If you do not operate a certified Quality Management System that complies with the requirements of \(1 S O 9001\) then your quality control system will be assessed during the pre-permit phase and the following quality control system requirements will be verified for compliance as a minimum:
- Appointed quality management representative.
- Record of internal quality audits.
- Control of documents and reports.
- Production planned and carried out under controlled conditions.
- Customer complaints and corrective action
- Purchasing and control of incoming materials
- Handling, storage, packaging, preservation and delivery of the product
- Calibration and verification of test and measurement equipment and accuracy of measurements
- Control of nonconforming product, and
- Compliance to regulatory requirements, when appropriate.
The quality control, performance shall at no time fall below the level prevailing at the time that the permit holder was assessed for the purpose of the issue of the Mark permit.