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Medical Devices, FDA, CMDCAS, CE Mark, etc.... In response to the publication of the ISO 9001:2000 standard, ISO 13485:1996 & ISO 13488:1996, the international quality management standards for the medical device manufacturing industry, have been combined into one standard: ISO 13485:2003.


ISO 13485:1996 provides both a a basis for addressing USA FDA requirements and those  of the Canadian Medical Devices Conformity Assessment System (CMDCAS) program. ISO 13485:2003 has also been adopted by the European Community as EN ISO 13485, European standards for CE Marking, replacing EN 46001.

While ISO 13485:2003 is structured in a similar way as the new ISO 9001:2000 including the celebrated process approach, it is a "stand-alone standard" and can be used without the ISO 9001:2000 standard. 

ISO 13485:2003 does require more documented procedures to meet customer requirements and regulatory requirements applicable to medical devices  than ISO 9001:2000, but the number of documented procedures required are not significantly greater than was required under ISO 13485:1996.

ISO 13485:2003 no longer longer directly references the requirements of ISO 9001, hence it is being touted as a "stand-alone standard." But those wishing maintain ISO 9001:2000 can do so seamlessly with the new 13485 standard, and will find them complimentary. If you have commercial accounts as well as medical device customers, maintaining both 13485 in tandem with ISO 9001 is your best option, and you'll find it relatively easy to do - Let us show you how!

Offering the best of what ISO 9001:2000 brought to quality, ISO 13485:2003 represents familiar ground to those already accustomed to ISO 9001:2000, and an obvious improvement to those already familiar with ISO 13485:1996. In implementing ISO 13485:2003, medical device manufacturers are embracing a standard that provides a better quality model to meet regulatory requirements and ensure quality than any previous or current standard.

You can rely on RH ANDERSEN to facilitate your ISO 13485 implementation or transition, train your staff and audit your system. At RH ANDERSEN we have more than 15 years experience in medical device standards, CMDCAS, FDA and CE Mark implementation Let us show you what we can do for you!


Don't have the time, staff or desire to audit your quality management system?


Let an RH ANDERSEN's  "Team ISO" consultant  perform your internal audits for you!


Need to audit a remote supplier? We can perform your supplier audits and help you exercise requisite control of your supply chain performance...


At RH ANDERSEN we are ready now to meet the challenge of optimizing, implementing or maintaining your ISO 13485 Quality Management System, help you implement/maintain your CE Mark; hand elp you comply with FDA, CMDCAS, requirements....

Call today for your free quality consultation:   

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