Discussion of Revisions Contained in ISO 13485:2016

Why Should You Attend:

This webinar will focus on changes to the QMS requirements contained in the latest version of the ISO 13485 standard. ISO 13485:2003 has served for many years as the international standard for QMS for the medical device industry. Many of the individual and regional medical device QMS requirements are based on the requirements contained in this standard. ISO Technical Committee 210, Working Group 1, has been working for the past three years to revise this standard. The revisions address new technological developments currently being employed by medical device companies (e.g., use of risk-based decision making within their quality management systems and the use of electronic IT systems). The revisions also reflect the current compliance expectations of the US FDA and other national and regional QMS regulations.

Areas Covered in the Webinar:

• Making risk-based decisions related to issues outside of product realization (e.g., personnel competency, complaint handling, corrective actions, preventive actions)
• Focusing management review on the suitability, adequacy, and effectiveness of your QMS
• Validation of all kinds of software related to your QMS
• Handling corrective actions without undue delay

Who Will Benefit:

• Quality Managers
• Quality Professionals
• HR Managers
• Regulatory Professionals
• Production Managers
• Risk Managers
• Project Managers
• Production Supervisors
• Process Owners
• Quality Audit Managers
• Company personnel who manage or operate directly within their organization’s quality management system

Instructor Profile:

Edward Kimmelman has been providing consultant services in the areas of regulatory compliance and quality management systems since 1998. During a 35-year career in industry, he has served in engineering, product management, and senior quality systems management positions.

Mr. Kimmelman is a past president of the NCCLS (currently CLSI) and has served as chairman of the HIMA (currently AdvaMed) Standards Section and Science & Technology Section. He recently retired as the convenor of the ISO/TC210, Working Group 1 on quality systems, the administrator of ISO 13485, medical devices – quality management systems – requirements for regulatory purposes. He has coauthored a reference book, The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, 2nd edition, ASQ – Quality Press, 2008.

He received a B.S. degree in mechanical engineering from Cornell University and a J.D. degree from the Seton Hall University School of Law.

Topic Background:

Medical device regulations require that manufacturers have enough people to perform all of the required tasks and that everybody is competent to do their job. The regulations also require the four dimensions of competency: education, training, background or skill, and experience. As a result, ISO 13485 requires an effectiveness evaluation of training or other actions to satisfy competency requirements.

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