Recognize the positioning and role in quality infrastructure

Standards, metrology, and accreditation are the three core elements of quality infrastructure (QI). Among them, accreditation gradually developed after World War II and appeared later than standards and metrology, but it holds equal importance to them. Especially in international trade, the international mutual recognition system of accreditation has played an active role in promoting broad international acceptance of quality infrastructure service organizations.

1. Definition and Scope of Accreditation

Accreditation is a third-party certification that evaluates whether conformity assessment bodies possess the corresponding technical and management capabilities based on international standards, national standards, or technical specifications.

From the perspective of conformity assessment, the objects of accreditation include laboratories, inspection bodies, certification bodies, verification/validation bodies, and personnel certification bodies. Laboratory accreditation began to appear in the 1940s, with laboratory users having a high awareness of accreditation and its value. Accreditation of certification bodies appeared later; with the increasing certification activities, there was a need to verify the technical competence of certification bodies, leading to the emergence of certification body accreditation. Similarly, inspection body accreditation is also an emerging and continuously developing accreditation activity.

Generally, accreditation is mainly conducted based on the ISO/IEC 17000 series of international standards issued by the International Organization for Standardization and the International Electrotechnical Commission, which is a necessary prerequisite for achieving international mutual recognition of accreditation.

Other international standards related to accreditation within the scope of quality infrastructure include: Good Manufacturing Practice (GMP), issued by the World Health Organization (WHO), applicable to national drug regulatory authorities and the pharmaceutical industry; Good Laboratory Practice (GLP), issued by the Organisation for Economic Co-operation and Development (OECD), applicable to non-clinical studies assessing the safety and efficacy of chemical substances (including drugs) on humans, animals, and the environment, and widely used in many countries.

Some market-based non-governmental organizations usually evaluate conformity assessment bodies wishing to participate in certain proprietary projects based on private standards. For example, in the automotive industry, large automobile manufacturers establish their own evaluation mechanisms to manage parts suppliers.

The concept of accreditation is also applied in many fields beyond conformity assessment, such as accreditation of comprehensive universities, financial institutions, medical facilities, and vocational training institutions. Although the accreditation concepts used in these fields are similar to those mentioned in quality infrastructure, the standards and rules they follow are completely different from the ISO/IEC 17000 series, so they are not within the scope of this study. This article mainly refers to the World Trade Organization (WTO) "Agreement on Technical Barriers to Trade" (TBT Agreement) and "Agreement on the Application of Sanitary and Phytosanitary Measures" (SPS Agreement), further refining the scope of accreditation under the quality infrastructure system.

2. International Standards Related to Accreditation

International standards related to accreditation issued by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) are detailed in Table 1.

(1) Accreditation of Conformity Assessment Bodies

Calibration Laboratories. Calibration laboratory accreditation is a traditional accreditation system, providing support services to laboratories similar to the newly emerging proficiency testing provider accreditation and reference material/standard sample producer accreditation.

Testing Laboratories. Accreditation was initially applied to laboratories conducting routine testing of products and materials in the fields of biology, chemistry, engineering, and physics, usually describing specific accreditation scopes based on combinations of fields, products, tests, and standards. For example, the same laboratory can be accredited for chemical testing of carbon and various alloy elements using methods required by specific standards, but not accredited if other methods are used. In recent years, the same principle has been applied to medical laboratories (mainly for diagnosis and monitoring rather than conformity assessment), diagnostic imaging (medical radiology and others), forensic identification, and software testing.

Certification Bodies. Accreditation of certification bodies originated in the early 1980s, initially related to product certification bodies, mainly determining the scope of accreditation based on products, standards, and related performance or safety. In the 1990s, with the emergence of ISO 9001: "Quality Management Systems Requirements," accreditation of management system certification bodies developed and achieved great success. Due to the involvement of general industry activities, the scope of accreditation for system certification bodies is broader than that for laboratory accreditation and product certification bodies. Other system standards—such as ISO 14001 (Environmental Management Systems), ISO 22000 (Food Safety Management Systems), and Hazard Analysis and Critical Control Points (HACCP)—have similar certification schemes.

Inspection Bodies. Inspection bodies are a newly emerging type of conformity assessment service. With the adjustment of government functions in many countries and the increasing marketization of related activities, the importance of inspection body accreditation has become more prominent. In this context, accreditation provides sustainable competence confirmation for government-recognized or designated inspection bodies.

