PPE Article 11B
PPE – Article 11B
As Notified Body 0338 and 0339, BTTG™ is accredited for Article 11B.
Category III PPE must undergo annual checking by a Notified Body, in accordance with Article 11 of the PPE Directive. Manufacturers have two options, 11A or 11B. The Article 11B procedure is suitable for manufacturers of Category III PPE with an approved quality-control system, such as ISO 9000 or similar systems.
BTTG™, Notified Body 0338 and 0339, is accredited for Article 11B and can 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 Article 11B process
The manufacturer should provide BTTG™ 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 BTTG™ decides that the system can produce PPE which conforms with the original model, with the Directive and with the relevant standards, then we will issue an Article 11B 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 BTTG™
- all of the manufacturer’s Article 10 Certificates, whether issued by BTTG™ or other Notified Bodies.
The Certificate is issued for 3 years, and can be updated with new sites, products, and technical files.
BTTG™, as a Notified Body, must 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 11B Certificate is issued, the manufacturer can then issue the Declaration of Conformity according to Article 12 of the PPE Directive, and affix the CE mark to their product in accordance with Article 13. The BTTG™ Notified Body number (either 0338 or 0339 as appropriate) must be shown beside the CE mark.
The BTTG™ number can be applied to any PPE item covered by the Article 11B Certificate. If a new product or new Technical File is approved by another Notified Body, BTTG™ should be informed before applying our number to the marking.
BTTG™ auditing services
BTTG™ 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 the United Kingdom, China and India. PPE manufacturers in Europe, Africa, Asia, and North 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 Article 11B audit with a Marine Equipment Directive Module D audit, providing a cost-effective solution for manufacturers targeting both markets.
BTTG™, through our UK based auditors, can also provide ISO 9000 certification, and can usually conduct a PPE Article 11B audit alongside the ISO 9000 audit. This allows a manufacturer to gain Quality Management Systems approval at the same time as fulfilling their regulatory obligations (see here for our ISO 9001 information).