ISO 13485 : 2013 specifies requirements for quality management system where an organization needs to signifies its ability to provide medical devices and regulatory requirements that work as per the customer needs.

ISO 13485 : 2013 specifies the ability of organization to provide medical devices and related services that meet the customer requirements and regulatory requirement applicable to medical devices.

The main objective of ISO 13485 : 2003 is to compose medical device regulatory requirements for quality management system. It includes devices excluding some of the requirement of ISO 9001 that are not appropriate for regulatory requirements.

If regulatory requirement allows the exclusions of design and development control then its is used as an excuse or justification for the exclusion from the quality management system.

Excluding all the unecessary rules organization whose quality management system suits this international standards can not claim conformity to ISO 9001 unless their quality management system suits to all the requirements of ISO 9001.

In case a requirement is not applicable because of the nature of medical devices then it cannot be included in the quality management system.

Benefits of ISO 13485

  • Increase access to more worldwide markets and that too with certification.

  • The manufacturers of medical devices has an advantage of being both 9001 certified as well as 13485 certified. Though it is not necessary for 9001 certification but it has some further benefits like it can help the businessman in his business as it focuses on various aspects that are good for all kind of businesses. Medical manufacturers only need 9001 certification when they need to branch out with other industries as 13485 cannot be replaced in place of 9001.

  • Highlights how to review and improve processes going on in your organization.

  • Meets the customers requirements and satisfaction.

  • Cost reduction and increased efficiency.

  • Demonstrate that the medical devices you produce are safer.

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