Diane Kulisek

The Quality Management System Speedway

The Quality Management System Speedway

Following are some popular views about the cars mentioned related to quality management systems, above. Substitute the descriptions of the cars for descriptions of a company’s QMS and you’ll realize what the CEO is actually asking for in the conversation.

Time for What Matters: Quality 4.0 and Beyond

Time for What Matters: Quality 4.0 and Beyond

No matter what our perspectives may be or how they may differ, time is the one thing money cannot buy. It matters how we spend it. Quality 5.0 is coming2 and, although formative, it speaks of massive integration between humans and machines, digital neural interfaces, levelling of the economic playing field, increased longevity, global quality of life, ecological healing, and prolonged existence of humankind off-planet. I want to be ready for that!

EU MDR Common Specifications Are Not Common

EU MDR Common Specifications Are Not Common

A ‘CS’ was to be a ‘Common Specification,’ intended to satisfy the EU MDR requirements. If you were working to comply with the EU’s Regulation on in vitro Diagnostic Medical Devices ((EU) 2017/746)2, or EU IVDR, the equivalent to a CS was referred to as a ‘CTS’ (“Common Technical Specification”).

Leading Organizational Quality

Leading Organizational Quality

What makes teams successful, based upon a study of employees working within process improvement teams for each of six large corporations, led to a list of approaches for achieving organizational quality, albeit one improvement project at a time. When I parsed these lists together with a focus upon leadership to achieve organizational quality, I was able to place the key concepts into the seven categories listed below.

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