Your Quality Management System: Understanding the Risk-Based Approach
In the management of quality, there is a 4-letter word that scares the quality group and managers more than any other.
That is the concept of R-I-S-K.

In 2015 and going forward the concept of ‘risk-based thinking’ or the ‘risk-based approach’ was formally brought into quality management system (QMS) standards of ISO 9001 and ISO 13485. This has brought the wrath of auditors and inspectors to ask for evidence of your implementation of risk in your QMS processes.

Join us for a discussion (and bring your burning questions) on how you can prepare for those auditors along with learning from one of the writers of these standards on the intent and the best practices associated with incorporating risk in your QMS.

Mark is an expert in risk concepts. He will help you understand that application of the risk-based approach will make your job easier.


If you have any questions, please contact Karen Peifer at
Date & Time
Thursday March 23rd, 2023 6:00pm CDT
End Date & Time
Thursday March 23rd, 2023 8:00pm CDT
St. Cloud State - Plymouth
9750 Rockford Rd
Plymouth, MN 55429-301
United States
Host Type
Webinar Link / Meeting Instructions
Date:  Thursday, March 23rd
Time:  6:00 pm CST - 8:00 pm CST
Location:   St. Cloud State - Plymouth 9750 Rockford Road, Plymouth MN 
Cost: -Minnesota ASQ Member - $20.00
           Non-Members - $40

Certificates of Completion: Issued via email, after workshop completion, for .2 ASQ RUs or CEUs
Additional Information
Instructor Bio

Mark Swanson
(ASQ CMQ/OE, CQE, CBA) is a Partner and leading consultant for Quality and Regulatory Expert Partners, LLC (QRx)
QRx is a partnership focused on helping small to mid-sized companies have the same regulatory and quality systems knowledge as large medical device companies. Mark has more than 23 years of experience in the medical device industry including all roles in quality. He is a senior member of ASQ and RAPS as well as a corporate AAMI member (serving on several AAMI 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 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 also participated with ISO TC176, WG24 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 that created IWA 31 (agreement on the application of risk management in standards). 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 Sponsor Information
The MN ASQ Biomedical Consortium (BMC) focuses on medical device, pharmaceuticals, and contract manufacturing sectors, to name a few.  ASQ Membership is not required to join.  There are many ASQ perks provided when joining the BMC. 

Consider becoming a member of one or both to enhance your professional experience. 
  • ASQ: 
  • To become a mmbember of the MN ASQ Biomedical Consortium, please email Karen Peifer at

The American Society for Quality (ASQ), is a knowledge-based global community of quality professionals, with nearly 80,000 members dedicated to promoting and advancing quality tools, principles, and practices in their workplaces and communities.  As your career partner, ASQ membership benefits are designed to help meet your growing needs as a quality professional.  Membership provides exclusive access to quality knowledge, solutions, and resources to solve challenges, and skill development to advance your career. ASQ is committed to providing enhanced expertise, professional networks, tools, and solutions to help our members advance their products, services, and industries. 
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Date & Time: 03/23/2023 06:00:00 PM CDT

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