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ISO 14971 risk matrix
A 5×5 severity × probability grid. Your actual scales and acceptability policy live in the risk management file — this is a working sketch.
4 — Critical
2 — Remote
RPN (S × P)
8
Medium — reduce as far as possible / ALARP discussion
5
10
15
20
25
4
8
12
16
20
3
6
9
12
15
2
4
6
8
10
1
2
3
4
5
Educational only. Not medical advice, not a regulatory determination, and not a substitute for qualified RA/QA, legal, clinical, or statistical counsel. ISO 14971 risk matrix does not submit to FDA, Notified Bodies, or IRBs.
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