ISO 9001:2015 and ISO 13485:2016 Are They Aligned?

With the release of ISO 9001:2015 and ISO 13485:2016, it’s time to explore their alignment. Decades ago, when I first started working with industry standards, the concept of alignment didn’t arise often. There were not enough widely adopted industry standards to worry about alignment. But today we are moving in the right direction with the widespread – often required – use of global standards. Now we need to consider alignment when we compare revised versions of standards against their predecessors […]

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Issues Driving the ISO 13485:2016 Revision

Standards are not revised in a vacuum. Industry changes, regulatory challenges, and feedback from medical device manufacturers, regulators, and auditors are all considered. In this two-part series, we discuss key changes to ISO 13485:2016 with Ed Kimmelman, an Oriel STAT A MATRIX Executive Management Consultant who recently retired as the Convenor of the ISO/TC 210, Working Group 1 on quality systems – the ISO working group responsible for developing ISO 13485:2016. For ISO 13485:2016, there were several issues that led […]

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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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