Division 3.2

The application of the quality system must ensure that the products conform to the provisions of this Directive which apply to them at every stage, from design to final controls.

All the elements, requirements and provisions adopted by the manufacturer for his quality system shall be documented in a systematic and orderly manner in the form of written policies and procedures. This quality-system documentation must make possible a uniform interpretation of the quality policies and procedures such as quality programmes, quality plans, quality manuals and quality records.F1 It shall include in particular the corresponding documentation, data and records arising from the procedures referred to in point (c).

It shall include in particular an adequate description of:

1. (a)

   the manufacturer's quality objectives;

2. (b)

   the organization of the business and in particular:

   • the organizational structures, the responsibilities of the managerial staff and their organizational authority where quality of design and 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 design and of the products, including control of products which do not conformF2,

   • where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;

3. (c)

   the procedures for monitoring and verifying the design of the products and in particular:

   • the design specifications, including the standards which will be applied and a description of the solutions adopted to fulfil the essential requirements which apply to the products when the standards referred to in Article 5 are not applied in full,

   • the techniques of control and verification of the design, the processes and systematic actions which will be used when the products are being designed,

   • a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in Section 10 of Annex 1 and the data on the tests conducted in this connection required to assess the safety, quality and usefulness of that substance or human blood derivative, taking account of the intended purpose of the device,

   • the pre-clinical evaluation,

   • the clinical evaluation referred to in Annex 7;

4. (d)

   the techniques of control and of quality assurance at the manufacturing stage and in particular:

   • the processes and procedures which will be used, particularly as regards sterilization, purchasing and the relevant documents,

   • product-identification procedures drawn up and kept up to date from drawings, specifications or other relevant documents at every stage of manufacture;

5. (e)

   the appropriate tests and trials which will be effected before, during and after production, the frequency with which they will take place, and the test equipment used.