⛨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
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
ISO 9001/ISO 13485 Auditor Training