ISO 9001:2000 vs. ISO 13485:200X—The Basics

Originally Published MDDI October 2002

COVER STORY

Purpose
 

ISO 9001:2000 is a general standard for all quality systems.
 

ISO 13485:200x is a specific standard for medical device quality systems only.

Authors

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.

Customer Feedback

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.

Improvement

ISO 9001:2000 focuses on continual improvement of the quality system.

ISO 13485:200x focuses on maintaining the effectiveness of the quality system.

Copyright ©2002 Medical Device & Diagnostic Industry