Tuesday, July 24, 2007

Revision of ISO 9001: 2000 expected to be released before August 2008

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Release of Next ISO 9001 Delayed Until Mid 2009
The world will have to wait a little longer for the next iteration of its best selling voluntary standard for quality management systems.
Meeting in Tralee, Ireland, standards writers publicly acknowledged for the first time that the planned 2008 release of the next ISO 9001 standard is overly ambitious given the level of progress to date.

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Following a recent meeting of ISO’s Technical Committee TC176 in Helsinki, Finland, from June 11th – 15th 2007, publication of the new version of ISO 9001 has been brought forward from 2009 and is now scheduled to be published in August 2008.


Experts representing over 70 ISO member bodies, met to discuss the comments received during circulation of the Committee Draft (“CD”) of the new standard, and concluded that in view of the very limited changes being proposed, the draft is now sufficiently mature to progress directly to the DIS (Draft International Standard) stage


The main changes being introduced into the new standard are as follows:
• Clause 0.2 (Process approach)
o Text added to emphasize the importance of processes being capable of
achieving desired outputs
• Clause 1.1 (Scope)
o Clarification that “product” also includes intermediate product
o Explanation regarding statutory, regulatory and legal requirements
• Clause 4.1 (General requirements)
o Notes added to explain more about outsourcing
o Types of control that may be applied to outsourced processes
o Relationship to clause 7.4 (Purchasing)
o Clarification that outsourced processes are still responsibility of the organization and must be included in the quality management system
• Clause 4.2.1 (Documentation)
o Clarification that QMS documentation also includes records
o Documents required by the standard may be combined
o ISO 9001 requirements may be covered by more than one documented
procedure
• Clause 4.2.3 (Document control)
o Clarification that only external documents relevant to the QMS need to be controlled
• Clause 4.2.4 (Records control)
o Editorial changes only (better alignment with ISO 14001)
• Clause 5.5.2 (Management rep)
o Clarifies that this must be a member of the organization’s own management
• Clause 6.2.1 (Human resources)
o Clarification that competence requirements are relevant for any personnel who are involved in the operation of the quality management system

• Clause 6.3 (Infrastructure)
o Includes information systems as example
• Clause 6.4 (Work environment)
o 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)
o 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)
o Clarifies that design and development review, verification and validation have distinct purposes
o 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)
o Clarifies that information needed for production and service provision includes preservation of the product
• Clause 7.5.4 (Customer property)
o 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)
o 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)
o 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)
o 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.


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