A Quality
Manual is a document that was first required by the ISO 9001 standard for
Quality Management Systems. A Quality Manual is a top-level document that
describes an organization’s Quality Management System
(QMS). It can be used
both internally (for employees) and externally (for customers and
auditors). It is
common for a good auditor to ask to see a Quality Manual in advance of an audit
to get a feel for the organization’s QMS. By looking at the contents
of a Quality Manual then an auditor will start to get an appreciation of an
organisation in advance of an audit.
Quality Manual Structure
It is normal
for a Quality Manual to be structured around the standard on which it is based,
and so if a Quality Manual is based around the requirements of EU GMP, then it
is normal to have a section of the Quality Manual corresponding to each of the
nine chapters of EU GMP. Poor Quality Manuals normally involve simply
copying the requirement of the standard into the manual itself. This is
of little value. A good Quality Manual covers HOW an organization intends to achieve the requirement of
the standard that it is based on, for example:
— how are
People looked after
— how are
suitable Premises and Equipment maintained and
— how
Documents and Records controlled
— And
so on.
A Quality Manual is a very useful document that not only gives guidance and direction to an organization’s own personnel, but gives a potential customer, inspector or auditor an appreciation of an organization from the outside. If designed well it can be used as a tool to sell an organization, to show what a positive quality ethos they have and can show how good an organization is and how seriously it takes its Quality Management System.
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