# For the Love of Internal Auditing

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-04-26
- Length: 33m
- Episode: 199
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-26-for-the-love-of-internal-auditing
- Listen: https://podcast.greenlight.guru/episode/for-the-love-of-internal-auditing

## Summary

Jon Speer, founder of Greenlight Guru, interviews Sara Adams, a medical device guru at Greenlight Guru, about the strategic value of internal auditing in medical device quality systems. They discuss shifting from checkbox compliance to risk-based auditing, debunking misconceptions that every finding requires a CAPA or that all processes must be audited annually. The conversation highlights the importance of planning, cross-functional collaboration, and using electronic QMS platforms like Greenlight Guru to streamline audits and improve regulatory readiness.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-26-for-the-love-of-internal-auditing#t=0) Introduction: The Value of Internal Auditing
- [2:37](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-26-for-the-love-of-internal-auditing#t=157) Mindset Shift: From Checkbox to Risk-Based Improvement
- [7:11](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-26-for-the-love-of-internal-auditing#t=431) Building Quality Culture and Management Buy-In
- [11:40](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-26-for-the-love-of-internal-auditing#t=700) Collaboration and Process Ownership Across Departments
- [18:55](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-26-for-the-love-of-internal-auditing#t=1135) Case Study: The Dangers of Rigid Audit Procedures
- [23:21](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-26-for-the-love-of-internal-auditing#t=1401) Debunking CAPA and Annual Audit Misconceptions
- [25:27](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-26-for-the-love-of-internal-auditing#t=1527) Strategies for Small Companies and Virtual Audits
- [29:42](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-26-for-the-love-of-internal-auditing#t=1782) Conclusion: Efficiency and Greenlight Guru's Role

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [AI & machine learning](https://hardwarepodcasts.com/topic/ai-and-machine-learning)

## Most relevant to

established companies

## Mentioned

- Greenlight Guru (company)
- ISO 13485:2016 (other)
- FDA (other)
- MDSAP (other)

## Related episodes from other shows

- [215 - Why Aren’t Technical People Leading Drug-Device Audits?](https://hardwarepodcasts.com/podcast/lets-combinate/2025-11-26-215-why-arent-technical-people-leading-drug-device-audits) (Let's Combinate)
- [249 - The Best Audit Advice Nobody Told Me](https://hardwarepodcasts.com/podcast/lets-combinate/2026-08-05-249-the-best-audit-advice-nobody-told-me) (Let's Combinate)
- [188 – Certified Quality Auditor(CQA) and Audits in the Future](https://hardwarepodcasts.com/podcast/lets-combinate/2025-05-14-188-certified-quality-auditor-cqa-and-audits-in-the-future) (Let's Combinate)
- [168 - Audits, Audits, Audits: Why They Matter in Pharma, Medical Devices, and Personal Growth](https://hardwarepodcasts.com/podcast/lets-combinate/2024-12-25-168-audits-audits-audits-why-they-matter-in-pharma-medical-devices-and-personal) (Let's Combinate)
- [S5E29 Steve Gompertz | Medical Device Quality Control & Regulatory Requirements](https://hardwarepodcasts.com/podcast/being-an-engineer/2024-07-19-s5e29-steve-gompertz-medical-device-quality-control-regulatory-requirements) (Being an Engineer)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-26-for-the-love-of-internal-auditing. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.