Paragraph 13
Directions shall be given for the purpose of securing compliance with the requirements laid down in the provisions of the third Directive listed in the right-hand column, the subject-matter of which are described in the left-hand column in respect of those provisions.
Relevant provisions of the third Directive | |
|---|---|
| Organisation and management (requirements as to organisational structure, management systems, and third party agreements) | Annex I, Part A |
| Personnel (number, competence, responsibilities and training) | Annex I, Part B |
| Equipment and materials (appropriate for use, validation, maintenance, and specifications) | Annex I, Part C |
| Facilities and premises (suitability, environment, storage, and maintenance) | Annex I, Part D |
| Documentation and records (standard operating procedures, document control, record reliability) | Annex I, Part E |
| Quality review (quality management system, investigations, corrective action, and reviews) | Annex I, Part F |