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Many medical device manufacturers are now requiring their suppliers to be ISO 13485:2003 certified. “Weʼve been ISO 9001:2000 certified for many years and this new level of certification provides us with the opportunity for producing a greater variety of products for a larger base of customers,” said Joe Bourgeault, director of quality, Diversified Plastics. “This takes our quality management system to the next level.”
While many ISO 13485:2003 requirements are taken directly from ISO 9001:2000, the two certifications are unique. The most important difference is that ISO 9001:2000 is a continual improvement process, where ISO 13485:2003 is medical industry-specific and emphasizes the documentation, implementation and maintenance of processes, procedures and requirements. Although the two ISO levels share some requirements, they are significantly different and certification for one cannot apply for the other. More information about ISO requirements can be found at the International Organization for
Standardization web site.
It took nearly a year for Diversified Plastics to complete the certification work. “We compared the ISO 13485:2003 requirements with our current procedures using new internal audits,” said Mary Scharber, certified quality engineer. “Then, to make sure all aspects of our business were compliant to the new requirements we worked to identify, update and document procedures and processes.” Annually, TUV USA, an international certification body, conducts an ISO compliance audit at Diversified Plastics. Additionally, Diversified Plastics conducts its own internal surveillance audits to keep up-to-date on any changes. Re-certification for ISO 13485:2003 takes place every three years.
While many ISO 13485:2003 requirements are taken directly from ISO 9001:2000, the two certifications are unique. The most important difference is that ISO 9001:2000 is a continual improvement process, where ISO 13485:2003 is medical industry-specific and emphasizes the documentation, implementation and maintenance of processes, procedures and requirements. Although the two ISO levels share some requirements, they are significantly different and certification for one cannot apply for the other. More information about ISO requirements can be found at the International Organization for
Standardization web site.
It took nearly a year for Diversified Plastics to complete the certification work. “We compared the ISO 13485:2003 requirements with our current procedures using new internal audits,” said Mary Scharber, certified quality engineer. “Then, to make sure all aspects of our business were compliant to the new requirements we worked to identify, update and document procedures and processes.” Annually, TUV USA, an international certification body, conducts an ISO compliance audit at Diversified Plastics. Additionally, Diversified Plastics conducts its own internal surveillance audits to keep up-to-date on any changes. Re-certification for ISO 13485:2003 takes place every three years.
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