and Goods Quality, products may not necessarily be goods.

Therefore, we provisionally define a batch of products or goods as follows:

Benefits of Conformity Certification by Method 7

Conformity certification by method 7 is often applied to many different types of products, especially those requiring strict quality control and high safety standards. This certification method brings benefits to consumers in terms of using quality and safe products and goods. It also benefits state management agencies by making it easier to manage imported and domestically produced products.

>>> Discover now: Guide for market entry requirements and conformity certification method 7 for electric fans

Limitations of Conformity Certification by Method 7

Due to the requirement that products or goods must be certified by batch, the cost of testing and certification can become a burden for importing businesses. Additionally, certification costs are also allocated into the selling price of goods, leading to higher prices.

In some cases, especially for ICT goods, the cost of testing and certification by method 7 can be higher than the import value of the batch.

Products and Goods Subject to Batch Conformity Certification

Conformity certification by method 7 is widely applied to many industries, especially to types of products and goods requiring high safety standards. Below is a detailed list of some types of products that are subject to batch conformity certification by method 7:

Procedure for Conformity Certification by Method 7

Step 1: Assessing the Homogeneity of the Batch

The conformity certification organization conducts an on-site inspection to assess the homogeneity of the batch. In practice, this step may be decided upon by the conformity assessment organization to be performed or not.

Step 2: Sampling for Testing

The conformity certification organization collects test samples using a statistical sampling method to ensure representativeness of the entire batch. The number of samples must be sufficient for testing and sample retention. Depending on the characteristics, size of the product, and the criteria to be tested, the number of samples can be one or more.

Step 3: Assessing the Conformity of the Test Samples

Samples of goods or products are tested at a designated laboratory, a laboratory registered in accordance with the law, or one recognized under mutual recognition agreements (MRA). The type of laboratory accepted for testing is regulated by the governing body of each group 2 product sector. Testing criteria for performance, safety, and reliability of the products and goods are conducted according to the limits and testing methods specified in the technical standards.

Step 4: Conformity Assessment

Based on the test results of the samples and the accompanying batch documentation, the conformity assessment organization reviews and evaluates the characteristics of these products and goods against the standards and regulations.

Step 5: Conclusion on Conformity

If the number of non-conforming test samples falls within the allowable limit, the batch of goods or products is deemed to comply with the regulations and will not be issued a conformity certification. If the number of conforming test samples meets the allowable limits within the standards and regulations, the batch of goods or products is considered to comply with the regulations. The certification organization will issue a conformity certification for the batch.

Validity of Conformity Certification by Method 7

The test results and conformity certification by method 7 are only valid for that specific batch of products or goods. If a business produces or imports a different batch of products or goods, conformity certification must be conducted again for the new batch.

Notes When Implementing Batch Conformity Certification

Organizations and individuals producing or importing need to pay attention to the following when implementing conformity certification by method 7:

• Sampling is usually done by the conformity certification organization. Businesses are not allowed to take samples themselves.

• Testing must be carried out on samples selected by the conformity certification organization, sealed by the certification organization.

• Test results on samples without the seal of the conformity certification organization will not be accepted for certification.

Trends in Applying Batch Conformity Certification

Currently, the application of conformity certification by method 7 is not increasing globally or in Vietnam. This is due to a trend in state management across countries to create a more favorable business environment while still ensuring consumer rights. Many countries are shifting from applying method 7 to applying method 1 and method 5, combined with enhanced state management in post-market surveillance.

In Vietnam, the Ministry of Science and Technology is one of the pioneers in drafting technical regulations, shifting a large number of products from conformity certification by method 7 to method 1.