Operational Qualification 820.75 & ISO 13485 § 7.5.6 (Executive Series #70)

Links GHTF Quality Management Systems - Process Validation Guidance: http://www.imdrf.org/docs/ghtf/final/... Medical Device Single Audit Program (MDSAP) Audit Approach: https://www.fda.gov/media/87544/download o Chapter 3: Tasks 7 o Chapter 6: Tasks 7, 8, 9, 11, 13, & 15 21 CFR 820.75: https://www.accessdata.fda.gov/script... ISO 13485:2016: https://www.iso.org/standard/59752.html Quality System Regulation Process Validation, Joseph Tartal: https://www.fda.gov/media/94074/download Requirement name and location Our requirement, Process Validation, comes directly from 820.75 and 13485 Section 7.5.6. Process Validation in 5 words: Process Qualifications Guarantee Conforming Product