Writing QMS Non conformities
Auditors can often get lazy when reporting nonconformities – a vague and ambiguous nonconformity will always lead to a vague and ambiguous corrective action. The recording of nonconformities should include the following:
1. WHAT: State what the issue is and clearly identify the specifics of the nonconformity including observation of the facts/evidence, what was found – with factual examples.
2. WHY: State why it is nonconformity – always answer the question ‘SO WHAT’ (what is the issue & why is it relevant?).
3. CRITERION NOT MET: State the ISO 9001 clause not met.
An example a nonconformity from an audit of an Internal Audit System could be
For example a nonconformity from an audit of an Internal Audit System could be
‘Corrective Actions have not been established for non conformities raised during audits performed in 2009. For example, audit reports 01/09, 03/09 and 04/09 all have non conformities raised with no evidence of corrective action.
ISO 9001:2008 Section 8.2.2 requires that an organisation shall take action to eliminate the cause of nonconformity without undue delay.’
By using this technique of writing nonconformities, you will ensure that your audit host has a clear understanding of the issue and the nonconformity is so objective that there is no room for debate.