{"product_id":"iso-13485-internal-auditor-course","title":"ISO 13485:2016 Internal Auditor Course (Online, Certificate of Completion)","description":"\u003cp\u003e\u003cstrong\u003eLearn to plan, conduct and report internal audits of an ISO 13485:2016 quality management system at manufacturers, contract manufacturers, suppliers and distributors.\u003c\/strong\u003e This self-paced ISO 13485 internal auditor training course gives you about 7 hours of video plus guided practice (about 20 learning hours in total): audit templates, auditor role-plays, a full mock audit of a catheter manufacturer with an evidence pack, quizzes, a final exam and an ISO Cloud Consulting Certificate of Completion. Comparable self-paced courses typically cost $500 to $700 and live classes over $1,000.\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 7 hours of video, about 20 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 with scenario questions\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 does ISO 13485 require for internal audits?\u003c\/h2\u003e\u003cp\u003eClause 8.2.4 requires planned internal audits to determine whether the QMS conforms to planned arrangements, ISO 13485 and applicable regulatory requirements, and is effectively implemented. You need a documented procedure, an audit programme based on the status and importance of processes, objective auditors, records with conclusions, and timely corrective action.\u003c\/p\u003e\u003ch2\u003eWhat you will be able to do\u003c\/h2\u003e\u003cul\u003e\n\u003cli\u003eAudit every clause of ISO 13485:2016: what to ask, what to sample, what records to expect and the typical findings, with particular depth on the medical device file, design and development files and design transfer, risk management records, process and software validation, supplier controls and quality agreements, UDI and traceability, complaint handling, regulatory reporting, advisory notices and CAPA.\u003c\/li\u003e\n\u003cli\u003eRun an internal audit programme that meets clause 8.2.4: status and importance, results of previous audits, recorded criteria, scope, interval and methods, impartiality, records with conclusions, and verified follow-up.\u003c\/li\u003e\n\u003cli\u003eRun the full audit cycle: plan, checklists, opening meeting, interviews and sampling (including device history records and design files), evaluating evidence, classifying findings, writing nonconformities, closing meeting, report and CAPA follow-up.\u003c\/li\u003e\n\u003cli\u003eAudit special processes and higher-risk areas: sterilization and sterile barrier validation, cleanroom and contamination control, implantable traceability, servicing, software validation.\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch2\u003eHow the course works\u003c\/h2\u003e\u003col\u003e\n\u003cli\u003eOrientation and the standard in depth for auditors.\u003c\/li\u003e\n\u003cli\u003eAuditing fundamentals (ISO 19011) and clause 8.2.4; how notified bodies and MDSAP auditing organizations audit, at overview level.\u003c\/li\u003e\n\u003cli\u003eThe audit cycle step by step, with templates you keep.\u003c\/li\u003e\n\u003cli\u003eAuditing special processes and higher-risk areas.\u003c\/li\u003e\n\u003cli\u003eRole-plays: auditor and auditee dialogues showing good and poor practice.\u003c\/li\u003e\n\u003cli\u003eMock audit capstone with evidence pack, model findings, model report and marking rubric.\u003c\/li\u003e\n\u003cli\u003eA knowledge check after every lesson that you must pass (100%, unlimited retries), module quizzes (70%), and an open-book final exam (Paper A: 60 questions including scenario sets, 120 minutes, 75% 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\u003eTemplates included\u003c\/h2\u003e\u003cp\u003eAudit programme, audit plan, process-based checklists for clauses 4 to 8, device history record, medical device file and design file sampling sheet, nonconformity report, audit report, CAPA verification form.\u003c\/p\u003e\u003ch2\u003eWho it is for\u003c\/h2\u003e\u003cp\u003eInternal auditors, quality engineers, supplier quality staff, process owners and consultants in the medical device sector. Foundations-level knowledge recommended; the \u003ca href=\"\/products\/iso-13485-foundations-course\"\u003eISO 13485:2016 Foundations Course\u003c\/a\u003e covers it.\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 auditor qualification (it is not CQI\/IRCA, Exemplar Global or PECB), it does not make you a certified or registered auditor, and it does not qualify you to perform third-party certification audits. 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 training evidence under clause 6.2 for your organisation's auditor competence records.\u003c\/p\u003e\u003ch2\u003eFrequently asked questions\u003c\/h2\u003e\u003ch3\u003eIs this course accepted by notified bodies?\u003c\/h3\u003e\u003cp\u003eNotified bodies and regulators assess your organisation's evidence of auditor competence, not a particular training brand. File the Certificate of Completion as training evidence under clause 6.2 and combine it with audit practice and supervision.\u003c\/p\u003e\u003ch3\u003eCan internal auditors audit their own work?\u003c\/h3\u003e\u003cp\u003eNo. Clause 8.2.4 requires that auditors do not audit their own work, and the selection of auditors must ensure objectivity and impartiality.\u003c\/p\u003e\u003ch3\u003eHow often must internal audits be done under ISO 13485?\u003c\/h3\u003e\u003cp\u003eAt planned intervals set by your audit programme, based on the status and importance of processes and previous results. Most organisations cover every process at least once a year.\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\u003eUse the \u003ca href=\"\/products\/iso-13485-internal-audit-kit\"\u003eISO 13485 Internal Audit Kit\u003c\/a\u003e for ready-made programmes and checklists, and read the free \u003ca href=\"\/pages\/iso-13485-internal-audit\"\u003eISO 13485 clause 8.2.4 internal audit guide\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).\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. You need your own licensed copy of ISO 13485:2016. 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":67767267131586,"sku":"ICC-COURSE-MD-IA","price":299.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0709\/8361\/4658\/files\/iso-13485-internal-auditor-course.png?v=1791815679","url":"https:\/\/isocloudconsulting.com\/products\/iso-13485-internal-auditor-course","provider":"ISO Cloud Consulting","version":"1.0","type":"link"}