Short answer: A major nonconformity affects the capability of the management system to achieve its intended results, for example where there is significant doubt that effective process control is in place or that products will meet requirements. A minor nonconformity does not. Certification cannot be granted until majors are corrected and the corrective action verified.
The definitions
ISO/IEC 17021-1 defines a nonconformity as non-fulfilment of a requirement. A major nonconformity affects the capability of the management system to achieve its intended results. A minor nonconformity does not.
A practical grading sequence
- Is a specified requirement not met, with objective evidence? If not, it is not a nonconformity.
- Is there significant doubt that process control is effective or that products or services will meet requirements? Then it is major.
- Do several minor findings on the same requirement show a systemic failure? Then it is major.
- Otherwise it is minor.
Example
On one shift, products rejected by a metal detector are re-run and packed without investigation, and detector checks are missing on several shifts. Product has been shipped. That is major: there is significant doubt that products meet requirements, and the failure is systematic. A single expired calibration certificate, where the instrument bias was in a conservative direction, is typically minor.
What happens next
| Major | Minor | |
|---|---|---|
| Before initial certification | Correction and corrective action must be verified (often by a follow-up visit) | Corrective action plan must be accepted |
| Verification | Before the decision | At the next audit |
Grading must never be negotiated for commercial reasons. If a client disagrees, the disagreement is recorded at the closing meeting and resolved by the certification body, and the client may appeal the certification decision.
Next step
What turns a finding into a major nonconformity, what a minor nonconformity means for certification, and how grading decisions should be made.
How nonconformities affect certification
