{"product_id":"iso-13485-training-competence-kit","title":"ISO 13485 Training \u0026 Competence Kit (8 Training Modules)","description":"\u003cp\u003eShow auditors that everyone in a quality-affecting role is competent: the procedure, the training matrix and records, and eight ready-to-run training modules, each with slides, a trainer guide, a learner workbook and an assessment.\u003c\/p\u003e\u003ch2\u003eWhat's inside (39 files)\u003c\/h2\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eProcedure and Records:\u003c\/strong\u003e Competence and Training SOP; Training Attendance Register; Training Effectiveness Log; Training Matrix; Training Record Log; Training Request Log.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTraining Modules\u003c\/strong\u003e (each with slides, trainer guide, learner workbook and assessment): CAPA; Complaint Handling; Design Control; Document Control; Internal Auditing; PMS and Vigilance; Records Management; Risk Management.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch2\u003eHow to use it\u003c\/h2\u003e\u003col\u003e\n\u003cli\u003eAdapt the competence and training SOP, including how effectiveness is evaluated.\u003c\/li\u003e\n\u003cli\u003eSet required training for each role in the training matrix.\u003c\/li\u003e\n\u003cli\u003eDeliver the modules: each has a slide deck, trainer guide, learner workbook and assessment.\u003c\/li\u003e\n\u003cli\u003eRecord attendance, results and effectiveness checks.\u003c\/li\u003e\n\u003cli\u003eReview the matrix whenever roles, procedures or regulations change.\u003c\/li\u003e\n\u003c\/ol\u003e\u003ch2\u003eWho it's for\u003c\/h2\u003e\u003cp\u003eQuality and HR teams that need to show competence under clause 6.2 and train staff without building courses from scratch.\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-starter-kit\"\u003eISO 13485 Starter Kit\u003c\/a\u003e and the \u003ca href=\"\/products\/iso-13485-complete-qms-kit\"\u003eComplete QMS Kit\u003c\/a\u003e, which cost less than buying kits separately.\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"ISO Cloud Consulting","offers":[{"title":"Default Title","offer_id":50498929393858,"sku":"ICC-13485-TRN","price":119.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/iso-13485-training-competence-kit.png?v=1790150995","url":"https:\/\/isocloudconsulting.com\/products\/iso-13485-training-competence-kit","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}