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Distributor's Link Magazine Fall Issue 2013 / VOL 36 / NO.4


48 THE DISTRIBUTOR’S LINK Lorri Hunt Lorri Hunt is the president of Lorri Hunt and Associates, and has 14 years experience in implementing quality management systems in diverse businesses such as Honeywell, the Department of Energy, and small businesses. She is an active member of the U.S. Technical Advisory Group to ISO Technical Committee 176. She serves as the chair for the United States group responsible for developing consensus positions related to ISO 9001 and 9004. She also served as the international Deputy Task Group Leader to the amendment to ISO 9001:2008. Lorri is a frequent contributor to quality publications and journals and is a co-author to the Insiders’ Guide to ISO 9001:2008. She is also a frequent conference speaker. ISO 9001 REVISION REACHES COMMITTEE DRAFT LEVEL Author’s Note: ISO 9001 is still in the revision process. Information in this article should not be used by organizations to make changes to its quality management system or for legal agreements. Information in this article will be useful in helping organizations understand the level of change that is coming. The revision to ISO 9001 was recently published as a Committee Draft (CD). While there is still a long way to go in the process, keeping current on what is going on with the ISO standard that has over one million users is important to organizations that use ISO 9001 as the foundation to their quality management system. The biggest change to users is the structure. Both the 1987 and 1994 versions of ISO 9001 used a “20- element” model that had familiarity to manufacturing industries. In the year 2000, ISO 9001 transitioned to a process approach and moved from the “20-element” model to a structure of five clauses. This structure was used for both the 2000 and 2008 versions of the standard. The ISO Technical Management Board has adopted a standardized format and common core text for use in all new and revised ISO management system standards, to promote greater ease of use for organizations that seek to integrate the requirements of (for example) ISO 9001, ISO 14001, ISO 50001 into a single, coherent system. This standardized format is referred to as Annex SL. Table I compares the clause titles of ISO 9001:2008 to the clause titles in the proposed version of ISO 9001. While there is not an ISO 9001 requirement for an organization to develop its quality management system and document architecture using the structure of ISO 9001, many organizations choose to do so because it is easier to understand and maintain compliance as well as demonstrate compliance to external parties. As a result, many organizations structured their quality management systems around the ISO 9001:2008 structure. Organizations that see the structure change might be overwhelmed. Before making any quality management system structure changes, it is important to consider the opportunities and issues associated with making such a change. Any change should add value. Making a change for the sake of lining up a quality management system to a structure of any kind adds unneeded cost and overhead to the organization. please turn to page 232


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