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Training content
Overview
ISO 13485 Medical Devices Quality Management System Auditor Training has been designed to train auditors who can evaluate the quality management systems of medical device organisations and conduct systematic audits.
The training is based on ISO 13485:2016 and ISO 19011:2026 for audit methodology. Risk management and legal requirements are also addressed from an auditor's perspective.
The language of the training is Turkish. The training is delivered online.
About the Training
The training covers ISO 13485 requirements, risk management, design and development, supplier control, production, sterilisation, traceability, complaints, nonconforming product, CAPA and audit techniques.
Who Should Attend?
- ISO 13485 auditors
- Auditor candidates
- Quality managers
- Medical device specialists
- Regulatory personnel
- Production and technical teams
- Certification personnel
Objectives and Outcomes
The aim is to enable participants to interpret ISO 13485 requirements from an auditor's perspective, evaluate medical device processes and conduct effective 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 suppliers.
- Audit traceability.
- Review CAPA processes.
- Prepare an audit plan.
- Write non-conformities.
- Prepare an audit report.
Programme and Method
Training Topics
- Introduction to ISO 13485:2016
- Quality Management System
- Documentation Requirements
- Management Responsibility
- Resource Management
- Risk Management
- Product Realisation
- Design and Development
- Purchasing and Supplier Control
- Production and Service Provision
- Cleanliness and Contamination Control
- Sterilisation Processes
- Identification and Traceability
- Measurement and Monitoring
- Complaint Handling
- Control of Nonconforming Product
- Corrective and Preventive Actions
- ISO 19011 Auditing Principles
- Audit Programme and Plan
- Interviewing and Sampling
- Objective Evidence
- Writing Nonconformities
- Audit Reporting
- Corrective Action Follow-up
Training Method
The training is delivered through subject presentations, medical device case studies, audit scenarios, evidence evaluation, nonconformity writing and reporting exercises.
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 ISO 13485 Auditor Training suitable for?
It is suitable for professionals who wish to undertake medical device quality management system audits.
What is the main purpose of ISO 13485?
It specifies quality system requirements to ensure that medical devices are managed in a manner that meets customer and applicable regulatory requirements.
Are ISO 13485 and ISO 9001 the same?
No. ISO 13485 is specific to the medical device sector and places greater emphasis on regulatory requirements, risk management, process validation and product safety.
Is risk management assessed during the audit?
Yes. The integration of risk management into the product life cycle and quality processes is assessed.
Are sterilisation processes within the scope of the audit?
Where applicable, sterilisation validation, process controls and related records are assessed within the scope of the audit.
What is the difference between Auditor Training and Internal Auditor Training?
Internal Auditor Training focuses on internal audits within an organisation. Auditor Training covers first-, second- and third-party audit approaches.
Is there an examination at the end of the training?
Yes. An assessment examination is administered at the end of the training.
References
- ISO 13485:2016
- ISO 14971:2019
- ISO 19011:2026
- ISO/IEC 17021-1:2015
- IAF MD 9
- Applicable Medical Device Legislation
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