ISO 13485

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

BTA Plus ISO 9001/ISO 13485/ISO 19011 Training ✓ December 7 and 8, 2022
ISO 9001/ISO 13485 Elements and Internal Audit ISO 19011


Auditor Certificate
ISO 9001/ISO 13485/
ISO 19011
The Training ISO 9001/ISO 13485 Elements, Internal Audit ISO 19011 and Strategic Management Review shows an effective know how and functional audit methodology in order to manage, audit and improve a quality system. The management of quality, risks, costs and performance is shown. The training is supplemented by ISO 13485 quality system elements and tools. Is includes team and individual audit learning and enables Quality Managers and Lead Auditors to audit the quality system. The 18 audit methods of ISO 19011 standard for Performance audit, Audit of context, risks and opportunities, Supply chain audit, Life cycle audit, Process audit, Audit sampling, Audit of compliance, Measurement of Customer Satisfaction, and Strategic Management Review demonstrate how to audit the QMS, increase profits, reduce costs and achieve planned results. Participants receive 16 hours Auditor Certificate ISO 9001/ISO 13485 and a training manual.
Day 1 🕣 8h30-16h30
Training ISO 9001/ISO 13485 Elements
  • Quality System, Principles and Structure
  • ISO 9001/ISO 13485 Elements and Tools
  • Audit of Context, Risks and Opportunities
  • Leadership and Customer Focus Strategy
  • Planning-Risk Actions, Objectives, Changes
  • Support, Resources and Competence
  • Infrastructure, Equipment and Knowledge
  • Operation Planning and Product realization
  • Design Validation and Usability
  • Audit of Performance and Effectiveness
  • Strategic Management Review
  • Continual Improvement Strategy
  • ISO 13485 Internal Audit in 201 Questions
Day 2 🕣 8h30-16h30
Internal Audit ISO 19011
  • Managing an Audit Programme
  • Audit preparation and documents review
  • 18 Audit Methods and Tools ISO 19011
  • Risks-Based Audit, Sampling and Confidence
  • Audit Planning and Internal Audit Activities
  • Audit of Quality System Documentation
  • Audit of Risks and Opportunities
  • Audit of Key Performance Indicators (KPI)
  • Audit of Performance and Effectiveness
  • Audit of Corrective Actions Effectiveness
  • Audit Conclusions and Audit Report
  • Lead Auditor and Auditor Competence
  • Strategic Management Review
💿 Auditor Training Manual
ISO 9001/ISO 13485, 459 pages plus CDR
  • Quality System, Principles and Structure
  • ISO 9001/ISO 13485 Elements and Tools
  • ISO 13485 Audit Training Supplemental
  • 201 Internal Audit Questions ISO 13485
  • 18 Audit Methods and Tools ISO 19011
  • 100 Criteria for Non-Quality Cost
  • 34 Audit Practices ISO 9001/ISO 13485
  • ISO 13485 System for Medical Device
  • Norms ISO 13485, ISO 14971, ISO 19011
  • Medical Device Life Cycle Activities
  • Management of risks, costs, performance
  • Audit and measurement forms ISO 13485
  • Continual Improvement Strategy
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Location | Ville Marie Hotel | 3407 rue Peel, Montreal, Quebec | Canada