Tomax, as a leading manufacturer of professional safety workwear, has successfully obtained the EU Module D certification under the PPE Regulation (EU) 2016/425, marking a significant milestone in its commitment to producing top-tier Category III personal protective equipment (PPE). This certification underscores Tomax’s adherence to the highest EU quality and safety standards, ensuring superior protection for workers in extreme-risk industries.
What is Module D Certification?
Module D certification is a rigorous conformity assessment procedure under the European Union's Personal Protective Equipment (PPE) Regulation (EU) 2016/425. It specifically applies to Category III PPE, which is designed to protect against risks that can cause serious or fatal consequences (e.g., chemical exposure, electric arcs, molten metal splashes, chainsaw cuts).
Core Principle of Module D
The essence of Module D is continuous quality assurance of the production process. Unlike certifications that only test product samples, Module D requires a notified body (an officially designated EU organization) to:
1. Audit and approve the manufacturer's full quality management system.
2. Ensure ongoing factory production control to guarantee that every batch of products consistently meets the required EU standards.
Key Requirements of Module D
1. Quality System Assessment: The manufacturer must implement a comprehensive quality management system, compliant with standards like EN ISO 9001, covering all processes from design to production and inspection.
2. Production Process Control: The notified body evaluates and monitors critical production processes to ensure they are consistently controlled and effective.
3. Final Product Inspection: The manufacturer must establish and maintain procedures for final product checks to verify compliance before release.
4. Ongoing Surveillance: The notified body conducts regular surveillance audits (typically annually) to ensure the manufacturer continues to comply with all requirements.
Module D vs. Other Certification Modules
The EU PPE Regulation offers different modules for different risk levels:
Risk Category | Protection Level | Required Certification Modules |
Category I | Simple, low-risk designs | Module A: Self-declaration by manufacturer |
Category II | Intermediate risks (e.g., safety glasses) | Module B (EC Type-examination) + Module C (random product testing) |
Category III | Complex, high-risk, life-threatening | Module B (EC Type-examination) + Module D (production quality assurance) or Module C2 |
For Category III products, Module D is often considered the gold standard as it certifies the entire manufacturing system rather than just relying on periodic product sampling (as in Module C2).
Validity and Importance
1. A Module D certificate is typically valid for 3 years, subject to successful annual surveillance audits.
2. For manufacturers like Tomax, achieving Module D certification is a significant milestone. It demonstrates to global B2B partners, distributors, and end-users a commitment to the highest levels of quality, safety, and reliability.
3. It provides a strong competitive advantage, as many professional buyers and specifiers in industries like oil & gas, utilities, and forest require their PPE suppliers to have Module D certification.
In summary, Module D certification is a comprehensive system that guarantees consistent production of high-quality, compliant, and life-saving protective workwear. It builds trust and is a key requirement for manufacturing and selling the most critical PPE in the European market.
