Acceptation of tests reports provided by manufacturers under PPE regulation (and ISO/IEC 17065)
The context is:
While assessing applicant CBs for accreditation for evaluation according PPE regulation, we have come across the following situation :
For PPE regulation, the practice is that notified bodies accept test reports (provided by clients) from other notified bodies (acting in this case as laboratories) without requiring a binding contract with the laboratory.
This practice is taken in application of the article 32.2 of PPE regulation (Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators).
The use of test reports provided by manufacturer is allowed in the Blue Guide (The last paragraph of 5.2.5 subcontracting by notified bodies of Blue guide mentions that the manufacturer can provide test reports or other elements of its technical documentation. The notified body can take these reports into account if it assumes full responsibility for the results. The notified body may accept the manufacturer’s test results for the conformity assessment provided that it justifies the reason for taking account of these tests).
But the Blue Guide also stipulates (5.2.5) that Subcontracting must be based on a contract, which makes it possible to ensure the transparency of and have confidence in the notified body’s operations.
Decision 768/2008 requires that where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article [R17] so, in the case the notified body is not in direct relation with the laboratory, how can he demonstrate that specific provisions of R17 for confidentiality and conflict of interest are met?
ISO/CEI 17065 (7.4.5) stipulates that the certification body shall only rely on evaluation results related to certification completed prior to the application for certification, where it takes responsibility for the results and satisfies itself that the body that performed the evaluation fulfils the requirements contained in 6.2.2 and those specified by the certification scheme.
The question is the following:
Is it acceptable for a certification body (acting as a notified body) to accept test reports provided by the manufacturer and issued from other laboratories (accredited according ISO/CEI 17025) when there is not a legally binding contract between the notified body and the laboratory ,as required by ISO/CEI 17065 (§6.2.2.3)?
March 2019
Based on the Blue Guide, it is possible provided that at least the following requirements are met:
- NB must justify the reason why he accepts the test of the manufacturer instead of making them.
- NB assumes full responsibility for the results of those tests, so the NB must ensure that these were made with the required competence so that provide confidence in the results (accredited laboratories), and additionally that maintain records to demonstrate that confidence.
- NB ensures that test have been done meeting the requirements of independence and impartiality required and therefore there are no conflicts of interest, and accordingly must demonstrate that the laboratory that conducted the tests is not related with the tested item nor there are other possible causes that can compromise their impartiality.
Conclusion
When a NB accepts existing manufacturer´s test reports meeting these requirements, it is not a process of outsourcing and therefore it is not necessary to have a legally binding contract with the laboratory used by the manufacturer, provided as we have said that the above warranties are given, so NB can assume full responsibility for the outcome of these tests.
However, if a specific test is requested by the NB as part of its evaluation activities, a contract will be required.