Originally Published MDDI October 2002
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ISO 9001:2000 is a general standard for all quality systems.
ISO 13485:200x is a specific standard for medical device quality systems only.
ISO 9001:2000 was created by ISO Technical Committee 176.
ISO 13485:200x was created by ISO Technical Committee 210, Working Group 1.
Quality Management Approach
Both standards call for a process approach to quality management.
Required Written Procedures
ISO 9001:2000 contains 6 required written procedures.
ISO 13485:200x requires 23 procedures, due to the specialized characteristics of medical devices.
ISO 9001:2000 requires evaluation of customer satisfaction, specifically monitoring customer perception as to whether the organization has met requirements.
ISO 13485:200x requires monitoring of information related to meeting requirements, specifically warnings of quality problems that may require corrective action.
ISO 9001:2000 focuses on continual improvement of the quality system.
ISO 13485:200x focuses on maintaining the effectiveness of the quality system.
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