ISO 13485 Internal Audits

An audit is a systematic, independent and documented processfor obtaining objective evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.   These can be audit criteria: standards, legislation, contracts, objectives/targets or any other specifications. An ISO 13485 audit uses as audit criteria:
  • The ISO 13485 standard
  • Legislation applicable to medical devices
Thus, the auditor should understand very well the regulations (EU) 2017/745 or 2017/746, as well as know other documents such as MEDDEV and NBMEd.   Ensure that the selected audit team has a deep knowledge of the ISO 13485 standard as well as all applicable legislation and documents.   Our proposal includes the following steps of an audit:  
  • Audit preparation
  • Field audit
  • Audit report
  • Follow up