Internal Quality Audit

Most clinical laboratories in the UK have now had several years experience of accreditation. The current CPA standards now include internal quality audit as a requirement, aligned with other quality Standards, such as ISO 9000 and ISO 17025, the Standard UKAS inspect against.

Quality audits are described by the Standard BS EN 30011-1, Guide to Quality System Auditing, 1993,  as "A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives".

Put more simply, internal quality audit is a way to establish whether all activities that affect quality are being carried out.  

Why perform internal quality audits

No quality system will continue to be maintained or to develop without regular testing by the use of audit techniques.  It is common for standards to slip between CPA inspections, which only take place every four years.  It has been stated that "You get what you inspect not what you expect!".  As work becomes more demanding it gets more difficult to keep track of all activities within the laboratory.  Internal quality audit helps prevent a drop in good laboratory practice and through regular review, provides a better understanding of the day to day problems which occur in the laboratory.

Internal Quality Auditor training

Audits should be performed by staff trained in audit technique.  As with all other areas within the laboratory, staff need to show competency in audit technique.  It is easy to appoint an audit officer but they often do not know where to start.  Quality audit training is available which provides an understanding of how to set up an audit programme and also, as well as providing initial training in audit technique, gives participants the tools to train others within their laboratory.

Objectives of the course

The course is designed to give participants a general understanding of accreditation standards (with particular emphasis on CPA) which they are likely to come across in a pathology laboratory and also an overview of quality systems.  Participants are instructed in all aspects of quality auditing which should allow them to perform internal quality audits and importantly to set up an audit programme in their own laboratory.

Participants are given a comprehensive manual to complement the course.

The course has been approved for CPD by the Royal College of Pathology and the IBMS.

If you would like us to run an audit course at your place of work, please email Dr Ian Sharp for more details.