Annex B-1 Principle components of a quality manual  

The quality system should be formalized in a quality manual which must be maintained and kept up-to-date.

The person responsible for authorization and compilation of the quality manual should be identified. A distribution list of the quality manual and identification of holders of controlled copies of the quality manual should be included.

The quality manual should contain, for example, the following items or their equivalent:

1) Scope.
2) References.
3) Definitions.
4) Statement of quality policy.
5) Organization and management.
6) Quality system audit and review.
7) Personnel.
8) Accommodation and environment.
9) Equipment and reference material.
10) Measurement, traceability and calibration.
11) Calibration and test methods.
12) Handling of calibration and test items.
13) Records.
14) Certificates and reports.
15) Sub-contracting of calibration or testing.
16) Outside support services and supplies.
17) Complaints.