29th December 2007
ISO9001 has been around now since 2000 and it is normal practise for Standards to be reviewed and updated every five years or so. This update is now overdue.
The PDCA model has been retained and one member of then committee said it should stand for ‘Please don’t change anything’ rather than PLAN-DO-CHECK-ACT.
The ISO Committee has proposed that only minor changes should be incorporated into the 2008 update:
Clause 0.2 (Process approach)
- Text added to emphasize the importance of processes being capable of achieving desired outputs
Clause 4.2.3 (Document control)
- Clarification that only external documents relevant to the QMS need to be
Clause 4.2.4 (Records control)
- Editorial changes only (better alignment with ISO 14001)
Clause 5.5.2 (Management rep)
- Clarifies that this must be a member of the organization’s own management
Clause 6.2.1 (Human resources)
- Clarification that competence requirements are relevant for any personnel who are involved in the operation of the quality management system
Clause 6.3 (Infrastructure
- Includes information systems as example
Clause 6.4 (Work environment)
- Clarifies that this includes conditions under which work is performed and includes, for example physical, environmental and other factors such as noise, temperature, humidity, lighting, or weather
Clause 7.2.1 (Customer related processes)
- Clarifies that post-delivery activities may include:
- Actions under warranty provisions
- Contractual obligations such as maintenance services
- Supplementary services such as recycling or final disposal
Clause 7.3.1 (Design & development planning)
- Clarifies that design and development review, verification and validation have distinct purposes
- These may be conducted and recorded separately or in any combination as suitable for the product and the organization
Clause 7.3.3(Design & development outputs)
- Clarifies that information needed for production and service provision includes preservation of the product
Clause 7.5.4 (Customer property)
- Explains that both intellectual property and personal data should be considered as customer property
Clause 7.6 (Now retitled Control of Monitoring and Measuring equipment)
- Explanatory notes added regarding the use of computer software:
“Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.”
Clause 8.2.1 (Customer satisfaction)
- Note added to explain that monitoring of customer perception may include input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, and dealer reports
Clause 8.2.3 (Monitoring / Measurement of process)
- Note added to clarify that when deciding on appropriate methods, the organization should consider impact on the conformity to product requirements and on the effectiveness of the quality management system.
I must emphasise that these are proposed changes and not ‘set in stone’.
The 2008 Standard is expected to be published in November 2008.
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