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Summary of Changes from 1994 Requirements
The following areas within a Client's existing quality system
(1994 edition of ISO 9001/2) may not to be compliant with the
new standard - ISO 9001:2001. Clients are recommended to address
the changes needed during the transition period in order to comply
with new system requirements.
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.
Detailed Changes
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