# #360: Is It Possible to "Buy" a QMS?

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2024-04-11
- Length: 32m
- Episode: 360
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-11-360-is-it-possible-to-buy-a-qms
- Listen: https://podcast.greenlight.guru/episode/360-is-it-possible-to-buy-a-qms

## Summary

Sara Adams, a quality engineering expert with extensive experience in FDA inspections, explains why Quality Management Systems (QMS) cannot be bought off-the-shelf, using a sourdough bread analogy to illustrate the need for customization. She details the layers of a QMS, from procedural documents to electronic storage, emphasizing that while tools like Greenlight Guru provide 'guardrails,' the specific procedures must be tailored to the company's risk profile and regulatory requirements. Adams highlights common pitfalls, such as using non-compliant signatures in SharePoint or paper-based systems, and stresses that the ultimate goal of any QMS decision is patient safety, not just passing an audit.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-11-360-is-it-possible-to-buy-a-qms#t=0) Introduction: Sara Adams and the QMS Misconception
- [5:54](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-11-360-is-it-possible-to-buy-a-qms#t=354) The Sourdough Bread Analogy: Starter, Ingredients, and Oven
- [14:37](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-11-360-is-it-possible-to-buy-a-qms#t=877) Paper vs. Electronic QMS: SharePoint, Signatures, and Compliance
- [20:29](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-11-360-is-it-possible-to-buy-a-qms#t=1229) FDA Inspections, Adulterated Signatures, and Patient Safety
- [25:25](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-11-360-is-it-possible-to-buy-a-qms#t=1525) Customizing QMS: Guardrails, Version Control, and ISO 13485

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)

## Most relevant to

early-stage companies, companies scaling up

## Mentioned

- Greenlight Guru (company)
- Cleio (company)
- ISO 13485 (other)
- FDA (other)
- SharePoint (tool)

## Related episodes from other shows

- [256 - The New FDA Inspection Playbook: Where to Start with QMSR](https://hardwarepodcasts.com/podcast/lets-combinate/2026-09-28-256-the-new-fda-inspection-playbook-where-to-start-with-qmsr) (Let's Combinate)
- [S1E12 Simplifying Quality Management | Jon Speer](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-05-s1e12-simplifying-quality-management-jon-speer) (Being an Engineer)
- [Digitizing Quality Management](https://hardwarepodcasts.com/podcast/the-manufacturing-executive/2022-08-09-digitizing-quality-management) (The Manufacturing Executive)
- [128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-20-128-former-fda-inspector-and-managing-consultant-vin-cafiso-cadavers-autopsies-t) (Let's Combinate)
- [090 - Software Validation, Automation, No-Code Quality Tools and QMS with Harsh Thakkar](https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-21-090-software-validation-automation-no-code-quality-tools-and-qms-with-harsh-thak) (Let's Combinate)

## 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/2024-04-11-360-is-it-possible-to-buy-a-qms. 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.