Automotive Learning to Diversify into Medical Device

New ISO 13485 Medical Device Manufacturing Curriculum, Integrates Proven Automotive Quality Tools and Methodologies

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. 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.

The Automotive Industry Action Group (AIAG) has announced 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.”

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