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Training content
Overview
ISO 13485 Medical Devices Quality Management System Awareness Training has been designed to provide an understanding of quality management system requirements and employee responsibilities in the medical device sector.
The training is based on the requirements of ISO 13485:2016. The standard supports compliance with quality and regulatory requirements in the design, production and servicing processes of medical devices.
The language of instruction is Turkish. The training is delivered online.
About the Training
The training covers the ISO 13485 structure, risk management, design, production, supplier control, traceability, complaints, nonconforming products and corrective actions.
Who Should Attend?
- Employees in the medical device sector
- Quality personnel
- Regulatory teams
- Production personnel
- Technical teams
- Purchasing personnel
- Management system coordinators
Objectives and Outcomes
The aim is for participants to gain a basic understanding of ISO 13485 requirements, recognise their quality and regulatory responsibilities, and understand their contribution to medical device safety.
By the End of the Training
Participants will be able to:
- Explain the purpose of ISO 13485.
- Recognise the basic requirements.
- Understand risk management.
- Understand the importance of quality records.
- Explain traceability.
- Identify nonconformities.
- Contribute to continual improvement.
Programme and Method
Training Topics
- Introduction to ISO 13485:2016
- Quality Management System
- Documentation and Records
- Management Responsibility
- Resource Management
- Risk Management
- Design and Development
- Supplier Management
- Production and Service Provision
- Process Validation
- Cleaning and Contamination Control
- Identification and Traceability
- Measurement and Monitoring
- Complaint Management
- Control of Nonconforming Product
- Corrective and Preventive Actions
- Continual Improvement
Training Method
The training is delivered through presentations, brief case studies and practical scenarios relating to medical device processes.
Attendance and Certificate
Certification Rules
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 Awareness Training suitable for?
It is suitable for anyone working in the medical device sector who wishes to gain a basic understanding of ISO 13485.
What is the main purpose of ISO 13485?
To enable medical device organisations to establish a quality management system 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 and process control.
Is risk management important?
Yes. Risk management is one of the key elements throughout the medical device life cycle.
Why is traceability important?
It supports the tracking of product and process history and enables effective action to be taken when necessary.
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
- Applicable Medical Device Legislation
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