In both the European Union and the European Economic Area, the marketing of Personal Protective Equipment (PPE) must comply with the technical criteria of Regulation EU 2016/425 (which amends Directive 89/686/EEC). This Regulation applies to manufacturers of Personal Protective Equipment and their authorised representatives, importers, etc., who are responsible for complying with its requirements.
The CE mark and the EU Declaration of Conformity ensure that PPEs will be able to move freely within the European Market. Depending on the type of risk they protect against, sales of PPEs may require an Authorised Body such as AENOR to issue a certificate of conformity for the type of risk at issue, based on assuring the quality of the production process (module D).
AENOR is authorised by the Ministry of Industry, Trade and Tourism and is accredited by the Spanish Accreditation Body (ENAC) for this certification.
Category II and III Personal Protective Equipment are scrutinised by an Authorised Body.
AENOR is authorised to verify the conformity of Category III PPEs, in accordance with Module D: Production process quality assurance.
The list of standards that have been harmonised to comply with Regulation EU 2016/425 on Personal Protective Equipment includes more than 200 standards. Therefore, it's a good idea to check which standards apply to a specific product.
The CE Mark and CE Declaration of Conformity enable manufacturers of Personal Protective Equipment to access the European Market without restriction, which avoids technical barriers. What's more, the CE Mark is recognised in other markets globally.
The CE Mark ensures consumers that the product will not compromise their safety and guarantees certain common safety standards in Europe.
The requirements and conformity assessment modules are set out in Regulation EU 2016/425 on Personal Protective Equipment.
As regards certification, AENOR is accredited and authorised to assess conformity, based on assuring the quality of the production process (module D).
Audit visits are included in a straightforward way in conventional ISO 9001 audits. They are certified by AENOR or other bodies.
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AENOR assurance for fire protection, physical safety and individual and collective safety
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ISO 9001 certification can be combined with CE marking certification