The ISO/IEC 17025 is a globally used laboratory accreditation standard that outlines requirements for the competence of testing and calibration laboratories. ISO 17025 Certification is a procedure by which an authoritative body gives formal recognition of technical competence for specific tests/measurements based on third party assessment based on ISO 17025:2017 standard guidelines. ISO/IEC 17025 standard is an evolution of the former ISO guide 25 and latest version is ISO/IEC 17025:2017. There are only 2 types of laboratories in the world and that is testing laboratory and calibration laboratory. This ISO/IEC 17025 standard is applicable for both the types of laboratories.
The title of this standard is "ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories". This standard is internationally recognized basic document for accreditation of laboratories
ISO 17020 is internationally recognized standard that requirements for the competence of operation of various types of inspection bodies. This International standard has been drawn up with the objective of promoting confidence in bodies performing inspection. ISO 17020 covers the activities of inspection bodies whose work can include the examination of materials, products, installations, plants, processes, work procedures or services, and the determination of their conformity with requirements. ISO/IEC 17020 Accreditation allows an organization to demonstrate integrity, reliability, and technical competence as well as compliance internationally recognized good practices. The standard was initially published in year 1998 and then it was revised in 2012.
ISO 17021 Standard specifies requirements for bodies providing audit and certification of management systems. It gives generic requirements for such bodies performing audit and certification in the field of quality, the environment and other types of management systems. ISO/IEC 17021:2015 Accreeditation is intended for the use by certification bodies and accreditation bodies. Certification of management systems is a third-party conformity assessment activity and bodies performing this activity are therefore third-party conformity assessment bodies.
ISO 17024 is an International Standard which sets out criteria for bodies operating certification of persons. This standard has been drawn up with the objective of achieving and promoting a globally accepted benchmark for organizations operating certification of persons. ISO / IEC 17024 Accreditation includes requirements for the development and maintenance of the certification scheme for persons upon which the certification is based. Accreditation to bodies engaged in ISO 17024 personal certification is a procedure by which an authoritative body gives formal recognition of technical competence for specific activities conducted by the certifying body, based on third party assessment based on ISO 17024:2012 standard.
ISO 17034:2016 specifies the general requirements for the competence and consistent operation of reference material producers. This International Standard outlines the general requirements for the producers of Reference Materials, including certified reference materials (CRMs). It supersedes ISO Guide 34:2009 and is aligned with the relevant requirements of ISO/IEC 17025. ISO 17034:2016 could also be used by regulatory authorities and accreditation bodies for assessing the competence of RMPs. ISO 17034 : 2016 Accreditation of Reference Material Producers benefits users as it provides confidence in the competence of the producer to characterise reference materials.
ISO 17043 specifies general requirement for the competence of providers of proficiency testing schemes and for the development and operation of proficiency testing schemes. These general requirements may be used as a basis for specific technical requirements for particular fields of application. ISO 17043 applies to centres' that organize intercomparisons in all areas. ISO 17043 Accreditation for organisations provides Proficiency Testing (PT) schemes, who wish to demonstrate their competence through formal compliance with a set of internationally-recognised requirements for the planning and implementation of proficiency testing programs.
ISO 17065 provides rules for organizations that certify products. ISO 17065 ensures that the resulting product certifications are impartial, consistent with international standards, and based on objective testing. The overall aim of certifying products, processes or services is to give confidence to all interested parties that a product, process or service fulfils specified requirements. The value of ISO 17065 Accreditation is the degree of confidence and trust that is established by an impartial and competent demonstration of fulfilment of specified requirements by a third party. The most recent revision of this standard was published in September 2012.
ISO 15189:2022 is globally used standard particular requirements for quality and competence that specifies the quality management system for Medical Laboratories. ISO 15189 is based on ISO/IEC 17025 (Requirement for competence of testing and calibration laboratory) and ISO 9001 (Requirement for Quality Management System). ISO 15189 Accreditation provides recognition of the medical laboratory's competence including both the management system and technical practice. ISO 15189:2022 accreditation involves an independent assessment of the medical laboratory that includes an examination of personnel qualifications and competence, equipment, reagents and supplies, quality assurance, and analytical, pre-analytical, and post-analytical factors.