Hardware Podcasts

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

Let's Combinate · 29 Apr 2026 · 12m

What this episode covers

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.

Most relevant to

early-stage companies

Topics

Mentioned

Tools
FMEA, HAZOP
Also
ICH Q9, ISO 14971, CISPQ, PAT

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