The clauses of the standard

The following pages describe the requirements of the standard. Brief descriptions of each requirement is provided however it is vital that each organisation identifies the method by which these are implemented.

Scope - Clause 1

1.2 If any exclusions apply to the existing Registered Scope, because they are not applicable within the new Clause 7 (e.g. design), they should be justified within the Quality Manual.

Refer to QEC guidance on clause 1.2 - Application

Quality Management System - Clause 4

4.1 There is a need to identify the processes within the QMS. The client must identify :

• how they will be applied and interact within the organisation,
• what resources will be required and
• how the processes will be measured and monitored.

The processes should also enable continual improvement.

4.2 Documentation requirements for the Quality Manual should cover :

• the scope of the system,
• a description of the processes and
• the six procedures, one of which is Preventive Action.