{"product_id":"iso-13485-supplier-control-kit","title":"ISO 13485 Supplier Control Kit","description":"\u003cp\u003eSelect, approve, monitor and re-evaluate suppliers in proportion to risk, with quality agreements that require change notification and incoming inspection records that show purchased product meets requirements.\u003c\/p\u003e\u003ch2\u003eWhat's inside (10 files)\u003c\/h2\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eProcedures:\u003c\/strong\u003e Incoming Inspection SOP; Supplier Control SOP.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eEvaluation and Approval:\u003c\/strong\u003e Approved Supplier List; Incoming Inspection Record; Supplier Audit Checklist; Supplier Evaluation Scorecard.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eQuality Agreements:\u003c\/strong\u003e Supplier Quality Agreement - EU MDR; Supplier Quality Agreement - Generic; Supplier Quality Agreement - US FDA.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch2\u003eHow to use it\u003c\/h2\u003e\u003col\u003e\n\u003cli\u003eClassify suppliers by risk in the Supplier Control SOP.\u003c\/li\u003e\n\u003cli\u003eScore each supplier with the evaluation scorecard and record approval in the approved supplier list.\u003c\/li\u003e\n\u003cli\u003eAudit critical suppliers with the checklist.\u003c\/li\u003e\n\u003cli\u003eSign a quality agreement that requires notification of changes before they are made.\u003c\/li\u003e\n\u003cli\u003eVerify purchased product at receipt in proportion to risk.\u003c\/li\u003e\n\u003c\/ol\u003e\u003ch2\u003eWho it's for\u003c\/h2\u003e\u003cp\u003eManufacturers and virtual manufacturers that rely on suppliers and contract manufacturers.\u003c\/p\u003e\u003ch2\u003eGood to know\u003c\/h2\u003e\u003cul\u003e\n\u003cli\u003eInstant download. Editable Microsoft Office files, no macros.\u003c\/li\u003e\n\u003cli\u003eIncludes a Start Here guide with the contents and how to use them.\u003c\/li\u003e\n\u003cli\u003eLicensed for one organization, including its sites.\u003c\/li\u003e\n\u003cli\u003eTemplates don't reproduce ISO standards. You need your own licensed copies.\u003c\/li\u003e\n\u003cli\u003eAlso in the \u003ca href=\"\/products\/iso-13485-complete-qms-kit\"\u003eISO 13485 Complete QMS Kit\u003c\/a\u003e, which costs less than buying kits separately.\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"ISO Cloud Consulting","offers":[{"title":"Default Title","offer_id":50498917925058,"sku":"ICC-13485-SUP","price":79.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/iso-13485-supplier-control-kit.png?v=1790150900","url":"https:\/\/isocloudconsulting.com\/products\/iso-13485-supplier-control-kit","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}