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Difference between ISO 13485:2016 and ISO 9001:2008

The standards are aligned clause-for-clause for the convenience of building on the knowledge of ISO 9001 and to build on the process-based model

  • It is a standalone standard and no certification needed
  • ISO 13485:2003 is exclusive for Medical Device
  • ISO 13485:2003 has additional requirements in particular for medical devices, depending on class of Medical Device
  • Requirements related to continuous improvement and customer satisfaction have been removed from ISO 13485:2016
  • There is a distinction between exclusions and ‘areas of non application’ relevant to the medical device business
  • Infection and contamination control are addressed in ISO 13485:2016
  • Identification and traceability more extensive in ISO 13485:2016

Upon first sight review, the major differences between ISO 9001 and ISO 13485:2016 seems small, but in other ways, they are very large and distinct. In particular the following

  • Good manufacturing practices (GMP)
  • Terms and Definitions of ISO 13485:2016
  • Documentation Requirements of ISO 13485:2016
  • Traceability Documentation
  • Risk Analysis
  • Manufacturing Facility
  • Quality Assurance
  • Quality Control

More about ISO 13485:2003

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