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Training content
Overview
ISO 13485 Medical Devices Quality Management System Transition Training has been designed to support the alignment of existing quality management systems with the requirements of ISO 13485:2016 and to provide an understanding of the requirements specific to the medical device sector.
The training is based on the current ISO 13485:2016 requirements, risk management and relevant regulatory expectations.
The language of the training is Turkish. The training is delivered online.
About the Training
The training covers ISO 13485 requirements, risk management, documentation, design, production, supplier control, validation, traceability, complaints, CAPA and system updating activities.
Who Should Attend?
- Quality managers
- Regulatory teams
- Medical device manufacturers
- Quality specialists
- Technical personnel
- Internal auditors
- Management system representatives
Objectives and Outcomes
The aim is for participants to understand the ISO 13485 requirements, identify gaps in the existing system and plan the necessary updates.
By the End of the Training
Participants will be able to:
- Explain the ISO 13485 requirements.
- Identify differences between systems.
- Assess risk management.
- Review documentation.
- Identify validation needs.
- Update CAPA processes.
- Conduct a gap analysis.
- Prepare a transition plan.
Programme and Method
Training Topics
- Overview of ISO 13485:2016
- Transition and Compliance Approach
- Quality Management System
- Regulatory Requirements
- Risk Management
- Documentation and Records
- Design and Development
- Supplier Management
- Production and Service Provision
- Process Validation
- Sterilisation Processes
- Traceability
- Complaint Management
- Control of Nonconforming Product
- CAPA Processes
- Gap Analysis
- Documentation Update
- Preparation of the Transition Plan
Training Method
The training is delivered through requirements comparisons, case studies, gap analysis and system update 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 achieve 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 Transition Training suitable for?
It is suitable for organisations and professionals seeking to align their quality system with ISO 13485 requirements.
Has a new edition of ISO 13485 been published?
No. The current standard is ISO 13485:2016 and it was reconfirmed in 2025.
Should a gap analysis be conducted during the transition?
Yes. It enables the existing system to be compared with ISO 13485 requirements.
Is risk management important during the transition?
Yes. The integration of risk management into quality processes is one of the fundamental requirements.
Do the documents need to be updated?
Yes. Affected procedures, instructions, records and technical documents should be reviewed.
Is a new ISO 13485 guidance document being developed?
Yes. ISO/CD TS 23485 is being developed as guidance on the implementation of ISO 13485:2016; it is not a new standard replacing ISO 13485.
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/TR 24971:2020
- ISO/CD TS 23485
- Applicable Medical Device Legislation
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