{"product_id":"iso-13485-foundations-course","title":"ISO 13485:2016 Foundations Course (Online, Self-Paced, Certificate)","description":"\u003cp\u003e\u003cstrong\u003eUnderstand ISO 13485:2016, the medical device quality management system standard, from the ground up.\u003c\/strong\u003e This online ISO 13485 training course explains every clause in plain English, written by a practising medical device quality and operations professional. About 4 hours of video (about 8 learning hours in total), worksheets, quizzes, a final exam and an ISO Cloud Consulting Certificate of Completion.\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eFormat:\u003c\/strong\u003e online, self-paced, any device\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAccess:\u003c\/strong\u003e unlimited access, granted the moment your order is paid\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eLength:\u003c\/strong\u003e about 4 hours of video, about 8 learning hours\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eAssessment:\u003c\/strong\u003e knowledge check after every lesson (100% to continue, unlimited retries), module quizzes (70%), open-book final exam\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eCertificate:\u003c\/strong\u003e Certificate of Completion with a unique number\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch2\u003eWhat is ISO 13485:2016?\u003c\/h2\u003e\u003cp\u003eISO 13485:2016 sets the quality management system requirements for organisations involved in the medical device life cycle, including design, production, distribution and servicing. It is the current edition and underpins regulatory QMS expectations in many markets, including EU MDR conformity, MDSAP and, since February 2026, the US FDA Quality Management System Regulation.\u003c\/p\u003e\u003ch2\u003eWhat you will be able to do\u003c\/h2\u003e\u003cul\u003e\n\u003cli\u003eRead the standard correctly: \"as appropriate\", \"documented\", the regulatory meaning of risk, and the roles of manufacturer, authorized representative, importer and distributor.\u003c\/li\u003e\n\u003cli\u003eUse the vocabulary: medical device, medical device family, complaint, advisory notice, life-cycle, post-market surveillance, sterile barrier system and the rest of clause 3.\u003c\/li\u003e\n\u003cli\u003eExplain what clauses 4 to 8 ask for, including the quality manual, the medical device file, document and record control, management review, competence, infrastructure and contamination control.\u003c\/li\u003e\n\u003cli\u003eFollow product realization end to end: risk management, design and development, purchasing, production and validation, identification and traceability, measuring equipment.\u003c\/li\u003e\n\u003cli\u003eDescribe the post-market system: feedback, complaint handling, reporting to regulatory authorities, nonconforming product, CAPA.\u003c\/li\u003e\n\u003cli\u003eExplain how ISO 13485 differs from ISO 9001 and where it sits in the global regulatory landscape (EU MDR\/IVDR, US FDA QMSR, MDSAP) at an overview level.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch2\u003eHow the course works\u003c\/h2\u003e\u003col\u003e\n\u003cli\u003eOrientation and vocabulary.\u003c\/li\u003e\n\u003cli\u003eClause 4: QMS and documentation.\u003c\/li\u003e\n\u003cli\u003eClause 5: management responsibility.\u003c\/li\u003e\n\u003cli\u003eClause 6: resource management.\u003c\/li\u003e\n\u003cli\u003eClause 7: product realization.\u003c\/li\u003e\n\u003cli\u003eClause 8: measurement, analysis and improvement.\u003c\/li\u003e\n\u003cli\u003eISO 13485 versus ISO 9001 and the regulatory landscape.\u003c\/li\u003e\n\u003cli\u003eA knowledge check after every lesson that you must pass (100%, unlimited retries), module quizzes (70%, unlimited retakes), and an open-book final exam (Paper A: 50 questions, 60 minutes, 70% to pass; a different Paper B is available if you need a second attempt), then your certificate.\u003c\/li\u003e\n\u003c\/ol\u003e\u003ch2\u003eWho it is for\u003c\/h2\u003e\u003cp\u003eNew QA and RA staff, engineers, production, supply-chain and customer-service staff at device manufacturers, contract manufacturers, suppliers and distributors; founders entering the device market; and anyone preparing for the \u003ca href=\"\/products\/iso-13485-internal-auditor-course\"\u003eISO 13485 Internal Auditor\u003c\/a\u003e or \u003ca href=\"\/products\/iso-13485-lead-implementer-course\"\u003eLead Implementer\u003c\/a\u003e courses. It also works as ISO 13485 awareness training for employees (clause 6.2); contact us for team seats.\u003c\/p\u003e\u003ch2\u003eAbout your certificate\u003c\/h2\u003e\u003cp\u003eYou receive an ISO Cloud Consulting \u003cstrong\u003eCertificate of Completion\u003c\/strong\u003e when you complete every lesson, pass every knowledge check and quiz, and pass the final exam. It is a certificate of completion only: it is not an accredited or certified qualification and it does not certify any organisation. ISO Cloud Consulting is a new company and intends to apply for international recognition of its course certificates before the end of 2027. Today it serves as documented evidence of training under ISO 13485:2016 clause 6.2.\u003c\/p\u003e\u003ch2\u003eFrequently asked questions\u003c\/h2\u003e\u003ch3\u003eHow is ISO 13485 different from ISO 9001?\u003c\/h3\u003e\u003cp\u003eISO 13485 is built for regulatory compliance rather than customer satisfaction and continual improvement alone. It requires more documented procedures, risk management across product realization, design controls, traceability, sterile and implantable requirements where relevant, and long record retention. It does not follow ISO 9001's harmonized structure.\u003c\/p\u003e\u003ch3\u003eWho needs ISO 13485 training?\u003c\/h3\u003e\u003cp\u003eEveryone whose work affects device quality: QA and RA, engineering, production, purchasing, warehouse and service staff. Clause 6.2 requires the organisation to determine competence, provide training and keep records.\u003c\/p\u003e\u003ch3\u003eDo I need to buy the standard?\u003c\/h3\u003e\u003cp\u003eYes. The course teaches the requirements in our own words and does not reproduce ISO text. Buy ISO 13485:2016 from ISO or your national standards body.\u003c\/p\u003e\u003ch3\u003eHow long do I have access?\u003c\/h3\u003e\u003cp\u003eUnlimited access, with no expiry date.\u003c\/p\u003e\u003ch2\u003eRelated\u003c\/h2\u003e\u003cp\u003eNeed documents? See the \u003ca href=\"\/products\/iso-13485-starter-kit\"\u003eISO 13485 Starter Kit\u003c\/a\u003e or the \u003ca href=\"\/products\/iso-13485-complete-qms-kit\"\u003eISO 13485 Complete QMS Kit\u003c\/a\u003e. Save with the \u003ca href=\"\/products\/iso-13485-complete-training-track\"\u003eISO 13485 Complete Training Track\u003c\/a\u003e (all three courses, $599). Explore the free \u003ca href=\"\/pages\/iso-13485-clauses-4-8-clause-hub\"\u003eISO 13485 clause hub\u003c\/a\u003e.\u003c\/p\u003e\u003cp\u003e\u003cem\u003eLessons are narrated with a natural-sounding AI voice from scripts written by the instructor; slides are included as downloads. 5-day fit guarantee, before taking the final exam. Course author: \u003ca href=\"\/pages\/about-iso-cloud-consulting\"\u003eIshan Maharaj, ISO Cloud Consulting\u003c\/a\u003e.\u003c\/em\u003e\u003c\/p\u003e","brand":"ISO Cloud Consulting","offers":[{"title":"Default Title","offer_id":67767264444610,"sku":"ICC-COURSE-MD-F","price":99.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/iso-13485-foundations-course.png?v=1791815675","url":"https:\/\/isocloudconsulting.com\/products\/iso-13485-foundations-course","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}