Division 3.2

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 inspection. 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 policies and procedures such as quality programmes, quality plans, quality manuals and quality records.

F1It 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 design and of product, including control of products which fail to 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, including the corresponding documentation, and in particular:

   • a general description of the product, including any variants planned, and its intended use(s),

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

   • the techniques used to control and verify the design and the processes and systematic measures which will be used when the products are being designed,

   • if the device is to be connected to other device(s) in order to operate as intended, proof must be provided that it conforms to the essential requirements when connected to any such device(s) having the characteristics specified by the manufacturer,

   • a statement indicating whether or not the device incorporates, as an integral part, a substance or a human blood derivative referred to in section 7.4 of Annex I 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,

   • a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Commission Directive 2003/32/EC ^f1 ,

   • the solutions adopted as referred to in Annex I, Chapter I, Section 2,

   • the pre-clinical evaluation,

   • the clinical evaluation referred to in Annex X,

   • the draft label and, where appropriate, instructions for use;

4. (d)

   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;

5. (e)

   the appropriate tests and trials which will 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 to trace back the calibration of the test equipment adequately.