MNASQ Program Meeting - March 2022 - "Risk-based thinking—why is this the best way?" 3904
MNASQ Program Meeting - March 2022 - "Risk-based thinking—why is this the best way?"
Title: Risk-based thinking—why is this the best way?

Category: Public Calendar

Date: March 8, 2022
Time: 6:30 pm-8:00 pm Central

Minnesota Section 1203 March Program Meeting.
Please join us for a virtual program meeting!

Date and Time
Tuesday, March 8, 2022
6:30 pm - 8:00 pm


Registration Link(ePly):

About the Presentation
With ISO 9001:2015, risk-based thinking methodology was formalized into the quality management system requirements. Also, ISO 13485:2016 incorporated this as the risk-based approach in medical device quality management.
The 4-letter word “risk” has many organizations scrambling around to apply it with FMEA’s, Fault-tree (FTA) and other risk assessment tools. In this session, we will talk about the use of risk and risk-based approach in quality systems across industries and give you some practical examples to help you bring the concept back to your company. Come with your questions and concerns to discuss the practical application of this risk-based methodology.

Mark Swanson (MBA, ASQ CMQ/OE, CQE, CMDA) is a Partner/CEO and principal consultant at Quality and Regulatory Expert Partners, LLC (QRx Partners); a partnership 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 including numerous quality and regulatory roles in the medical device industry. He is a senior member of ASQ, RAPS member and a corporate AAMI member (serving on several AAMI standard development committees).
Mark has spent the last several years as an active member of ISO Technical Committee 210 (ISO TC210), Working Group 1 (WG1) working on the revision of ISO 13485 that was published on in March 2016, was the project co-lead for the guidebook on ISO 13485 and lead US member of Working Group 6 (WG6) on post-market surveillance (ISO TR 20416). He has also participated with ISO TC176 on ISO 9000/9001:2015 and in the AAMI group responsible for TIR 102, to formally compare ISO 13485 to the US FDA Quality System Regulation. To add to this, Mark also participated in the US TAG for risk management (ISO 14971) and the workshop with ISO TC262 that created IWA 31 (agreement on the application of risk management in standards) and ISO 31000 (risk management). In this work he leads the 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.

Event Agenda and Details
Tuesday, 3/8/2022, from 6:30 pm to 8:00 pm
Event Agenda
6:30 pm -- Welcome & Announcements
6:35 pm -- Section Business
6:45 pm -- Presentation
7:45 pm -- Closing Announcements
8:00 pm -- Meeting Adjourns
Date & Time
Tuesday March 8th, 2022 6:30pm CST
End Date & Time
Tuesday March 8th, 2022 8:00pm CST
Virtual Meeting on Zoom
Minneapolis, MN
United States
Meeting, Social Event
Host Type
Webinar Link / Meeting Instructions
Please join us for a virtual program meeting!
Date and Time
Tuesday, March 8, 2022
6:30 pm - 8:00 pm


Registration Link:
Additional Information
Questions? Send email to
Event Sponsor Information
Founded in 1948, ASQ Minnesota Section has grown to be one of the largest sections within the ASQ community.  With almost 1800 members, approximately 80% of our members live or work within the Greater Twin Cities area. We provide a wide variety of opportunities for individuals seeking to connect with like-minded professionals and increase their ability to make our world work better.

You can also find us on LinkedIn and Facebook.

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Date & Time: 03/08/2022 06:30:00 PM CST