Aligning the requirements of ISO 13485:2003 to ISO 9001:2008 (Part 5 of 5: Measurement, Analysis and Improvement)

By: Mona Elkhatib


Section 8 of the standard focused on maintaining the effectiveness of the Quality Management System. There are several key requirements that are in ISO 13485:2003 that are not required for ISO 9001:2008. These are mainly focused on the market safety and regulatory requirements.


These requirements include:

  • advisory notices
  • complaint handling
  • mandatory reporting


Below is a summary of the key differences between the two standards:


ISO 9001 ISO 13485 Changes
8.1 General P Maintain the effectiveness of the QMSRegulations may require Statistical procedures
8.2.1 Customer Satisfaction P Documented procedure for Feedback
8.2.2 Internal Audit None No changes
8.2.3 Process Monitoring None No changes
8.2.4 Product Monitoring Documented proceduresProduct cannot be released until all planned activities completed. Requirements for implantable devices
8.3 Nonconforming products P ConcessionsRework
8.4 Analysis of Data 8.4(a) Documented proceduresFeedbackRecords shall be maintained
8.5.1 Continual Improvement P Maintain effectiveness of QMSAdvisory noticesComplaint handlingMandatory reporting
8.5.2 Corrective Action 8.5.2(d)8.5.2(e) Including updating documentationRecording results of investigation
8.5.3 Preventive Action 8.5.3(d) Recording results of investigation

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