Certification

Personal protective equipment (PPE) is equipment designed and manufactured to be worn or handled by a person for protection against one or more risks to their health or safety.

Before being placed on the market, PPE must be assessed to demonstrate its compliance with the essential health and safety requirements of Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment. Once the PPE has been established as compliant with the regulation, the CE marking can then be affixed to the product, allowing it to be sold and marketed on the European market. The CE marking is the marking by which the manufacturer indicates that PPE meets the applicable requirements laid down in the Union harmonisation legislation that provides for its affixing.

As a manufacturer*, you must at the same time draw up an EU declaration of conformity with the regulation for your PPE.

* According to Regulation (EU) 2016/425, a manufacturer is any natural or legal person who manufactures PPE, or has it designed or manufactured, and who markets it under his or her own name or brand.

Regulation (EU) 2016/425 classifies PPE into 3 risk categories:

Category I

Category I includes only the following minimum risks:

Superficial mechanical injuries;

Contact with mild cleaning products or prolonged contact with water;

Contact with hot surfaces with temperatures not exceeding 50 °C;

Eye damage due to exposure to sunlight (except when observing the sun);

Non-extreme atmospheric conditions.

Category II

Category II includes risks other than those described in categories I and III.

Category III

Category III includes only risks that can have very serious consequences such as death or irreversible damage to health. Examples include the following:

Substances and mixtures that are hazardous to health;

Hot environments whose effects are comparable to those of an air temperature equal to or greater than 100 °C;

Cold environments whose effects are comparable to those of an air temperature equal to or less than – 50 °C;

Electric shock and working under voltage.

If, for category I PPE, the PPE certification is carried out by the manufacturer itself, following the module A assessment procedure set out in Annex IV of the regulation, for category II and III PPE, the manufacturer must use a European Notified Body to assess the conformity of the PPE with the essential requirements of Regulation (EU) 2016/425 and allow the CE marking to be affixed and the PPE to be subsequently placed on the market.

Personal Protective Equipment (PPE) Certification

Qualitylab is currently in the process of obtaining accreditation under the NP EN ISO/IEC 17065 standard (Product Certification Accreditation issued by IPAC) to become a European Notified Body. This accreditation will confirm our competence to perform specific conformity assessment tasks and guarantee our confidentiality and impartiality in PPE certification decisions.

By certifying PPE with Qualitylab, you can provide your customers with certified PPE with complete confidence and accuracy, thanks to our independent technical assessment and our solid knowledge of Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment.

Product certification by the Notified Body

QualityLab will be recognised as a Notified Body under the following scope and certification schemes:

The Flexible Accreditation List can be found at the following link.
You can find our directory of certified products at the following link.
Our notification areas are continually updated on the NANDO website.
The respective links will be made available shortly.

Steps for EU Type Examination – Module B
EU Type Examination is the part of the conformity assessment procedure in which a notified body examines the technical design of the PPE, verifies and certifies that the product complies with the essential health and safety requirements of Regulation (EU) 2016/425 that apply.

The EU-type examination of the certification programme for PPE, categories II and III according to Annex V of Regulation (EU) 2016/425 (Module B), consists of the following steps:

• Submission of the EU-type examination application by the manufacturer
• Submission of the technical file by the manufacturer (according to Annex III of Regulation (EU) 2016/425)
• QualityLab carries out appropriate examinations and tests, in accordance with the requirements of ISO/IEC 17065, to verify conformity with the corresponding essential health and safety requirements (Annex II of Regulation (EU) 2016/425 of 9 March 2016)
• Upon successful completion of the assessment activities of the applicable essential health and safety requirements, QualityLab issues the EU-Type Examination Report and the corresponding certificate

The quotation for the certification costs will be sent after completing the EU type-examination application and submitting all technical documentation.

Steps for Internal Production Control and Supervised Checks at Random Intervals – Module C2

QualityLab checks the conformity of Category III PPE type based on internal production control and supervised checks at random intervals.

The aim is to verify the homogeneity of production and the conformity of the model with the type described in the EU type-examination certificate and with the applicable essential health and safety requirements – Annex II to Regulation (EU) 2016/425 of 9 March 2016.

Product checks will be carried out at least once a year. The first check must be carried out before the PPE is placed on the market (see letter GROW.H.2/IAR/CC/ issued on 23 April 2024 by the European Commission).

This control is carried out as follows:

1. Submission of the application for Conformity Assessment of PPE in accordance with VII of EU Regulation 2016/425 – Module C2, by the manufacturer
2. If Module B has not been carried out by QualityLab, the manufacturer must send the following:

– Technical documentation referred to in Annex III of the Regulation;

– Copy of the EU Type Examination Certificate

– Information on the expected date and place of inspection

3. QualityLab carries out product inspections 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;
4. QualityLab selects an appropriate statistical sample of the PPE manufactured at a location agreed between the parties and verifies the conformity of the samples collected with the marking and instructions for use requirements as well as the test reports;
5. QualityLab verifies the homogeneity of production and prepares the Assessment Report. If the conformity of the product and the homogeneity of production are validated, QualityLab issues the Certificate of Conformity – Module C2.

The quote for the costs of certification will be sent after completing the Conformity Assessment – ​​Module C2 request and sending all the documentation requested by QualityLab.

The General Conditions for the provision of product certification services are described in the respective service requests. Other documentation can be provided upon request via email geral@qualitylab.pt

Steps for assessing conformity in textile materials and accessories for protective clothing

Conformity assessment is carried out in accordance with health and/or safety standards and/or technical specifications and following the NP EN ISO/IEC 17065 standard and the guidelines for certification schemes (NP EN ISO/IEC 17067). The certification scheme adopted is Type 1a, in which one or more samples of the product are subjected to assessment activities (tests). The certificate issued does not cover subsequent production items.

For the Type 1a certification scheme, no follow-up is required since the attestation only refers to the product items that have been subjected to assessment activities.

Whenever a Customer makes a request for conformity assessment, QualityLab acts in such a way as to:

✓ Provide all the information necessary for the assessment process.

✓ Provide all the necessary clarifications about the specific requirements of the product and the scope of the conformity assessment.

✓ Request the documentation required for the conformity assessment process.

The quote for certification costs will be sent after completing the request for Conformity Assessment for Textile Materials and Accessories for Protective Clothing and sending all the documentation requested by QualityLab.

The General Conditions for the provision of product certification services are described in the respective service requests. Further documentation can be provided upon request by email to geral@qualitylab.pt

In the Future….

The QualityLab certification team will monitor and participate in the development work of product certification at European level, in the Technical Committees for standardization and in the meetings promoted by the European Commission regarding Personal Protective Equipment legislation.