GOST R 54881-2021 PDF

Scope: The requirements of this standard apply to the format and scope of information that is required to be included in an audit report of a medical device manufacturer's quality management system (QMS) for submission to regulatory authorities participating in the MDSAP program. The audit organization must use this format when reporting on any audits conducted, with the exception of the first stage of the audit. In relation to an unscheduled or inspection audit, the auditing organization should record in detail the elements examined and identify those elements that were not included in the scope of the audit.

GOST R 54881-2021 history

2021 GOST R 54881-2021 Medical device regulatory audit reports
1970 GOST R 54881-2011 Guidelines for auditing of quality management systems of medical device manufacturers to conform to requlating requirements. Part 3. Audit report