ISO 9001:2008 - What’s New?

This ‘fourth edition’ of the Standard was released on the 15th November 2008. It is not a revision but it only introduces amendments, clarifications and some additional ‘Notes’. It also aims to increase compatibility with ISO 14001:2004.
While there are many cosmetic changes and those based on semantics, here is an abbreviated list of the notable differences between the 2000 and 2008 versions:
1. Cl 1.1: The definition of the term ‘Product’ now includes also ‘any intended output resulting from the product realization process’.
2. Cl 4.1 : There are a number of additional requirements as regards outsourced processes. One is, ‘The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system’. The meaning of ‘outsourced product’ is now made clear as a process that is needed for the QMS (specially with respect to Cls. 7.2.1 and 7.4) but is chosen to be performed by an external agency. An additional note makes it clear that outsourcing will not absolve the company of the responsibility for conformity to requirements. The note also covers how the company can decide on the extent of control to be exercised on the BPO. For greater ‘officail’ clarification on the term ‘outsourced processes’, see the ISO site at: http://isotc.iso.org/livelink/livelink/3553354/Outsourced.doc?func=doc.Fetch&nodeid =3553354
3. Cl 4.2.1 : It is now made very clear that records also are treated as documents and you determine which records are necessary for effective planning, operation and control of your processes.
4. Cl 4.2.3 : Now you need to determine which of the external documents are necessary for the planning and operation of the QMS and control their distribution. This eliminates the earlier vagueness on this subject.
5. Cl 4.2.4 : This again emphasizes that Records also must be controlled.
6. Cl 7.5.3 : While the 2000 version mentioned that the product status shall be identified with respect to monitoring and measurement requirements, now it is made clear that this applies throughout the product realization.
7. Cl 7.6 : In the 2000 version, there was a note which suggested seeing ISO 10012 parts 1 & 2 (QA systems for measuring equipments) for reference; this note is now removed. Instead, a note is added suggesting that the suitability of computer software may be checked by verification and by configuration management.
8. Cl 8.2.1 : The 2000 version states only that the method of obtaining customer perception ‘shall be determined’. Now a new note points out that this can be done through Customer Satisfaction surveys, customer data on product quality, user opinion survey, lost business analysis, compliments, warranty claims and dealer reports.
9. Cl 8.2.3 : A change has been now made to show that correction and corrective action to meet the planned results of the QMS are not just for the product conformity but cover the system conformity. And a Note is added to say that the type and extent of measurements could be based on the nature of the process impacting on the product and the QMS.
10. 8.5.2 & 8.5.3 : Now it is not sufficient to only ‘review’ the corrective and preventive actions but you have to review their effectiveness.
It is worthwhile noting that the certification to ISO 9001:2000 will be valid till 14th November 2010; but all recertifications and new certifications will be only to the 2008 version from November 2009. You can get your certifying body to audit you to the 2008 edition during the forthcoming surveillance audit itself.

- Ref: Annexure B of ISO 9001:2008