PPE Module D
PPE Module D
Shirley Technologies (Europe) Limited are accredited for Module D.
Category III PPE must undergo annual checking by a Notified Body, in accordance with the PPE Regulation (EU) 2016/425. Manufacturers have two options, Module C2 or Module D. The Module D procedure is suitable for manufacturers of Category III PPE with an approved quality-control system, such as ISO 9001 or similar systems.
We are able to offer approval of a manufacturer’s quality system for the items within our scope, including protective clothing, gloves, hoods, balaclavas, aprons, vests and related protectors, as well as firefighter boots and helmets.
The Module D process
The manufacturer must provide Shirley® with its quality-control system documentation. We will then audit the production sites and other premises included in the quality system, such as head office, design offices etc. Once we decide that the system can produce PPE which conforms with the original model, with the Regulation and with the relevant standards, then we will issue an Module D Certificate.
The Certificate will cover the following:
- all of the manufacturer’s production sites covered by the audits.
- all of the manufacturer’s products and technical files notified to Shirley Technologies (Europe) Limited.
- all of the manufacturer’s Module B Certificates, whether issued by Shirley Technologies (Europe) Limited or other Notified Bodies.
The Certificate is issued for 3 years, and can be updated with new sites, products, and technical files.
We will then continue to monitor the quality-control system by carrying out surveillance audits, generally once per year.
CE Marking and the Declaration of Conformity
Once the Module B Certificate is issued, the manufacturer can then issue the EU Declaration of Conformity according to Article 15 of the PPE Regulation, and affix the CE mark to their product in accordance with Article 17. Our notification number must be shown beside the CE mark.
The number can be applied to any PPE item covered by the Module D Certificate. If a new product or new Technical File is approved by another Notified Body, we should be informed before applying our number to the marking.
Auditors are trained to the principles of ISO 9001 and have many years’ experience of auditing PPE manufacturers and textile producers, they cover the globe from our bases in Ireland, the United Kingdom, China and India. PPE manufacturers in Europe, Africa, Asia, and North and South America may rely on our professional auditing staff to deliver product specific, high-quality auditing to internationally renowned quality management auditing standards.
For manufacturers of firefighter equipment for marine use, our auditors can often combine the PPE Module D audit with a Marine Equipment Directive Module D audit, providing a cost-effective solution for manufacturers targeting both markets.
Through our Ireland and UK based auditors, we can also provide ISO 9001 certification, and can usually conduct a PPE Module D audit alongside the ISO 9001 audit. This allows a manufacturer to gain Quality Management Systems approval at the same time as fulfilling their regulatory obligations.