A full Medical Device Single Audit Program (MDSAP) Audit is comprised of seven chapters, and each of the Chapters contains multiple audit tasks. Each audit task references the applicable clause of ISO 13485:2016 and specific regulatory requirements from the MDSAP participating countries. There is a specific focus during the audit on Risk Management and linkages between the processes.
The MDSAP is based on a three- year audit cycle. Initial Certification Audits are a complete audit of the device manufacturer’s quality management system (QMS). The Initial Certification Audit is followed by a partial Surveillance Audit each of the following two- years and a complete Re-audit, also referred to as a “Recertification Audit” in the third- year.
Auditing Organizations are required by the participating MDSAP regulatory authorities to conduct unannounced audits in circumstances when high scoring major non-conformities have been identified.
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