EXTENDMAX – Since July 1, 2020, ExtendMax has partnered with hundreds of domestic and international clients, facilitating conformity certification for thousands of radio transmission and IT products. However, this period has also been marked by significant challenges for both us and our clients in applying Method 1 of conformity certification for IT products. These challenges mainly stem from administrative procedures and document verification rather than any changes or declines in product quality. Among the new requirements for conformity certification, the quality management system certificate (ISO 9001 or its equivalent) has introduced considerable complexities, incurring significant additional costs and time in certifying products for market entry. In this article, ExtendMax provides an in-depth look at the conformity certification methods, analyzing whether the ISO 9001 requirement aligns with the fundamental regulations on conformity certification in Vietnam. Most importantly, we highlight some practical solutions to contribute to improving product quality management practices.
Overview of ISO 9001 Standard
What is the ISO 9001 standard?
The ISO 9001 standard is a quality management system standard developed by the International Organization for Standardization (ISO), providing requirements and guidelines for establishing and operating quality management systems within organizations. ISO 9001 is applicable to all types of organizations, businesses, and entities across various fields, ranging from manufacturing and service providers to public administration.
What is the purpose of ISO 9001?
ISO 9001:2015 was developed to standardize organizational activities, particularly those related to quality management systems. It also aims to support risk management within business operations.
What is required to obtain an ISO 9001 certificate?
To obtain an ISO 9001 certificate, a company needs to establish a quality management system in compliance with ISO 9001 standards and undergo an evaluation by a certification body (third party). For manufacturing companies, the certification body evaluates not only management processes but also production processes. If the evaluation results are satisfactory, the certification body issues the ISO 9001 certificate and periodically monitors (every 9 to 12 months) the maintenance of the quality management system.
Does having ISO 9001 ensure better products or services?
According to TCVN ISO 9001:2015, organizations applying the standard set their own quality policies and objectives for the inputs and outputs of their quality management systems. This means that the likelihood of achieving desired outcomes for products and services is higher.
Since input and output goals are determined by the organization itself (which may be higher or lower than other companies), ISO 9001 primarily focuses on managing systems to ensure consistent input and output quality. Therefore, products or services provided by a company with ISO 9001 certification are not necessarily better than those of a non-certified company. To evaluate whether the quality of a product or service is high or low, it is necessary to compare it with another technical standard or the products and services of other companies.
Why is ISO 9001 required for ICT conformity certification?
Inherited from Decision No. 190/2011/QĐ-CVT
According to Decision No. 190/2011/QĐ-CVT, prior to June 30, 2020, the methods for conformity certification of radio and telecommunications products applied to domestically manufactured and imported products (foreign-made) were as follows:
Method 1: Tipical sample testing.
This applied to domestically manufactured products from entities that already had a quality management system certificate, as well as to imported products.
Method 2: Type testing combined with production process evaluation.
This applied to domestically manufactured products from entities that did not yet have a quality management system certificate.
(Certification Method 2 under Decision No. 190/2011/QĐ-CVT is equivalent to Method 5 certification as stipulated in Circular No. 28/2012/TT-BKHCN)
Circular No. 10/2020/TT-BTTTT: ISO 9001 for Method 1
According to Circular No. 10/2020/TT-BTTTT, as of July 1, 2020, conformity certification under Method 1 requires the manufacturer to hold an ISO certificate. This applies to both imported products and domestically manufactured products.
During a meeting with manufacturers and import companies to introduce the new conformity certification methods under Circular No. 10/2020/TT-BTTTT, the leadership of the Authority of Telecommunications explained that the requirement for ISO 9001 certification for imported products is intended to ensure fairness for domestic manufacturers.
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Does Certification Method 1 require ISO 9001?
According to Circular No. 28/2012/TT-BKHCN, Method 1 only requires "type testing" and does not include a requirement for "production process evaluation." The application of Method 1 for conformity certification under the Ministry of Science and Technology (MOST) and other ministries (except the Ministry of Information and Communications - MIC) is consistently implemented without requiring a quality management system certificate (ISO 9001 or equivalent).
Indeed, the principles for applying Method 1 are specified in Appendix II of Circular No. 28/2012/TT-BKHCN as follows:
"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 product or goods allows for clear identification by specific types or models;
b) It is not feasible to evaluate requirements to ensure the maintenance of stable quality."
