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ISO9001:2008 | |
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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) 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): 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): 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: o Actions under warranty provisions o Contractual obligations such as maintenance services o 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): 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) 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. [Please
check ISO/DIS 9001:2008 for details. FDIS is expected in Feb 2008] |