Ex Quality Systems
We offer ATEX Quality Assurance Notifications and IECEx Quality Audit Reports through a team of auditors based around the world. All have experience in auditing in multiple locations and with a range of protection methods.
The aim of the audit is to confirm the quality system and manufacturing process is operating effectively and results in compliant product manufactured. The audit is a quality system audit, but also includes review of the manufacturing processes to confirm that the system is operating in practice. In order to provide a comprehensive assessment of the system and processes for clients new to Ex product manufacturing, it is best to audit once the product undergoing certification has completed initial evaluation and product testing. It should also be possible to demonstrate, on prototype units, that the manufacturing processes and documentation are completed correctly.
Details are gathered at the quotation stage, to establish the protection methods, certification schemes to be covered, and the range of technical expertise required of the auditor. Clients who would like to change their quality approval body to Eurofins CML are welcome to contact us for a detailed discussion about your requirements.
An initial review of the manufacturer quality manual may be necessary to confirm the requirements of EN ISO/IEC 80079-34 have been addressed. Following initial review, an auditor will be assigned and a suitable audit date agreed.
The audit is conducted in accordance with ISO/IEC 17021-1:2015, and any findings are provided to the client at the end of the audit. Findings may be in the form of observations, or requirements to address. Simple documentation issues can be addressed and evidence provided in pdf format. Once cleared, the audit report can be completed and the quality certificate issued. In the event that one or more major issues are found during the audit, a second visit may be necessary to confirm the quality system is operating effectively.
Clients operating multiple manufacturing sites will require additional audits or extended audits to cover all the necessary detail.
Training is also offered in QA requirements and compliance.
In general, to enable the issue of an ATEX product certificate, a manufacturer must hold a valid Quality Assurance Notification (QAN).
Generally, we test small numbers of samples of products as part of the approval process. The Quality Assurance Notification(QAN) is required for continuous monitoring of systems and processes in relation to those ATEX products. A periodic audit of the manufacturing process by a qualified auditor is required to maintain the validity of the QAN
ATEX Quality Assurance Notification (QAN)
Manufacturers must comply with the appropriate Annex of the ATEX Directive (IV, V, VI, VII or IX) in line with the ATEX zone in which the equipment is to be placed.
The audit of the manufacturing location(s) of the product entails a review of records and a check of the design specification of the equipment. A surveillance audit then takes place approximately every 18 months, (12 months if ISO 9001 certification is not held) with a new ATEX QAN certificate issued every 3 years.
Manufacturers of IECEx approved equipment are legally required to have in place a quality management system for the production of their equipment.
This is known as a Quality Audit Report (QAR) for IECEx.
Along with having in place an ISO 9001 quality management system the manufacturer must be able to demonstrate compliance with the IECEx operational document ISO/IEC 80079-34.
After an initial audit, annual surveillance audits are required, however, under the rules of the IECEx if a manufacturer holds an ISO 9001 accreditation from a certification body holding national accreditation (e.g. UKAS) and are a member of the International Accreditation Forum (IAF MLA) then the surveillance audit can be on the basis of an 18 month period