Guest user Created: May 27, 2019 Last commented: May 27, 2019

Estimation of timeline for ISO 13485 certification

We as a company are thinking about achieving 13485 certification. Is there a rough estimated time schedule on how long the certification process will take starting from zero? We have already looked into the ISO and implemented some processes, however for planning further steps we wanted to setup a timeline.

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Verlene Law May 27, 2019

Answer:

The implementation process will usually take between 3 months to 18 months depending on the size of the company. You can utilize this link to calculate the time that might be needed: https://advisera.com/9001academy/iso-9001-duration-calculator/ For the certificate stage, you should give yourself around 2 months to prepare.

For more information, please read article:

Checklist of ISO 13485 implementation and certification steps
https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/

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May 27, 2019

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