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Training content
Overview
ISO 13485 Medical Devices Quality Management System Internal Auditor Training has been designed to train internal auditors who can assess the conformity and effectiveness of a medical device quality management system.
The training is based on ISO 13485:2016 and ISO 19011:2026.
The language of the training is Turkish. The training is delivered online.
About the Training
The training covers ISO 13485 requirements, risk management, design, production, supplier control, traceability, complaints, CAPA and internal auditing techniques.
Who Should Attend?
- Internal auditor candidates
- Quality personnel
- Regulatory teams
- Medical device specialists
- Production personnel
- Technical teams
- Management system personnel
Objectives and Outcomes
The aim is for participants to interpret ISO 13485 requirements, evaluate medical device processes and conduct effective internal audits.
By the End of the Training
Participants will be able to:
- Interpret ISO 13485 requirements.
- Evaluate risk management.
- Audit design processes.
- Review production controls.
- Evaluate supplier processes.
- Audit traceability.
- Review CAPA processes.
- Prepare an audit plan.
- Document nonconformities.
- Follow up corrective actions.
Programme and Method
Training Topics
- Introduction to ISO 13485:2016
- Quality Management System
- Documentation and Records
- Management Responsibility
- Resource Management
- Risk Management
- Product Realisation
- Design and Development
- Supplier Management
- Production and Service Provision
- Process Validation
- Sterilisation Processes
- Identification and Traceability
- Complaint Management
- Control of Nonconforming Product
- CAPA Processes
- ISO 19011 Auditing Principles
- Internal Audit Planning
- Interviewing and Sampling
- Objective Evidence
- Writing Nonconformities
- Audit Reporting
- Corrective Action Follow-up
Training Method
The training is delivered through lectures, medical device case studies, audit scenarios, evidence evaluation and practical exercises in writing nonconformities.
Attendance and Certificate
Certification Rule
A certificate of attendance is issued to all participants whose attendance has been confirmed. To receive a certificate of achievement, participants must obtain a passing grade in the examination at the end of the training; participants who use all their examination attempts but do not pass will be issued a certificate of attendance.
FAQ and Resources
Who is the ISO 13485 Internal Auditor Training suitable for?
It is suitable for professionals who will be involved in internal audits of medical device quality management systems.
Which areas are assessed during an internal audit?
Risk management, design, production, suppliers, validation, traceability, complaints and CAPA processes are assessed.
Is risk management important in an internal audit?
Yes. The integration of risk management into the product lifecycle and quality processes is assessed.
Is process validation assessed during the audit?
Yes. The validation of applicable processes and the relevant records are reviewed.
Why is ISO 19011 used?
It provides guidance on planning and conducting internal audits and on auditor competence.
Is there an examination at the end of the training?
Yes. An assessment examination is conducted at the end of the training.
References
- ISO 13485:2016
- ISO 14971:2019
- ISO/TR 24971:2020
- ISO 19011:2026
- Applicable Medical Device Legislation
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