It can be difficult to maintain a focus on strategic concerns when your organization is required to maintain compliance with standards and regulations. Tracking and auditing can be tedious! For example, if you’re a medical device manufacturer, you may need to maintain ISO 13485 compliance for good standing among your suppliers and customers — and at the same time, meet all the requirements of 21 CFR 820 and other regulations that govern production and postmarket. (To read more about the challenges, check out Wienholt’s 2016 post.) There’s a lot to keep track of.
But strategy is important, and alignment is even more important! And in my opinion (and the opinion of many others who have been working in quality for a long time), the easiest way to improve alignment and get “Big Q” quality is to use the Baldrige Excellence Framework from the Baldrige Performance Excellence Program, administered by NIST.
In Is Good, Good Enough for You? Taking the Next Step After ISO 9001:2015, former Baldrige Program Executive Director Harry Hertz outlines similarities and differences between one common quality management framework — ISO 9001:2015 — and Baldrige. After a comprehensive look at how the two frameworks can complement one another, Harry notes that Baldrige can help your organization grow beyond the conformance mindset:
I have not shared all the commonalities of or differences between ISO 9001:2015 and the Baldrige Excellence Framework. Instead, I have tried to show the organizational possibilities of building on conformity assessment to establish a holistic approach for achieving excellence in every dimension of organizational performance today, with a look to the strategic imperatives and opportunities for the future. Baldrige helps an organization take this journey with a focus on process (55% of the scoring rubric) and results (45% of the rubric), recognizing that great processes are only valuable if they yield the complete set of results that lead to organizational sustainability… I encourage organizations that have not gone beyond conformity to take the next step in securing your future.