- Latest available (Revised)
- Original (As made)
This is the original version (as it was originally made).
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 |
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Explanatory Memorandum sets out a brief statement of the purpose of a Statutory Instrument and provides information about its policy objective and policy implications. They aim to make the Statutory Instrument accessible to readers who are not legally qualified and accompany any Statutory Instrument or Draft Statutory Instrument laid before Parliament from June 2004 onwards.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
Click 'View More' or select 'More Resources' tab for additional information including: