TABLE OF CONTENTS Quality in an analytical laboratory, or in any other organisation, can only be maintained by ensuring that the pursuit of quality is fully integrated into all laboratory activities and practised by laboratory staff at all times. The arrangements for managing quality can be divided into two groups. Firstly the relatively fixed arrangements such as administrative procedures and secondly dynamic processes that vary according to the nature of samples or tests, e.g. including characterised samples, known as quality control samples, with test samples. [18] [19] [20] [21]
A quality system is a set of procedures and responsibilities which a company or organisation has in place to ensure that staff have the facilities and resources to carry out measurements that will satisfy their clients. The quality system is a combination of quality management, quality assurance and quality control (see Section 5.4). The terms related to these activities are:
Assessment
Assessor
Audit schedule
Audit trail
External audit
Horizontal audit
Internal audit
Management review
Quality assurance
Quality audit
Quality manager
Quality manual
Technical manager
Vertical audit
Quality assurance is the planned and systematic control, implemented in the quality system, which provides confidence that the analytical service and the data generated provide the quality required by the client.
Internal quality assurance provides confidence to the management whereas external quality assurance provides confidence to the client. They are planned activities designed to ensure that the quality control activities are being properly implemented.
The quality manual is the primary source...
