ISO 9001: 2015 AND QUALITY MANAGEMENT

1. ISO 9001: 2015 AND QUALITY MANAGEMENT November 2018

2. THE NATURE OF QUALITY • Meeting Customers’ and the Organisation’s Needs • Integral Part of Systems Processes • Assuring Quality Systematically • Prevention Culture • Right First Time • Continual Improvement • Links with Other Systems

3. THE PRINCIPLES OF ISO 9001: 2015 • Customer Focused Organisation • Leadership • Involvement of People • Process Approach • System Approach to Management • Continual Improvement • Factual Approach to Decision Making • Mutually Beneficial Supplier Relationships

4. PLAN-DO-CHECK-ACT MODELOF ISO 9001

5. ISO 9001: 2015ANNEX SL STRUCTURE • 4. Context of the Organisation • 5. Leadership • 6. Planning • 7. Support • 8. Operation • 9. Performance Evaluation • 10. Improvement

6. ISO 9001: 2015 • 4. Context of the Organisation 4.1 Understanding the Organisation and its Context 4.2 Understanding the Needs and Expectations of Interested Parties 4.3 Determining the Scope of the Quality Management System 4.4 Quality Management System and its Processes

7. ISO 9001: 2015 • 5. Leadership 5.1 Leadership and Commitment 5.2 Policy 5.3 Organisational Roles, Responsibilities and Authorities

8. ISO 9001: 2015 • 6. Planning 6.1 Actions to address Risks and Opportunities 6.2 Quality Objectives and Planning to achieve them 6.3 Planning of Changes

9. ISO 9001: 2015 • 7. Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented Information

10. ISO 9001: 2015 • 8. Operation 8.1 Operational Planning and Control 8.2 Requirements for Products and Services 8.3 Design and Development of Products and Services 8.4 Control of externally provided Processes, Products and Services 8.5 Production and Service Provision 8.6 Release of Products or Services 8.7 Control of Non-conforming Outputs

11. ISO 9001: 2015 • 9. Performance Evaluation 9.1 Monitoring, Measurement, Analysis and Evaluation 9.2 Internal Audit 9.3 Management Review

12. ISO 9001: 2015 • 10. Improvement 10.1 General 10.2 Non-conformity and Corrective Action 10.3 Continual Improvement

13. ISO 9001: 2015THE KEY CHANGES • Context of the Organisation • Leadership • Risks and Opportunities • Support – including Outsourcing • Performance Evaluation

14. ORGANISATION • No specific requirement for a Quality Manager, however… • Defined Employee Responsibilities • Top Management Role • Clear Lines of Authority and Accountability • Shows Trained Staff

15. DOCUMENT HIERARCHY • Quality Manual – no requirement now - Policies, Organisation, ISO 9001 • Process Maps - Why, Who by, How • Reference Documents - Work Instructions, Forms • MUST BE KEPT CURRENT

16. PROCESS APPROACH • Scope - What it is about • Objective - Why you do it • Responsibilities - Who does it • Documentation - Forms, records • Process Method - How to do it

17. PROCESS APPROACH • Defining the Core Processes that add value • Agreeing Best Practice • Checking Performance Measures • Checking Internal and External Standards • Monitoring Status • Consistent Performance

18. CONTINUAL IMPROVEMENT • Record Mistakes and Problems • Immediate Corrective Action • Analyse Trends • Monitor Effectiveness of Changes • Continual Improvement • Performance Evaluation • Interpretation of Results and Analysis

19. MAINTAINING THE SYSTEM • Internal Quality Audits • Management Review • Independent Certification and Surveillance • Complements Investors in People • Annex SL Format – other standards

20. BENEFITS OF ISO 9000 • EXTERNAL • Internationally Recognised Standard • Approved Supplier Status • Competitive Advantage in Tendering for Work • Clear Demonstration of Systems in Place to Funders and Stakeholders

21. BENEFITS OFISO 9000 • INTERNAL • Less Waste of Time and Effort • Improved Efficiency and Effectiveness • Fewer Complaints • Culture of Problem Prevention and Continual Improvement • Links with other Systems