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Training content
Overview
ISO 13485:2016 Medical Devices Quality Management Systems Lead Auditor Training is a comprehensive training programme designed to develop lead auditors who can evaluate the quality management systems of organisations operating in the medical device sector against international standards and relevant regulatory requirements, plan and conduct audits, and manage audit teams.
The training covers the requirements of ISO 13485:2016, the design, development, production, storage and distribution processes for medical devices, risk management under ISO 14971, product safety, traceability, sterilisation and process validation, audit principles, audit planning and implementation processes, the assessment of nonconformities, and audit reporting methods.
In addition to the technical requirements for auditing medical device quality management systems, the programme also examines the relevant national and international regulatory requirements.
The programme aims to enhance participants’ theoretical knowledge through case analyses, practical audit exercises, risk assessment examples and audit reporting exercises.
Objectives and Outcomes
Training Objective
The objective of this training is to provide participants with the knowledge and skills required to interpret the requirements of ISO 13485:2016, evaluate medical device quality management system processes, conduct risk-based audits and carry out lead auditor activities.
Learning Outcomes
Participants who complete the training are expected to acquire the following knowledge and skills:
- Interpret the purpose, scope and requirements of ISO 13485:2016
- Evaluate medical device quality management system processes and their effectiveness
- Explain the key differences between ISO 13485 and ISO 9001
- Evaluate applicable statutory and regulatory requirements relating to medical devices
- Audit medical device risk management processes within the scope of ISO 14971
- Evaluate medical device design and development processes
- Audit production, purchasing, storage and distribution processes
- Evaluate sterilisation, process validation and the control of special processes
- Examine processes for the identification and traceability of medical devices and product conformity
- Evaluate complaint management, feedback and post-market surveillance processes
- Apply audit planning and conduct techniques in accordance with ISO 19011:2026
- Determine the audit scope, criteria and objectives
- Manage the audit team and coordinate audit activities
- Collect objective audit evidence and evaluate nonconformities
- Prepare audit reports and evaluate the effectiveness of corrective actions
Programme and Method
- Day – Introduction to the Medical Devices Quality Management System and Standard Requirements
- Purpose, scope and structure of the ISO 13485:2016 standard
- Fundamental concepts of a medical device quality management system
- Definition of a medical device and an overview of medical device classifications
- Relationship and differences between ISO 13485 and ISO 9001
- Medical device life cycle and quality management
- Process approach and risk-based management
- Regulatory requirements for medical devices
- EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746)
- Overview of medical device legislation in Türkiye
- Clause 4: Quality management system
- Establishment and maintenance of quality management system processes
- Management of documented information and records
- Creation and control of medical device files
- Validation of software used in the quality management system
- Clause 5: Management responsibility
- Quality policy, quality objectives and responsibilities
- Management review processes
- Clause 6: Resource management
- Personnel competence, training and awareness
- Infrastructure, work environment and contamination control
- Day – Medical Device Risk Management, Design and Development Processes
- ISO 13485 Clause 7: Product realisation requirements
- Planning of product realisation processes
- Risk management in accordance with ISO 14971:2019
- Preparation of a medical device risk management plan
- Hazard identification and risk analysis
- Risk evaluation and risk control measures
- Evaluation of residual risks and risk management records
- Determination of customer and regulatory requirements
- Design and development planning
- Design inputs and design outputs
- Design review activities
- Design verification and validation
- Design transfer and management of design changes
- Control of design and development files
- Purchasing processes and supplier evaluations
- Identification and monitoring of critical suppliers
- Verification of purchased products
- Practical exercise: Auditing medical device design files and risk management processes
- Day – Production Controls, Validation, Traceability and Performance Evaluation
- Planning and control of medical device production processes
- Requirements for production and service provision
- Product cleanliness and contamination control
- Specific requirements for sterile medical devices
- Evaluation of cleanrooms and controlled production environments
- Process validation and validation records
- Validation of sterilisation and sterile barrier system processes
- Control of software systems used in production
- Product identification and traceability
- UDI requirements, where applicable
- Protection of customer property
- Product preservation, packaging, storage and distribution
- Control and calibration of monitoring and measuring equipment
- Clause 8: Measurement, analysis and improvement
- Management of feedback and customer complaints
- Regulatory authority reporting processes
- Internal auditing and monitoring of process performance
- Product monitoring and measurement activities
- Control of nonconforming products
- Data analysis, corrective and preventive actions
- Practical exercise: Evaluation of production, validation and traceability records
- Day – Audit Principles, Planning and Conducting the Audit
- Audit principles in accordance with ISO 19011:2026
