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© Operational Excellence Consulting. All rights reserved.
Copyrights of all the pictures used in this presentation are hel...
© Operational Excellence Consulting. All rights reserved. 2
Learning Objectives
1. Provide background knowledge on ISO 900...
© Operational Excellence Consulting. All rights reserved. 3
Contents
1. Overview of ISO 9001
2. ISO 9001 Structure
3. ISO ...
© Operational Excellence Consulting. All rights reserved.
4
“It is not enough to
do your best; you
must know what to
do, t...
© Operational Excellence Consulting. All rights reserved. 5
About ISO
 Non-governmental organization (NGO) established in...
© Operational Excellence Consulting. All rights reserved. 6
About ISO
 Developed more than 18,000 standards for all
dimen...
© Operational Excellence Consulting. All rights reserved. 7
What is ISO 9001?
 ISO 9001 is the world’s most popular and m...
© Operational Excellence Consulting. All rights reserved. 8
How Does ISO 9001 Work?
 Identifies what requirements you mus...
© Operational Excellence Consulting. All rights reserved. 9
Why is a Quality Management System
Important?
 Achieve custom...
© Operational Excellence Consulting. All rights reserved. 10
Advantages of Certification
 Compliance with customer
requir...
© Operational Excellence Consulting. All rights reserved. 11
Development of ISO 9001
Quality Management System (QMS)
ISO 9...
© Operational Excellence Consulting. All rights reserved. 12
Quality Management Principles
1.
Customer
Focus
2.
Leadership...
© Operational Excellence Consulting. All rights reserved. 13
Key Improvements to ISO 9001:2015
 Increased emphasis on ach...
© Operational Excellence Consulting. All rights reserved. 14
ISO 9001 – Key Differences
ISO 9001:2008 ISO 9001:2015
0 Intr...
© Operational Excellence Consulting. All rights reserved. 15
Emphasis on Process Approach
 Understanding and meeting
cust...
© Operational Excellence Consulting. All rights reserved. 16
Risk-based Management
 To improve customer
confidence and sa...
© Operational Excellence Consulting. All rights reserved. 17
Benefits of the New ISO 9001:2015
 Puts greater emphasis on ...
© Operational Excellence Consulting. All rights reserved.
18
“It is most important
that top management
be quality-minded. ...
© Operational Excellence Consulting. All rights reserved. 19
ISO 9001 Approach is Based on the
Plan-Do-Check-Act (PDCA) Cy...
© Operational Excellence Consulting. All rights reserved. 20
The ISO 9001 Structure is Aligned to the
Common Structure for...
© Operational Excellence Consulting. All rights reserved. 21
PDCA and ISO 9001 Clause Structure
© Operational Excellence Consulting. All rights reserved. 22
ISO 9001 Clause Structure (4-10)
PLAN DO CHECK ACT
4. Context...
© Operational Excellence Consulting. All rights reserved. 23
2018
2017 Full conformance
with new
standard
Recertification
...
© Operational Excellence Consulting. All rights reserved. 24
ISO 9001 Certification Process
Implementation
of QMS
Conduct ...
© Operational Excellence Consulting. All rights reserved. 25
Internal Audit
 To ensure the whole Quality
System is audite...
© Operational Excellence Consulting. All rights reserved. 26
Audit Approach
 Focuses on employees’ understanding of the
o...
© Operational Excellence Consulting. All rights reserved. 27
Audit Emphasis
 Measurement and results are of greater
impor...
© Operational Excellence Consulting. All rights reserved. 28
Continual Improvement
Establish objectives and processes
need...
© Operational Excellence Consulting. All rights reserved. 29
Audit Findings
Minor Non-conformity
Observation
Major Non-con...
© Operational Excellence Consulting. All rights reserved. 30
How to Handle the Audit Session?
 Do not panic
 Ask and cla...
© Operational Excellence Consulting. All rights reserved. 31
Auditee’s Conduct
 Polite
 Professional
 Positive / Recept...
© Operational Excellence Consulting. All rights reserved. 32
Interacting with Auditors
 Be honest and open
 Recognize th...
© Operational Excellence Consulting. All rights reserved.
33
“In the race for
quality, there is
no finish line.”
David Kea...
© Operational Excellence Consulting. All rights reserved.
About
Operational
Excellence Consulting
© Operational Excellence Consulting. All rights reserved. 35
About Operational Excellence
Consulting
 Operational Excelle...
© Operational Excellence Consulting. All rights reserved.
END OF PARTIAL PREVIEW
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ISO 9001:2015 (QMS) Awareness Training by Operational Excellence Consulting

Thousands of companies in over 100 countries have adopted ISO 9001:2015 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.

