A Technical File must be completed to reflect the product design, referenceing design philosophy and safety measures employed, and will contain the Test Reports and Test Results obtained during the product compliance evaluation process.
The Technical File will be held by the Ex Notified body for Category 1 and 2 equipment, but may be held by the Manufacturer for Category 3 equipment.
A Certificate Holder must be selected that is an official Ex Notified Body.
An Ex Certificate is issued based upon all necessary tests being completed satisfactorily and the manufacturer’s statements of compliance.
A QA Notified Body is appointed to monitor the manufacturer's Quality Management.
A Quality Assurance Notification Certificate issued by the QA Notified Body to verify confidence in the manufacturer's ability to produce product with the necessary manufacturing and quality controls in operation. This QA Notified Body must take into account existing Quality System approvals that may already exist.