In contrast, according to Circular No. 10/2020/TT-BTTTT, ICT products can only be certified under Method 1 if "the products and goods are manufactured on production lines certified with a quality management system certificate (ISO 9001 or equivalent)." This creates a fundamental difference in Method 1 as applied by MOST compared to MIC.
As mentioned above, manufacturers can only obtain ISO 9001 or equivalent certification after establishing a quality management system and undergoing production process evaluation by a third party. This means that ICT product conformity certification under Method 1 inherently requires "production process evaluation," which is conducted by a third party (the ISO 9001 certification body).
The evaluation and monitoring required to maintain ISO 9001 certification (by the ISO certification body) inherently involve considering requirements to ensure the maintenance of stable quality.
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Issues arising from the ISO 9001 requirement
Due to the requirement for ISO 9001 certification, the conformity certification process for ICT products faces several challenges, creating difficulties in management and additional costs for businesses. Some typical issues include:
- Generating additional costs for conformity certification evaluation (assessing the validity of the ISO 9001 certificate, evaluating the factory to verify whether the products are truly manufactured on an ISO-certified production line, verifying the authenticity of the ISO 9001 certificate, etc.). The cost of factory evaluation to verify whether the product is truly manufactured on an ISO-certified production line can be particularly high when the factory is located abroad or the manufacturer has multiple OEM/ODM factories.
>>> Read more: Cost items for IT equipment conformity certification
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Prolonging the conformity certification process due to the need to verify and evaluate the ISO 9001 certificate. In some cases, the conformity certification body must contact the ISO 9001 certification organization for verification. At times, verification becomes nearly impossible when the importing company purchases products through intermediaries and has no direct connection with the manufacturer or the ISO 9001 certification body. This inadvertently causes businesses to violate the requirement to conduct the conformity announcement within the 15-day timeframe stipulated in Decree No. 74/2018/NĐ-CP.
>>> Read more: Comprehensive guidance on Conformity Declaration
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Creating difficulties in managing the validity of conformity certification. Businesses are required to report to the certification body on the maintenance of the validity of their quality management system certificates. The certification body must monitor the validity of the conformity certificates for each product corresponding to the ISO 9001 certification of each production line and notify each company holding conformity certificates whenever the ISO 9001 certificate is nearing expiration.
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Causing confusion in cases where the ISO 9001 certificate expires or is delayed in renewal, while the conformity certificate remains valid. Theoretically, businesses often have multiple products manufactured before the ISO 9001 certificate expires, which are stored as inventory for long-term sale. Additionally, the process of renewing (or monitoring for maintaining the validity of) the ISO 9001 certificate may encounter difficulties or delays, causing interruptions in its validity. However, according to the conformity certification procedures of the Telecommunication Quality Measurement Center, the conformity certificate may be revoked if the ISO 9001 certificate expires for more than 10 days. The basis for revoking the conformity certificate is considered weak in terms of legal grounds, potentially leading to legal disputes between the conformity certification body and the certificate holder.
What are the solutions for management without requiring ISO 9001?
To address the challenges mentioned above and facilitate conformity certification for ICT products, ExtendMax has researched several solutions outlined below. These solutions can be implemented individually or in combination to achieve the goals of state management while making it easier for businesses to operate:
- Adopt the original Method 1 certification approach from the Vietnam MOST: This method does not require an ISO 9001 certificate (which inherently involves production process evaluation by an ISO certification body).
- Categorize Group 2 goods under the Ministry of Information and Communications: Divide products into groups and clearly define the conformity certification methods for each group. For example: Apply Methods 5 and 7 for high-risk products that may cause safety hazards. Apply Method 1 (without requiring ISO 9001) for products with low safety risks.
- Focus on "post-market inspection" for quality management: Ease the burden and reduce costs for businesses at the conformity certification stage (pre-market inspection), and strengthen monitoring, inspection, and audits after certification (post-market inspection). Strictly penalize violations of conformity certification and declaration regulations.
Legal Disclaimer:
This article is based on the research of legal expert Tran Thanh Phuong to provide information and legal analysis regarding the conformity certification process for ICT products. It is not intended to promote or serve as a basis for violating state quality management policies.