Preparation for a QMS certification audit
Domain 7 is about the audit itself: who certifies, how the audit is staged, and what must be finished before the certification body arrives.
Accreditation, certification, auditing
An accreditation body assesses certification bodies against ISO/IEC 17021-1; certification bodies audit organizations against ISO 9001 and issue certificates. Auditors work to the guidance of ISO 19011. Certification is a sampling activity and is not a guarantee of product quality, and the audit team does not make the certification decision - a competent person or committee independent of the team does.
The certification cycle
Initial certification runs in two stages. Stage 1 checks readiness: scope, process map, documented information, completed internal audit and management review, and whether stage 2 is viable. Stage 2 evaluates implementation and effectiveness. Certificates run on a three-year cycle with surveillance audits at least once a year (not in the recertification year), and recertification before expiry.
Nonconformities and findings
The audit team grades nonconformities as major or minor. A major normally blocks certification until correction and corrective action are verified; minors may be accepted with an action plan verified at a later audit. The organization responds with correction, root cause, corrective action and evidence.
Worked example
A stage 1 audit finds the internal audit programme covers only clause 8 and that no management review has been held. Stage 2 is deferred until a full-cycle audit and a management review are completed. At stage 2 a major nonconformity is raised against 7.1.5: gauges in use were past calibration with no status identification.
Traps
- Confusing accreditation with certification.
- Assuming a quality manual or a management representative is mandatory - neither is.
- Expecting the certificate to prove defect-free product, or that every minor must be closed before issue.