Outsourced Processes ISO 13485 § 415 Executive Series 58

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Links • 21 CFR 820.50: https://www.accessdata.fda.gov/script... • ISO 13485:2016§ 4.1.5: https://www.iso.org/standard/59752.html • Medical Device Single Audit Program (MDSAP) Audit Approach: https://www.fda.gov/media/87544/download • o Chapter 1 •  Task 5 • o Chapter 3 •  Task 13 • o Chapter 7 •  Tasks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 • o Annex 4 • Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers, By GHTF: https://pdf4pro.com/cdn/ghtf-sg3-qual... • FDA Small Business Regulatory Education for Industry (REdI) Conference, by Aileen I. Velez Cabassa: https://www.fda.gov/files/drugs/publi... • Supplier Quality and Purchasing Controls: https://www.advamed.org/issues/regula... • Purchasing Controls and Supplier Qualification, by Mary Vater: https://medicaldeviceacademy.com/purc... • Requirement name and location • Our requirement, Outsourced Processes, comes directly from ISO 13485 Section 4.1.5. This links to 820.50 in the QSR. • Outsourced Processes in 5 words: • Qualify Suppliers Executing Outsourced Processes

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