4.2.1 System Documented
Purpose
The Quality Management System documentation shall include;
- documented statements of quality policy and quality objectives,
- a quality manual,
- documented procedures and records required by the International Standard. A documented procedure is one that has been established, documented, implemented and is maintained.
- A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document, and
- documents, including records, determined by the organisation to be necessary to ensure the effective planning, operation and control of its processes. The extent of the documentation can differ from one organisation to another due to;
- the size of organisation and type of activities,
- the complexity of processes and their interactions, and
- the competence of personnel.
This documentation can be in any form or type of medium.
Procedure
[enter-your-company-name-here] has documented all systems and procedures that are required to comply with the requirements of the International Standard ISO9001-2008 and to provide documentation for the organisation to operate effectively.
The documentation includes statements of quality policy and quality objectives, a quality manual, documented procedures and records. In some cases, a single document will address the requirements for one or more procedures.
A requirement for a documented procedure will, in some cases, be covered by more than one document.
The documentation may be in any form or type of medium such as written, electronic, diagrammatic or visual depending upon the application.