MDSAP nonconformity grading

MDSAP grades each nonconformity on a scale from 1 to 5 so auditing organizations can decide how quickly the manufacturer must respond.

The grading method starts from two questions. Does the nonconformity have an indirect or a direct impact on the quality management system? Is this the first occurrence or a repeat? Direct impact scores higher than indirect impact. A repeat scores higher than a first occurrence. The grade can be escalated further, up to 5, when a required documented process is absent or when nonconforming medical devices were released. The official MDSAP grading document is the authority for the arithmetic and for any timeline that attaches to a grade. Check the current revision before you quote a number of days in a procedure.

Grade is not the same as the minor/major/critical language many ISO 13485 reports still use. If you are in MDSAP, record the grade and the factors. If your internal procedure also uses minor and major, define how the two scales meet so people do not invent a conversion in the closing meeting.

HAVGATE ties a finding to the MDSAP task number and stores a severity classification. Put the numeric grade in the finding when your procedure requires it, and show the impact and occurrence you used. Read the longer explanation on the MDSAP checklist page.