MDSAP Audit Approach (MDSAP AU P0002) C6-T5-T6: Define and maintain the infrastructure and work environment needed for conformity, including equipment maintenance, personnel health and clothing, environmental monitoring, special-condition training and control of contaminated product

What does C6-T5-T6 require?

The organisation must determine and document the buildings, work areas, process equipment and support services needed for conformity, ensure they allow product to meet requirements, and document, carry out and record maintenance of equipment that matters for quality. It must also set and maintain requirements for personnel health, cleanliness and clothing where they could affect quality; monitoring and control of environmental conditions; training or supervision of staff working in special environments; and control of contaminated or possibly contaminated product, including returns. Brazil: facilities must allow suitable people flow and biosafety standards must be used where applicable (RDC 665/2022 Arts 67 and 76). Clauses: ISO 13485:2016 4.2.1, 6.3, 6.4, 7.5.1; TG(MD)R Sch 1 Pt 2 EP 7.2 and 8; CMDR 14; RDC 665/2022 Arts 67, 68, 78; MO169 Arts 6, 24, 25, 40.