3.0 Introduction to the quality manual

The Quality Manual describes the Quality Management System (QMS) of the Clinical Microbiology Departments & the Environmental Laboratory.

This manual fulfils two functions: it describes the QMS for the benefit of the laboratory’s own management and staff, and it provides information for users and for inspection/accreditation bodies.

This Quality Manual can be regarded as the index volume to the management, laboratory, clinical, testing and quality procedures. Subsequent sections of this Quality Manual are arranged so that they equate with sections of ISO 15189 and are aligned with ISO 17025 as per Appendix 2. There is a brief description of the way in which the service seeks to comply with the particular section of the standard and references are given to appropriate procedures.

The quality management system its examination processes are continually evaluated and quality assured. The results feed back to maintain and, where required, improve the quality management process and to ensure that the needs and requirements of users are met.

Multisite Accreditation

For GGC Microbiology, the laboratories are accredited under a single UKAS number and operate under a single management structure.

Each site has a comparable volume of work and carries out almost identical tests. Some services are only offered on one location and these are specified with the laboratory user manuals and are clear on the UKAS schedule. Where a test is only offered on one site this is detailed in the risk continuity SOP with mitigation and contingency detailed.

For all tests that carried out on both sites the SOP’s are identical as is the equipment, reagents and training.

As detailed in the resilience section each site has the capacity to take work from one site to the other in times of emergency. Staff may be asked to transfer with work in times of contingency. If this were to be put in place familiarisation and a mini induction would be carried out for all staff transferring between sites. All areas of GEN 1 have been considered and are in place to enable the laboratories to be set up for multisite accreditation.

UKAS GEN 1 - General Principles for the Assessment of Conformity Assessment Bodies by the United Kingdom Accreditation Service provides guidance on the assessment and accreditation of multi-site laboratories and describes how UKAS will assess and make reference to multi-site laboratory accreditations.