ISO 9001:2026 Lead Auditor

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01

Course description

Lead Auditor training in Quality Management Systems under ISO 9001:2026, based on ISO 19011 guidelines and the requirements of internationally recognised accreditation bodies, for first-, second- and third-party audits.

02

Course objective

Equip participants to act as Lead Auditors in general QMS (not limited to medical devices), with command of the process approach, risk-based thinking and the PDCA cycle applied to ISO 9001:2026.

03

Course programme

40h of in-depth learning
  1. 01

    Development of ISO 9001 and key changes in 2026

  2. 02

    The process approach and risk-based thinking

  3. 03

    ISO 9001:2026 requirements, clause by clause

  4. 04

    Auditing principles and ISO 19011 guidelines

  5. 05

    Planning, conducting and reporting

  6. 06

    Nonconformities and corrective actions

  7. 07

    Simulations and cross-sector case studies

04

Who can attend?

  • Quality professionals from any sector, internal auditors, consultants and prospective auditors for ISO 9001 certification bodies.