In most cases, an audit by a notified body is a prerequisite to market medical devices in the European market.
„Systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled“
Source: ISO 9000:2015
As for medical device manufacturers, the ISO 13485 audit is the most important one. Only if this audit has been passed successfully, notified bodies may issue an ISO 13485 respectively annex II certificate. Those certifications, in return, are requirements for a conformity assessment according to annex II of the Medical Device Directive (MDD) respectively annex IX of the Medical Device Regulation (MDR) and thus for legally marketing the products.
ISO 13485 Audits may only be performed by accredited bodies. When interpreting ISO 13485, auditors rely on the explanation of ISO 14969.
The FDA does not perform audits, but rather inspections. This means that at best, inspections by the FDA are concluded without any findings but do not lead to the issue of a certificate. In contrast, audits by European notified bodies, at best, result in the issue of a certificate. The FDA does not check compliance with ISO 13485, but with 21 CFR part 820.
Depending on the audit's focus, the following types can be distinguished:
Further distinctions are:
ISO 19011 describes demands on audits (planning, execution and documentation) and auditors.
Further provisions stipulate the duration of audits.
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If the auditor attests "non-conformity", your notified body may refuse or withdraw the certificate. Withal it is known in general what the auditor examines:
The following numbers refer to the above figure.
If there are deviations regarding the 2nd and 3rd point, you will have a problem.
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