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The Role of Laboratory Accreditation in Market Regulation
Release time:2023-10-31 Number of views:248order

(excerpted from "Essence and Function of Accreditation", edited by the National Accreditation Commission for Conformity Assessment of China, published by China Standards Publishing House)


1. Recognition of the technical support role for market regulation

Laboratory accreditation, as an important means of proving the ability of qualified assessment institutions and an important way of transmitting trust, has played a positive role in adapting to economic globalization, promoting product quality and safety, regulating market behavior, guiding consumption, protecting the environment and life health, promoting economic construction and social development, and other aspects.


In terms of government regulation, laboratory accreditation serves as a technical support for government departments to designate relevant policies, playing a technical guarantee role in macroeconomic regulation, regulating the conformity assessment market, and protecting consumer rights, promoting the construction of an integrity system in the conformity assessment market. Recognition has increased the confidence of government management departments in using qualification assessment results such as certification, testing, and inspection, reduced the uncertainty in making relevant decisions and the technical evaluation process in administrative licensing, reduced the risks and costs of administrative supervision, and enhanced social credibility.


2. Relevant discussions from other organizations

For governments and regulatory agencies, using data from accredited laboratories for critical analysis can increase confidence in making important decisions based on sequential data, reduce uncertainty in decisions related to human health and environmental protection, increase public confidence, eliminate unnecessary reviews, and improve review efficiency.

Conformity assessment/accreditation is a confirmation that the requirements of relevant regulations have been met, which is a means to enhance the confidence of market and regulatory authorities in products, processes, systems, personnel, or institutions. Through this confirmation, product suppliers can reduce their concerns about the market, regulatory authorities, and trade barriers.


3. International use of recognition results

In Europe, the European Parliament and the Council have adopted regulations on market surveillance requirements for recognition and product marketing (REGULATION (EC) No765/2008), providing a legal framework for European recognition services. This regulation covers both voluntary and legislative requirements for the recognition system of conformity assessment, and is scheduled to be officially implemented in January 2010. Indicating that the EU has recognized the role of recognition through legislation as a means of demonstrating compliance with mandatory requirements.

In the Americas, regulators and government departments in various countries are increasingly relying on the results of recognized conformity assessment agencies when formulating mandatory measures in different fields, such as food safety, environmental protection, toy safety, and concrete, steel, and electronic products.


4. Regarding the relationship between recognition and administrative licensing, administrative supervision, and market access systems

Some people believe that once a certain enterprise has passed the certification, testing, or inspection of an approved and recognized conformity assessment agency, its products should be able to enter the market; Once obtaining certification certificates, testing or inspection reports with international mutual recognition marks, customs clearance can be directly carried out; Some people equate the supervision of accreditation agencies over conformity assessment agencies with the supervision of national administrative agencies. Some understandings are caused by the vague concept of the relationship between recognition and administrative licensing, recognition and administrative supervision, and recognition and market access systems.


(1) Recognition and Administrative Licensing

According to Article 2 of the Administrative Licensing Law of the People's Republic of China, administrative licensing refers to the act of a national administrative organ approving citizens, legal persons, or other organizations to engage in specific activities based on their application and after legal review.

According to the definition of administrative license, the executing body of administrative license is the national administrative agency, which is based on national laws, regulations or rules and approves the behavior of citizens, legal persons, or other organizations engaged in specific activities.

According to needs, a certain administrative licensing system can make it a necessary condition for the approval of administrative licensing to obtain recognition qualifications from qualified assessment institutions.

 

(2) Recognition and administrative supervision

Administrative supervision refers to the supervision by national administrative organs over the compliance of administrative counterparts with laws, regulations, or rules with their statutory powers.


The accreditation supervision implemented by accreditation institutions is a supervisory activity conducted to assess whether a qualified assessment institution can continue to meet the accreditation requirements after obtaining accreditation qualifications. If the accreditation body discovers through supervision that the conformity assessment body cannot continue to meet the accreditation requirements, the accreditation qualification granted to the conformity assessment body will be suspended or revoked.


If the accreditation granted by an accreditation body to a conformity assessment institution becomes a reference or necessary condition for administrative supervision, the supervision results of the accreditation body on the conformity assessment institution will also affect the supervision implemented by the national administrative authorities on the corresponding conformity assessment institution.


In China's certification and recognition regulatory system, recognition has become a part of the five in one regulatory system that includes legal norms, administrative supervision, recognition constraints, industry self-discipline, and social supervision. It not only plays a unique role in recognition supervision, but also plays an active technical support role in administrative supervision.



(3) Recognition and Market Access System

Market access is usually closely related to regulations or rules in a specific field. Market access is usually the direct control or intervention of the government, based on certain rules, allowing market entities and trading partners to enter a certain market field.


When market access considers it necessary and sufficient for a product to pass certification, testing, or inspection by a recognized conformity assessment agency, the product can directly enter the market if it meets the certification, testing, or inspection requirements; Otherwise, even if the product passes certification, testing, or inspection by a recognized conformity assessment agency, it must obtain the qualification to enter the market in accordance with market access requirements in accordance with the law.


In international trade, for products with specific market access requirements and other requirements for conformity assessment beyond recognition, even if there is an international mutual recognition agreement with an accreditation agency, the government must recognize the recognition results. Only products certified, tested or inspected by an accredited conformity assessment agency can legally obtain market access qualifications from relevant countries or regions.


According to surveys conducted by the International Laboratory Accreditation Organization in recent years, the degree to which accredited qualification assessment results are accepted by regulatory authorities in various countries has continued to increase.


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