The annexes of the medical device directive contains a number of requirements concerning the quality system. These are requirements that the manufacturer must meet. Please note: this does not mean that the manufacturer must operate an approved quality management system such as ISO 13485:2003!
Annex V specifies certain requirements to the quality management system, such as:
- All the elements, requirements and provisions adopted by the manufacturer for his quality system must be documented in a systematic and orderly manner in the form of written policy statements and procedures.
- This quality system documentation must permit uniform interpretation of the quality policy and procedures such as quality programs, plans, manuals, and records.
- the manufacturer's quality objectives;
- the organizational structures, the responsibilities of the managerial staff and their organizational authority where manufacture of the products is concerned,
- the methods of monitoring the efficient operation of the quality system and in particular its ability to achieve the desired quality of the product, including control of products which fail to conform;
- the inspection and quality assurance techniques at the manufacturing stage and in particular:
- the processes and procedures which will be used, particularly as regards sterilization, purchasing, and the relevant documents,
- the product identification procedures drawn up and kept up to date from drawings, specifications or other relevant documents at every stage of manufacture;
- the appropriate tests and trials to be carried out before, during and after manufacture, the frequency with which they will take place, and the test equipment used; it must be possible adequately to trace back the calibration of the test equipment.