Days 1 & 2 – In-depth Review of ISO 9001:2015

Introduction and Definitions

Quality Management Principles

ISO 9001:2015 Structure

Process Approach

Risk-Based Thinking

4.0 Understanding the Organization

• Organizational context
• Interested parties
• Scope of the QMS
• QMS processes

5.0 Leadership

• Leadership and commitment
• Quality policy
• Roles, responsibilities, and authorities

6.0 Planning

• Risks and opportunities
• Quality objectives
• Planning of changes

7.0 Support

• Resources
• Competence
• Awareness
• Communication
• Documented information

8.0 Operation

• Operational planning and control
• Requirements for products and services
• Design and development of products and services
• Externally provided products andservices
• Production and service provision
• Release of products andservices
• Control of nonconforming output

9.0 Performance Evaluation

• Monitoring, measurement, analysis, and evaluation
• Internal audit
• Management review

10.0 Improvement

• Nonconformity and correctiveaction
• Continuous improvement

Day 3 – Auditing Management Systems according to ISO 19011:2018

• Terms and Definitions
• Auditing Principles
• Audit Program

+ Risks and opportunities
+ Roles and responsibilities

• Audit Preparation
• Audit Plan
• Audit Opening
• Conducting the Audit
• Audit Methods
• Audit Findings
• Audit Report
• Audit Closure
• Internal Auditor Performance