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QMS Auditing & Inspection Readiness – ISO 13485:2016 Internal Auditor Course & Certification
Intermediate
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Each course includes:
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with any changes to ISO 13485:2016, ISO 19011:2018, ISO 14971:2019, EU MDR 2017/745, IVDR 2017/746, MDSAP, and US FDA 21 CFR Part 820 / QMSR as our training courses are constantly monitored, reviewed and updated.
Learn from Industry Experts
The course content has been developed by IRCA-certified ISO 13485 lead auditors and former notified-body assessors to ensure that learners can apply audit principles and clause interpretation in a real medical-device QMS. Every lesson follows the same pedagogical rhythm — concept cards, a real case study, an audit-flag warning, an audit-side checklist, a standards map, a do/do-not rulebook, and a scenario knowledge check.
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About
QMS Auditing & Inspection Readiness – ISO 13485:2016 Internal Auditor is a comprehensive program designed to equip professionals with the knowledge and practical skills required to audit medical device quality management systems and prepare organizations for regulatory inspections. The course is based on ISO 13485:2016, ISO 19011 auditing principles, and global medical device regulatory expectations.
This QMS Auditing & Inspection Readiness – ISO 13485:2016 Internal Auditor Course & Certification provides practical training in audit planning, execution, reporting, CAPA management, risk-based auditing, and inspection readiness. Participants learn how to assess compliance, identify nonconformities, evaluate QMS effectiveness, and support continuous improvement within medical device organizations. Upon completion, learners receive certification demonstrating competency in ISO 13485 internal auditing and inspection preparedness.
Who Should Enrol?
- Quality Assurance, Quality Management, and Compliance Professionals in the medical device industry.
- Internal Auditors, Lead Auditors, and Regulatory Affairs Professionals responsible for QMS compliance.
- Medical Device Manufacturing, Operations, and Process Improvement Personnel.
- CAPA, Risk Management, and Inspection Readiness Teams supporting regulatory compliance activities.
- Entry-level professionals and consultants seeking ISO 13485 Internal Auditor certification and medical device auditing expertise.
What you will learn
Understand ISO 13485:2016 requirements, medical device QMS principles, and the global regulatory landscape governing medical device manufacturers.
Learn audit planning, preparation, execution, reporting, and follow-up activities using ISO 19011 auditing principles and risk-based approaches.
Develop expertise in identifying nonconformities, managing CAPA processes, evaluating audit evidence, and assessing QMS effectiveness.
Gain knowledge of inspection readiness, common regulatory findings, auditor competencies, and integration of risk management principles from ISO 14971.
Course Syllabus
- ISO 13485 + Medical Device QMS
- Concepts (part 1)
- Concepts (part 2)
- ISO 13485 in a mid-size medtech
- What regulators look for
- ISO 13485 vs ISO 9001 — where they diverge
- Regulatory Landscape + ISO 13485
- Concepts (part 1)
- Concepts (part 2)
- One QMS, four regulators
- Regulatory overlay — mapping ISO 13485 to regional regs
- Principles of Auditing (ISO 19011)
- Audit Principles
- Audit Types
- Risk-Based Audit Approach
- Auditor Ethics
- Auditor Competence
- Auditor Responsibilities
- Concepts (part 1)
- Concepts (part 2)
- A competent auditor — what it looks like
- ISO 13485 Clause-by-Clause Audit Approach
- Concepts (part 1)
- Concepts (part 2)
- Auditing design controls on an implantable device
- Clause-by-clause auditor questions (sample)
- Audit Planning + Preparation
- Concepts (part 1)
- Concepts (part 2)
- Scope
- Objectives
- Criteria
- Desk Review
- Risk-Based Checklist
- Audit Team & Schedule
- Planning an audit of a Class III cardiac device manufacturer
- ISO 13485 audit plan template — essential contents
- Conducting the Audit
- Concepts (part 1)
- Concepts (part 2)
- A productive day auditing a medtech R&D function
- On-site audit toolkit
- Concepts (part 1)
- Concepts (part 2)
- A finding, written for a medical device context
- Finding classification in medical device audits
- Concepts (part 1)
- Concepts (part 2)
- Root Cause Analysis
- Corrective Action
- Preventive Action
- Effectiveness Check
- Re-Audit
- Closure
- A medical device CAPA done right
- CAPA workflow — seven stages
- Role + Competencies of an ISO 13485 Auditor
- Concepts (part 1)
- Concepts (part 2)
- A difficult audit, handled well
- The behavioural auditor — skills + behaviours
- Common Audit Findings in Medical Devices
- Concepts (part 1)
- Concepts (part 2)
- Design Control Gaps
- Traceability
- Documentation & the Design History File (DHF)
- Supplier Quality Management
- CAPA, Complaints & Vigilance Reporting
- Risk Management — ISO 14971
- Three case studies from real medical device inspections
- Design Controls Failure — Class II Surgical Device
- Supplier Quality Failure — Cardiovascular Device FSCA
- Data Integrity Failure — SaMD Certification Suspended
- Audit Readiness + Inspection Preparation
- Concepts (part 1)
- Concepts (part 2)
- An unannounced MDR audit — handled well
- Inspection readiness — four-layer framework
- Concepts (part 1)
- Concepts (part 2)
- ISO 14971 Risk Management Lifecycle
- Risk Management File (RMF)
- Post-production Monitoring
- Linking ISO 14971 to ISO 13485 audit — seven connections
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