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Pre-Audit Checklist For Medical Devices




The Pre Audit Checklist is a list that organizes the to-do list you have been trying to make to prepare your quality management system for the audit. It has every part of your QMS to go over ranging from marketing information to what change controls are open.

What is this Pre-Audit Medical Device Checklist for?

This checklist is for a medical device company that has had their Quality Management System established and has been using it for one month or one year. This checklist is perfect for going over every detail necessary to nail your next audit.

Preparing your Quality Management System for Anything

This document will help you create your final to-do list of open items, and unsent records, or finish up those edits to that SOP. This will help your quality manager prepare to smooth out all the details. Look to Rook for support for preparing your QMS for an audit.

Internal Audits

Internal Audits are conducted by someone who has never seen or edited the company’s QMS system. This auditor is responsible for finding major and minor findings with the intended goal of making sure there are no gaps in the QMS so when an external auditor comes your company will pass with flying colors. Contact Rook for one of our quality managers to audit your company’s QMS system.

External Audits

External Audits are unexpected reviews of your quality management system by an outside regulatory body such as the FDA, or ISO.

Why Do I Need This Checklist?

Your company needs this checklist to find that one gap you didn’t remember. This checklist will offer an outsider’s perspective with just a simple organized list to jumpstart your brain into audit mode.

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