2 Normative references
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 15189 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 (2026): Guidelines for auditing management systems
- ISO 15189 (2022): Medical laboratories - Requirements for quality and competence
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.