Other standards - Quality in blood and tissue establishments and hospital blood banks - Chapter 2

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.

The following table lists some key standards for inspection, licensing, accreditation and certification.

Table 2.1 Key standards

Standard	Applicable to	Responsible body
Standard Caldicott Report 1997 (implemented 1998)	Applicable to Confidentiality of patient data	Responsible body Department of Health and Social Care
Standard Care Quality Commission Fundamental Standards 2014	Applicable to Health and social care services in England	Responsible body Care Quality Commission
Standard No data	Applicable to No data	Responsible body No data