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. Table 2.1 provides information on some key standards inspection, licensing, accreditation and certification.
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.
Table 2.1 List of some key inspection/licensing/accreditation/certification standards
| Key standards | Applicable to | Responsible body | Website |
|---|---|---|---|
|
Caldicott Report 1997, implementation 1998 |
Confidentiality of patient data |
Department of Health |
|
|
Care Quality Commission Fundamental Standards 2014 |
Health and social care services in England |
Care Quality Commission |
|
|
Health and Care Standards 2015 |
Healthcare in Wales |
Healthcare Inspectorate Wales |
|
|
Health and Social Care Standards 2017 |
Care and treatment delivered by NHS Scotland |
NHS Quality Improvement Scotland |
|
|
Quality standards for health and social care 2006 |
The availability and quality of health and social care services in Northern Ireland |
The Regulation and Quality Improvement Authority, Department of Health, Northern Ireland |
|
|
European Foundation for Quality Management (EFQM) Self-Assessment |
Measurement of the effectiveness and, over time, the improvement in a Blood Service’s management system. Helping understand where they are on the path to excellence |
British Quality Foundation |
|
|
European Blood Inspection System (EuBIS) |
The safety of blood transfusion in Europe |
Institut für Transfusionsmedizin und Immunhämatologie |
|
|
Standards for Histocompatibility & Immunogenetics Testing |
Histocompatibility and Immunology (H&I) – reference and tissue typing |
European Federation for Immunogenetics (EFI) |
|
|
The Data Protection Act UK General Data Protection |
Protection regarding processing of personal data of UK residents | Information Commissioner's Office | www.ico.org.uk |
| General Data Protection Regulation | Protection regarding processing of personal data of EU residents | EU Commission | www.eugdpr.org |
|
Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture |
Validation of computer systems |
International Society for Pharmaceutical Engineering |
|
|
Good Manufacturing Practice (GMP) guidelines |
Pharmaceutical environments |
The European Commission publishes this online as EudraLex Volume 4 |
https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en |
|
HTA Directions 011/2021 – the standards required under the Human Tissue (Quality and Safety of Tissues and Cells for Human Application) Regulations 2007 HTA Codes of Practice |
Quality and Safety Assurance for Human Tissue and Cells for Patient Treatment |
Human Tissue Authority |
|
|
International standards for unrelated haematopoietic stem cell donor registries WMDA Accreditation Programme |
Stem cell and donor registries |
World Marrow Donor Association (WMDA) |
|
| ISO 15189 Medical Laboratories - requirements for quality and competence | Medical laboratories | UKAS | www.ukas.com |
|
ISO 17799 Information Security Management |
Information security |
BSI British Standards |
|
|
ISO 9000 2000 and ISO 9001 2008 Quality management system requirements |
Quality management system |
BSI British Standards |
|
| ISO 20000 IT Service Management Standard | Service management | BSI British Standards | www.bsigroup.com |
| ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes | Management of medical devices | BSI British Standards | www.bsigroup.com |
|
Joint Accreditation ICT Europe and EBMT (JACIE) assessment standard |
Stem Cell Immunology – Human Progenitor Cells (SCI – HPC) collection, processing and storage |
The Joint Accreditation Committee ISCT & EBMT (JACIE) |
|
|
NHSLA risk management assessment programme for NHS Trusts |
Management of claims and litigation |
National Health Service Litigation Authority |
|
|
PRINCE2 |
Project control |
Cabinet Office |
www.gov.uk/government/publications/best-management-practice-portfolio/ |