Managing ISO 9001 for Medical Device Distributors who are not manufacturers

You can implement ISO 9001 if you are a Medical Device Distributor. However, Medical device regulative MDR 2017/745, which takes full effect on May 2021, has described in Article 14 General obligations of the distributors https://advisera.com/13485academy/mdr/general-obligations-of-distributors/ 

Further, in Article 16 Cases in which obligations of manufacturers apply to importers, distributors, or other persons, it is stated in point 3 that distributors shall ensure to have in place a quality management system. The quality management system shall cover, among others, procedures which ensure that the translation of information with the manufacturer is accurate and up-to-date, and procedures ensuring that the distributor is informed of any corrective action taken by the manufacturer in relation to the device in question in order to respond to safety issues or to bring it into conformity with this Regulation.

Also, manufacturers need to be in compliance with harmonized standards published by the Offical Journal of European Union as described in Article 8. On that list, the only standard that covers the quality management system is ISO 13485:2016 so it is expected that all manufacturers have implemented this standard.;

For more information, please see the following:

• EU MDR Article 8 Use of harmonized standards - https://advisera.com/13485academy/mdr/use-of-harmonised-standards/
• List of the harmonized standard https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2020:090I:TOC

To understand what harmonized standards are, please see the article:

• What are EU harmonized standards? https://advisera.com/13485academy/blog/2020/06/12/what-are-eu-harmonized-standards/

For more information regarding ISO 13485 please see the following links:

• What is ISO 13485? - https://advisera.com/13485academy/what-is-iso-13485/
• Six key benefits of ISO 13485 implementation - https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/
• Checklist of ISO 13485 implementation and certification steps - https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/
• EU MDR Article 16 Cases in which obligations of manufacturers apply to importers, distributors or other persons https://advisera.com/13485academy/mdr/cases-in-which-obligations-of-manufacturers-apply-to-importers-distributors-or-other-persons/
• Similarities and differences between ISO 9001:2015 and ISO 13485:2016 https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/