Background:
A certification scheme based on ISO/IEC 17065 has been created to assure the responsible supply of marine ingredients, and the review is initially focusing on the scheme owner’s Chain of Custody standard. The object of conformity assessment is a process; the process of ensuring satisfactory systems for product identification, traceability, and segregation. Product quality is not considered in this standard; that will follow in future submissions from the scheme owner if this review is successful.
To do a proper audit of the process, the auditor must do a walk-through of the facility and observe the processes employed to ensure proper identification and segregation of product. Interviews with personnel will be necessary to confirm that the processes are properly managed, and documents will have to be reviewed to ensure satisfactory traceability.
As the chain of custody audits have some management systems elements, there are several clauses of ISO/IEC 17021‑1 that are applicable (as per ISO/IEC 17065 clause 6.2.1, prompted also by clause 3.1.7 bullet 5 in EA-1/22).
One feature of this scheme is that a minor NC is only raised where, ‘based on objective evidence the conformity of the product is not in doubt.’
In this case, as the NC could only relate to a management system element of the scheme, the scheme owner considers that clause 9.4.9 of ISO/IEC 17021-1 applies:
9.4.9 Cause analysis of nonconformities
The certification body shall require the client to analyse the cause and describe the specific correction and corrective actions taken, or planned to be taken, to eliminate detected nonconformities, within a defined time.
So the scheme allows for the possibility that a certification decision can be taken based on a corrective action plan for minor NCs.
It could be considered that, for this particular scheme, the approach from the scheme owner is satisfactory.
However, it could also be considered that in ISO/IEC 17065, only conformity or nonconformity is possible, and that all nonconformities must be solved before decision.
Question
Is the scheme owner’s approach, as described above, acceptable?
Factors which may influence the deliberations
In an ISO/IEC 17065 scheme accepted by EA , not all requirements must be met before decision. Producers only need to attain 95% Minor Must compliance to achieve Integrated Farm Assurance certification.
September 2024
Context :
An EA CC TFG dedicated to this issue concluded in March 2023 that the following points are important to be considered:
- 4.7 requires the verification that nonconformities have been corrected. – Which verification could be acceptable, on site, remote, documentary review? There might be some adjustment of the verification method, based on the risk posed by the NC on the product conformity. This shall be established in the certification scheme. – What is to be verified, the correction, the corrective action plan (to be set but not yet implemented)? This shall be established in the certification scheme.
- Is it possible to have a distinction between certification requirements (which must be fulfilled before certification decision) and other additional/supporting minor requirements which could be fulfilled after the certification decision? These additional requirements shall be identified in the certification scheme and the certificate should be fully transparent and unambiguous on which additional requirements were fulfilled and which were not fulfilled when the certification decision was made. These provisions shall be established in the certification scheme.”
Nevertheless, the situation is here, and already existing for different schemes (as Food safety, organic, CE marking…).
Some preliminary remarks attached to the question:
- Introducing the fact that the scheme bears some management requirements as a rationale to accept minor NCs and their way of treatment “17021 like” was not considered as appropriate by the TF, some of the management requirements having a potential effect of the conformity of the product and this approach jeopardizing the intent of a product certification, which is delivering the assurance that a product continuously meets the product requirements.
- Another remark is that the question is inappropriately mixing process and product : as the object of conformity assessment is a process (the process of ensuring satisfactory systems for product identification, traceability, and segregation), the feature of this scheme being that “a minor NC is only raised where, ‘based on objective evidence the conformity of the product is not in doubt”, is misleading; it should be “a minor NC is only raised where, ‘based on objective evidence the conformity of the process is not in doubt “. There is not consistency between a process certification and the fact that minor NC does not affect the product.
Based on above, the answer is:
YES, the scheme owner’s approach could be acceptable provided that the conformity assessment scheme establishes:
- which findings are to be considered as NC (i.e. compromising, in the sense of ISO/IEC 17065, the conformity of the product, process or service) and what are the other types of findings (no matter the wording used)
- the type of objective evidence expected to demonstrate that the conformity of the product (when the scheme is a product certification) or the process (when the scheme is a process certification) or the service ((when the scheme is a service certification) is not in doubt
- what is to be verified before decision, for all kinds of findings, correction or corrective action plan (to be set but not yet implemented at the time of certification decision)
- that the CB shall receive answers for every finding describing the specific correction and corrective actions taken, or planned to be taken, examines these answers and considers them as relevant before granting certification, and follows the delay of implementation of corrective action planned to be taken.