⛨ ISO 13485

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

BTA Plus ISO 9001/ISO 13485 Training | November 13 and 14, 2024 in Montreal ✓

ISO 9001/ISO 13485 Elements, 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 provides effective knowledge and a 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 medical device quality system elements. The audit team learning and individual audit practices enable Quality Managers and Lead Auditors to audit the QMS. The 18 ISO 19011 audit methods for performance audit, risk and opportunity audit, supply chain audit, audit programme, life cycle audit, process audit, compliance audit, customer feedback and strategic management review demonstrate how to audit the QMS, increase profits, reduce costs and achieve planned results. Participants will receive a 16-hour 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
  • Audit of Context, Risks and Opportunities
  • Leadership and Customer Focus Strategy
  • Risk Actions Planning and Quality Objectives
  • Support, Resource, Competence, Knowledge
  • Infrastructure, Equipment, Documentation
  • Operation Planning and Product realization
  • Design Validation and Usability
  • Audit of Performance and Effectiveness
  • Strategic Management Review
  • Customer feedback/Post-market surveillance
  • ISO 13485 Internal Audit in 201 Questions

Day 2 🕣 8h30-16h30
Internal Audit Programme 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 Performance and Effectiveness
  • Audit of Corrective Actions Effectiveness
  • Audit Conclusions and Audit Report
  • Lead Auditor and Auditor Competence
  • Strategic Management Review
  • Continual Improvement Strategy

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

  • Quality System, Principles and Structure
  • ISO 9001/ISO 13485 Elements and Methods
  • 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 Medical Device Quality System
  • 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