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The minor changes to ISO 9001:2000 was published on the 15th November 2008 and issued as ISO 9001:2008 - The summary of the changes are shown below and the rules for upgrading:
From the joint International Accreditation Forum (IAF) and International Organisation for Standardisation (ISO) communiqué - they have recognised that ISO 9001:2008 introduces no new requirements. ISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 based on eight years of their experience of implementing the standard worldwide with about 1 million certificates issued in 170 countries to date by the various certification bodies such as ourselves. This will mean that one year after 15th November 2008 all new accredited certifications (new certifications and re-certifications) will be issued to ISO 9001:2008.
From 15th November 2010 all existing certification issued to ISO 9001:2000 will no longer be valid. In simple terms this means that at your next scheduled audit which falls on or before 15th November 2009 you have the option to upgrade to ISO 9001:2008, or postpone your upgrade until the next visit scheduled between 15th November 2009 and 15th November 2010. Whichever option you select the upgrade assessment will take place during your routine surveillance/re-assessment audit and at no extra cost to yourselves.
BS EN ISO 9001:2008 – Introduction and summary of the changes
The new standard in appendix B details the changes between ISO 9001:2000 and ISO 9001:2008 to enable the reader to quickly understand the changes that have taken place, for example: Section 0.1 General – in the introduction, ISO 9001:2008 adds “organisational environment”, “change”, and “risk” to the list of the factors that influence the design and implementation of a quality management system. Then later in section 0.1, ISO 9001:2008 changes “regulatory” to “statutory and regulatory” and clarifies that the customer, statutory, and regulatory requirements are those applicable to the product and or service. Section 4 now includes additional notes which identify clearly the factors influencing the control of an outsourced process and clarifies that a single document may now include the requirements for one or more procedures. A requirement for a documented procedure may also be covered by more than one document.
The addition of the “statutory and” regulatory requirements continues throughout the revised standard with an additional note that these can be expressed as legal requirements. In a number of cases in section 5.1 through 5.4 there are no changes in ISO 9001:2008, the same for section 5.5.1, 5.5.3 and 5.6 with only a minor change in section 5.5.2 that the “Top management shall appoint a member of the organisation’s management who, irrespective of other responsibilities, shall have responsibility and authority that includes:” – as some companies in the past have outsourced the Management Representative role to someone in a different organisation, or even to their consultant, this text may be aimed at that practice.
Section 6 mainly replaces the word “quality” with “conformity to product/service requirements” and states “that work can be affected directly or indirectly by personnel performing any task within the quality management system.” Section 6.3 also now includes information systems as part of the infrastructure requirements.
Section 7 now includes “post delivery activities e.g. actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal” with section 7.2. A few word changes and notes have been added in section 7.3 which describe details of the preservation of the product that is required e.g. product packaging etc. No changes have occurred to clause 7.4. There are some minor word changes in section 7.5 and the addition of the words, “product and the maintenance of record. Section 7.5.4 now includes reference to “personal data” and Section 7.6 describes predominantly word changes from “devices” to “equipment.”
Section 8, in detail section 8.1 “conformity of the product” has been revised to “conformity to product requirements”, and a new note has been added to section 8.2.1 to provide examples of monitoring customer perceptions. Section 8.2.2 contains minor word changes to clarify that “records of the audits and their results have to be maintained”. Within sections 8.2.3 & 8.2.4 additional notes and clarification have been provided for determining suitable methods when establishing the evidence of conformity with the acceptance criteria for release and for delivery to the customer. Section 8.3 has been slightly re-phrased and in section 8.4 the referenced clauses have been updated. There have been no changes to section 8.5.1. Sections 8.5.2 and 8.5.3 now include the term “reviewing the effectiveness of the corrective/preventative actions taken”.
This introduction/summary of the changes is not intended to be a definitive guide but to demonstrate that that ISO 9001:2008 has introduced no new requirements but simply clarified some of the existing requirements. You are strongly recommended to obtain a copy of the standard and the additions/deletions and revise as applicable your documented quality management system or integrated management system as soon as possible, such that you are able to upgrade to BS EN ISO 9001:2008 at your next scheduled visit.
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