AITEX has recently been approved by ENAC (The National Accreditation Body) as a Certification Body for Personal Protection Equipment in compliance with ISO/IEC 17065:2012.
AITEX has recently been approved by ENAC (The National Accreditation Body) as a Certification Body for Personal Protection Equipment in compliance with ISO/IEC 17065:2012 within EU Regulation 2016/425, under the following evaluation of conformity schemes: Module B (EU Type Examination), Module C2 (Conformity of type based on production monitoring plus random supervised product monitoring) and Module D (Conformity of Type based on production QA).
The scope of Approval 155 C-PR364 granted to AITEX can be viewed on ENAC’s website (www.enac.es) covering the scope, products and hazards that AITEX can test. AITEX is also registered as Notified Body number 161 on the European Commission’s website (nando).
This new approval enables AITEX to provide certification of category II and III PPEs as both types require the application of Module B and, in the case of Category III, either Module C2 or D.
Depending on the evaluation procedure within (EU) 2016/425 which the client requires AITEX to test for as a Notified Body:
Module B: the EU Examination of Type is the part of the evaluation procedure that a Notified Body uses to approve the technical design of a PPE, verifying and certifying that the design complies with essential health and safety requirements required by the Regulation.
Module C2: the Notified Body will test the product to verify the QA procedures during manufacture and the homogeneity of the PPE and its conformity with the type described on the EU Type Examination Certificate and applicable health and safety requirements.
Module D: the Notified Body will evaluate the internal QA system to verify compliance with the requirements referred to in para. 3.2 Annexe VIII. It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the applicable harmonised standard.
The accreditation process integrated the requirements of ISO / IEC 17065: 2012 to the systems that AITEX previously applied, to certify under the conformity assessment schemes of Module B and C2 Personal Protection Equipment, establishing for these products the application procedures for Module D, which AITEX had previously only used for Marine Equipment. Thus, by integrating systematics with different scopes, AITEX has standardised within a single Accreditation Scope, the certifications for which it is approved, specifically in 155 C-PR364. For further details, visit the official ENAC website.
For more information:
European Commission: Notified bodies nando