Installation Qualification 820.75 & ISO 13485 § 7.5.6 (Executive Series #67)

Links • GHTF Quality Management Systems - Process Validation Guidance: http://www.imdrf.org/docs/ghtf/final/... • 21 CFR 820.75: https://www.accessdata.fda.gov/script... • ISO 13485:2016: https://www.iso.org/standard/59752.html • Medical Device Single Audit Program (MDSAP) Audit Approach: https://www.fda.gov/media/87544/download o Chapter 3: Task 7 o Chapter 6: Tasks 5, 7, 8, 9, 11, 13 & 15 Our topic, Installation Qualification, is covered by 820.75 and 13485 Section 7.5.6. For more detailed information on process validation and Installation Qualification go to the GHTF document. Process Validation in 5 words: Install, Check, & Start Equipment