MDSAP Audit Approach (MDSAP AU P0002) C6-T3: Run production and service under controlled conditions: product information, procedures and workmanship criteria, suitable equipment, monitoring devices, process and product monitoring, release activities, labelling and packaging operations and change requirements

What does C6-T3 require?

Each production and service process must be planned and carried out under controlled conditions, including available product characteristics information; documented procedures, requirements, work instructions, reference materials, reference measurements and workmanship criteria; suitable equipment; available and used monitoring and measuring devices; monitoring of process parameters and product characteristics; release, delivery and post-delivery activities; defined labelling and packaging operations; and written requirements governing changes to methods and processes. Clauses: ISO 13485:2016 7.5.1, 8.2.5, 8.2.6; TG(MD)R Sch 3 Pt 1 cl 1.4(5)(d)(e); RDC 665/2022 Arts 30, 62 to 66, 84, 88; MO169 Arts 40, 57 to 59; 21 CFR 820.45.