Accreditation explained - learn the basics and the key ISO standards for conformity assessment.
Role of accreditation bodies
Accreditation bodies occupy a central position in the quality infrastructure and play a decisive role in ensuring the competence and integrity of conformity assessment bodies. In Germany this function is carried out by the German Accreditation Body (DAkkS), which acts as the sole national accreditation body under the EU Regulation 765/2008.
The primary task of accreditation bodies is to assess and accredit conformity assessment bodies such as laboratories, inspection bodies and certification bodies. They evaluate the technical competence, independence and integrity of these bodies based on internationally recognized standards, in particular the ISO/IEC 17000 series. Through this process it is ensured that accredited bodies are able to perform their specific tasks reliably and competently.
Accreditation bodies carry out regular surveillance and re-evaluations of accredited bodies to ensure their continued compliance with accreditation requirements. This includes on-site assessments, document reviews and evaluation of performance in proficiency tests. Continuous monitoring maintains confidence in the work of accredited bodies.
Furthermore, accreditation bodies act as a link between national regulatory authorities and the international accreditation system. They work closely with authorities to ensure that accreditation meets regulatory requirements and contributes to the implementation of legal provisions. At the same time they represent national interests in international forums such as the European co-operation for Accreditation (EA), the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC).
Another important task of accreditation bodies is to foster mutual understanding and harmonization of accreditation practices at international level. By participating in multilateral agreements such as the EA MLA (Multilateral Agreement), the IAF MLA or the ILAC MRA (Mutual Recognition Arrangement), they help ensure that accreditations and the resulting conformity assessments are recognized worldwide. This facilitates international trade and reduces technical barriers.
Accreditation bodies also play an important role in the further development of the accreditation system. They participate in the development of new standards and guidelines, offer training and informational events for conformity assessment bodies, and promote general understanding of the importance of accreditation in business and society.
The accreditation hierarchy
The accreditation hierarchy is a complex, multi-level system that operates at national, regional and international levels to ensure the quality and comparability of conformity assessments worldwide. At the base of this hierarchy are national accreditation bodies, such as the German Accreditation Body (DAkkS) in Germany. These bodies are responsible for accrediting conformity assessment bodies such as laboratories, inspection bodies and certification bodies and for regularly reviewing their competence.
At the next level up is the European co-operation for Accreditation (EA), which serves as the regional umbrella organization for national accreditation bodies in Europe. The EA plays a crucial role in harmonizing accreditation practices within Europe and promotes mutual recognition of accreditations between European countries. It conducts peer evaluations of national accreditation bodies to ensure their competence and conformity with international standards.
On the global level there are two important organizations: the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC). The IAF focuses mainly on the accreditation of certification bodies for management systems, products, processes and services as well as validation and verification bodies. It works toward worldwide harmonization of accreditation practices and promotes mutual recognition of accreditations among its members.
ILAC, on the other hand, focuses on the accreditation of laboratories and inspection bodies. It works closely with the IAF to create a global network for recognition of accreditations. Both organizations, IAF and ILAC, maintain multilateral recognition arrangements (MLA/MRA) that allow accreditations and the resulting conformity assessments to be accepted worldwide.
In this hierarchy the various levels cooperate closely. National accreditation bodies are generally members of the EA (in Europe) and also of the IAF and ILAC. The EA itself is a regional member of both the IAF and ILAC. This networked structure ensures a consistent approach to accreditation from the national to the global level.
In summary, this multi-level structure aims to create a coherent and internationally recognized accreditation system. It ensures that conformity assessments carried out by accredited bodies enjoy global confidence and acceptance. This promotes international trade, reduces technical barriers and contributes to the improvement of the global quality infrastructure.
The ISO 17000 series
The ISO/IEC 17000 series forms the foundation for international standardization in the field of conformity assessment. This family of standards, developed jointly by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), defines the fundamental principles, requirements and guidance for conformity assessment bodies and their activities. It plays a central role in ensuring the quality, consistency and comparability of conformity assessments worldwide.
At the head of this series is ISO/IEC 17000, which establishes the vocabulary and general principles for conformity assessment. It provides the conceptual basis for all other standards in the series and ensures a uniform understanding of the terminology used throughout the field of conformity assessment.
ISO/IEC 17011 defines the requirements for accreditation bodies that accredit conformity assessment bodies. It ensures that accreditation bodies operate competently and impartially and thus guarantee confidence in the bodies they accredit. This standard is crucial for the integrity of the entire accreditation system.
For laboratories, ISO/IEC 17025 is the key standard. It specifies the general requirements for the competence of testing and calibration laboratories. This standard ensures that laboratory results are reliable, accurate and internationally comparable. Complementing this is ISO 15189, which sets specific requirements for medical laboratories.
ISO/IEC 17020 is aimed at inspection bodies. It ensures that organizations performing inspections do so competently, consistently and impartially. This standard is applied in many areas, from technical inspections to food safety.
There are several specific standards for certification bodies: ISO/IEC 17021 sets requirements for bodies that audit and certify management systems. ISO/IEC 17024 addresses organizations that certify persons, while ISO/IEC 17065 defines the requirements for bodies that certify products, processes and services.
ISO/IEC 17029 defines general principles and requirements for validation and verification bodies. This standard forms the basis for accrediting organizations that offer validation and verification services. It specifies competence requirements and criteria for carrying out validation and verification processes in various areas, including environmental information, sustainability reports and financial information.
ISO/IEC 17043 is relevant for providers of proficiency testing. It ensures that these providers are competent to organize and evaluate interlaboratory comparisons. This standard contributes significantly to quality assurance in laboratory work.
For the production of reference materials, which play an important role in many areas of conformity assessment, ISO 17034 is authoritative. It defines the requirements for the competence of reference material producers and forms the basis for their accreditation.
The series is complemented by additional standards and technical specifications that address specific aspects of conformity assessment. For example, ISO/IEC 17007 provides guidance for the preparation of normative documents to be used in conformity assessment. Although this standard is not used directly for accreditations, it supports the development of consistent and effective conformity assessment programs.
The ISO/IEC 17000 series is continuously reviewed and expanded to keep pace with technological developments and the changing requirements of the global market. It forms a coherent system of standards that provides the basis for trustworthy and internationally recognized conformity assessments. By applying these standards, the quality and safety of products and services worldwide are promoted, international trade is facilitated and consumer confidence is strengthened.