Supervised product checks at random intervals /Module C2/ PPE Cat. III
Conformity to type based on internal production control plus supervised product checks at random intervals /Module C2/
Notified Body No. 2534 CERTEX performs EU type examination for the II & III category of the personal protective equipment. ITT CERTE also performs supervision for PPE category III (own certificates as well as certificates issued by the other Notified Bodies).
The supervision is performed on the basis of Annex VII of Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC /Module C2/.
The Notified Body shall carry out product checks in order to verify the homogeneity of production and the conformity of the PPE with the type described in the EU type examination certificate and with the applicable essential health and safety requirements.
The product checks shall be carried out at least once a year, at random intervals determined by the Notified Body. The first product checks shall be carried out no more than one year after the date of issue of the EU type-examination certificate.
An adequate statistical sample of the manufactured PPE shall be selected by the Notified Body at a place agreed between the body and the manufacturer. All items of PPE of the sample shall be examined, and appropriate tests set out in the relevant harmonised standard(s) and/or equivalent tests set out in other relevant technical specifications shall be carried out in order to verify the conformity of the PPE with the type described in the EU type examination certificate and with the applicable essential health and safety requirements.
Where the Notified Body referred to in point 3 is not the body that issued the relevant EU type-examination certificate, it shall contact that body in the event of difficulties in connection with the assessment of the conformity of the sample.
The acceptance sampling procedure to be applied is intended to determine whether the manufacturing process ensures the homogeneity of production and performs within acceptable limits, with a view to ensuring conformity of the PPE.
If the examination and testing reveal that the production is not homogeneous, or that the PPE does not comply with the type described in the EU type examination certificate or with the applicable essential health and safety requirements, the Notified Body shall take measures appropriate to the fault(s) recorded and inform the notifying authority thereof.
To cover a PPE category III certificate by the conformity to type based on internal production control plus supervised product checks at random intervals /Module C2/ you should send us an application. You can find the forms at the web site CE - EU type examination /Download>>>/ and sign the agreement with the Notified Body.
If you have already signed a supervision agreement with other Notified Body it should be terminated.