1.0 Introduction

A Quality Management system exists within the Clinical Microbiology Service of Greater Glasgow and Clyde (GG&C) Health board in order to establish quality policy and quality objectives and to achieve those objectives.

This is done through a process of quality planning which is the part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfil quality objectives.

The Quality Management system ensures that:

  • Laboratory management establishes written quality objectives, which are consistent with the quality policy and are regularly reviewed
  • This quality manual is reviewed regularly, updated as required and any changes communicated to all personnel concerned
  • There is an quality & compliance manager who has responsibility for the implementation and maintenance of the quality management system
  • There is a process of document control
  • The control of process and quality records are according to current legislation, regulations and guidelines
  • The control of clinical material is according to current legislation, regulations and guidelines
  • Laboratory management conducts an annual review of the laboratory’s quality management system and all its services

This Quality Manual is cross-referenced to the procedures and forms used by Microbiology.

The layout of the Quality Manual follows that of the ISO 15189:2012 Standard for Medical Laboratories. The quality manual is aligned with both ISO 15189:2012 & ISO 17025:2017 requirements.

In order to achieve an effective quality management system, there is a hierarchy structure of documentation which covers all the processes undertaken by the laboratory.