Many companies struggle with teaching the basic concepts and awareness of ISO 9001 to their employees.  Because of resource constraints, you may not have the time to create the presentation (which takes the most time when teaching the material).  This PowerPoint solves this problem.  When you are done teaching this material to your employees, your employees will be much more informed and comfortable with ISO 9001.

LEARNING OBJECTIVES

1. Provide background knowledge on ISO 9001
2. Gain an overview of ISO 9001 structure and the certification process
3. Understand the audit approach
4. Gather useful tips on handling an audit session

CONTENTS
 
1. Overview of ISO 9001
2. ISO 9001 Structure
3. ISO 9001 Certification
4. Audit Approach
5. Handling an Audit Session

To download this complete presentation, please go to: http://www.oeconsulting.com.sg

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ISO 9001:2015 (QMS) Awareness Training by Operational Excellence Consulting

  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 9001:2015 Awareness
  2. 2. © Operational Excellence Consulting. All rights reserved. 2 Learning Objectives 1. Provide background knowledge on ISO 9001 2. Gain an overview of ISO 9001 structure and the certification process 3. Understand the audit approach 4. Gather useful tips on handling an audit session NOTE: As this is a PREVIEW, only selected slides are shown. To download the complete presentation, please visit: http://www.oeconsulting.com.sg
  3. 3. © Operational Excellence Consulting. All rights reserved. 3 Contents 1. Overview of ISO 9001 2. ISO 9001 Structure 3. ISO 9001 Certification 4. Audit Approach 5. Handling an Audit Session
  4. 4. © Operational Excellence Consulting. All rights reserved. 4 “It is not enough to do your best; you must know what to do, then do your best.” W. Edwards Deming
  5. 5. © Operational Excellence Consulting. All rights reserved. 5 About ISO  Non-governmental organization (NGO) established in 1947, based in Geneva, Switzerland  Has a membership of 160 national standards institutes from countries in all regions of the world
  6. 6. © Operational Excellence Consulting. All rights reserved. 6 About ISO  Developed more than 18,000 standards for all dimensions of sustainable development: economic, environmental and societal • Examples :  ISO 9001 – Quality Management Systems (QMS)  ISO 14001 – Environmental Management Systems (EMS)  ISO 27001 – Information Security Management Systems (ISMS)  American National Standards Institute (ANSI) is U.S. representative to ISO
  7. 7. © Operational Excellence Consulting. All rights reserved. 7 What is ISO 9001?  ISO 9001 is the world’s most popular and most commonly used standard for Quality Management Systems (QMS)  International consensus on good management practice  Focuses on meeting customer requirements and other interested parties  Distilled into standard requirements  Covers any organization – whatever the size, industry or culture
  8. 8. © Operational Excellence Consulting. All rights reserved. 8 How Does ISO 9001 Work?  Identifies what requirements you must meet  Does not identify how you meet the requirements  Every Quality Management System is unique  Allows for flexibility  Allows management to ‘stay in the driving seat’
  9. 9. © Operational Excellence Consulting. All rights reserved. 9 Why is a Quality Management System Important?  Achieve customer satisfaction  High cost of poor performance  Gain repeat business  Increase profitability  Increase effectiveness  Higher consistency
  10. 10. © Operational Excellence Consulting. All rights reserved. 10 Advantages of Certification  Compliance with customer requirements specifying certification  Independent check of conformity  Indicates an effective Quality System  National/International recognition  Provides competitive advantage  Improves company image
  11. 11. © Operational Excellence Consulting. All rights reserved. 11 Development of ISO 9001 Quality Management System (QMS) ISO 9001:1987 (1st issue) ISO 9001:2000 (3rd issue) ISO 9001:2008 (4th issue) ISO 9001:2015 (5th issue) 1994 2000 2008 2015 Recertification audits to the new standard 1987 ISO 9001:1994 (2nd issue)
  12. 12. © Operational Excellence Consulting. All rights reserved. 12 Quality Management Principles 1. Customer Focus 2. Leadership 3. Engagement of People 4. Process Approach 5. Improvement 7. Relationship Management Quality Management Principles 6. Evidence-based Decision Making
