Qualification

This definition comes from guidance for notified bodies, where each role has defined qualification criteria. Manufacturers face the same question in their competence records, where a degree or certificate alone does not show qualification unless the relevant experience is documented too. In manufacturing, the same word also means equipment and process qualification (IQ, OQ, PQ), which is a different concept.

Qualification: education, full set of knowledge and experience which makes staff suitable to carry out specific tasks or roles.

NBOG BPG 2017-2 Rev.1 (MDCG-endorsed), Section 3, Definitions (3.1)