# 236: ICH Q9: Quality Risk Management (QRM) + ISO 14971 Differences

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-04-29
- Length: 12m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-04-29-236-ich-q9-quality-risk-management-qrm-iso-14971-differences
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/236-ICH-Q9-Quality-Risk-Management-QRM--ISO-14971-Differences-e3ik4d1

## Summary

Subhi Saadeh, Founder of Let’s Combinate, explains the ICH Q9 Quality Risk Management (QRM) framework, defining risk as the combination of probability and severity. He details the five-step QRM process—initiation, assessment, control, communication, and review—and emphasizes that efforts must be commensurate with the level of risk. Saadeh contrasts ICH Q9 with ISO 14971, noting that ISO 14971 requires explicit risk management planning and verification of implementation effectiveness, whereas Q9 offers more flexibility in tool selection like FMEA or HAZOP. The episode highlights how supply disruption constitutes a patient risk and stresses the importance of scientific knowledge over gut feel in quality decisions.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-04-29-236-ich-q9-quality-risk-management-qrm-iso-14971-differences#t=0) Introduction: Subhi Saadeh and ICH Q9 Overview
- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-04-29-236-ich-q9-quality-risk-management-qrm-iso-14971-differences#t=0) Defining Risk: Probability and Severity in ICH Q9

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Materials & manufacturing processes](https://hardwarepodcasts.com/topic/materials-and-processes)

## Most relevant to

early-stage companies

## Mentioned

- ICH Q9 (other)
- ISO 14971 (other)
- FMEA (tool)
- HAZOP (tool)
- CISPQ (other)
- PAT (other)

## Related episodes from other shows

- [#422: ISO 14971 and the Road to Risk Management with Edwin Bills](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-09-01-422-iso-14971-and-the-road-to-risk-management-with-edwin-bills) (Global Medical Device Podcast)
- [Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-10-inside-look-into-iso-14971-2019-iso-tr-24971-2020-from-the-authors-point-of-view) (Global Medical Device Podcast)
- [#325 The Role of dFMEAs in Risk Management for Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-30-325-the-role-of-dfmeas-in-risk-management-for-medical-devices) (Global Medical Device Podcast)
- [#474: Behind the QMSR Audits: The Top 5 FDA Citations & Risk Management Pitfalls](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-09-21-474-behind-the-qmsr-audits-the-top-5-fda-citations-risk-management-pitfalls) (Global Medical Device Podcast)
- [How does EU MDR impact your Quality Management System?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-02-22-how-does-eu-mdr-impact-your-quality-management-system) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2026-04-29-236-ich-q9-quality-risk-management-qrm-iso-14971-differences. 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 Let's Combinate.