GLOSSARYGlobal
Root Cause
The underlying reason a nonconformity occurred, determined so that removing it prevents recurrence. Restating the nonconformity is not a root cause. No standard defines the term. ISO 13485 clause 8.5.2 requires the cause to be determined.
Avoid This Mistake
Neither ISO 9000 nor ISO 13485 defines root cause in its terms and definitions. Clause 8.5.2 requires determining the causes of a nonconformity and uses no such label.