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

ISO 9001/ISO 13485/ISO 19011 Training ✓ December 7 and 8, 2022

• One registration: $1265.00 | Two registrations: $2530.00
• ISO 9001/ISO 13485 Quality System Elements, Structure, Tools
• ISO 13485 Audit Training Supplemental
• 201 Audit Questions ISO 13485 | 180 Audit Questions ISO 9001
• 18 Audit Methods ISO 19011 | Audit system forms ISO 13485
• 100 Criteria for Non-Quality Cost | Performance Audit
• 34 Internal Audit Practices | Audit of providers and suppliers
• ISO 13485 Quality System for Medical Device
• Quality Documents, Standards ISO 13485, ISO 14971, ISO 19011
• Medical Device Life Cycle Activities | Risk Management ISO 14971
• Audit and Measurement forms for ISO 13485 Quality System
• Customer Feedback Form | Mandatory Reporting Form
• Customer Satisfaction Survey | Continual Improvement Strategy

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.