SME discusses changes to new quality management systems standard


Back in the early 2000s, I became somewhat of the the quality management systems (QMS) guru at Eric Mower & Associates while supporting the public relations needs of an international product testing company. Who would have thought I’d brush off that hat again for another client, 15 years later?

Now, supporting Strand Marketing from my home office, I have the pleasure of writing for KMC Systems, a well-established, medical engineering and contract manufacturing firm. My first assignment was this blog update about ISO 13485:2016, a QMS standard of which compliance is required for medical device manufacturers wishing to enter markets around the globe.