ASQL Revisions to ISO 9000 & 9001 Are Coming. Why are these changes important?

When:  Mar 18, 2025 from 05:30 PM to 07:00 PM (CT)

Associated with  Minnesota Section

ISO 9000 is the foundation of the Quality Management System Standards and changes are coming. It looks like the updates to ISO 9000 will be published ahead of 9001. Mark is on both working groups.

Mark will dive deeper into and explain the Fundamental Concepts and Principles of Section 2 of the ISO 9000 Standard that forms the foundation for ISO 13485 and 9001 requirements. Section 2 is significant because it discusses the fundamentals, principles, and, most importantly, how to develop your QMS. This is important for ALL quality management systems, including those developed under the QS Regulation, soon-to-be QMSR.

The updates will contain content around the following:

• Integration of emerging technologies
• Expansion of the concept of customer satisfaction
• Renewed focus on quality assurance
• Further clarifications that the QMS is an integral part of the business processes

Buying out-of-the-box procedures for a QMS is not the best solution; there is no one-size-fits-all.  Understanding these concepts, like the risk-based approach, will let you know if your QMS is suitable, adequate…effective.  Do you really need perfection on day 1?

Mark will go over the 7 Quality Management Principles:

• ·         Customer Focus
• ·         Leadership
• ·         Engagement of People
• ·         Process Approach
• ·         Improvement
• ·         Evidence-based Decision Making
• ·         Relationship Management

What do these Principles mean, what is their rationale, why do you need them, what are their benefits, and what actions can be taken to achieve those benefits? Quality doesn’t automatically occur when a checklist mentality is used.  Come learn the ‘why’ of your quality management system processes.

Who should attend?  Any quality-minded individual who wants to understand the concepts of quality, achieving quality, the management of quality concepts, and the processes and interrelated pieces that make up a quality management system.

Venue ONSITE:  St. Cloud State – Plymouth Campus, 9750 Rockford Rd, Suite #100, Plymouth MN

• A light meal will be provided.

Venue ONLINE:  A Zoom link will be provided closer to the event.

Date: Tuesday, March 18, 2025

Time:  5:30 pm to 7:00 pm CST

Cost:  ASQ Members $30

              Non-Members $60

               Students, $10 or free when registering with current school email and code BMCS

               Groups of 5 or more $30

Certificates of Completion: Issued via email, after event completion, for .2 ASQ RUs or .2 CEUs

Questions: Please contact Karen Peifer, Committee Chair at

Your Speaker

Mark Swanson, President and lead consultant of Quality and Regulatory Expert Partners, LLC (QRx)

(ASQ CMQ/OE, CQE, CBA)

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 20 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 has 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.

Sponsor Information

The MN ASQ Biomedical Consortium (BMC) is a group of quality professionals promoting and advancing quality tools, principles, and practices through educational events.  We focus on the medical device industry but promote events for other regulated environments.

• Follow us on LinkedIn to stay informed of upcoming events:https://www.linkedin.com/showcase/90642322/

To become a member of the MN ASQ Biomedical Consortium, please contact Karen Peifer, Committee Chair or Sahi Datla, Committee Co-Chair, 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.

ASQ:  https://www.asq.org/

More information

Location

Online and Onsite as St. Cloud State – Plymouth
9750 Rockford Road
Suite 100
Plymouth, MN 55442

Online Instructions:

Url: http://mp.gg/2njyv7iuvw
Login: A Zoom invite will be sent closer to the event date.