Quality

ISO audit

TL;DR

A systematic, independent and documented audit conducted against an ISO management-system standard — internal (1st-party), supplier (2nd-party) or certification body (3rd-party).

ISO audits are conducted per ISO 19011 (auditing principles) and, for certification bodies, ISO/IEC 17021-1. For ISO 9001 / 13485 / 14001 / 27001 / 45001 etc. the typical cycle is a Stage 1 documentation review, Stage 2 implementation audit, then annual surveillance audits and a triennial recertification.

Findings are classified Observation / Minor Nonconformity / Major Nonconformity. A Major NC blocks certification until a corrective-action plan is accepted; a Critical NC (some schemes) can suspend certification immediately.

Regulatory anchors
  • ISO 19011:2018
  • ISO/IEC 17021-1:2015
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