
The ANSI National Accreditation Board (ANAB) provides accreditation and training services to the certification body, validation and verification body, inspection and laboratory related communities. ANAB’s accreditation portfolio includes ISO/IEC 17021-1 management systems certification bodies, ISO/IEC 17025 calibration and testing laboratories and forensic laboratories, ISO/IEC 17065 product certification bodies, ISO/IEC 17020 inspection bodies and forensic agencies, ISO 14065 greenhouse gas validation and verification bodies, ISO 17034 reference material producers, ISO/IEC 17043 proficiency test providers, property and evidence control units, ISO/IEC 17024 personnel credentialing organizations, and ASTM 2659 certificate accreditation programs. ANAB also provides training on topics related to accreditation standards and conformity assessment. Access the official ANAB and ANSI storefront to purchase these listed standards to start your accreditation journey today.
ISO/IEC 17024:2012 contains principles and requirements for a body certifying persons against specific requirements, and includes the development and maintenance of a certification scheme for persons.
ISO/IEC 17025:2017 specifies the general requirements for the competence, impartiality and consistent operation of laboratories.
ISO/IEC 17025:2017 is applicable to all organizations performing laboratory activities, regardless of the number of personnel.
Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others use ISO/IEC 17025:2017 in confirming or recognizing the competence of laboratories.
ISO/IEC 17020:2012 specifies requirements for the competence of bodies performing inspection and for the impartiality and consistency of their inspection activities.
It applies to inspection bodies of type A, B or C, as defined in ISO/IEC 17020:2012, and it applies to any stage of inspection.
This document specifies general requirements for the competence, impartiality and consistent operation of biobanks including quality control requirements to ensure biological material and data collections of appropriate quality.
This document is applicable to all organizations performing biobanking, including biobanking of biological material from multicellular organisms (e.g. human, animal, fungus and plant) and microorganisms for research and development.
Biobank users, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others can also use this document in confirming or recognizing the competence of biobanks.
This document does not apply to biological material intended for food/feed production, laboratories undertaking analysis for food/feed production, and/or therapeutic use.
NOTE 1 International, national or regional regulations or requirements can also apply to specific topics covered in this document.
NOTE 2 For entities handling human materials procured and used for diagnostic and treatment purposes ISO 15189 and other clinical standards are intended to apply first and foremost.
ISO 17034:2016 specifies general requirements for the competence and consistent operation of reference material producers.
ISO 17034:2016 sets out the requirements in accordance with which reference materials are produced. It is intended to be used as part of the general quality assurance procedures of the reference material producer.
ISO 17034:2016 covers the production of all reference materials, including certified reference materials.
This document specifies general requirements for the competence and impartiality of proficiency testing (PT) providers and consistent operation of all proficiency testing schemes. This document can be used as a basis for specific technical requirements for particular fields of application.
Users of proficiency testing schemes, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies and others can use these requirements in confirming or recognizing the competence of proficiency testing providers.
This document specifies requirements for quality and competence in medical laboratories.
This document is applicable to medical laboratories in developing their management systems and assessing their competence. It is also applicable for confirming or recognizing the competence of medical laboratories by laboratory users, regulatory authorities and accreditation bodies.
This document is also applicable to point-of-care testing (POCT).
NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.
ISO/IEC 17021-1:2015 contains principles and requirements for the competence, consistency and impartiality of bodies providing audit and certification of all types of management systems.
Certification bodies operating to ISO/IEC 17021-1:2015 do not need to offer all types of management system certification.
Certification of management systems is a third-party conformity assessment activity and bodies performing this activity are therefore third-party conformity assessment bodies.
This document contains general principles and requirements for the competence, consistent operation and impartiality of bodies performing validation/verification as conformity assessment activities.
Bodies operating according to this document can provide validation/verification as a first-party, second-party or third-party activity. Bodies can be validation bodies only, verification bodies only, or provide both activities.
This document is applicable to validation/verification bodies in any sector, providing confirmation that claims are either plausible with regards to the intended future use (validation) or truthfully stated (verification). However, results of other conformity assessment activities (e.g. testing, inspection and certification) are not considered to be subject to validation/verification according to this document. Neither are situations where validation/verification activities are performed as steps within another conformity assessment process.
This document is applicable to any sector, in conjunction with sector specific programmes that contain requirements for validation/verification processes and procedures.
This document can be used as a basis for accreditation by accreditation bodies, peer assessment within peer assessment groups, or other forms of recognition of validation/verification bodies by international or regional organizations, governments, regulatory authorities, programme owners, industry bodies, companies, clients or consumers.
NOTE This document contains generic requirements and is neutral with regard to the validation/verification programme in operation. Requirements of the applicable programmes are additional to the requirements of this document.