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ISO 9001: 2015 Quality Management System
Course Objectives
By the end of the course, participants will be able to:
- Develop a Business Risk and Opportunities Register for their business
- Understand how to perform a Gap Analysis assessment of their current system
- Advise their leadership team of the key leadership principles of Clause 5 of the standard
- Apply best practice techniques in transitioning their system and implementing it across their organization
- Understand the impact of human factors in the implementation and effectiveness program
- Prepare ISO 9001:2015 audit checklists
- Undertake ISO 9001:2015 Management review meetings
Course Outline
Overview of ISO 9001:2015
- Introduction to ISO and 9001
- The history of the standard
- Certification and the process to achieve
- What is Annex SL
- Key principals of the change
- Benefits of the change
- Integration with other ISO standards
Differences between ISO 9001:2008 and ISO 9001:2015
- 2008 v 2015 comparison matrix
- Changing terminology and meaning
- Gap Analysis Audit
- Leadership
- The changing emphasis concerning documentation
- Process management
- Threats and Opportunities
Risk Based Thinking and the Process Approach
- What is the Process Approach
- Benefits of a Process Approach
- Introducing Risk through threats and opportunities to a Quality Management Systems
- James Reason’s Swiss Cheese Model approach to Risk Based Thinking and the Process Approach
Transition Principles of ISO 9001:2015
- Why Leadership is now a separate section
- The importance of Awareness and Communication
- Internal Audit
- Management Review
- The changing emphasis concerning documentation
- Human Factors of Implementation
Expectations and Detailed requirements of ISO 9001:2015
- Expectations on you by a certification body
- Timeline for transition
- Leadership expectations
- How to help your organization through transition
Course Objectives
By the end of the course, participants will be able to:
- Develop a Business Risk and Opportunities Register for their business
- Understand how to perform a Gap Analysis assessment of their current system
- Advise their leadership team of the key leadership principles of Clause 5 of the standard
- Apply best practice techniques in transitioning their system and implementing it across their organization
- Understand the impact of human factors in the implementation and effectiveness program
- Prepare ISO 9001:2015 audit checklists
- Undertake ISO 9001:2015 Management review meetings
Course Outline
Overview of ISO 9001:2015
- Introduction to ISO and 9001
- The history of the standard
- Certification and the process to achieve
- What is Annex SL
- Key principals of the change
- Benefits of the change
- Integration with other ISO standards
Differences between ISO 9001:2008 and ISO 9001:2015
- 2008 v 2015 comparison matrix
- Changing terminology and meaning
- Gap Analysis Audit
- Leadership
- The changing emphasis concerning documentation
- Process management
- Threats and Opportunities
Risk Based Thinking and the Process Approach
- What is the Process Approach
- Benefits of a Process Approach
- Introducing Risk through threats and opportunities to a Quality Management Systems
- James Reason’s Swiss Cheese Model approach to Risk Based Thinking and the Process Approach
Transition Principles of ISO 9001:2015
- Why Leadership is now a separate section
- The importance of Awareness and Communication
- Internal Audit
- Management Review
- The changing emphasis concerning documentation
- Human Factors of Implementation
Expectations and Detailed requirements of ISO 9001:2015
- Expectations on you by a certification body
- Timeline for transition
- Leadership expectations
- How to help your organization through transition