Generate a Quantifiable ROI from Your Quality System Audit Program

Some Quality System (QS) audit programs can feel like an anchor dragging behind the organization. They cost time and money, and they do not yield data that management can use to make business decisions. There’s no ROI beyond maintaining the required conformance to a standard and/or regulation. But other organizations have learned how to use their audit programs to collect process performance data in addition to documenting their compliance. They use this data to identify problems, make decisions, and propel […]

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ISO 9001:2015 Changes Offer New Opportunities for Leadership Engagement

ISO 9001:2015 was published in September 2015. We are nearly a year into the transition period for ISO 9001:2015, and affected organizations are busy assessing the gaps between their current processes and ISO 9001:2015’s requirements. Common gaps include several areas related to input from top management. Although addressing these requirements will take some effort, they provide opportunities to increase top management’s engagement in the quality management system. New Requirements for Top Management in ISO 9001:2015 ISO 9001:2015 Requirement: Context of […]

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Three Major Opportunities Within ISO 13485:2016

The revised ISO 13485:2016 standard brings changes. Your organization will have to invest time and resources responding to the changes and complying with the new requirements. We recommend reframing this effort—which is necessary to retain certification—as a series of changes and opportunities. For example, here are three major changes in ISO 13485:2016 and the opportunities arising from these changes: The ISO 13485:2016 standard’s clause structure is not aligned with the clause structure of ISO 9001:2015. Impact and Opportunity: If your […]

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