{"product_id":"iso-13485-process-validation-iq-oq-pq-pack","title":"Process Validation IQ\/OQ\/PQ Pack (ISO 13485 Clause 7.5.6)","description":"\u003cp\u003eValidate a production process the way auditors expect, without starting from a blank page. This pack gives you the procedure, the plan, the IQ, OQ and PQ protocols, the summary report and the statistics, all written for ISO 13485:2016 clause 7.5.6, plus sterilization and sterile barrier templates. A completed pouch heat-seal validation shows you what \"done\" looks like.\u003c\/p\u003e\u003ch2\u003eWhat's inside (27 files)\u003c\/h2\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eProcess Validation Procedure (Word):\u003c\/strong\u003e scope, the verify-or-validate decision, IQ, OQ and PQ, sample size rationale, deviations, revalidation, production software and outsourced processes, with a clause 7.5.6 a) to g) traceability table.\u003c\/li\u003e\n\u003cli\u003e\u003cstrong\u003eValidation Master Plan and Validation Determination Form (Word).\u003c\/strong\u003e\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eIQ, OQ and PQ Protocol and Report templates (Word):\u003c\/strong\u003e checks, study design, acceptance criteria, results tables, deviations and sign-offs.\u003c\/li\u003e\n\u003cli\u003e\u003cstrong\u003eValidation Summary Report, Deviation and Revalidation Assessment Forms (Word).\u003c\/strong\u003e\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduction Software Validation Protocol (Word):\u003c\/strong\u003e risk-based, in line with FDA's 2025 Computer Software Assurance guidance.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eValidation Toolkit Workbook (Excel):\u003c\/strong\u003e process register, screening, pFMEA, zero-failure sample sizes, sampling plans that allow failures, tolerance intervals, Ppk, revalidation log and traceability.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eWorked Example:\u003c\/strong\u003e a complete, realistic (fictional) pouch heat-seal validation: IQ, an 8-run OQ design, 3 PQ runs, the validated window and a monitoring plan.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSterilization and Sterile Barrier Templates (11 files):\u003c\/strong\u003e sterilization SOP, sterile barrier system validation plan and master pack, sterilization IQ, OQ and PQ protocols and reports, load and biological indicator log, load configuration templates.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eEquipment Qualification Extras (4 files):\u003c\/strong\u003e user requirement specification, IQ checklist, validation traceability matrix, process FMEA.\u003c\/li\u003e\n\u003cli\u003e\u003cstrong\u003eStart Here guide (PDF).\u003c\/strong\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch2\u003eWho it's for\u003c\/h2\u003e\u003cp\u003eQuality and manufacturing engineers at medical device manufacturers and contract manufacturers who need to validate sealing, bonding, moulding, marking, sterilization or similar processes, or who have a process validation finding to close.\u003c\/p\u003e\u003ch2\u003eBuilt on\u003c\/h2\u003e\u003cp\u003eISO 13485:2016 clauses 7.5.6 and 7.5.7, the FDA QMSR (21 CFR Part 820, effective 2 February 2026), GHTF\/SG3\/N99-10:2004 process validation guidance, ISO 11607-2 for sterile barrier sealing, and ISO\/TR 80002-2 for software.\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\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\u003eNeed production records and product release too? See the \u003ca href=\"\/products\/iso-13485-production-traceability-kit\"\u003eProduction \u0026amp; Traceability Kit\u003c\/a\u003e, or get everything in the \u003ca href=\"\/products\/iso-13485-complete-qms-kit\"\u003eComplete QMS Kit\u003c\/a\u003e.\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"ISO Cloud Consulting","offers":[{"title":"Default Title","offer_id":50497780515010,"sku":"ICC-13485-PV","price":99.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/iso-13485-process-validation-iq-oq-pq-pack-v11.png?v=1790154453","url":"https:\/\/isocloudconsulting.com\/products\/iso-13485-process-validation-iq-oq-pq-pack","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}