{"product_id":"iso-13485-equipment-calibration-work-environment-kit","title":"ISO 13485 Equipment, Calibration \u0026 Work Environment Kit","description":"\u003cp\u003eKeep measuring equipment calibrated, infrastructure maintained and the work environment under control, with the registers and logs auditors ask for under clauses 6.3, 6.4 and 7.6.\u003c\/p\u003e\u003ch2\u003eWhat's inside (22 files)\u003c\/h2\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eEquipment and Calibration:\u003c\/strong\u003e Calibration Master Register; Calibration Request and Result Form; Calibration Status Labels; Equipment Check Log; Equipment Data Sheet; Equipment Management SOP; Equipment Registers; Out-of-Tolerance Impact Assessment.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eInfrastructure and Maintenance:\u003c\/strong\u003e Asset Register; Generator Maintenance Log; HVAC Maintenance Log; Infrastructure and Maintenance SOP; Maintenance Request Log; Preventive Maintenance Log.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eWork Environment and Contamination Control:\u003c\/strong\u003e Area Hygiene Log; Gowning Checklist; Gowning SOP; PPE Register; Pest Control Log; Warehouse Hygiene Log; Work Environment and Contamination Control SOP.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch2\u003eHow to use it\u003c\/h2\u003e\u003col\u003e\n\u003cli\u003eList all monitoring and measuring equipment in the calibration master register with intervals.\u003c\/li\u003e\n\u003cli\u003eLabel calibration status and record checks between calibrations.\u003c\/li\u003e\n\u003cli\u003eWhen equipment is found out of tolerance, assess the effect on product already made.\u003c\/li\u003e\n\u003cli\u003eSet preventive maintenance for equipment that affects product quality.\u003c\/li\u003e\n\u003cli\u003eDefine work environment and gowning requirements and keep the hygiene and pest control logs.\u003c\/li\u003e\n\u003c\/ol\u003e\u003ch2\u003eWho it's for\u003c\/h2\u003e\u003cp\u003eManufacturing sites with measuring equipment, controlled areas or cleanrooms.\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":50498920087746,"sku":"ICC-13485-EQ","price":79.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/iso-13485-equipment-calibration-work-environment-kit.png?v=1790150935","url":"https:\/\/isocloudconsulting.com\/products\/iso-13485-equipment-calibration-work-environment-kit","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}