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By Kelly Huckabone
What is audit readiness? Many different quality leaders have their own perspective of what the term “audit readiness” means. I think it means having a strong and mature quality system in place that supports your operations. If you have a mature system, which includes but is not limited to the following, you will have all the key processes to support an audit, whether is it planned or unannounced:
When employees feel connected to the quality system, it becomes part of the culture and part of what they do each day so they should feel confident to be able to discuss what they do with an auditor.
Don’t get me wrong, each quality leader will still go through some sort of audit preparation prior to a planned audit and that is a great way to review what should already been in place.
About the Author
Kelly Huckabone is the North American Audit Program Manager who oversees Unity Lab Service’s internal and external customer and supplier audit programs. Kelly is a certified risk manager, lead auditor with ASQ, and has been conducting audits for over 25 years for different quality systems, including ISO 9001, 13485, and 17025, as well as Health Canada and the FDA.
Contact me at firstname.lastname@example.org if you have any questions.