ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor
ISO 13485:2016 is the internationally accepted standard that specifies the requirements for a Quality Management System (QMS) specifically tailored to the medical device industry. This standard ensures that organizations consistently design, manufacture, and deliver safe and effective medical devices that meet both customer expectations and regulatory requirements.
An ISO 13485 Internal Auditor is responsible for conducting systematic and independent audits within the organization to verify compliance with the standard. The auditor evaluates processes, documentation, and records to ensure the QMS is properly implemented, maintained, and continually improved.
Aim of ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor
The primary aim of an ISO 13485:2016 Internal Auditor is to systematically evaluate the organization’s Quality Management System (QMS) to ensure:
- Full compliance with ISO 13485:2016 requirements and applicable medical device regulations
- Effective implementation and maintenance of quality processes
- Identification and documentation of any non-conformities or areas for improvement
- Support for continuous improvement of the QMS
- Assurance of patient safety, product quality, and regulatory readiness
Course Overview
ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor
Total Modules 4
Training Credits 18
Directed Learning Hours (DLH) 60
Course Code BUK1954
- Educational Qualification
- Diploma, Bachelor’s, or Master’s degree in Engineering, Science, Biotechnology, Medical Technology, Pharmacy, or any related technical field.
- Work Experience
- Minimum 1-2 years experience working in medical device manufacturing, quality assurance, regulatory affairs, or related fields.
- Experience with Quality Management Systems (QMS), preferably in medical devices or regulated industries.
- Knowledge & Skills
- Basic understanding of quality management principles and regulatory requirements related to medical devices (FDA, MDR, etc.).
- Familiarity with ISO 13485 standard is preferred but not mandatory.
- Good communication, analytical, and auditing skills.
| Course Code | Curriculum Title | Credit | DLH |
|---|---|---|---|
| BUK1953-1 | Introduction to ISO 13485:2016 | 3 | 10 |
| BUK1953-2 | Understanding ISO 13485 Requirements | 3 | 10 |
| BUK1953-3 | Regulatory and Compliance Requirements | 3 | 10 |
| BUK1953-4 | Principles of Auditing | 3 | 10 |
| BUK1953-5 | Audit Planning and Preparation | 3 | 10 |
| BUK1953-6 | Practical Exercises and Case Studies | 3 | 10 |
Module 1: Introduction to ISO 13485:2016
- Overview of ISO 13485:2016 standard
- Importance of QMS in medical device industry
- Key terms and definitions
- Regulatory landscape (FDA, EU MDR, etc.)
Module 2: Understanding ISO 13485 Requirements
- Clause-wise detailed explanation:
- Quality Management System requirements
- Management responsibility
- Resource management
- Product realization (design, development, production)
- Measurement, analysis, and improvement
Module 3: Regulatory and Compliance Requirements
- Overview of medical device regulations and standards
- FDA 21 CFR Part 820 basics
- EU MDR and other global regulatory frameworks
- Risk management (ISO 14971 overview
Module 4: Principles of Auditing
- Purpose and benefits of internal audits
- Types of audits (internal, external, supplier)
- ISO 19011 auditing guidelines
- Roles and responsibilities of auditors
Module 5: Audit Planning and Preparation
- Developing audit plans and checklists
- Reviewing documentation and processes
- Setting audit objectives and scope
- Communication skills for auditors
Module 6: Conducting the Audit
- Audit opening meeting
- Gathering objective evidence (interviews, observations, records)
- Identifying non-conformities and observations
- Auditor behavior and interpersonal skills
Module 7: Audit Reporting and Follow-up
- Writing audit reports
- Categorizing findings (non-conformities, observations)
- Conducting closing meetings
- Corrective and preventive actions (CAPA)
- Follow-up and verification of actions
Module 8: Practical Exercises and Case Studies
- Real-world audit scenarios
- Role-playing audit interviews
- Writing non-conformance reports
- Root cause analysis and corrective action planning
Module 9: Examination and Certification
- Written assessment or quiz
- Review of practical exercises
- Certification of successful completion
- Quality Assurance and Quality Control Personnel
- Regulatory Affairs Professionals
- Production and Manufacturing Managers
- Design and Development Engineers
- Internal and External Auditors
- Consultants and Trainers
- Anyone with a Science or Engineering Background
- All Modules within this qualification are assessed internally by the approved training Centre and externally verified by BURRAQ UK. The program uses a criterion-referenced assessment approach to ensure that learners successfully meet all required learning outcomes.
- A Pass in any unit is granted only when the learner submits valid, reliable, and authentic evidence that demonstrates achievement of the assessment criteria. The Assessor is responsible for reviewing this evidence and confirming that the learner has attained the expected standard.