# 185 - ISO 10013, Document Control in Pharma & Devices: SOPs, Work Instructions, and RACI Done Right with Aaron Snyder

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-04-23
- Length: 25m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-04-23-185-iso-10013-document-control-in-pharma-devices-sops-work-instructions-and-raci
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/185---ISO-10013--Document-Control-in-Pharma--Devices-SOPs--Work-Instructions--and-RACI-Done-Right-with-Aaron-Snyder-e31qqti

## Summary

Aaron Snyder, founder of Quality Systems Explained and former VP of QA at Allotex and Fresenius Kabi, explains the hierarchy of quality documentation, distinguishing between policies, SOPs, and work instructions. He emphasizes that while SOPs define 'what' to do, work instructions must detail 'how' to do it, particularly when using electronic systems like MasterControl or TrackWise. Snyder highlights the critical role of RACI matrices in defining clear roles and responsibilities to prevent ambiguity and ensure accountability in regulated environments.

## Chapters

- [0:07](https://hardwarepodcasts.com/podcast/lets-combinate/2025-04-23-185-iso-10013-document-control-in-pharma-devices-sops-work-instructions-and-raci#t=7) Introduction and Documentation Hierarchy
- [2:24](https://hardwarepodcasts.com/podcast/lets-combinate/2025-04-23-185-iso-10013-document-control-in-pharma-devices-sops-work-instructions-and-raci#t=144) SOPs vs. Work Instructions and Electronic Tools
- [11:22](https://hardwarepodcasts.com/podcast/lets-combinate/2025-04-23-185-iso-10013-document-control-in-pharma-devices-sops-work-instructions-and-raci#t=682) Document Control, Change Management, and Training
- [18:09](https://hardwarepodcasts.com/podcast/lets-combinate/2025-04-23-185-iso-10013-document-control-in-pharma-devices-sops-work-instructions-and-raci#t=1089) RACI Matrices and Defining Roles
- [20:56](https://hardwarepodcasts.com/podcast/lets-combinate/2025-04-23-185-iso-10013-document-control-in-pharma-devices-sops-work-instructions-and-raci#t=1256) Standardization and Conclusion

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

established companies

## Mentioned

- Quality Systems Explained (other)
- Allotex (company)
- Fresenius Kabi (company)
- ISO 10013 (other)
- MasterControl (tool)
- TrackWise (tool)
- ETQ (tool)
- Agile (tool)
- Arena (tool)
- RACI Matrix (tool)

## Related episodes from other shows

- [Leaning into Lean Documentation](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-07-leaning-into-lean-documentation) (Global Medical Device Podcast)
- [Meet a Guru: Taylor Brown](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-01-meet-a-guru-taylor-brown) (Global Medical Device Podcast)
- [Meet a Guru: Tom Rish](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-05-meet-a-guru-tom-rish) (Global Medical Device Podcast)
- [#420: MedTech Synergy: The Project Manager and Quality Professional Relationship](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-08-18-420-medtech-synergy-the-project-manager-and-quality-professional-relationship) (Global Medical Device Podcast)
- [#329 The Right Way to Start a QMS: When, How, & What](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-27-329-the-right-way-to-start-a-qms-when-how-what) (Global Medical Device Podcast)

## Citing this page

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