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 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 programmes, plans, manuals and records.

It must 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 quality of product, including control of products which fail to 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 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;

4. (d)

   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.