New ISO 13485 Medical Device Manufacturing Curriculum, Integrates Proven Automotive Quality Tools and Methodologies
Southfield, Mich. (Vocus) August 12, 2009 -- The Automotive Industry Action Group (AIAG) announced today the launch of a program to educate medical device manufacturers in quality improvement tools and methodologies.
Earlier this year, the state of Michigan publicized a program to help manufacturers - especially auto suppliers - diversify into new emerging manufacturing market sectors. To aid its members in making this type of transition, AIAG has developed a medical device manufacturing curriculum. This curriculum introduces manufacturers to ISO 13485:2003, the standard requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services. In addition, it introduces the quality core tools: Advanced Product Quality Planning (APQP), Failure and Mode Effects Analysis (FMEA), Measurement Systems Analysis (MSA) and Statistical Process Control (SPC); along with other quality methodologies like problem solving and error proofing, and important supply chain regulatory requirements for manufacturers.
"Auto suppliers are ideally positioned to capitalize on a transition into a high growth manufacturing area such as medical devices because they have manufacturing and quality improvement know-how," said J. Scot Sharland, executive director for AIAG. "Diversifying and taking tested and proven quality tools and methodologies into a vertical industry will help these organization's to strengthen their company balance sheet and keep people working."
AIAG has been providing education and training programs to automotive organizations for more than 20 years. Learn more about the organization at www.aiag.org.
AIAG is a unique not-for-profit organization where for more than 25 years, OEMs, suppliers, service providers, government and academia have worked collaboratively to drive cost and complexity from the supply chain via global standards development and harmonized business practices. AIAG membership has grown to include preeminent OEMs such as Caterpillar, Chrysler LLC, Daimler, Ford Motor Company, General Motors, Honda, Navistar International, Nissan, Toyota and many of their part suppliers and service providers. For more information, please visit the organization's Web site at www.aiag.org.
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