Risk-based Decisions/Thinking/Approach for Quality Management Systems

MN ASQ Biomedical Consortium Presents:

Risk Based Decisions/Thinking/Approach for Quality Management Systems (QMS)

The concepts of using risk to determine actions is not new, but several ISO standards have incorporated this into several of the Management System Standards (including ISO 9001 and ISO 13485).
  *   Where does this come from?
  *   Who should be responsible for the various aspects? Do I need a QMS process for this?
  *   How do we make sure we are incorporating these requirements within established QMS?
  *   What is the best way to show (audit) evidence of my implementation?
  *   What is the regulator (FDA and others) view on this?
These are just a few of the questions that will be addressed by Mark Swanson, President of H&M Consulting Group, LLC as he discusses the risk topic.
This seminar will focus on the risk-based approach outlined by ISO 13485 and other management systems that have implemented this concept as outlined by ISO. This workshop will focus on practical exercises in several different areas of the management system and how you could apply this to your quality management system.

Mark Swanson (ASQ CMQ/OE, CQE, CBA) is the President and lead consultant of H&M Consulting Group; a group focused on helping small to mid-sized companies have the same regulatory and quality systems knowledge as the large medical device companies. Mark has almost 20 years of experience in the medical device industry including all quality roles. He is a senior member of ASQ, corporate AAMI member (serving on several AAMI committees) and a RAPS member.

Mark has spent the last six years as an active member of ISO Technical Committee 210 (TC210), Working Group 1 (WG1) working on the revision of ISO 13485:2003 that was published on March 1, 2016, was the project co-lead for the guidebook on ISO 13485 and has also participated with ISO TC176, WG24 on ISO 9001:2015. He continues to contribute work in Working Group 6 working on the guidance for post-market surveillance and The US TAG and IWA31 for risk management. This work includes 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.

IMPORTANT NOTES:

0.3 RUs will be offered for this seminar.  Breakfast will be served beginning at 7:30AM. Seminar starts at 8am.

Click here to read this important update regarding ASQ's Recertification Process.

Be sure to check our 0000ff;">website for upcoming events like Monthly Program Meetings, Certification Exam Prep classes, and more!