Links
21 CFR 820.50: [ Ссылка ]

ISO 13485:2016 § 4.1.5 & 7.4: [ Ссылка ]

Medical Device Single Audit Program (MDSAP) Audit Approach: [ Ссылка ]
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: [ Ссылка ]

FDA Small Business Regulatory Education for Industry (REdI) Conference, by Aileen I. Velez Cabassa: [ Ссылка ]

Supplier Quality and Purchasing Controls: [ Ссылка ]

Purchasing Controls and Supplier Qualification, by Mary Vater: [ Ссылка ]

Requirement name and location
Our requirement, Purchasing Controls, comes directly from 820.50 and 13485 Section 4.1.5 & 7.4

Purchasing Controls in 5 words:
Use Only Approved Suppliers

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