Accreditation requirements

Accreditation

The requirements to be met by the conformity assessment bodies applying for accreditation have been described in details in the following document:

Rulebook on General Requirements for the Competence of Conformity Assessment Bodies (R 04)

All standards require the conformity assessment body to have available all documentation clarifying the identity of the body, the organization, the quality system, documents control, trained staff, technical skills and competencies, working procedures, appropriate records and issued documents.

Laboratories can be accredited for testing or calibration provided they meet the requirements stated in the Standard MKS EN ISO/IEC 17025 – General requirements for the competence of testing and calibration laboratories. The Standard MKS EN ISO/IEC 17025 also specifies requirements on stating opinions and providing interpretation in the laboratory reports however, the IARM does not offer accreditation for such an activity.

Medical laboratories must meet the requirements of the МКС EN ISO 15189:2022 standard to obtain accreditation. With the publication of the new edition of МКС EN ISO 15189:2022, the requirements for POCT – point of care testing, are included.

Certification Bodies can acquire accreditation for certification of products/processes/services and certification of managements systems.

Certification Bodies for products, processes and services can acquire accreditation provided they meet the requirements of the Standard МКС EN ISO/IEC 17065

– Conformity assessment — Requirements for bodies certifying products, processes and services. Bodies certifying products/processes shall issue certificates of conformance for product/process with applicable technical or other regulations, standards or technical specifications.

Management System Certification Bodies can acquire accreditation if they meet the requirements of the Standard MKS EN ISO/IEC 17021 – 1 – Conformity assessment — Requirements for bodies providing audit and certification of management systems — Part 1: Requirements In addition, they shall also meet the requirements of level 4 standards, MKC EN ISO/IEC 17021-2; MKC EN ISO/IEC 17021-3; MKTС ISO/IEC TS 17021-10, and applicable EA and IAF mandatory documents.

Management system certification bodies shall issue certificates to organizations in cases when their management system complies with the requirements of one of the standards (MKS EN ISO 9001, MKS EN ISO 14001, MKS EN ISO 45001).

Inspection Bodies can acquire accreditation provided they meet the requirements of the Standard MKS EN ISO/IEC 17020– General criteria for the operation of various types of bodies performing inspection, as well as ILAC P15

Application of ISO/IEC 17020 for the Accreditation of Inspection Bodies

Inspection bodies, on the basis of the product testing results, their design and use, the process, production and overall work, shall assess the conformity thereof with other specific or general requirements. Upon completed inspection, they shall issue a report or certificate entailing a compulsory conformity statement.