MN ASQ - Program Meeting - July 2025 - ISO 9001 Updates

When:  Jul 8, 2025 from 06:30 PM to 08:00 PM (CT)
Associated with  Minnesota Section

July 2025 Program Meeting – “ISO 9000 & 9001: Changes coming in 2025, 2026 & 2027 – Perspectives from an ISO Working Group Member” by Mark Swanson

When: Tuesday, July 8, 2025

Where: Virtual

Recertification units available:

0.1 RU Meeting (Business/Networking)
0.1 RU Workshop (1 hour)

Agenda:

6:30 P.M.  Welcome, Announcements
7:00 P.M.  Presentation: Mark Swanson, “ISO 9000 & 9001: Changes coming in 2025, 2026 & 2027 – Perspectives from an ISO Working Group Member” 
7:55 P.M.  Closing Notes

About the Presentation:

Title: ISO 9000 & 9001: Changes coming in 2025, 2026 & 2027 – Perspectives from an ISO Working Group Member

Attend this presentation to learn more about:

  • Restored appreciation for the content in ISO 9000 – we will outline how this sets the foundation for your quality management requirements and the expectations for the results that implementing a QMS should have
  • Understanding working group member perspective on ‘changes’ to ISO 9001
  • Thoughts on how to prepare for the publication of the revisions to ISO 9001
  • How you can provide input to the revisions of ISO 9000/9001 (and 9002)

Mark will answer your questions on the content of these key standards

About Our Speaker:

Mark Swanson (MBA, ASQ CMQ/OE, CQE, CMDA) is one of the Founding Partners of Quality and Regulatory Expert Partners, LLC; a partnership focused on helping small to mid-sized companies have the same regulatory and quality management systems knowledge as large companies. Mark has more than 25 years of experience in the medical device industry/quality management, including numerous quality and regulatory roles. He is a senior member of ASQ, RAPS member and a corporate AAMI member (serving on several AAMI standard development committees). Mark currently serves as the exam chair for the Certified Medical Device Auditor (CMDA) certification through ASQE.

Mark has spent the last several years as an active member of ISO Technical Committee 210 (ISO TC210), Working Group 1 (WG1) working on ISO 13485 that was published in March 2016. He is the project leader to update the Practical Guide (handbook) on ISO 13485 (ISO TS 23485) and in the AAMI group responsible for TIR 102, the comparison of ISO 13485 to the US FDA Quality System Regulation and contributor to the Advisory group for the final rule (new QMSR). He also participates with ISO TC176 on ISO 9000/9001:2015 and is currently part of both working groups on the revisions to be published in 2025/2026 and the secretary of the group updating ISO 9002. To add to this, Mark also participates in the US TAG for risk management (ISO 14971) and liaison from ISO TC210 to ISO TC262 for risk management. In this work he leads the discussions regarding the impact of changes in the ISO management system standards (MSSs) and how to effectively integrate these various international standards and other regulations into a single management system.

Register now using the link below!

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