- an optional preliminary audit to assess the condition of the company’s management system against the requirements of the ISO 13485 standard;
- a gap analysis will identify the system’s strengths and potential areas for improvement;
- a certification audit, with the aim of assessing the compliance of the management system to the requirements of ISO 13485, through a documentary analysis and on-site findings;
- issuance of the certificate of conformity;
- annual surveillance audits and triennial renewal audits.
ISO 13485 audits can be combined with audits against the ISO 9001 standard or the requirements of EU Directive 93/42/EEC.