Significant Changes cited in 2008 Revised ISO 9001
Changes Cited in 2008 Revised issue of ISO 9001 is been summed up as below Clause 0.2 (Process approach): • Text added to emphasize the importance of processes being capable of achieving desired outputs Clause 1.1 (Scope) • Clarification that 'product' also includes intermediate product • Explanation regarding statutory, regulatory and legal requirements Clause 4.1 (General requirements) • Notes added to explain more about outsourcing • Types of control that may be applied to outsourced processes Relationship to clause 7.4 (Purchasing) • Clarification that outsourced processes are still responsibility of the organization and must be included in the quality management system Clause 4.2.1 (Documentation) • Clarification that QMS documentation also includes records • Documents required by the standard may be combined • ISO 9001 requirements may be covered by more than one documented procedure Clause 4.2.3 (Document control) • Clarification that only external documents relevant to ...