Management System Monitoring
Companies today, regardless of size, face ever increasing demands for profitability, quality, and technology that contributes to sustainable development. In order to turn these pressures into a competitive advantage, there exists a need to develop an efficient management system tailored to the business processes and utilise it systematically to maintain and constantly improve the company’s overall performance.
Certified Conformity Ltd. auditors are trained to the principles of ISO 9001 and have many years’ experience of auditing PPE manufacturers and machine producers, they cover the globe from our bases in the United Kingdom, 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.
PPE – 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.
Certified Conformity Ltd, is accredited by UKAS for Article 11B and can offer approval of a manufacturer’s quality system for the items within our scope for fall arrest equipment.
THE ARTICLE 11B PROCESS
The manufacturer should provide Certified Conformity Ltd. 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 Certified Conformity Ltd 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 Certified Conformity
- All of the manufacturer’s Article 10 Certificates, whether issued by Certified Conformity or other Notified Bodies.
The Certificate is issued for 3 years, and can be updated with new sites, products, and technical files.
Certified Conformity Ltd, as a Notified Body, must continue to monitor the quality-control system by carrying out surveillance audits, generally once per year.
CE MARKING & 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. Certified Conformity Ltd Notified Body number must be shown beside the CE mark.
Certified Conformity Ltd. 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, Certified Conformity Ltd should be informed before applying our number to the marking.