Certification

Dolomiticert s.c.a.r.l was authorised to issue certifications, as a notified body, in accordance with EU Regulation 2016/425 approved by the European Parliament and Council on 9 March 2016 for Personal Protective Equipment (PPE) in 2008.

CERTIFICATIONS

Setting the product certification process in motion requires manufacturers to:

fill in and submit an EC type examination certificate application for the product to be certified together with the required technical documentation, in conformity with the requirements set out in Annex III of Regulation (EU) 2016/425 for new products, pursuant to Module B of EU Regulation 2016/425. The technical documentation must include the test reports used for technical product validation purposes.

Category 3 personal protective equipment applications alone require manufacturers to supply:

  • a module C2 examination application – supplemented by an EC type-examination certificate and technical dossier in the event that this certificate was not issued by Dolomiticert – for the assessment of production process compliance, together with officially monitored random interval product checks in accordance with module C2 of EU Regulation 2016/425.

  • a module D application together with the system documentation required for the purposes of production process quality system compliance with module D of EU Regulation 2016/425.

CERTIFICATIONS

EC type-examination certificate application (for module B certifications)

Form to fill in to present an examination application

M.16.108.2.001-Domanda-di-esame-UE-del-tipo-Rev.3-del-06.11.2020

Instructions for filling in the examination application

PQ 16.108.002 Domanda di esame UE del tipo (Rev.2 del 06.11.2020)

CERTIFICATIONS

Technical documentation

In addition to the EC type-examination application, a further requirement is technical product documentation including all the information contained in the procedure shown below, in accordance with EU Regulation 2016/425 approved by the European Parliament and Council on 9 March 2016.

Technical documentation

PQ 16.108.003 Documentazione Tecnica (Rev.1 del 15.05.2020)

CERTIFICATIONS

Checks in accordance with Module C2 and Module D

Dolomiticert performs checks in accordance with:

Module C2 (random interval product checks performed under official supervision) for category 3 personal protective equipment (PPE) in accordance with EU Regulation 2016/425 approved by the European Parliament and Council on 9 March 2016.

Module C2

M.16.108.2.004 Domanda di prove (Modulo C 2) (Rev.2 del 06.11.2020)

Module D Quality assurance of the production process testing for category 3 personal protective equipment (PPE), in accordance with EU Regulation 2016/425 approved by the European Parliament and Council on 9 March 2016.

Module D

M.16.108.2.003 Domanda di Sorveglianza (Modulo D) (Rev. 2 del 06.11.2020)

CERTIFICATIONS

Certification regulations

All those interested in Dolomiticert’s certification services can view its procedures by downloading the following conformity assessment certification procedures pursuant to EU Regulation 2016/425 approved by the European Parliament and Council on 9 March 2016.

Certification regulations

PQ 16.101.004 Regolamento per la certificazione dei dispositivi di protezione individuale (Rev.6 del 30.11.2020)

Accreditations

Dolomiticert s.c.a.r.l was authorised to issue certifications, as a notified body, in accordance with EU Regulation 2016/425 approved by the European Parliament and Council on 9 March 2016 for Personal Protective Equipment (PPE) in 2008.