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Implementation duration
I have a question for you.
I am experienced with ISO9001 and 13485. Conducted many audits as the company representative.
I am working with a small startup site, no employees or equipment yet and am tasked with putting in a 13485 system in an ISO8 cleanroom operation.
Using your toolkit and no employees, other than a few senior leadership individuals who will not help much, how long should I allocate to getting all the procedures in place to pass an audit?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Expert
Kristina Zvonar Brkić
Apr 26, 2021
We estimate that for companies up to 10 employees it is necessary up to 3 months to implement the quality management system according to the ISO 13485:2016.
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Apr 23, 2021
Apr 26, 2021
Apr 26, 2021