003 - “Standard Understanding” with Mark Swanson

In this episode I sit down with Mark Swanson. We discuss Mark’s background and early career, his entrance into QA, his participation on standard work groups for ISO13485 and ISO9001, the standards process and more. Mark Swanson (ASQ CMQ/OE, CQE, CBA) is the President and a Principal Consultant of Quality and Regulatory Expert Partners (QRx Partners); a partnership consulting firm focused on helping small to mid-sized companies have the same regulatory and quality systems knowledge as the large medical device companies. Mark has more than 20 years of experience in the medical device industry including all quality roles. He is a senior member of ASQ, corporate AAMI member (serving on several AAMI committees) and a RAPS member. Mark has spent several years as an active member of ISO Technical Committee 210 (TC210), Working Group 1 (WG1) that published the revision of ISO 13485 in 2016 and was the project co-lead for the guidebook on ISO 13485. Mark is the chair of AAMI mirror committee for WG6 on post-market surveillance, member of the US mirror committee for JWG1 for ISO 14971/TR 24971 and has also participated with ISO TC176, on ISO 9000:2015 & ISO 9001:2015 as well as IWA31 on the application of risk management. This work includes discussions regarding the impact of changes in the ISO quality management system standards, the integration of various standards and how to effectively integrate these various international standards and other regulations into a single management system.