ED Decision 2022/021/R
ASSESSMENT, AUDIT, AND CONTROL OF VENDOR AND SUBCONTRACTOR
For the purposes of AMC1Ā 21.A.139(d)(2)(ii) and AMC2Ā 21.A.139(d)(2)(ii), vendors and subcontractors are referred to as āsuppliersā,whether they hold production organisation approvals (POAs) or not; audit and control are hereinafter referred to as āsurveillanceā. Implementing or significantly changing procedures to use an OP for supplier assessment and surveillance is a significant change to the quality system, and it requires approval in accordance with pointĀ 21.A.147.
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