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.
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workshop
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22/02/2019 Last update