© Operational Excellence Consulting. All rights reserved.
Copyrights of all the pictures used in this presentation are hel...
4© Operational Excellence Consulting. All rights reserved.
Outline
• Overview of ISO 9000
• ISO 9001
Process Approach
The ...
7© Operational Excellence Consulting. All rights reserved.
What is ISO 9000?
• International consensus on good management ...
10© Operational Excellence Consulting. All rights reserved.
ISO 9000 Series
• ISO 9000
Quality Management Systems: Fundame...
13© Operational Excellence Consulting. All rights reserved.
Why is a Quality Management System
Important?
• Customer satis...
© Operational Excellence Consulting. All rights reserved.
Process Approach
This document is a partial preview. Full docume...
19© Operational Excellence Consulting. All rights reserved.
Process Model
Process
Control
Input and
input specifications
P...
22© Operational Excellence Consulting. All rights reserved.
Basic Objective
• Organization must be able to demonstrate:
Aw...
25© Operational Excellence Consulting. All rights reserved.
5 Key Clauses of ISO 9001
Value-adding activities
Information ...
28© Operational Excellence Consulting. All rights reserved.
Managing Processes
• Identify required process outputs
• Defin...
31© Operational Excellence Consulting. All rights reserved.
Documentation Requirements 2
• Control of Documents and Record...
34© Operational Excellence Consulting. All rights reserved.
Chapter 5 – Management Responsibility
• Management commitment
...
37© Operational Excellence Consulting. All rights reserved.
Chapter 6 – Resource Management
• Provision of resources
• Hum...
40© Operational Excellence Consulting. All rights reserved.
Chapter 7 – Product Realization 2
• Production and service
pro...
43© Operational Excellence Consulting. All rights reserved.
Chapter 8 – Measurement, Analysis &
Improvement 2
• People
Res...
46© Operational Excellence Consulting. All rights reserved.
What Are Audits Used For?
• Looking at the overall process
• A...
49© Operational Excellence Consulting. All rights reserved.
Audit Focus
Effectiveness of QMS
in achieving the organization...
52© Operational Excellence Consulting. All rights reserved.
Document Review
• Can be done in advance
of actual site visit
...
55© Operational Excellence Consulting. All rights reserved.
Assessment Findings
Positive Aspects
Areas of Improvement
Mino...
© Operational Excellence Consulting. All rights reserved.
Handling the Audit Session
This document is a partial preview. F...
61© Operational Excellence Consulting. All rights reserved.
Rights of Auditor 1
• Can change areas/projects to be audited
...
64© Operational Excellence Consulting. All rights reserved.
Auditee’s Conduct
• Polite
• Professional
• Positive / Recepti...
67© Operational Excellence Consulting. All rights reserved.
Interacting with Auditors – Don’ts
for Auditees
• Assume audit...
© Operational Excellence Consulting. All rights reserved.
End of Presentation
To view the full list of training presentati...
73© Operational Excellence Consulting. All rights reserved.
ISO 9001:2008 Clauses
1.0 Scope
2.0 Normative Reference
3.0 Te...
76© Operational Excellence Consulting. All rights reserved.
ISO 9001:2008 Clauses (Continued)
7.0 Product Realization (Con...
1
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ISO 9001 Awareness

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Thousands of companies in over 100 countries have adopted ISO 9001 as their quality management standard. Many more are pursuing this certification. Why? Because ISO 9001 helps your company assure quality, save money and customers expect it. ISO 9001 applies to all types of organizations. Being one of our best sellers, this professionally-developed presentation can be used to brief staff, new hires and potential auditees so as to create awareness on the ISO 9001 quality system. This presentation focuses on the ISO9001 requirements, the audit approach and offers practical tips on how handle an audit session.

CONTENTS:

1. Overview of ISO 9000
2. ISO 9001
- Process Approach
- The Requirements (Clauses)
- Audit Approach
3. Handling the Audit Session

