Internal Audits According to ISO 19011 for Medical Device Manufacturers and Their Suppliers
This course provides a structured and practice oriented introduction to internal audits for medical device manufacturers and their suppliers. Participants learn how to plan, conduct, document, and follow up on audits in accordance with ISO 19011:2018, while also meeting regulatory and normative expectations such as ISO 13485 or ISO 9001. The training covers the full audit cycle, auditor competence, supplier audits, and effective remote audit techniques.
Course Outline
- Regulatory and normative requirements for internal audits
- Principles and structure of ISO 19011:2018
- Planning, conducting, documenting, and following up on audits
- Auditor competence and audit methods
- Risk based audit planning and supplier audits
- Tools and techniques: checklists, sampling, communication
- Remote audit approaches and best practices
- Establishing and managing an effective audit program
Course Tutor
Aimen Ghanemi, M.Sc., is a Senior Consulting Medical Device professional with more than 10 years of experience in the medical device industry. He has served as a lead auditor according to ISO 19011 for more than 10 years and has held quality management leadership responsibilities, including serving as Head of Quality Management and coordinating teams for global product registrations and quality management certification.
His expertise includes quality management systems, medical device regulations, CAPA, registration, project management, supplier qualification, and audits and inspections. He has experience with ISO 9001, ISO 13485, MDR, QSR and GMP, as well as international registrations for medical devices and related technical documentation. He has also coordinated product realization activities as a project and operations manager for joint replacement and surgical instruments, working across development, supply chain management, quality assurance, logistics and sales.
Aimen holds a Master of Science in Biomedical Engineering from Hamburg University of Applied Sciences in Germany. He is a lead auditor according to ISO 19011 for quality management systems in accordance with ISO 9001, GMP, ISO 13485, Regulation (EU) 2017/745 and MDSAP.
Learning Outcomes
Requirements for Internal Audits
- Understanding legal, regulatory, and normative expectations
- ISO 13485 and ISO 9001 audit requirements and the role of internal audits in quality management systems
ISO 19011:2018 – Guidelines for Auditing
- Applying audit principles and understanding auditor competence
- Scope, terminology, and definitions
- Audit principles, audit types, and auditor/lead auditor competence
- Audit activities and methods
Internal Audit Process
- Confident planning, execution, and documentation of audits
- Audit structure and workflow
- Planning and preparation
- Conducting audits using communication, questioning, and sampling techniques
- Identifying and documenting nonconformities
- Reporting and follow up actions
Audit Program Management
- Designing and maintaining an effective audit program
- Risk based planning and prioritization
- Documentation and records
- Supplier audits, expectations, and evaluation criteria
Practical Implementation
- Using tools and techniques for efficient audits
- Creating and applying checklists
- Using different information sources and audit techniques
- Case studies and practical examples
- Conducting remote audits effectively
Who Should Attend
- Medical device manufacturers
- Persons Responsible for Regulatory Compliance (PRRC)
- Auditors and auditees
- Quality management representatives
- Quality management personnel
This course is ideal for professionals who need a clear, applicable understanding of internal audits and their regulatory significance. It equips participants to conduct audits confidently, manage audit programs effectively, and meet the expectations of ISO 19011 and ISO 13485/9001. The training provides practical tools, real world examples, and proven techniques — including remote audit methods — to strengthen both internal and supplier audit performance.
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