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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 assess 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 the ISO 13485:2016 standard; medical device design, development, production, storage and distribution processes; risk management in accordance with 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 addresses 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
Purpose of the Training
The purpose 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 perform 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 legal 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, traceability and conformity of medical devices
- 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 – ISO 13485 Requirements and Medical Device Risk Management
- Purpose, scope and structure of the ISO 13485:2016 standard
- Fundamental principles of a medical device quality management system
- Differences between ISO 13485 and ISO 9001
- Medical device life cycle and regulatory requirements
- Overview of MDR, IVDR and Turkish medical device legislation
- Clause 4: Quality management system
- Clause 5: Management responsibility
- Clause 6: Resource management
- Clause 7: Product realisation
- Clause 8: Measurement, analysis and improvement
- Medical device risk management under ISO 14971
- Design and development processes
- Supplier management and purchasing controls
- Production and process validation
- Sterilisation and contamination control
- Product identification, traceability and record management
- Complaint handling, feedback and corrective actions
- Practical exercise: Assessment of medical device risks and quality management system requirements
- Day – Audit Principles and Conducting the Audit
- Audit principles under ISO 19011:2026
- Overview of ISO/IEC 17021-1 and IAF MD 9 audit requirements
- First-, second- and third-party audits
- Duties and responsibilities of the lead auditor
- Preparation of the audit programme and audit plan
- Determination of the audit scope, criteria and objectives
- Stage 1 and Stage 2 certification audits
- Document review and checklist preparation
- Opening meeting and audit interviews
- Collection and evaluation of audit evidence
- Risk-based auditing and sampling techniques
- Auditing medical device design and development processes
- Evaluation of production, sterilisation and validation processes
- Auditing traceability, complaint handling and corrective actions
- Practical exercise: Audit planning and a sample medical device quality management system audit scenario
- Day – Audit Findings, Reporting and Lead Auditor Practices
- Formulation of audit findings
- Identification and classification of nonconformities
- Evaluation of major and minor nonconformities
- Writing nonconformities based on objective evidence
- Evaluation of audit conclusions
- Preparation of the ISO 13485 audit report
- Conducting the closing meeting
- Evaluation of corrective actions and root cause analyses
- Closure of nonconformities and follow-up audits
- Surveillance and recertification audits
- Management of the audit team and lead auditor responsibilities
- Case study: Evaluation of medical device quality management system nonconformities
- Practical exercise: Writing nonconformities and audit reporting
Attendance and Certificate
Certificate 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 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 wishing 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 matters 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 that provide related products or services to the medical device sector.
4. Does 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 in relation 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 use 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 covers ISO 13485 requirements, medical device risk management, design and production processes, and auditing practices in detail. The 3-day programme provides 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, reviewing 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 scheduled online or face-to-face according to 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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