Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Jimbo11, Sep 3, 2018.
I'm looking for ideas/checklist on how to prepare in advance to run a successful external audit.
it's your first time? What type of audit is it? Do you know what the auditor is going to audit?
Andy, I've been through audits in the past. However, I will be the point person this time. Hence, I want to begin preparing now.
The auditor will be auditing our Quality Systems.
Is it a CB audit? Customer audit? Is it a Stage 1, Stage 2, surveillance? Have you got their audit plan?
Separate names with a comma.