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ISO 9001 Awareness

  1. 1. © Operational Excellence Consulting. All rights reserved. Copyrights of all the pictures used in this presentation are held by their respective owners. © Operational Excellence Consulting. All rights reserved. ISO 9001 Awareness
  2. 2. 4© Operational Excellence Consulting. All rights reserved. Outline • Overview of ISO 9000 • ISO 9001 Process Approach The Requirements (Clauses) Audit Approach • Handling the Audit Session Copyrights of all the pictures used in this presentation are held by their respective owners. This document is a partial preview. Full document download can be found on Flevy: http://flevy.com/browse/document/iso-9001-awareness-149
  3. 3. 7© Operational Excellence Consulting. All rights reserved. What is ISO 9000? • International consensus on good management practice • Looks for repeatability and meeting customer requirements • Distilled into standard requirements • Covers any organization – whatever the size, industry or culture This document is a partial preview. Full document download can be found on Flevy: http://flevy.com/browse/document/iso-9001-awareness-149
  4. 4. 10© Operational Excellence Consulting. All rights reserved. ISO 9000 Series • ISO 9000 Quality Management Systems: Fundamentals and Vocabulary • ISO 9001 Quality Management Systems: Requirements • ISO 9004 Quality Management Systems: Guidelines for performance improvements Focus of this presentation This document is a partial preview. Full document download can be found on Flevy: http://flevy.com/browse/document/iso-9001-awareness-149
  5. 5. 13© Operational Excellence Consulting. All rights reserved. Why is a Quality Management System Important? • Customer satisfaction • Cost of poor performance • Repeat business • Increased profitability • Increased effectiveness • Consistency This document is a partial preview. Full document download can be found on Flevy: http://flevy.com/browse/document/iso-9001-awareness-149
  6. 6. © Operational Excellence Consulting. All rights reserved. Process Approach This document is a partial preview. Full document download can be found on Flevy: http://flevy.com/browse/document/iso-9001-awareness-149
  7. 7. 19© Operational Excellence Consulting. All rights reserved. Process Model Process Control Input and input specifications Process Activities and Sub-Processes Output and output specifications Resources Roles Process Owner Process Goal Quality Parameters and Key Performance Indicators Process Enablers This document is a partial preview. Full document download can be found on Flevy: http://flevy.com/browse/document/iso-9001-awareness-149
  8. 8. 22© Operational Excellence Consulting. All rights reserved. Basic Objective • Organization must be able to demonstrate: Awareness of customer requirements Customer satisfaction Improvement Prevention Consistently meet customer requirements This document is a partial preview. Full document download can be found on Flevy: http://flevy.com/browse/document/iso-9001-awareness-149
  9. 9. 25© Operational Excellence Consulting. All rights reserved. 5 Key Clauses of ISO 9001 Value-adding activities Information flow Management Responsibility Resource Management Measurement, analysis, improvement Product Realization Input Output Product/ service Continual improvement of the Quality Management System CustomerRequirements CustomerSatisfaction (4) “System” Clause (6) Asset Clause (5) Leadership Clause (7) Delivery Clause (8) Closed-Loop Clause This document is a partial preview. Full document download can be found on Flevy: http://flevy.com/browse/document/iso-9001-awareness-149
  10. 10. 28© Operational Excellence Consulting. All rights reserved. Managing Processes • Identify required process outputs • Define process objectives in line with corporate objectives • Determine necessary inputs and controls people, facilities, work environment • Monitor to ensure achievement • Know what is good progress at interim stages • Establish escalation channels for adverse trends • Process ownership This document is a partial preview. Full document download can be found on Flevy: http://flevy.com/browse/document/iso-9001-awareness-149
  11. 11. 31© Operational Excellence Consulting. All rights reserved. Documentation Requirements 2 • Control of Documents and Records This document is a partial preview. Full document download can be found on Flevy: http://flevy.com/browse/document/iso-9001-awareness-149
  12. 12. 34© Operational Excellence Consulting. All rights reserved. Chapter 5 – Management Responsibility • Management commitment • Customer focus • Quality policy • Quality management system planning Quality objectives QMS planning • Responsibility, authority & communication Internal communication Management representative • Management Review This document is a partial preview. Full document download can be found on Flevy: http://flevy.com/browse/document/iso-9001-awareness-149
  13. 13. 37© Operational Excellence Consulting. All rights reserved. Chapter 6 – Resource Management • Provision of resources • Human resources Competence, awareness and training • Infrastructure • Work environmentThis document is a partial preview. Full document download can be found on Flevy: http://flevy.com/browse/document/iso-9001-awareness-149
  14. 14. 40© Operational Excellence Consulting. All rights reserved. Chapter 7 – Product Realization 2 • Production and service provision Operations control, validation of processes, identification and traceability, customer property, preservation of product • Control of monitoring and measuring devices This document is a partial preview. Full document download can be found on Flevy: http://flevy.com/browse/document/iso-9001-awareness-149
