The ISO 9001 standard is well into its revision process, with potential outcomes that could affect your business. What changes are being considered, which are likely to be adopted, and how should Quality and Operations departments prepare so they're not left behind?
Join ISO Working Group member Mark Swanson and his partner, Steve Gompertz, as they break down the review process, highlight proposed updates, and reveal how these changes could disrupt quality systems and redefine quality management in 2025 and beyond.
What You'll Learn:
- How the ISO 9000 & 9001 revision timelines work and the rationale behind changes
- Likely changes based on the design specification to 9000/9001 and their implications for Quality and Operations teams
- How the growth from 6 to 20 fundamentals in ISO 9000 could reshape ISO 9001, ISO 13485, and other quality management system requirements (e.g., FDA 21 CFR Part 820 and EU MDR) — and how to prepare
- How proposed changes in 9000 and 9001 align with emerging trends in manufacturing, including precautions with AI, and what might replace your QMS (attend to learn more!)
This session is for Quality and Compliance professionals, Operations and Production leaders, Continuous Improvement and Regulatory specialists, ISO Consultants, and C-suite executives.
- Even if you can't make it, register anyway and receive the replay link. -
Mark is a co-founder of QRx Partners. In addition to being an active member of several ISO working groups (TC210, 9001, and WG1 for ISO 13485 revisions), he is a recognized subject matter expert on quality management systems, including risk management, design and development, and continuous improvement. He has extensive experience with US QSR (21CFR820), ISOs 9001 and 13485, CMDR/CMDCAS, MDD, IVDD, JPAL, TGA, ANVISA, and MDSAP. 
Steve is a leader in Quality Systems management with over 30 years of experience in the medical technology industry. His career includes roles in quality systems development and implementation, project management, engineering automation, configuration management, audit, and software development for companies including Pelican BioThermal, St. Jude Medical (now Abbott), Boston Scientific, Medtronic, Vital Images, and Control Data. He is now a consultant to the medical technology industry at QRx Partners, providing guidance on quality systems and regulatory compliance.
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provides highly configurable QMS solutions to help manufacturing and life sciences firms across sectors such as automotive, biotechnology, chemicals, consumer goods, electronics, energy, industrial equipment, medical devices, and pharmaceuticals reduce their Cost of Quality (CoQ), improve operational excellence, and meet ISO, FDA, OSHA, EPA, and GxP compliance.
