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ISO 19011

What is ISO 19011?

The international standard that provides guidance on managing audit programmes, conducting internal or external audits, and evaluating the competence of auditors. ISO 19011 applies to all management system audits.

Audit

Each of these is named in at least one of the same controls as iso 19011. The number is how many controls name both.

What the standards actually require on iso 19011

Requirements naming iso 19011 across 6 standards, quoted from the control text.

ISO 19011:2018, 7.2.5 applies with no ISMS-specific addition: an ISMS audit team leader should have gained additional audit experience that develops the team-leader competence of 7.2.3.4, while another audit team leader directs and guides them.

iso-iec-27007-2020::7.2.5 · Achieving audit team leader competence →

Regulated companies formally assess every supplier of computerized systems and services used in GxP regulated work, including cloud service providers, external service providers and internal functions, with the approach based on critical thinking about what is...

gamp-5-good-automated-manufacturing-practice::M2 · Appendix M2 Supplier Assessment →

NSS-17 + NSS-42-G require ongoing assurance + regulator interface + reporting + continuous improvement. Assurance activities: internal cyber security audit + management review + control effectiveness testing + penetration testing + red team exercises + ISO 270...

IAEA-NSS17-Assurance-Regulator-Inspection-Reporting-Improvement · IAEA NSS-17 - Assurance Activities + Regulator Interface + Inspection + Reporting + Information Sharing + Continuous Improvement →

The organization audits the process regularly, or arranges audits, to evaluate its performance. The audit informs on whether the process follows the complaints-handling procedures and whether it is suitable and effective for the objectives.

iso-10002-2018::8.5 · 8.5 Auditing of the complaints-handling process →

Audits may check how quality plans are implemented and whether they work, confirm and monitor that specified requirements are met, keep suppliers under surveillance, or give customers or other interested parties an independent and objective assessment;

iso-10005-2005::5.19 · Audits →

The plan should set out which kinds of audit will be carried out for the case, what they will cover and how deep they will go, and what will be done with their results. Audits can serve several ends: checking that quality plans are implemented and work;

iso-10005-2018::6.17 · Audits →

Questions people ask about iso 19011

What is ISO 19011?
The international standard that provides guidance on managing audit programmes, conducting internal or external audits, and evaluating the competence of auditors. ISO 19011 applies to all management system audits.
Why is ISO 19011 important for compliance?
ISO 19011 is a key concept in Audit. Understanding iso 19011 helps organizations meet regulatory requirements, reduce risk, and demonstrate due diligence during audits. Our compliance platform maps 1,016 frameworks with 316K cross-framework control mappings.
Which compliance frameworks address ISO 19011?
ISO 19011 appears in the requirement text of ISO/IEC 27007:2020, GAMP 5 - Good Automated Manufacturing Practice, IAEA Nuclear Security Series - Computer Security at Nuclear Facilities (NSS-17-T Rev 1), ISO 10002:2018, ISO 10005:2005. Across these standards we have identified 48 controls that name it directly, each linked to the control text on the compliance platform.
Where can I learn more about ISO 19011?
Explore our compliance framework pages to see how iso 19011 applies across different standards and regulations. Our implementation guides provide step-by-step guidance, and the compliance platform offers AI-powered analysis of how this concept maps across 1,016 frameworks.

See how ISO 19011 applies across compliance frameworks

Our platform maps 1,016 frameworks with 316K cross-framework control mappings. Explore how this concept is addressed across standards.

Written and maintained by Gerard Blokdyk, The Art of Service.