{"product_id":"certification-iso-iec-17021-12015-iso-134852016-scheme","title":"Certification - ISO IEC 17021-12015 - ISO 134852016 Scheme","description":"\u003cp\u003eA certification-scheme documentation package for bodies certifying ISO 13485:2016 medical device quality management systems under ISO\/IEC 17021-1:2015. ISO 13485 certification underpins market access for medical device manufacturers and their suppliers, and certifying it demands scheme documentation that reflects regulatory context — this package provides it: a Quality Manual establishing the certification body's management system and impartiality architecture; the ISO 13485 scheme document; fourteen procedures governing application review and audit-time determination for device manufacturers by risk class and process complexity, audit programme design, Stage 1 and Stage 2 execution — including evaluation of design and development controls, risk management per ISO 14971 linkage, sterile and software processes, and post-market feedback — technical review and certification decision, surveillance and recertification, special audits, suspension and withdrawal, appeals, complaints, auditor competence in medical device technologies, internal audit and management review; and fourteen forms covering the certification life cycle. With 48 controlled documents including an ISO 13485:2016 certification audit checklist, a CB compliance checklist against ISO\/IEC 17021-1, medical-device audit guidance and auditor training materials, the editable kit equips certification bodies to operate an accreditation-ready medical device QMS scheme.\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eIncluded:\u003c\/strong\u003e 48 ready-to-use, fully editable documents (manual, procedures, forms, records, checklists, guidance and training material).\u003c\/p\u003e\u003cp\u003e\u003cstrong\u003eLicense:\u003c\/strong\u003e single-organization license; delivered electronically as a ZIP archive.\u003c\/p\u003e","brand":"Apex Global Solutions AGS","offers":[{"title":"Default Title","offer_id":56517097947476,"sku":"AGS-15-013","price":1900.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1052\/4996\/4372\/files\/Certification-ISO-IEC-17021-12015-ISO-134852016-Scheme.png?v=1784574604","url":"https:\/\/agskits.com\/products\/certification-iso-iec-17021-12015-iso-134852016-scheme","provider":"apex global solutions","version":"1.0","type":"link"}