ISO 13485:2016 + RDC ANVISA 665/2022 + ISO 19011:2026 Internal Auditor

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01

Course description

A 24-hour programme training Internal Auditors for medical device Quality Management Systems, integrating ISO 13485:2016, ANVISA RDC 665/2022 and the guidelines of the new ISO 19011:2026 (4th edition). The only Brazilian course bringing together the four core QMS standards in a single programme, including risk management under ISO 14971:2019/Amd 1:2020, and placing international requirements such as FDA QMSR, MDR/IVDR, Health Canada, TGA and PMDA in context. It also covers advanced topics such as Software as a Medical Device (SaMD) and Computerised System Validation (CSV).

02

Course objective

Enable participants to plan, conduct, document and follow up internal audits of medical device QMS, with an integrated understanding of ISO 13485:2016, ANVISA RDC 665/2022, ISO 19011:2026 and ISO 14971:2019/Amd 1:2020. On completing the programme, professionals identify nonconformities and opportunities for improvement, conduct remote and hybrid audits using digital evidence, and ensure the effectiveness of their organisation's quality management system.

03

Course programme

24h of in-depth learning
  1. 01

    ISO 13485 Fundamentals and Interpretation

    Clauses 4 to 8 of ISO 13485:2016, the PDCA cycle, the process approach, risk-based thinking, the relationship with ISO 9001 and sector-specific regulations, and GHTF/IMDRF terminology. Software as a Medical Device (SaMD) and Computerised System Validation (CSV) applied to the QMS.

    4h
  2. 02

    ANVISA Regulation and Risk Management

    The Brazilian regulatory context, RDC 665:2022 (scope, classification, GMP), point-by-point correlation with ISO 13485, ANVISA registration/listing/notification, traceability and medical device vigilance. The complete risk management process under ISO 14971:2019, with FMEA, FTA and HAZOP applications.

    4h
  3. 03

    Auditing Guidelines under ISO 19011:2026

    Auditing principles, the risk-based approach, audit types (first, second and third party) and developments in the 4th edition: remote and hybrid audits, digital evidence, organisational context, compliance and supply chain auditing. Auditor competence and evaluation, planning, preparation and the ISO 13485 × RDC 665 correlation matrix.

    4h
  4. 04

    Conducting Internal Audits

    Opening meeting, interview techniques (in person, remote and hybrid), collection of objective evidence (including digital evidence), audit trails, assessment of conformity versus effectiveness, classification of findings (minor nonconformity, major nonconformity, observation, opportunity for improvement), writing findings and the closing meeting.

    4h
  5. 05

    Reports, CAPA and the International Regulatory Context

    Audit report structure and writing, root cause analysis (5 Whys, Ishikawa, FMEA, 8D), effective CAPA plans, effectiveness verification and KPIs for audit programmes. International context: MDSAP, FDA QMSR (in force since February 2026), MDR 2017/745, IVDR 2017/746, Health Canada, TGA, PMDA and the role of IMDRF.

    4h
  6. 06

    Practical Exercises and Audit Simulation

    Three case studies (document review, real nonconformity scenarios, supplier auditing), a complete process-based audit plan, an integrated ISO 13485 × RDC 665 × ISO 19011:2026 checklist, a full internal audit simulation (role play), report writing, a CAPA plan and final competence assessment.

    4h

04

Who can attend?

  • Quality Managers and Coordinators responsible for the QMS at medical device manufacturers, importers and distributors
  • Practising or trainee Internal Auditors conducting first- and second-party QMS audits
  • Quality and Regulatory Affairs Engineers involved in regulatory compliance, ANVISA registrations, CE marking and certification
  • Management Representatives responsible for implementing and overseeing the QMS under ISO 13485
  • R&D, Production and Clinical Engineering professionals involved in medical device design, validation and control
  • Consultants specialising in quality, regulatory affairs and medical devices
  • Importers and Distributors marketing medical devices and healthcare products in Brazil
  • Technical Managers (pharmacists, engineers and other professionals designated as the responsible technical professional before ANVISA)

Certification

HSC Global Certificate