ISO 9001:2008 - Proposed changes | Capable People Blog

Here’s a summary of the proposed changes to the standard based on the current draft. Nothing too significant, a clarification here, a re-wording there, but NO significant additions or removals

Many auditors will be wanting to know what the likely training requirements will be for the transition. Well, whilst no specific requirements have yet been published, we can only compare the transition training requirements to those required for auditors to OHSAS 18001. When this standard was re-issued in 2007 the changes were more numerous and significant than the ones listed below. In that instance OHSAS auditors were only required to demonstrate 4 hours structured CPD – with no requirement for specific registered training

ISO 9001 transition training requirements are likely to be similar or possibly even less. We’ll update you as and when clear guidance on the subject is released

Summary of proposed changes

Clause	Clause Title	Change 2000 – 2008
0.2	Process approach	Wording change to emphasise that processes must be capable of achieving desired outputs
1.1	Scope	Wording change to clarify that “product can also mean “intermediate product” and a note to explain that statutory and regulatory requirements may be expressed as legal requirements
4.1	General requirements	Notes will be included to clarify the requirements regarding “outsourcing” and its relationship with “purchasing”
4.2.1	General documentation requirements	Notes will be included to emphasise that “documentation” can also include “records” and that mandatory procedures may be in the form of combined documents, or that requirements may be covered by more than one document
4.2.3	Document control	Note to clarify that only external documents affecting the QMS need to be controlled
5.5.2	Management representative	Clarification that the MR must be a member of the organisation’s OWN management
6.2.1	Human resources	Clarification that competence requirements apply to any personnel whose work affects the QMS
6.3	Infrastructure	Clarifies that this includes Information Systems
6.4	Environment	Clarification of circumstances that are covered by this clause
7.2.1	Customer related processes	Clarification of what may be covered by “post delivery activities”
7.3.1	Design & development planning	Clarification that review, validation and verification all have distinct purposes but may be conducted and recorded either separately or in a combined way if appropriate
7.3.3	Design & development outputs	Clarification that product preservation requirements must be considered
7.5.4	Customer property	Clarification that intellectual property and personal data are covered by the clause
7.6	Control of monitoring & measuring devices	Retitled. Replace “devices” with “equipment”. Explanation of its applicability to software
8.2.1	Customer satisfaction	Note offers examples of how perception data may be captured
8.2.3	Monitoring and measurement of processes	Clarification that identifies that consideration be given to product conformity and QMS effectiveness