The standards allow a great deal of flexibility in the nature and structure of QMS documentation. A quality manual is essential, to provide an overview of all functions, and a link to all other documentation. For a very small laboratory with few functions, a quality manual may be the only QMS document required; usually, however, there are many others.

The quality manual must contain a quality policy, which is understood by all staff.

The QMS documentation must document all key areas of activity of the organisation.