  13. 13. © Operational Excellence Consulting. All rights reserved. 13 Key Improvements to ISO 9001:2015  Increased emphasis on achieving value for the organization and its customers  A greater emphasis on leadership and organizational context  The focus on risk-based thinking  Emphasis on objectives, measurements and change  Stakeholder-focused communication and awareness  Decreased emphasis on documentation
  14. 14. © Operational Excellence Consulting. All rights reserved. 14 ISO 9001 – Key Differences ISO 9001:2008 ISO 9001:2015 0 Introduction 0 Introduction 1 Scope 1 Scope 2 Normative references 2 Normative references 3 Terms and definitions 3 Terms and definitions 4 Quality management system 4 Context of the organization 5 Management responsibility 5 Leadership 6 Planning 6 Resource management 7 Support 7 Product realization 8 Operation 8 Measurement, analysis and improvement 9 Performance evaluation 10 Improvement
  15. 15. © Operational Excellence Consulting. All rights reserved. 15 Emphasis on Process Approach  Understanding and meeting customer requirements  How do processes value add  Measure process performance and effectiveness  Continual improvement of processes based on measurement
  16. 16. © Operational Excellence Consulting. All rights reserved. 16 Risk-based Management  To improve customer confidence and satisfaction  To assure consistency of quality of products and services  To establish a proactive culture of prevention and improvement  Successful companies intuitively take a risk-based approach Risks Opportunities
  17. 17. © Operational Excellence Consulting. All rights reserved. 17 Benefits of the New ISO 9001:2015  Puts greater emphasis on leadership engagement  Helps address organizational risks and opportunities in a structured manner  Uses simplified language and a common structure and terms  Addresses supply chain management more effectively  Is more user-friendly for service and knowledge-based organizations
  18. 18. © Operational Excellence Consulting. All rights reserved. 18 “It is most important that top management be quality-minded. In the absence of sincere manifestation of interest at the top, little will happen below.” Joseph M. Juran
  19. 19. © Operational Excellence Consulting. All rights reserved. 19 ISO 9001 Approach is Based on the Plan-Do-Check-Act (PDCA) Cycle Organization and its context (4) Customer Requirements Customer Satisfaction Products and services Results of the QMS Needs and expectations of relevant interested parties (4) Leadership (5) Performance evaluation (9) Support & Operation (7,8) Planning (6) Improvement (10) Plan Do CheckAct
  20. 20. © Operational Excellence Consulting. All rights reserved. 20 The ISO 9001 Structure is Aligned to the Common Structure for MSS 1. Scope 2. Normative references 3. Terms and definitions 4. Context of the organization 5. Leadership 6. Planning 7. Support 8. Operation 9. Performance evaluation 10. Improvement
  21. 21. © Operational Excellence Consulting. All rights reserved. 21 PDCA and ISO 9001 Clause Structure
  22. 22. © Operational Excellence Consulting. All rights reserved. 22 ISO 9001 Clause Structure (4-10) PLAN DO CHECK ACT 4. Context of the organization 5. Leadership 6. Planning for the QMS 7. Support 8. Operation 9. Performance evaluation 10. Improvement 4.1 Understanding the organization and its context 5.1 Leadership and commitment 6.1 Actions to address risks and opportunities 7.1 Resources 8.1 Operational planning and control 9.1 Monitoring, measurement, analysis and evaluation 10.1 General 4.2 Understanding the needs and expectations of interested parties 5.2 Quality policy 6.2 Quality objectives and planning to achieve them 7.2 Competence 8.2 Determination of requirements for products and services 9.2 Internal audit 10.2 Nonconformity and corrective action 4.3 Determining the scope of the QMS 5.3 Organizational roles, responsibilities and authorities 6.3 Planning of changes 7.3 Awareness 8.3 Design and development of products and services 9.3 Management review 10.3Continual improvement 4.4 QMS and its processes 7.4 Communication 8.4 Control of externally provided products and services 7.5 Documented information 8.5 Production and service provision 8.6 Release of products and services 8.7 Control of nonconforming process outputs, products and services
  23. 23. © Operational Excellence Consulting. All rights reserved. 23 2018 2017 Full conformance with new standard Recertification audits to new standard 2015- 2018 2015 Transition to full compliance Published ISO 9001:2015 (Sep 2015) ISO 9001:2015 Certification Transition Timeline Recertification audits to new standard 2016 Companies that are currently certified to ISO 9001:2008 have to transition to the 2015 version by September 14, 2018
