What kind of assessment activities the Notified Body need to do in case of the subcontracted laboratory has ISO/IEC 17025 accreditation for the given scope? And what kind of assessment activities the Notified Body need to do in case of the subcontracted laboratory has ISO/IEC 17025 accreditation but NOT only for the given scope or if the subcontracted laboratory does not maintain ISO/IEC accreditation at all?
In order to obtain accreditation for notification purposes, NB shall have appropriate testing capability that may be assured by:
- (a) having an own laboratory within the same legal entity accredited for the scope corresponding to NB activities;
- (b) having a legally binding contract concluded with a subcontractor’s laboratory accredited for the appropriate scope;
- (c) having an own non-accredited laboratory or outsource testing to non-accredited laboratories (internal and external resources). In such cases, the NB shall have evidence to demonstrate that the laboratories meet the applicable requirements of the EN ISO/IEC 17025 standard;
For cases b) and c), it is not only the requirements of ISO/IEC 17025 which need to be fulfilled by the subcontractor (whether accredited or not), but also the requirements of the application legislation, namely that :
- the laboratory is competent for the pre-analytical phase if the subcontracting includes sampling (Art R 17 point 7 of Decision 768);
- all the specific requirements related to impartiality (Art R17 3, 4, 5 and 8) are fulfilled, notably with respect to being a third-party body independent of the organisation or the product the subcontractor assesses;
- the lab has subscribed a liability insurance (Art R17 9);
- the lab is aware of the activities of the notified body coordination group (Art R17 11).