2.3 Other standards - Quality in blood and tissue establishments and hospital blood banks
There are a number of other standards that help define how a quality management system should be designed to meet the needs of a particular aspect of a Service’s work. Information on some key standards inspection, licensing, accreditation and certification are provided below.
They are all applicable within England. Some apply directly to the whole of the UK (e.g. the International Standards), others to England and Wales (e.g. the NHS Litigation Authority Risk management assessment programme). Where there is not a direct cross-reference the reader should investigate further to determine how the standards might apply.
All the primary sources cited here are places where sound advice on management systems to address the various requirements of a modern Blood Service can be found. These will support the design and establishment of a system that can be confidently subjected to an external inspection process. The list is not intended to be exhaustive and by the nature of change is only current at the time of publication. It is for this reason version numbering has not been applied to the available standards; they will be constantly updated.
- Key standard
-
Caldicott Report 1997, implementation 1998
- Applicable to
-
Confidentiality of patient data
- Responsible body
-
Department of Health
- Website
- Key standard
-
Care Quality Commission Fundamental Standards 2014
- Applicable to
-
Health and social care services in England
- Responsible body
-
Care Quality Commission
- Website
- Key standard
-
Health and Care Standards 2015
- Applicable to
-
Healthcare in Wales
- Responsible body
-
Healthcare Directorate Wales
- Website
- Key standard
-
Health and Social Care Standards 2017
- Applicable to
-
Care and treatment delivered by NHS Scotland
- Responsible body
-
NHS Quality Improvement Scotland
- Website
- Key standard
-
Quality standards for health and social care 2006
- Applicable to
-
The availability and quality of health and social care services in Northern Ireland
- Responsible body
-
The Regulation and Quality Improvement Authority, Department of Health, Northern Ireland
- Website
- Key standard
-
European Foundation for Quality Management (EFQM) Self-Assessment
- Applicable to
-
Measurement of the effectiveness and, over time, the improvement in a Blood Service’s management system
- Responsible body
-
British Quality Foundation
- Website
- Key standard
-
European Blood Inspection System (EuBIS)
- Applicable to
-
The safety of blood transfusion in Europe
- Responsible body
-
Institut für Transfusionsmedizin und Immunhämatologie
- Website
- Key standard
-
Standards for Histocompatibility and Immunogenetics Testing
- Applicable to
-
Histocompatibility and Immunology – reference and tissue typing
- Responsible body
-
European Federation for Immunogenetics (EFI)
- Website
- Key standard
-
The Data Protection Act – UK General Data Protection
- Applicable to
-
Protection regarding processing of personal data of UK residents
- Responsible body
-
Information Commissioner's Office
- Website
- Key standard
-
General Data Protection Regulation
- Applicable to
-
Protection regarding processing of personal data of EU residents
- Responsible body
-
EU Commission
- Website
- Key standard
-
Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture
- Applicable to
-
Validation of computer systems
- Responsible body
-
International Society for Pharmaceutical Engineering
- Website
- Key standard
-
Good Manufacturing Practice (GMP) guidelines
- Applicable to
-
Pharmaceutical environments
- Responsible body
-
The European Commission publishes this online as EudraLex Volume 4
- Key standard
-
HTA Directions 011/2021 – the standards required under the Human Tissue (Quality and Safety of Tissues and Cells for Human Application) Regulations 2007 – and HTA Codes of Practice
- Applicable to
-
Quality and Safety Assurance for Human Tissue and Cells for Patient Treatment
- Responsible body
-
Human Tissue Authority
- Website
- Key standard
-
International standards for unrelated haematopoietic stem cell donor registries – WMDA Accreditation Programme
- Applicable to
-
Stem cell and donor registries
- Responsible body
-
World Marrow Donor Association (WMDA)
- Website
- Key standard
-
ISO 15189 Medical Laboratories – requirements for quality and competence
- Applicable to
-
Medical laboratories
- Responsible body
-
United Kingdom Accreditation Service (UKAS)
- Website
- Key standard
-
ISO 17799 Information Security Management
- Applicable to
-
Information security
- Responsible body
-
BSI British Standards
- Website
- Key standard
-
ISO 9000 2000 and ISO 9001 2008 Quality management system requirements
- Applicable to
-
Quality management system
- Responsible body
-
BSI British Standards
- Website
- Key standard
-
ISO 20000 IT Service Management Standard
- Applicable to
-
Service management
- Responsible body
-
BSI British Standards
- Website
- Key standard
-
ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes
- Applicable to
-
Management of medical devices
- Responsible body
-
BSI British Standards
- Website
- Key standard
-
Joint Accreditation ICT Europe and EBMT (JACIE) assessment standard
- Applicable to
-
Stem Cell Immunology – Human Progenitor Cells (SCI-HPC) collection, processing and storage
- Responsible body
-
The Joint Accreditation Committee ISCT and EBMT (JACIE)
- Website
- Key standard
-
NHSLA risk management assessment programme for NHS Trusts
- Applicable to
-
Management of claims and litigation
- Responsible body
-
National Health Service Litigation Authority
- Key standard
-
PRINCE2
- Applicable to
-
Project control
- Responsible body
-
Cabinet Office
Last updated on 19 February 2014