- Medical device quality management system audit requirements in accordance with ISO/IEC 17021-1 and IAF MD 9
- First-, second- and third-party audits
- Duties, authority and responsibilities of the lead auditor
- Preparation and management of the audit programme
- Risk-based audit approach
- Determination of the audit scope, criteria and objectives
- Medical device risk classes and the impact of technical scope on audit planning
- Audit duration and resource planning
- Formation of the audit team and allocation of duties
- Stage 1 and Stage 2 certification audits
- Document review and audit preparation
- Preparation of the audit plan and checklists
- Conducting the opening meeting
- Audit interviews and effective questioning techniques
- Collection and verification of audit evidence
- Sampling methods and evidence-based evaluation
- Auditing medical device design, production and quality control processes
- Evaluation of suppliers and outsourced processes
- Remote audit methods and digital audit techniques
- Practical exercise: ISO 13485 audit plan and sample audit scenario
- Day – Audit Reporting and Lead Auditor Practices
- Identification and evaluation of audit findings
- Classification of conformity and nonconformities
- Evaluation of major and minor nonconformities
- Writing nonconformities based on objective evidence
- Linking nonconformities to the relevant clauses of the standard
- Evaluation of findings that could affect patient and user safety
- Formulation of audit conclusions
- Preparation of the audit report
- Conducting the closing meeting
- Evaluation of corrections and corrective actions
- Review of root cause analysis
- Effectiveness review of corrective and preventive actions
- Closure of nonconformities and follow-up audits
- Surveillance and recertification audits
- Overview of the certification decision process
- Lead auditor's team management, communication and decision-making skills
- Case study: Evaluation of audit findings relating to design, production, sterilisation and traceability processes
- Audit reporting exercise
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
1. Who is the ISO 13485 Lead Auditor Training suitable for?
It is suitable for quality professionals, biomedical engineers, production and design managers, regulatory affairs specialists, management system auditors, internal auditors and professionals who wish to audit medical device quality management systems.
2. What is the difference between ISO 13485 and ISO 9001?
While ISO 9001 defines general quality management system requirements, ISO 13485 contains quality management system requirements specific to the medical device sector. ISO 13485 places particular emphasis on areas such as compliance with regulatory requirements, risk management, design controls, validation, traceability and product safety.
3. Is the ISO 13485 standard applicable only to medical device manufacturers?
No. ISO 13485 can be implemented by organisations involved in the design, development, production, storage, distribution, installation and servicing of medical devices, as well as by organisations providing related products or services to the medical device sector.
4. Does the ISO 13485 training cover MDR and IVDR requirements?
Yes. The training covers the EU Medical Device Regulation (MDR 2017/745), the In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746) and relevant national regulations insofar as they relate to quality management system audits.
5. Is ISO 14971 risk management included in the training?
Yes. The training covers medical device risk management in accordance with ISO 14971:2019, including hazard identification, risk assessment, risk control measures and the auditing of risk management records.
6. Is obtaining ISO 13485 certification sufficient to use the CE marking?
No. ISO 13485 certification demonstrates the conformity of the organisation’s quality management system. To apply the CE marking, the conformity assessment requirements of the relevant legislation applicable to the product must also be met.
7. What is the difference between the 5-day and 3-day training courses?
The 5-day programme provides comprehensive coverage of ISO 13485 requirements, medical device risk management, design and production processes, and auditing practices. The 3-day programme offers intensive content for participants who already have knowledge of quality management systems and auditing.
8. Does the training include practical exercises?
Yes. The training includes practical exercises in risk assessment, the review of design and production processes, audit planning, case study analysis, writing nonconformities and audit reporting.
9. Can the training be delivered online or face to face?
Yes. The training can be arranged online or face to face, depending on the requirements of participants and organisations.
10. Is there an examination at the end of the training?
A final examination is planned as part of the programme to assess participants’ knowledge and skills.
11. Is a certificate issued at the end of the training?
Yes. The relevant training certificate is issued based on the attendance requirements and assessment results.
Resources
- ISO 13485:2016 – Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
- ISO 14971:2019 – Medical Devices – Application of Risk Management to Medical Devices
- ISO/TR 24971:2020 – Medical Devices – Guidance on the Application of ISO 14971
- ISO 19011:2026 – Guidelines for Auditing Management Systems
- ISO/IEC 17021-1:2015 – Requirements for Bodies Providing Audit and Certification of Management Systems
- IAF MD 9:2023 – Application of ISO/IEC 17021-1 in the Field of Medical Device Quality Management Systems (ISO 13485)
- Regulation (EU) 2017/745 – Medical Device Regulation (MDR)
- Regulation (EU) 2017/746 – In Vitro Diagnostic Medical Device Regulation (IVDR)
- FDA 21 CFR Part 820 – Quality Management System Regulation (QMSR)
- Türkiye Medical Device Regulation
- Türkiye In Vitro Diagnostic Medical Device Regulation
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