Overview of ISO/IEC 17011

Auditors looking at robot arms in factory.

ISO/IEC 17011 is an international standard that specifies the requirements for competence, consistent operation, and impartiality of accreditation bodies assessing and accrediting conformity assessment bodies. The current edition was released in 2017, which replaced the 2004 edition of the standard. For those who want to gain an understanding of how an accreditation body operates, ANAB offers an online, self-paced training course, Overview of ISO/IEC 17011.

How Is ISO/IEC 17011 Used?

As the international standard establishing requirements for accreditation bodies assessing and accrediting conformity assessment bodies, ISO/IEC 17011 is used as a requirements document for peer evaluations of accreditation bodies who participate in international mutual recognition arrangements. As part of these mutual recognition arrangements, participating accreditation bodies are evaluated to the requirements of ISO/IEC 17011 to ensure competence and provide confidence that accreditation bodies around the world operate to the same standards.

ISO/IEC 17011 specifies the base requirements for operations of accreditation bodies. ANAB utilizes the requirements of ISO/IEC 17011 to establish a robust quality management system and processes for carrying out the assessment of competence and impartiality of conformity assessment bodies for the specified conformity assessment activities.

The standard contains requirements grouped together by topic:

  • General requirements related to legal entity status, accreditation agreements, impartiality, financing and liability management, and establishing accreditation schemes;
  • Structural requirements including organizational structure, legal status, and authority;
  • Resource requirements related to competence of personnel, personnel involved in the accreditation process, personnel records, and outsourcing;
  • Process requirements related to accreditation and application requirements, preparation for assessments, performing assessments, making the accreditation decision, the accreditation cycle, complaints and appeals, and record keeping;
  • Information requirements related to confidentiality and publicly available information;
  • Management system requirements related to document and record control, nonconformities and corrective actions, improvement, internal audits, and management reviews.

The standard also contains an annex, which is informative, detailing the knowledge and skills for performing accreditation activities. The annex is formatted as a table linking accreditation activities to the necessary knowledge and skills needed to perform those activities as outlined in the competence requirements for personnel in the body of the standard.

Conformity Assessment Activities

Conformity assessment bodies perform conformity assessment activities. Conformity assessment activities typically covered by accreditation include testing, calibration, inspection, biobanking, certification of management systems, persons, products, processes, and services, provision of proficiency testing, production of reference materials, and validation and verification. It is these activities that are documented on a defined scope of accreditation based on the accreditation standard and program, such as ISO/IEC 17025 for laboratories, ISO/IEC 17065 for product certification bodies, and ISO/IEC 17021-1 for management system certification bodies.

ANAB Recognition

ANAB participates in international and regional arrangements for multilateral recognition aimed at facilitating global market opportunities by building worldwide reliability of conformity assessment activities, thus enhancing the acceptance of goods and services across geographic borders. ANAB maintains international recognition through the International Accreditation Forum (IAF) and International Laboratory Accreditation Cooperation (ILAC) via multilateral recognition arrangements, demonstrating conformance to ISO/IEC 17011 via peer assessments in order to ensure regulators, stakeholders and the business community can have confidence in the certificates and reports issued by ANAB accredited conformity assessment bodies.

ANAB Training: Overview of ISO/IEC 17011

The self-paced course titled Overview of ISO/IEC 17011 is designed to help participants gain knowledge of the requirements of ISO/IEC 17011. It also provides an understanding of the activities performed by accreditation bodies, such as ensuring impartiality of the assessment process, establishing and maintaining competence of personnel, and accreditation oversight. The training covers all of the clauses of ISO/IEC 17011 and provides a practical understanding of the topics covered via quizzes throughout the training.

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