ISO 13485:2016 Lead Auditor - Quality Management Systems for Medical Devices

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01

Course description

A Lead Auditor training course in Quality Management Systems for medical devices, comprising 40 hours (5 days) and focusing on third-party (certification) audits. Structured around ISO 13485:2016, in accordance with ISO 19011:2026 (4th edition) and integrated with the international regulatory context (ANVISA RDC 665/2022, FDA 21 CFR 820/QMSR, MDR 2017/745, IVDR 2017/746 and MDSAP), including risk management under ISO 14971:2019. Aligned with the Exemplar Global, IRCA and RAPS schemes, it prepares participants to pursue international Lead Auditor certification. Delivered in person or synchronously online (live).

02

Course objective

Equip professionals to plan, conduct, report on and lead third-party audits of medical device Quality Management Systems, based on ISO 13485:2016 and in accordance with ISO 19011:2026, integrated with the international regulatory context (ANVISA, FDA, CE/MDR, MDSAP). On completion, participants act as internationally recognised Lead Auditors, prepared to pursue certification with Exemplar Global, IRCA and RAPS.

03

Course programme

40h of in-depth learning
  1. 01

    ISO 13485:2016 Fundamentals

    History and development of the standard, scope and field of application, specific terms and definitions, the process approach, the relationship with ISO 9001 and ISO 14971, and permitted exclusions.

  2. 02

    International Regulatory Context

    ANVISA (RDC 665/2022), FDA 21 CFR 820 (QMSR), MDR 2017/745 and IVDR 2017/746, MDSAP (Medical Device Single Audit Program), Health Canada, TGA, PMDA, global harmonisation and IMDRF.

  3. 03

    QMS Requirements (Clauses 4-5)

    Quality Management System, documentation requirements, quality manual, document and record control, management responsibility and management review.

  4. 04

    QMS Requirements (Clauses 6-7)

    Provision of resources, infrastructure and work environment, contamination control, personnel competence, product realisation planning, design and development controls, purchasing, production and process validation, and control of monitoring and measuring equipment.

  5. 05

    QMS Requirements (Clause 8)

    Process and product monitoring and measurement, feedback, complaint handling and post-market surveillance, internal auditing, control of nonconforming product, data analysis, corrective and preventive action (CAPA), and continual improvement.

  6. 06

    Risk Management, ISO 14971:2019

    The risk management process (analysis, evaluation and control), residual risk and benefit-risk assessment, integration with QMS process controls, post-production information and auditing risk processes from a third-party perspective.

  7. 07

    Auditing Principles, ISO 19011:2026

    Auditing principles, audit types (first, second and third party), joint and combined audits, the auditor profile, the audit programme, the code of conduct and ethics, managing conflicts of interest and the three-year cycle (Stage 1 / Stage 2 and surveillance).

  8. 08

    Audit Planning and Preparation

    Defining scope and criteria, preliminary document review, preparing the audit plan and determining audit duration based on IAF guidance, developing checklists, allocating resources and team members, and communicating with the auditee.

  9. 09

    Conducting the Audit

    Opening meeting, interview and sampling techniques, collection of objective evidence, audit trails, auditing processes versus procedures, and time management.

  10. 10

    Findings and Reports

    Classification of findings (major nonconformity, minor nonconformity, observation, opportunity for improvement), writing findings (evidence, criteria and deviation), closing meeting, final report, follow-up and implications for certification.

  11. 11

    Auditor Competence

    The role of the lead auditor, managing multidisciplinary teams, conflict resolution, decision-making, effective communication, competence required by certification bodies (EAC/IAF/NACE codes), and conducting audits with technical experts.

  12. 12

    Simulation and Final Assessment

    A full audit simulation (role play) in a realistic medical device manufacturer scenario, a written examination (multiple-choice and essay questions), continuous practical assessment, individual feedback and guidance on professional registration.

04

Who can attend?

  • Internal and external QMS auditors
  • Regulatory Affairs (RA) professionals
  • Quality Managers and Coordinators
  • Medical device and IVD consultants
  • Certification Body and Notified Body professionals
  • Technical Managers before ANVISA, FDA and competent authorities
  • Professionals seeking international Lead Auditor certification