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Distributor's Link Magazine Spring Issue 2016 / Vol 39 No2

30 THE DISTRIBUTOR’S

30 THE DISTRIBUTOR’S LINK Lorri Hunt Lorri Hunt, a U.S. technical expert and co-convener for ISO 9001:2015. She is the coauthor of the upcoming ISO 9001:2015 Handbook, A Practical Guide to Implementation published by Paton Profession. She is an Exemplar Global lead auditor, a frequent contributor to quality publications and journals, and a speaker all over the world. She is the president of Lorri Hunt and Associates Inc. and may be contacted at lorri.hunt@gmail.com. THREE THINGS TO KNOW ABOUT THE ISO 9001:2015 REVISION ISO 9001:2015 was published in September 2015. With the release of any standard, there is always speculation related to what is required or not required by a revision. Here are three things that users should know about the revision that will help them with the transition. The Standard Is Less Prescriptive ISO 9001 is no longer a standard that is used just by manufacturing organizations. This resulted in the need to adapt the standard to provide requirements that can be implemented by any type of organization. This was accomplished by reducing the prescriptive nature of some requirements and the integration of the term products and services, which replaces products. In other instances, the word product has been replaced by output, which could be a product, service, or process. This improves the understanding for these types of organizations. When reviewing the revised requirements, some users might feel the need to make some change to the quality management system. However, the change to products and services should not require change for many users. For users in the service industry, this change along with revised language to clarify the requirement could result in the need to make some small modification to the quality management system. CONTRIBUTOR ARTICLE Understand Documented Information and Auditability In addition to the transition to products and services, the standard is less prescriptive in some of its requirements as risk-based thinking can be leveraged to determine when documented information is needed. This change means that there are no specific requirements for documented procedures or a quality manual. In the 1994 version of the standard, there were seventeen requirements for documented procedures. This was reduced to six required documented procedures for the 2000 and 2008 versions of ISO 9001. Now organizations will need to determine what documented information is needed beyond the minimal requirements included in ISO 9001:2015. Clause 4.4.2 (quality management system and its processes) include requirements that an organization determine what documented information it needs to demonstrate control of processes and provide objective evidence of conformance. This change in requirement should not have that large of an influence on the level of documented information that an organization determines it needs, because organizations have typically required more documented information than the specific requirements that were included in ISO 9001. CONTINUED ON PAGE 118

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