40 THE DISTRIBUTOR’S LINK Lorri Hunt Lorri Hunt, a U.S. technical expert and co-convener for ISO 9001:2015. She is the co-author 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. THE ISO 9001 TRANSITION IS OVER, NOW WHAT? Organizations that are certified to ISO 9001 will have all transitioned to ISO 9001:2015 by September 15, 2018. With this milestone comes a sense of relief. However, it is important that organizations do not rest on their laurels but ensure that the actions that were completed as part of the transition are sustainable. Specifically, attention should be given to the “new” requirements of the standards that focus on the strategic direction of the organization. Many of the new requirements in ISO 9001:2015 are activities that are traditionally performed in organizations. In some cases, during the transition organizations struggled with understanding their business to the new requirements. The ISO 9001 standard brings a sense of structure to these requirements for larger organizations and provides a roadmap to smaller organizations or organizations that conducted the required analysis for the strategic direction of the organization in an informal manner. The revised standard incorporates requirements that focus on the strategic direction of the organization. This means that business-related decisions have a direct correlation to ISO 9001:2015 requirements. There are several requirements where consideration of the strategic direction is required. Ensuring these requirements were not just compliant at the time of the CONTRIBUTOR ARTICLE transition audit but have a repeatable approach is key to ongoing success. Requirements to confirm include the following: 4.1 Context of the Organization – The standard now requires that organizations determine the external and internal issues that could affect the organization. The requirement also requires that the organization monitor and review these requirements. Furthermore, there is a requirement in management review (clause 9.3) that organizations review changes in the external and internal issues. During the transition, many organizations could discuss this requirement while others did not always truly understand the meaning of the requirement. They may have in a generic sense met the intent of the requirement, but not necessarily the spirit of it. For these organizations, the repeatability of implementation during the surveillance audit may be difficult to demonstrate. The external and internal issues are meant to be dynamic and that organizations consider changes in issues that could affect the strategic direction of the organization. With that said, it is not absolute that these issues change every time they are reviewed, but it is possible that there would be needed changes based on changes in industry (e.g. more automation), competition, growth (e.g. new customers or product lines) or political (e.g. tariffs, laws). CONTINUED ON PAGE 144
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MID-WEST FASTENER ASSOCIATION TABLE
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Women In The Fastener Industry (WIF
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