  15. 15. 43© Operational Excellence Consulting. All rights reserved. Chapter 8 – Measurement, Analysis & Improvement 2 • People Resource Availability Competence, Awareness & Training Infrastructure & Work Environment • Process Quality Trends and Models (e.g. Six Sigma, CMMI) Better, Cheaper, Faster (e.g. re-useable components) Process Management Process Improvement (e.g. defect rate, cost of poor quality) • Technology Availability of Tools Application of Tools This document is a partial preview. Full document download can be found on Flevy: http://flevy.com/browse/document/iso-9001-awareness-149
  16. 16. 46© Operational Excellence Consulting. All rights reserved. What Are Audits Used For? • Looking at the overall process • Auditing conformity • Auditing effectiveness • Approving Suppliers / Subcontractors • Assessing for Certification • Investigating problems • Way of improving This document is a partial preview. Full document download can be found on Flevy: http://flevy.com/browse/document/iso-9001-awareness-149
  17. 17. 49© Operational Excellence Consulting. All rights reserved. Audit Focus Effectiveness of QMS in achieving the organization’s objectives and in providing products that conform to customer requirements This document is a partial preview. Full document download can be found on Flevy: http://flevy.com/browse/document/iso-9001-awareness-149
  18. 18. 52© Operational Excellence Consulting. All rights reserved. Document Review • Can be done in advance of actual site visit • Purpose To ensure that, in theory, the Documented Quality System (DQS) meets the requirements of ISO 9001 or other standards This document is a partial preview. Full document download can be found on Flevy: http://flevy.com/browse/document/iso-9001-awareness-149
  19. 19. 55© Operational Excellence Consulting. All rights reserved. Assessment Findings Positive Aspects Areas of Improvement Minor Nonconformity Major Nonconformity This document is a partial preview. Full document download can be found on Flevy: http://flevy.com/browse/document/iso-9001-awareness-149
  20. 20. © Operational Excellence Consulting. All rights reserved. Handling the Audit Session This document is a partial preview. Full document download can be found on Flevy: http://flevy.com/browse/document/iso-9001-awareness-149
  21. 21. 61© Operational Excellence Consulting. All rights reserved. Rights of Auditor 1 • Can change areas/projects to be audited • Can add in more projects to be audited if they wish to verify something • May start the audit session earlier, or extend the session, if necessary. Auditees should avoid scheduling other meetings before or after the scheduled times. This document is a partial preview. Full document download can be found on Flevy: http://flevy.com/browse/document/iso-9001-awareness-149
  22. 22. 64© Operational Excellence Consulting. All rights reserved. Auditee’s Conduct • Polite • Professional • Positive / Receptive • Sincere • Commitment • Formal but not overly serious This document is a partial preview. Full document download can be found on Flevy: http://flevy.com/browse/document/iso-9001-awareness-149
  23. 23. 67© Operational Excellence Consulting. All rights reserved. Interacting with Auditors – Don’ts for Auditees • Assume auditors are familiar with your organization’s QMS • Challenge auditors • Show more competence in ISO 9001 • Argue internally • Express unfairness • Ask for solution • Fix non-conformities on the spot This document is a partial preview. Full document download can be found on Flevy: http://flevy.com/browse/document/iso-9001-awareness-149
  24. 24. © Operational Excellence Consulting. All rights reserved. End of Presentation To view the full list of training presentations, please visit us at: Operational Excellence Consulting http://www.oeconsulting.com.sg This document is a partial preview. Full document download can be found on Flevy: http://flevy.com/browse/document/iso-9001-awareness-149
  25. 25. 73© Operational Excellence Consulting. All rights reserved. ISO 9001:2008 Clauses 1.0 Scope 2.0 Normative Reference 3.0 Terms and Definitions 4.0 Quality Management System 4.1 General Requirements 4.2 Documentation Requirements 4.2.1 General 4.2.2 Quality Manual 4.2.3 Document Control 4.2.4 Control of Records 5.0 Management Responsibility 5.1 Management Commitment 5.2 Customer Focus This document is a partial preview. Full document download can be found on Flevy: http://flevy.com/browse/document/iso-9001-awareness-149
  26. 26. 76© Operational Excellence Consulting. All rights reserved. ISO 9001:2008 Clauses (Continued) 7.0 Product Realization (Continued) 7.3 Design and Development 7.3.1 Design and Development Planning 7.3.2 Design and Development Inputs 7.3.3 Design and Development Output 7.3.4 Design and Development review 7.3.5 Design and Development verification 7.3.6 Design and Development validation 7.3.7 Control of Design and Development Changes 7.4 Purchasing 7.4.1 Purchasing Process 7.4.2 Purchasing Information 7.4.3 Verification of purchased Product This document is a partial preview. Full document download can be found on Flevy: http://flevy.com/browse/document/iso-9001-awareness-149
  27. 27. 1 Flevy (www.flevy.com) is the marketplace for premium documents. These documents can range from Business Frameworks to Financial Models to PowerPoint Templates. Flevy was founded under the principle that companies waste a lot of time and money recreating the same foundational business documents. Our vision is for Flevy to become a comprehensive knowledge base of business documents. All organizations, from startups to large enterprises, can use Flevy— whether it's to jumpstart projects, to find reference or comparison materials, or just to learn. Contact Us Please contact us with any questions you may have about our company. • General Inquiries support@flevy.com • Media/PR press@flevy.com • Billing billing@flevy.com

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