ISO90012008Implementation.PDFVIP

ISO 9001:2008 Implementation Ray Ness ISO 9001:2008 Implementation 1 Introduction While the changes in the ISO 9001:2008 standard are minor in nature, they may still require you to update your quality management system (QMS). With this article, you’ll gain insight and information that will help you prepare for a seamless transition. We’ll start with a brief review of the changes published in ISO 9001:2008, as well as the concepts of Customer Satisfaction and the Process Approach. Next, we’ll go through a case study example of “Review and Refresh” implementation. Finally, you’ll be introduced to a useful process auditing tool for evaluating your QMS. The changes in ISO 9001:2008 ISO 9001:2008 was published on November 15, 2008. As of November 15, 2009, all audits must be performed against the requirements of this new version of the standard. Any remaining ISO 9001:2000 certificates will become invalid on November 15, 2010. Until then, certificates to ISO 9001:2000 will be considered equal to certificates to ISO 9001:2008. Compared to ISO 9001:2000, no new requirements have been introduced. Most of the changes are for ease of use and improved compatibility with ISO 14001:2004; these are in the form of “notes” at the end of certain elements/clauses. Information marked “NOTE” is not a requirement to be audited – it is guidance in understanding or clarifying the associated requirement. Annex B of ISO 9001:2008 has a full, detailed list of the changes from ISO 9001:2000. The following is a brief outline of the most significant changes: Clause Revision 4.1 Notes 2 3 explain outsourced processes. The organization has to control outsourced processes. 4.2.1.c .d Added “Records” for documentation requirements. Also note 1. 4.2.3.f Added clarification of documents for control. ISO 9001:2008 Implementation 2 Clause