- Latest available (Revised)
- Original (As adopted by EU)
Commission Directive 2005/62/ECShow full title
Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments (Text with EEA relevance)
You are here:
What Version
More Resources
Revised version PDFs
- Revised 15/08/20160.18 MB
Legislation originating from the EU
When the UK left the EU, legislation.gov.uk published EU legislation that had been published by the EU up to IP completion day (31 December 2020 11.00 p.m.). On legislation.gov.uk, these items of legislation are kept up-to-date with any amendments made by the UK since then.
This item of legislation originated from the EU
Legislation.gov.uk publishes the UK version. EUR-Lex publishes the EU version. The EU Exit Web Archive holds a snapshot of EUR-Lex’s version from IP completion day (31 December 2020 11.00 p.m.).
Status:
This is the original version (as it was originally adopted).
1.INTRODUCTION AND GENERAL PRINCIPLES
1.1.Quality system
1.Quality shall be recognised as being the responsibility of all persons involved in the processes of the blood establishment with management ensuring a systematic approach towards quality and the implementation and maintenance of a quality system.
2.The quality system encompasses quality management, quality assurance, continuous quality improvement, personnel, premises and equipment, documentation, collection, testing and processing, storage, distribution, quality control, blood component recall, and external and internal auditing, contract management, non-conformance and self-inspection.
3.The quality system shall ensure that all critical processes are specified in appropriate instructions and are carried out in accordance with the standards and specifications set out in this Annex. Management shall review the system at regular intervals to verify its effectiveness and introduce corrective measures if deemed necessary.
1.2.Quality assurance
1.All blood establishments and hospital blood banks shall be supported by a quality assurance function, whether internal or related, in fulfilling quality assurance. That function shall be involved in all quality-related matters and review and approve all appropriate quality related documents.
2.All procedures, premises, and equipment that have an influence on the quality and safety of blood and blood components shall be validated prior to introduction and be re-validated at regular intervals determined as a result of these activities.
Options/Help
Print Options
PrintThe Whole Directive
PrintThe Whole Annex
PrintThis Division only
Legislation is available in different versions:
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 adopted by EU): The original version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.
Opening Options
Different options to open legislation in order to view more content on screen at once
More Resources
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as adopted version that was used for the EU Official Journal
- lists of changes made by and/or affecting this legislation item
- all formats of all associated documents
- correction slips
- links to related legislation and further information resources
More Resources
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
- the original print PDF of the as adopted version that was used for the print copy
- correction slips
Click 'View More' or select 'More Resources' tab for additional information including:
- lists of changes made by and/or affecting this legislation item
- confers power and blanket amendment details
- all formats of all associated documents
- links to related legislation and further information resources
All content is available under the Open Government Licence v3.0 except where otherwise stated. This site additionally contains content derived from EUR-Lex, reused under the terms of the Commission Decision 2011/833/EU on the reuse of documents from the EU institutions. For more information see the EUR-Lex public statement on re-use.