Quality Manual and other Documentation

A system for auditing and reviewing quality procedures is a specific requirement of ISO/IEC 17025, ISO 9001 and GLP. This is a critically important aspect of any quality management system so we will consider these activities in some detail. The first, and most important, thing to realize about Quality Audit and Management Review is that they are two completely different activities. This section deals with auditing while Section 9.5 deals with management review. 

What do you think is meant by these different types of audit  

You may have already experienced an audit so would be able to identify an internal audit. This is an inspection carried out by staff of the laboratory but who are independent of the work activity carried out in the area being audited, i.e. the auditee. Both the second-party and 

It may seem unnecessary to have audits especially when there seem to be so many different types of audit. However, in spite of all of the documented procedures there are problems that can arise in analytical laboratories due to changes in staff, procedures, equipment, sample type and number of samples. For a laboratory to provide a consistent standard of quality in the face of all of these regular operational changes, Quality Audits need to be carried out. Audits will identify the problems which are expected to emerge, and provide a system to put them right. 

For laboratories seeking external accreditation of their work, audits must be planned and written down so that the laboratory can show that they are being carried out. You should note that a laboratory will not be criticized for finding problems when they audit their work. The important thing is to be on the lookout for problems, to find them where they exist and to put them right. No laboratory should rely solely on periodic assessments by an external body to ensure that standards of quality are continuously maintained. There are a number of reasons for this. 

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