{"product_id":"iso-13485-production-traceability-kit","title":"ISO 13485 Production \u0026 Traceability Kit","description":"\u003cp\u003eControl production and prove every batch was made, inspected and released correctly: batch and device history records, an inspection and test plan with a release decision, identification and traceability through distribution, and ten ready-to-use work instructions.\u003c\/p\u003e\u003ch2\u003eWhat's inside (27 files)\u003c\/h2\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduction Control:\u003c\/strong\u003e Batch Manufacturing Record; Cleanliness of Product Records; Cleanliness of Product SOP; Device History Record Index; Pre-Production Checklist; Production Control SOP; Router Traveler; Yield Reconciliation.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAcceptance and Release:\u003c\/strong\u003e Product Acceptance and Release Workbook (inspection and test plan, batch record review with automatic release decision, release log).\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eIdentification, Traceability and Storage:\u003c\/strong\u003e Identification and Traceability Toolkit; Identification, Traceability and Preservation SOP (including UDI); Status and Identification Labels; Traceability and Warehousing Registers.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eWork Instructions:\u003c\/strong\u003e WI Courier Carrier Handover; WI Customer Property Intake Return; WI Dispatch and Proof of Delivery; WI Environmental Logger Use; WI Incoming Goods Inspection; WI Labelling Status Marking; WI Quarantine Handling; WI Returns Evaluation; WI Sterilization Load Indicator Review; WI Vehicle Inspection.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eInstallation and Servicing:\u003c\/strong\u003e Installation Activities SOP; Service Report; Servicing Activities SOP.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch2\u003eHow to use it\u003c\/h2\u003e\u003col\u003e\n\u003cli\u003eAdapt the production control SOP and set up the batch record and router for one product.\u003c\/li\u003e\n\u003cli\u003eDefine inspections and tests in the release workbook's inspection and test plan, and review each batch record before release.\u003c\/li\u003e\n\u003cli\u003eSet identification, status and traceability rules and apply the labels.\u003c\/li\u003e\n\u003cli\u003eIssue the work instructions that apply to your warehouse and distribution.\u003c\/li\u003e\n\u003cli\u003eAdd installation and servicing procedures if your devices need them.\u003c\/li\u003e\n\u003c\/ol\u003e\u003ch2\u003eWho it's for\u003c\/h2\u003e\u003cp\u003eManufacturers and contract manufacturers who need production, release and traceability records.\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\u003eValidating a process? See the \u003ca href=\"\/products\/iso-13485-process-validation-iq-oq-pq-pack\"\u003eProcess Validation IQ\/OQ\/PQ Pack\u003c\/a\u003e.\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":50498919628994,"sku":"ICC-13485-PROD","price":99.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/iso-13485-production-traceability-kit.png?v=1790150925","url":"https:\/\/isocloudconsulting.com\/products\/iso-13485-production-traceability-kit","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}