2008 changes to ISO 9001

Overview
Every few years all international standards are reviewed to ensure their continued relevance. ISO 9001 underwent a major overhaul in 2000 and another revision was issued in November 2008. The changes are minimal and provide further clarification of the clauses rather than additional requirements. More detailed information can be viewed on the ISO website. To obtain a personalized quotation for audit to the ISO 9001 standard click here.

Existing ISOQAR Customers

ISOQAR customers have until the 14th November 2010 to comply with the changes. However, if a re-assessment is due before then, but after 14th November 2009, it must be against the new standard. Guidance and support will be provided during surveillance visits or by telephone. Below you will find a checklist of the changes we have identified and intend to audit against.

New Customers
Before 15th November 2009 (a year after the issue of ISO 9001: 2008) new customers can choose to be audited against either the 2000 or 2008 version of ISO 9001. After this date all new audits will be against ISO 9001: 2008. However, new customers are encouraged to opt for the new standard straightaway. More information can be found on the International Accreditation Forum's website. The salient information is towards the end of the article.

Obtaining a copy of ISO 9001: 2008

The standard itself is copyright so we are unable to distribute it. You can buy or download it from a variety of sources including The Stationery Office and ISO itself. Search for "ISO 9001 requirements" not just "ISO 9001" to locate the standard more readily.

ISO 9001: 2008 Checklist

The 2008 version of the standard has no requirements additional to the 2000 edition it replaces. It merely provides clarification to the existing requirements.

Here is a summary of the changes we have identified: (also available here as a pdf ) Clause Clarification Does the company have a copy or access to a copy of ISO 9001: 2008? Have all references been amended to reflect an upgrade to ISO 9001: 2008? Confirm that any outsourced process is fully controlled where there is potential for an impact on the product or service provided. This should be controlled through clause 7.4. The type and extent of control should be defined. Confirm that the Management Representative is a member of the organisations own management. Ensure that any person performing work affecting "conformity of the product/service" is competent. Include information systems as a supporting service. Confirm that all applicable work environment conditions have been considered. Ensure any post delivery activity is covered (e.g. warranty, recycling, disposal obligation). Design review, verification and validation have distinct purposes. Confirm that they have been conducted and recorded as suitable for the product or the organisation. Ensure that the preservation of the product has been considered as applicable. Personal data and intellectual property (e.g. software) may now be considered as customer property and reported if unsuitable, lost or damaged. Title amended. "Control of monitoring and measuring equipment." Confirmation that computer software may not be subject to traditional calibration. May be focused on verification and configuration management. Calibration status identification does not have to be physically on the equipment, provided that the identification employed can determine the calibration status. Ensure that the Management of the "units" audited have implemented correction and corrective actions. Confirm that appropriate monitoring and measurement processes have been implemented, dependant on the Addressed? Yes / No

4.1

5.5.2 6.2.1 6.3 6.4 7.2.1 7.3.1 7.3.3 7.5.4 7.6

8.2.2 8.2.3

8.2.4 8.3

8.5.2 8.5.3

impact of the product/service and the effectiveness of the management system. The standard specifies that when products are released to the customer the company must maintain records of who is responsible to sign off the product for delivery. Corrective action taken should be appropriate to the effects, or the potential effects of the nonconformity when nonconforming product is detected AFTER delivery or use has started. Review of the effectiveness of corrective actions taken. Review of the effectiveness of preventative actions taken.