Guest user Created: Apr 05, 2017 Last commented: Apr 05, 2017

Transition of ISO 13485 and maintaining ISO 9001

Our company is manufacturing of Customize Orthopedic shoes . As of now we are currently holding the ISO 9001:2008 and ISO 13485:2012 and have a plan to upgrade in to ISO 13485:2016 by next year. Is it possible to cancel the ISO 9001:2008 and focus to ISO 13485. what do you advice.

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Strahinja Stojanovic Apr 05, 2017

Answer:

If you do not have requirements by your customers to have ISO 9001 certificate, my advice would be to cancel the certificate. The reason is that the new version of ISO 13465 is aligned with ISO 9001:2008 and does not follow new ISO 9001:2015. Keeping both standards will make you have all old requirements from ISO 9001:2008 together with new requirements of ISO 9001:2015 and ISO 13485:2016 and there is no need to create such robust system if there are no requirements by the customers in this regards. And you will also save money on the certification fees.

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Apr 05, 2017

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