⛨ ISO 13485

Training ISO 9001/ISO 13485 Internal Audit
ISO 19011 and Strategic Management Review

ISO 9001/ISO 13485 Elements, Internal Audit ISO 19011 ISO 9001/ISO 13485 Auditor Training| August 19 and 20, 2026 in French ✓

ISO 9001/ISO 13485 Elements, Internal Audit ISO 19011

  • 1 registration $1265 2 registrations $2530 4 registrations $5060
  • 1 registration forISO 9001/ISO 13485/ISO 14001 is $1365
  • ISO 9001/ISO 13485 System elements and specific requirements
  • ISO 13485 Audit Training Supplemental
  • 211 Audit Questions ISO 13485 | Risk Management ISO 14971
  • ISO 19011:2026 Audit Programme and 18 Audit Methods
  • 100 Non-Quality Cost Criteria | 24 Audit and Measurement Forms
  • 37 Internal Audit Practices | Practical Internal Audit Exam
  • Quality Documents for ISO 13485 Medical Device Quality System
  • Quality Standards ISO 9001, ISO 13485, ISO 14971, ISO 19011
  • Medical Device Life Cycle Activities | Post-market surveillance
  • Customer feedback forms | Customer Satisfaction Survey
  • ISO 9001/ISO 13485 Continual Improvement Strategy


Auditor Certificate
ISO 9001/ISO 13485/
ISO 19011:2026
The Training ISO 9001/ISO 13485 provides effective knowledge and a functional audit methodology in order to manage, audit and improve a Quality Management System (QMS). The management of quality, risks, costs and performance are shown. The training is supplemented by ISO 13485 medical device quality system elements. The audit team learning and individual audit practices learning, enable Quality Managers and Lead Auditors to audit the ISO 13485 QMS. The ISO 19011:2026 standard 18 audit methods for audit programme, performance audit, risk and opportunity audit, process audit, compliance audit, supply chain audit, customer feedback and strategic management review demonstrate how to audit the QMS, increase benefits, reduce costs and how to achieve planned results. Participants will receive ISO 9001/ISO 13485/ISO 19011 Auditor Certificate and a new training manual.

Day 1 🕣 8h30-16h30
Training ISO 9001/ISO 13485 Elements

  • Quality system, principles and structure
  • ISO 9001/ISO 13485 Elements and methods
  • Managing context, risks and opportunities
  • Leadership, Customer focus growth strategy
  • Planning risk actions and quality objectives
  • ISO 14971 Risk management model
  • Support, Resource, Awareness, Knowledge
  • Infrastructure, Equipment, Documentation
  • Operation Planning and Product realization
  • Design Validation and Usability
  • Nonconformities and Corrective Action
  • Strategic Management Review
  • ISO 13485 Internal Audit in 211 Questions

Day 2 🕣 8h30-16h30
Audit Programme ISO 19011:2026

  • Managing an Audit Programme
  • Audit Planning and Conducting an Audit
  • 18 Audit Methods ISO 19011:2026
  • Audit Sampling, Audit Confidence and Risk
  • Audit Preparation and documents review
  • Audit of Quality System Documentation
  • Audit of Risks and Opportunities
  • Audit of Performance and Effectiveness
  • Audit of Conformity and Corrective Actions
  • Audit Conclusions and Audit Report
  • Practical internal audit exam
  • Lead Auditor and Auditor Competence
  • Strategic Management Review

💿 Auditor Training Manual
ISO 9001/ISO 13485, 459 pages

  • Quality system, principles and structure
  • ISO 9001/ISO 13485 Elements and methods
  • ISO 13485 Audit Training Supplemental
  • 211 Internal Audit Questions ISO 13485
  • 18 Audit Methods ISO 19011:2026
  • 100 Criteria for Non-Quality Cost
  • 37 Audit Practices ISO 9001/ISO 13485
  • ISO 13485 Medical Device Quality System
  • Norms ISO 9001, ISO 13485, ISO 14971
  • Medical Device Life Cycle Activities
  • Management of risks, costs, performance
  • Audit and measurement forms ISO 13485
  • Continual Improvement Strategy
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Venue | Ville Marie Hotel | 3407 rue Peel, Montreal, Quebec | Canada