Personnel Certification. Although not part of conformity assessment services, personnel certification is still considered part of the ISO/IEC 17000 (Conformity Assessment) series and achieves international mutual recognition through signing the International Accreditation Forum (IAF) mutual recognition agreement. Personnel certification mainly identifies individuals with specific knowledge, experience, or skills and certifies their ability to apply relevant skills. It is not equivalent to academic certification, although related academic credentials may be important inputs in the certification process. The personnel certification process must be independent of related certification training programs. Personnel certification covers a wide range, evaluating and certifying the competence of safety professionals, non-destructive testing experts, supply and procurement management professionals, construction industry supervisors, quality system auditors, and other related personnel.

Verification and Validation Bodies. Verification and validation provide objective evidence confirming that specific intended uses or prescribed requirements have been met. As conformity assessment activities, verification and validation can be understood as activities recognizing the reliability of claimed information. Other terms related to verification and validation assessment objectives include statements, declarations, announcements, conclusions, predictions, or reports. The main difference between the two activities lies in the timing of the claims being assessed. Verification applies to claims about future intended uses or predicted results (recognition of reasonableness), while validation applies to claims about events that have occurred or results already obtained (recognition of authenticity).

(2) Accreditation: Means of Measuring Competence and Impartiality

The ultimate goal of accreditation is to provide independent confirmation of the technical competence and impartiality of the accredited body. Therefore, in addition to the mandatory implementation of management system documents and system controls, the technical competence of personnel in the accredited body is crucial.

Similarly, facility and environmental controls are also important, especially in the field of metrology. With improvements in measurement, calibration, and testing accuracy, such controls are usually more stringent. These aspects will be evaluated during the accreditation process.

3. Effects and Applications of Accreditation

Accreditation has evolved from a specific economic means of providing competence confirmation for laboratories to a widely applied mutual recognition system worldwide. With the growth of trade over the past two to three decades, the demand for credit evidence proving the authenticity of conformity assessment results in international trade has also increased. Accreditation has become an important means of providing this credit evidence, helping to save costs, improve efficiency, and avoid duplicate assessments.

(1) Accreditation Clients

Government departments. Accreditation provides reliable technical support for establishing and consolidating intergovernmental trade agreements. These agreements may be bilateral or multilateral negotiation agreements, or accreditation may serve as a prerequisite for mutual acceptance of conformity assessment results among member countries of a common market. The long-term goal is for governments and social parties among agreement members to fully trust accredited conformity assessment services. In this way, the free trade goal of "test, inspection, and certification once, recognized globally" is gradually being realized.

Statutory regulatory bodies. Accreditation is the "passport" for conformity assessment services to gain global recognition and can be used to demonstrate that products comply with technical regulations, sanitary and phytosanitary measures. Reliable accreditation schemes based on relevant international standards are key to the recognition of conformity assessment results. Through global recognition, accreditation supports statutory regulatory bodies in fulfilling their supervisory responsibilities.

Enterprises. Accreditation provides credit certification for products and service enterprises to obtain relevant conformity assessment services from inspection, testing, and certification bodies. Therefore, enterprises can choose suppliers in the future who have obtained conformity assessment services and are recognized (certified) as meeting competency standards. If product evaluation and certification meet specific standards, excellent product manufacturers and service providers can be distinguished from less reputable suppliers, creating competitive advantages for enterprises. Accreditation ensures "once accredited, recognized globally" by using consistent standards, specifications, and conformity assessment methods, which also helps reduce conformity assessment costs and avoid the risk of products and services being rejected in international trade.

Consumers. Products and services that have been tested or certified, if the conformity assessment activities conducted are impartial and meet technical competence requirements, will greatly enhance consumer confidence in the related products and services. Accreditation provides credit endorsement for the quality and safety of products and services.

(2) Accreditation Effects

Economy. Accreditation supports the overall development of the economy, helps local enterprises open up international markets, supports industrial development by enhancing competitiveness, and creates an open and transparent market environment by clearly describing the scope of accredited capabilities. Accreditation also supports anti-bribery management, requiring that relevant conformity assessment results, annual audits, on-site assessments, peer evaluations, and record management throughout the entire process value chain are traceable.

Health and Safety. Accreditation confirms the competence of quality infrastructure service organizations such as occupational health and safety-related medical laboratories and inspection bodies, pressure equipment inspection bodies, and special equipment elevator inspection bodies, providing health and safety guarantees for government departments and the public, contributing to the overall improvement of social health and safety. For medical laboratories, the International Organization for Standardization (ISO) has issued a specific international standard ISO 15189:2012 "Medical laboratories — Requirements for quality and competence"; other health and safety-related service organizations need to be accredited according to relevant general standards.

Environment. With the worsening of environmental issues, more and more government departments, industry organizations, and the public regard conformity assessment services (including inspection, testing, certification, or their combinations) as important means to enhance the effectiveness of environmental protection measures. Accreditation provides competence confirmation for government departments and industry organizations to trust conformity assessment results in environmental protection.