ISO 9001:2008 - the changes.
Clause 4. Quality management system
Clause 4.1 (General requirements) (a), instead of requiring you to "identify" the processes needed in your system, it now requires that you "determine" them. This means that provided you know what they are, you don't need to specify them. At the end of clause 4.1, you are now no longer required to define any outsourced processes. But you must define the controls used to control them. A new Note (2) in clause 4.1 now says that clause 7.4 may apply to outsourced processes
Clause 4.2.3 (control of documents) has been amended slightly. The scope of "documents of external origin" has been clarified to state that it only applies to those external documents which are needed for the planning & operation of the system.
Clause 4.2.4 (control of records) has been extensively rewritten but seems to mean exactly what it did before.
Clause 5. Management responsibility
Clause 5.1 (management commitment) (a) now says "statutory and regulatory" instead of "regulatory".
Clause 5.5.2 (Management representative) clarifies that this must be a member of the organization' s own management, instead of just "of the management"
Clause 6. Resource 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. In clause 6.2.2, training is now only required "where applicable" to achieve the necessary competence. The other changes to this clause are just clarifications or changes for consistency with other clauses. Competence still remains a matter of interpretation rather than definition.
Clause 6.3 (Infrastructure ) (c) now includes "information systems" under the "Infrastructure of the organisation.
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 Product realisation
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, certification 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 7.5.2 has always been one which confuses people. In essence, if you can verify your products are correct before they leave the building you probably don't need to validate your processes. Note 1 implies that the clause probably applies to service industries. Note 2 gives examples of some service industries and manufacturing industries to which this clause probably applies.
Clause 7.5.3 for Identification &traceability have been increased. Product status must be identified throughout the production process.
Clause 7.5.4 (Customer property), explains that both intellectual property and personal data should be considered as customer property.
Clause 7.5.5 have been "harmonised" with 7.5.4 but their requirements have not altered at all.
Clause 7.6 (Now re-titled 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 Improvement.
Clause 8.2.1 (Customer satisfaction) is now accepted that customer perception of meeting requirements is just an "indicator", not a measurement of the performance of the system. 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 8.2.2 (auditing) has been "harmonised" but its requirements have not altered at all.
Clause 8.2.3 (Monitoring / Measurement of process) Two words have been added which could have a large impact on your system. The sub-clauses (a) - (d) only apply "where practicable". Also, the last sentence of the 2000 version of the standard has now been moved up to become sub-clause (d). 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.
8.5.2 (corrective action) and clause 8.5.4 will require a review of the effectiveness of the actions taken. (Most assessors and auditors currently assume that it says this already, although it doesn't!).