2 Normative references T 42
Standards on audit and quality
The advice given by the ISO 19011 standard can be summarized in the following fields:
- audit principles - clause 4
- audit program - clause 5
- audit activities - clause 6
- auditor competences - clause 7
A good knowledge of the ISO 13485 standard is required to understand and follow this module.
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This module is based on the following generic and international standards:
- ISO 19011 (2018): Guidelines for auditing management systems
- ISO 13485 (2016): Medical devices - Quality management systems - Requirements for regulatory purposes
- ISO 9000 (2015): Quality management systems - Fundamentals and vocabulary
- ISO 9004 (2018): Quality management - Quality of an organization - Guidance to achieve sustained success
All of these standards and many more can be ordered in electronic or paper format on the ISO site.
More than 28,000 standards (in English and other languages) are available for free on the Public.Resource.Org site.