ISO 13485, ISO 9001:2000, AS 9100, AND TS 16949

Abstract

The two-hour Q and A period will focus on full open-ended audience participation. The audience is free to ask any and all questions pertaining to all aspects of ISO Registration. Experts, with more than eight decades of experience combined, will be available to answer questions particularly to the areas of Medical Device, Automotive, Aerospace, and the new 2000 Revision of the ISO 9001 International Standard.

Panel members will discuss implementation methodologies and issues, auditing tools and techniques, and lessons learned from real situations encounters by the experts over the years.

Bios

Joseph Azary has more than 14 years experience in the Regulatory Affairs and Quality Assurance in the medical device industry.

Joseph has a bachelor's degree in biological sciences and a master's degree in business administration. He is an ASQ certified Quality Auditor, Regulatory Affairs Certified (RAC), and has completed and successfully met the testing requirements of the RAB certified lead assessor course for ISO 9001:2000.

U.S. Surgical Corporation, Johnson & Johnson, Fuji Photo Film (Fuji Medical division) are among Joseph's past employer's.

Additionally, Joseph has worked with over 55 companies assisting with projects ranging from ISO 13485 and 9001 certification, FDA compliance, quality system development, auditing, training, and 510(k) submissions.

Woody Cashman M.S.M. M.Ed. is President and Principle Consultant of Woody Cashman and Associates. He is five-degreed and is an ASQ Certified CSSBB, CQMgr, CRE, CQE, CSQE, CQA, CQA-HACCP, CQA-BIOMED, CQT, CQIA, CCT, and CMI. He is the only person certified in all twelve disciplines by ASQ in 2003. He is an APICS Certified CIRM and a NAPM Certified CPM. He is an International Register of Certificated Auditors [IRCA] Registered QMS Auditor; # 1183558.

He has impressive and documented hands-on accomplishments including ISO/QS/TS/AS implementation and registration of twenty-one companies in twenty-eight locations. Digital Equipment Corporation previously employed him for 21 years, primarily in the area of Quality. He has been a self-employed businessman for three decades as an owner/operator of four local businesses.

He has authored many articles for business and industry, and has authored the CRE Solutions Text published by QCI of Indiana.

He is a Senior member of the American Society for Quality, the current Chair for the New England Quality Council, and Immediate Past Chair, Membership, Seminar, and Database chair for the local section of ASQ. He was past Membership, Database, Seminar, Historian, Examining, Recertification, Certification, Section Management Program, and Chair for the Western Mass section of the American Society for Quality. He is the only person to serve as Chair on three separate occasions for the Western Mass section.

Martin Millea is a quality professional with over twenty years experience in the quality field, having worked for, and consulted to a diverse variety of organizations, both at home and abroad.

Mr. Millea is a graduate of Boston University, a "Fellow" in the American Society for Quality, an ASQ Certified Quality Auditor, and is a certified RAB Quality Management System Auditor. Marty has been an active ASQ member since 1987 and is a past section chair. He served on the ASQ Board of Directors from 1994 - 1999, and is currently Co-chair of the Society Ethics Committee and Member Advocate. He also sits on and chairs major committees both nationally and at the local level.

Daniel S. Whelan; CQA, CQMgr. As a Senior Member of the American Society for Quality, he has pursued his interest in quality system development, maintenance and assessment. Certified by ASQ as a Quality Auditor in 1989, Mr. Whelan has conducted numerous audits in the medical device industry and elsewhere, both domestically and overseas in Central & South America and in Europe. He has conducted training in a number of subjects, including; ISO 9000, Quality Awareness, Quality Auditing, System Documentation, FDA Good Manufacturing Practices, and Complaint Handling.

More recently certified by ASQ as a Quality Manager, he continues to concentrate his efforts in medical device quality and the ISO 9000 series standards. His current activities include membership on the Industry Advisory Board of the American Certification Corp.; a Boston based Quality System Registrar. Mr. Whelan is a Past Chair of the Boston Section of ASQ and was the 1999 recipient of the Boston Society Award, a nationally recognized prize for distinguished achievements in the quality profession.