Guest user Created: Sep 30, 2021 Last commented: Oct 05, 2021

Amount of staff ISO 13485

We have seen a reduction in staff in company due to reduction in sales and we are wondering how that can affect our ability to hold and maintain iso 13485. Are there any fixed numbers of staff that one must have to obtain iso 13485 and if staff continues to reduce, what actions should we take. For instance we have our iso certification next week and if we are approved for the iso13485, what can happen afterwards if lets say people decide to leave the company? We are a total of 5 personell today, what would happen if we are only 2 or 3? Should this be risk assessed?

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Kristina Zvonar Brkić Oct 05, 2021

No, ISO 13485: 2016 nowhere defines how many employees a company must have in order to be in compliance with it.

If you continue to reduce your staff, this will be reflected on your processes, so you need to adjust them, to create a new job schedule, new job responsibilities descriptions, and the like.

Nothing will change drastically if the number of your employees is reduced from 5 to 3. The biggest risk that may arise is whether you now have enough staff to continue to ensure quality when delivering your product or service.

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Sep 30, 2021

Oct 05, 2021

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