Situation: The certification process in the CB is as follows :
- The CB auditor performs the audit and writes non conformities in case there are. His/her action stops after that.
- The reviewer (technical officer inside the CB) is in charge of the follow up of the audit which includes analysis of the answers from the client to the nonconformities and recommendation on closing or not the nonconformity
- The reviewer is in charge of reviewing other results from the evaluation process (e.g. test results)
- This reviewer makes a recommendation for the certification
- The certification decision is taken by the CB’s Director
Question: Is the analysis of the answers from the client to the nonconformities (and opinion on closing or not the nonconformity) part of the audit or can it be considered as part of the review?,
- In other words is the analysis of the answers from the client to the non conformities is an evaluation task and shall be considered as an evaluation activity or is this analysis of client answers part of the evaluation process without being considered as an evaluation task belonging to evaluation activities?
Depending on the answer, is it fulfilling (or not) 7.5 requirements that the reviewer performs the analysis of the answers from the client to the non conformities raised in audit?
Mars 2017
Clause 7.5.1 of ISO/IEC 17065 states “7.5.1
- The certification body shall assign at least one person to review all information and results related to the evaluation. The review shall be carried out by person(s) who have not been involved in the evaluation process.”
Therefore in, an independent review is required. The review, acceptance and verification of answers to nonconformities is an evaluation activity and the individual performing these tasks cannot, therefore, perform the review required by clause 7.5.1 of ISO/IEC 17065.
If the product certification scheme requires that the certification body performs management system auditing as part of product certification, it shall meet the applicable requirements of ISO/IEC 17021-1. The applicable requirements concerning handling the client’s response to non-conformities are specified in Clause 9.5.2 of ISO/IEC17021-1 which states that prior to making a certification decision:
- that for any major non-conformities, the certification body has reviewed, accepted and verified the correction and corrective actions and
- that for any minor nonconformities it has reviewed and accepted the client’s plan for correction and corrective action.
In this case, the review and acceptance of the client’s plan for correction and corrective action, in respect of minor non-conformities, is not part of the evaluation as there is no verification of the correction and corrective action, and the individual performing these tasks can perform the review required by clause 7.5.1 of ISO/IEC 17065