MDSAP Audit Approach (MDSAP AU P0002) C1-T6: Determine competence needs for work affecting quality, close gaps, check effectiveness in proportion to risk, keep competence records and qualify consultants

What does C1-T6 require?

The organisation must decide the competence (education, training, skills, experience) needed for work affecting product quality, act to achieve or maintain it, check that the action worked in a way proportionate to the risk of the work (showing competence, not mere attendance), make staff aware of how their work affects quality and objectives, and keep competence records. Brazil: any consultant advising on design, purchasing, manufacturing, packaging, labelling, storage, installation or servicing must be suitably qualified and contracted as a formal service supplier under purchasing controls (RDC 665/2022 Arts 16 and 17). Clauses: ISO 13485:2016 4.2.1, 6.2; RDC 665/2022 Arts 8 and 13 to 15; MO169 Arts 6, 22, 23.