  24. 24. © Operational Excellence Consulting. All rights reserved. 24 ISO 9001 Certification Process Implementation of QMS Conduct Internal Audit and Review Result by Top Management Selection of a Certification Body Stage 1 AuditStage 2 Audit Confirmation of Registration Continual Improvement and Surveillance Audits
  25. 25. © Operational Excellence Consulting. All rights reserved. 25 Internal Audit  To ensure the whole Quality System is audited to check: • The system is being followed • The system meets ISO 9001 requirements • The system is effectively implemented and maintained
  26. 26. © Operational Excellence Consulting. All rights reserved. 26 Audit Approach  Focuses on employees’ understanding of the organization’s processes and verifies that these processes are: • complied with • under control • achieving the desired results Provide evidence, e.g. records, meeting minutes, reports, data and emails
  27. 27. © Operational Excellence Consulting. All rights reserved. 27 Audit Emphasis  Measurement and results are of greater importance than mere presence of documented information
  28. 28. © Operational Excellence Consulting. All rights reserved. 28 Continual Improvement Establish objectives and processes needed to deliver results (in line with the QMS) Check the processes against policy, objectives, targets, regulations and report results (auditing) Take actions to continually improve the QMS Implement the needed processes of the QMS Plan Do Check Act
  29. 29. © Operational Excellence Consulting. All rights reserved. 29 Audit Findings Minor Non-conformity Observation Major Non-conformity
  30. 30. © Operational Excellence Consulting. All rights reserved. 30 How to Handle the Audit Session?  Do not panic  Ask and clarify  Admit obvious non-conformities  Offer evidence and explain patiently  Take note of improvement areas highlighted by the auditor  Show internal audit report, when necessary
  31. 31. © Operational Excellence Consulting. All rights reserved. 31 Auditee’s Conduct  Polite  Professional  Positive / Receptive  Sincere  Commitment  Formal but not overly serious
  32. 32. © Operational Excellence Consulting. All rights reserved. 32 Interacting with Auditors  Be honest and open  Recognize they may be experts  Realize they may not be subject matter experts  Understand the purpose of the meeting and review related records prior to interviews  Turn mobile phones to silent mode
  33. 33. © Operational Excellence Consulting. All rights reserved. 33 “In the race for quality, there is no finish line.” David Kearns, former CEO of Xerox
  34. 34. © Operational Excellence Consulting. All rights reserved. About Operational Excellence Consulting
  35. 35. © Operational Excellence Consulting. All rights reserved. 35 About Operational Excellence Consulting  Operational Excellence Consulting is a management training and consulting firm that assists organizations in improving business performance and effectiveness.  The firm’s mission is to create business value for organizations through innovative operational excellence management training and consulting solutions.  OEC takes a unique “beyond the tools” approach to enable clients develop internal capabilities and cultural transformation to achieve sustainable world-class excellence and competitive advantage. For more information, please visit www.oeconsulting.com.sg
  36. 36. © Operational Excellence Consulting. All rights reserved. END OF PARTIAL PREVIEW To download this presentation, please visit: www.oeconsulting.com.sg

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Thousands of companies in over 100 countries have adopted ISO 9001:2015 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.  Many companies struggle with teaching the basic concepts and awareness of ISO 9001 to their employees.  Because of resource constraints, you may not have the time to create the presentation (which takes the most time when teaching the material).  This PowerPoint solves this problem.  When you are done teaching this material to your employees, your employees will be much more informed and comfortable with ISO 9001. LEARNING OBJECTIVES  1. Provide background knowledge on ISO 9001 2. Gain an overview of ISO 9001 structure and the certification process 3. Understand the audit approach 4. Gather useful tips on handling an audit session ​ CONTENTS   1. Overview of ISO 9001 2. ISO 9001 Structure 3. ISO 9001 Certification 4. Audit Approach 5. Handling an Audit Session To download this complete presentation, please go to: http://www.oeconsulting.com.sg

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