ISO 17021 is a series of standards that set out requirements for organizations who provide certificates of conformity to all types of management systems. These organizations are commonly referenced to as certification bodies (CBs) or registrars.
The ISO 17021 standards are used by accreditation bodies (ABs) to assess the processes that certification bodies (CBs) have in place to ensure that they are impartial and the results of their assessments are consistent.
The Draft International Standard (DIS) of ISO 17021-2 was issued for comment on May 5, 2016 and the DIS of ISO 17021-3 was issued for comment on July 19, 2016. The comment period on both standards is now closed and revisions of both standards are expected to be published before the end of 2016.
The ISO TR-45005 technical report provides guidelines for organizations on how to manage the risks arising from COVID-19 to protect work-related health, safety and well-being, and is offered as a free download.
The new MDSAP guidelines introduce the relationship between the MDSAP grading system and major/minor nonconformity grading. These common nonconformity classification terms, defined in accreditation standard ISO 17021-1:2015 (clause 3.12 and 3.13) for Certification Bodies, are often utilized in medical device certification programs to assign impact and priority to the implementation of corrective actions. 2b1af7f3a8