ISO 17021-1 states in clause 9.4.5:
Audit findings summarizing conformity and detailing nonconformity shall be identified, classified and recorded.
…opportunities for improvement may be identified and recorded. Audit findings, however, which are nonconformities, shall not be recorded as opportunities for improvement.
Clause 3.12 defines major nonconformity and clause 3.13 defines minor nonconformity
Clause 9.5.2 sets out how to deal with major nonconformities and with minor nonconformities.
Is it acceptable if CB introduced a such findings classification system ?
1) Major nonconformity – findings with crucial impact on non-fulfilment of MS objectives
2) Minor nonconformity – finding does not affect the ability of MS to achieve its objectives
3) Observation – finding could potentially lead to nonconformity in the future
4) Opportunity for improvement
Action prior to making decision has to assure that:
- All major nonconformities have to be cleared so that corrections and corrective actions have to be reviewed and accepted
- For all minor nonconformities it has reviewed and accepted the client’s plan for correction and corrective action
- For all observations CB does not require any corrections or corrective actions or any client’s plan for correction and corrective action prior decision is taking. The next audit examines the client’s response to such a finding.
- In case of opportunity for improvement, no action is required.
Especially, we would like to know whether Observation as defined by the CB system is in line with ISO/IEC 17021-1 if the standard allows two types of nonconformities and opportunities for improvement only.
March 2020
ISO/IEC 17021-1:2015 says;
9.4.5.1 Audit findings summarizing conformity and detailing nonconformity shall be identified, classified and recorded to enable an informed certification decision to be made or the certification to be maintained.
“9.4.5.2 Opportunities for improvement may be identified and recorded, unless prohibited by the requirements of a management system certification scheme. Audit findings, however, which are nonconformities, shall not be recorded as opportunities for improvement.”
“3.11
nonconformity
non-fulfilment of a requirement”
The CB should be careful when defining the nonconformities. In this case, the definition of “Major Nonconformity” as “findings with crucial impact on non-fulfilment of MS objectives” is not comply with the definition in the standard (3.12 major nonconformity: “nonconformity (3.11) that affects the capability of the management system to achieve the intended results”). In the CB’s definition whether the finding is non-fulfilment of a requirement of MS standard or not is not clear. Same situation is valid for the definition of “minor nonconformity” of the CB.
According to the standard approach, firstly the finding shall be nonconformity and then needed to be classified. It is possible to write anything to indicate non-fulfilment of the MS objectives even if it complies with the standard requirements.
The names of the findings or nonconformities are not important, but at least the meanings or definitions of the nonconformities shall be the same.
If the CB audit team members can clearly and easily differentiate “the observations” and “opportunity for improvement”, the CB may use these terminology unless prohibited by the requirements of a management system certification scheme according to clause 9.4.5.2.