ISO (International Organization for Standardization) has published the 4th edition of ISO 9001:2008 Quality Management System – Requirements on 15 November 2008.
The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and its compatibility with ISO 14001:2004. ISO 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard.
Certification to ISO 9001:2008 is not an “upgrade”, and the organization that certified to ISO 9001:2000 should be afforded the same status as those who have already received a new certificate to ISO 9001:2008
No new requirements were introduced in this edition but, in order to benefit from the clarifications of ISO 9001:2008, current ISO 9001:2000 user will need to take into consideration whether the clarifications introduced have an impact on the current interpretation of ISO 9001:2000, as changes may be necessary to the current QMS. Here is an implementation guideline published in ISO Management System Magazine (advice-for-users-on-iso90012008).
Following is a general guideline of the review & implementation:
A wide diffusion of this implementation guidance is recommended, in particular the comparison table between ISO 9001:2008 and ISO 9001:2000, given in Annex B to ISO 9001:2008 that I have enclosed for reference (click here to download the file).
In general, some clauses of the revised ISO 9001:2008 have been tightened whilst others have been softened. Many of the changes are limited to amended phrases or even wording (e.g. “devices” being replaced by “equipment”), in other cases paragraphs were re-ordered but with no effect onto existing management systems.
So, what are the new requirements of the new standard? Here are the summary list:
- Statutory requirements are having the same scale as any customer or regulatory requirements. It’s also clarified that these requirements are restricted to those applicable to the product.
- The statutory requirements had been referred in connection with purchased products and product realization. Means supplier also have to compliance with the legal requirements. (Note explain statutory requirements can be a legal requirement)
- Clearer explanation on the “out-sourced” processes. Out-sourced process is part of purchasing processes.
- A purchased process is just like any other product that the organization purchased. If it’s affecting the product it must be under the quality system.
- You may include two quality processes in one document and split one process to two documents.
- Clarify that external documentation are the ones needed for the quality management system.
- The management representative must be a member of the own management team.
- Now requires the organization to ensure that necessary competence has been achieved.
- Information system in now officially considered as part of infrastructure.
- Parameters such as humidity, noise and temperatures, concerning the employees’ health are considered as working environment.
- Measuring is considered as one of the activities of product realization.
- Clarifies that design and development review, verification, and validation have distinct purposes but may be conducted and recorded separately or in any combination as suitable for the product and the organization..
- The product must be identifying not only on the shelves but also throughout the realization process.
- Specify that personal data should be considered customer property.
- Clarifies that post-delivery activities may include actions under warranty provisions, contractual obligations such as maintenance services and supplementary services such as recycling or final disposal.
- The management is now responsible for preventive and corrective actions regarding non-conformities that were discovered during audit.
- The organization should determine the type of the monitoring and measuring according to the processes and how will this affect the quality management system.
According to a joint announcement by the ISO and the IAF (International Accreditation Forum), the two organizations have agreed to an implementation plan for a smooth migration to ISO 9001:2008.
- Certification to ISO 9001:2008 will only be issued after publication of ISO 9001:2008 (i.e after 15 November 2008) and after a routine surveillance audit or re-certification audit against ISO 9001:2008.
- One year after publication of ISO 9001:2008 (i.e. after 14 November 2009), all certifications issued (new certifications and re-certifications) must be to ISO 9001:2008.
- Two years after publication of ISO 9001:2008 (i.e. after 14 November 2010), existing ISO 9001:2000 certifications will not be valid.
The Technical Committee that develop the ISO 9001 standard, ISO/TC 176/SC 2 has also developed an introduction and support package of documents explaining what the differences are between ISO 9001:2008 and the year 2000 version, why and what they mean for users. These documents are available on the ISO Web site.
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(Source of information : ISO Press Statement and the ISO Web Site)