Information only Gents,The
ISO 9000:2000 family of quality management system standards is being
updated with an anticipated final release date in 2009. The updated
standards (ISO 9001 and ISO 9004) are being released as committee
drafts and are drafts for review. The two documents are not intended to
be used for quality system design purposes. As committee drafts, the
two standards are offered for public review and comment only.
The main changes being introduced into the new standard are as follows:
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 the QMS need to be controlled
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.