The ISO 19011 is applicable to all organizations performing internal or external audits of management systems. As such it is not only addressing auditors, but also organizations implementing management systems or conducting audits of management systems for contractual or regulatory reasons.
The 2018 version includes tips on auditing "risks and opportunities" as well as information on applying risk-based thinking to the audit process (both currently not transposed into the ISO 13485 but mainly introduced by the ISO 9001).
Further interesting topics of the new revision:
- Guidance on conducting an audit has been expanded, particularly the section on audit planning
- Generic competence requirements for auditors has been expanded.