Who looks forward to audits? Not most people except for maybe the actual auditor. Hold yourself accountable and stay audit-ready, so you can remove any pre existing concerns from the equation altogether.
In this episode of the Global Medical Device Podcast, Jon Speer talks to Taylor Brown, a medical device guru at Greenlight Guru and certified Lead Auditor for ISO 13485.
Taylor offers valuable tips on one of her favorite topics—audit etiquette. She explains her beliefs around how practicing a high level of conduct during audits alongside a right-sized quality system results in True Quality medical devices with high marks from your auditor.
“It’s easy when you’re in the hot seat to kind of have your brain go blank and forget everything that you’ve ever done, and it’s kind of emotional being in the hot seat.”
“It’s definitely not a free-for-all...it’s a very controlled, evidence-based process going through an audit.”
“Controlling and preparing what you can ahead of time to make that audit go as smooth as possible is how I would define audit etiquette.”
“Every record that you create within your QMS, every procedure that you write is really preparation for an audit.”
ABOUT THE GLOBAL MEDICAL DEVICE PODCAST:
The Global Medical Device Podcast powered byGreenlight Guruis where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...