The Fundamental of PPE Certification: ISO 17025 and ISO 17065

The quality and reliability of personal protective equipment (PPE) is paramount due to its importance in protecting the health and safety of users. The European Union (EU) and the United Kingdom (UK) have stringent regulations in place to ensure that PPE products are safe and effective.  

For PPE Regulation EU 2016/425 specifies requirements for the design, manufacture, and marketing of PPE. Under this regulation, ISO 17025 and ISO 17065 are seen to be the two fundamental standards that play a pivotal role in the certification of PPE.   

In this article, we delve into these two standards and discuss how brands and manufacturers can obtain EU and UKCA type examination certification to place PPE on the European markets. 

What is ISO 17025?

ISO 17025 is the international standard for the competence of testing and calibration laboratories. This standard specifies the general requirements for the competence, impartiality, and consistent operation of laboratories. ISO 17025 is crucial because it ensures that laboratories produce accurate and reproducible calibration and testing data. 

What is ISO 17065?

ISO 17065, on the other hand, pertains to the requirements for conformity assessment bodies, processes, and services. It focuses on ensuring that certification processes are conducted in a consistent, impartial, and reliable manner, which builds trust and assurance in the certifications granted for products like PPE.

How ISO 17025 and ISO 17065 are Related to PPE?

The certification process for PPE brands and manufacturers hinges on the pivotal importance of ISO 17025 and ISO 17065. The PPE Regulation EU 2016/425 enforces the requirements outlines in Regulation (EC) No 765/2008, which lays down rules on the accreditation of conformity assessment bodies and general principles of the CE marking, and provides a framework for the market surveillance of products and controls on products from third countries.

In this regulatory framework, ISO 17025 and ISO 17065 play integral roles, underlining their significance in ensuring the quality and compliance of personal protective equipment.

An ISO 17025 accredited laboratory means their testing competence is validated and their results are internationally recognised. This accreditation is important when undergoing a PPE EU or UKCA type examination where the authenticity and accuracy of testing data is scrutinised.

Furthermore, the bodies that certify PPE must comply with ISO 17065. This ensures that the certification process is impartial and consistent, providing confidence in the safety and efficacy of PPE products adhering to required standards.

Requirements to Get an EU or UKCA Type Examination Certificate to Put PPE in the EU and UK Markets

To sell PPE in the EU, an EU type examination certificate is required for Category II PPE (e.g., oven gloves, high visibility garments, thermal resistance garments, mechanical risks PPE) and Category III PPE (e.g., Chemical PPE, firefighters, thermal resistance against an electric arc exposure).  

For selling PPE in the UK markets, either an EU type examination certificate or a UKCA type examination certificate is compulsory for Category II PPE and Category III PPE. Both the EU type examination certificate and the UKCA type examination certificate are integral components of the personal protective equipment regulation.  

These certificates affirm that the prototype certified complies with the essential requirements of Regulation (EU) 2016/425 by means of safety standards and performance requirements. Key requirements include: 

Technical Documentation: This includes the design, manufacture, and operation of the product, ensuring all details are documented comprehensively, and the Manufacturer’s information and Declaration of Conformity. The full list of required data is listed in the ANNEX III of the PPE Regulation EU 2016/425. 

ISO 17025 Accredited Lab Testing: Tests performed by laboratories accredited under ISO 17025 to ensure the reliability of results of the materials that are going to be used in the PPE Type. 

ISO 17065 Certification Process: The conformity assessment bodies issuing the certificate must be certified under ISO 17065 to ensure impartiality and consistency in certification and notified by the Ministry of Industry. To request for the EU Type examination certificate, the manufacturer shall apply using an Application form the Module B to a Notify Body. 

Submission of Samples: Samples of PPE must be submitted for testing and assessment as well, as per the harmonised standards or technical specifications of the EU. 

Common Unaccredited Process

The manufacturers must ensure that the test reports of their materials have been performed by an accredited laboratory and that all the tests included in them are in the accreditation scope of the laboratory too, so they can be used in an assessment process to get the EU Type examination certificate.

How can the Eurofins Softlines & Leather network of laboratories help?

Within the Eurofins network of companies, our laboratories have obtained ISO 17025 and ISO 17065 accreditation. The following laboratories are accredited as European Notified Body or UK Approved Body to provide a variety range of PPE product testing and certification services: 

• Eurofins Textile Testing Spain is a Notified Body (No. 2865)  
• Eurofins Product Testing Italy is a Notified Body (No. 0477)  
• Eurofins E&E CML Limited is a UK Approved Body (2503) and UKNI Notified Body  
• Eurofins MTS Consumer Product Testing UK is a UK Approved Body (No. 2377) and UKNI Notified Body 

Our team of PPE experts are here to assist you in meeting your specific compliance needs, guiding you through the PPE certification processes for market entry in different regions. 

Visit Eurofins PPE Certification page to get more information or Contact Us here or send your inquiry directly to ppe-es@cpt.esurofinseu.com.