A quality management system is documented in a Quality Manual.
There are two useful purposes for the Quality Manual:
1) to provide a consistent interface for external auditors
The auditors need a consistent entry point into an organisation to be able to assess the organisation against a number of external standards.
2) to create the controlled environment for delivering Products and Services
All employees need to understand how products and services are delivered to customers. A Quality Manual (if written for the team members) can provide a clear picture of the roles and responsibilities and work (processes and procedures) necessary to deliver products and services to customers. These processes provide the basis for training and skill development of the people within the organisation. The processes should also identify the relevant tools and resources necessary to carry out this work.
In organisations, there may be unique or specific controlled environments. These are typcially defined in a Quality Plan that supports the Quality Manual.
Though there is no required standard for a quality manual, they generally contain the following sections:
Organisation, Roles, and Responsibilities
Including guidance to Auditors
Mapping to external standards
Generally, each process has a well defined structure. (See the Process Assets topic).
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