Division 3.2

Application of the quality system must ensure that the products conform to the type described in the EC type-examination certificate.

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.

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 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 qualityX1of the design and of the products, including control of products which do not conformF1,

   • F2where the manufacture and/or final inspection and testing of the products, or elements thereof, are 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 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;

4. (d)

   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.