Seminario Internacional Repensar la ISO desde la ISO 9001:2015. Presentation by Jack West

Transcription

1 Seminario Internacional Repensar la ISO desde la ISO 9001:2015 Presentation by Jack West

2 Progress is impossible without change, and those who cannot change their minds cannot change anything. George Bernard Shaw 2015 John E (Jack) West 2

3 Globalization could not have occurred if the World had not created ISO Dr. Armand V. Feigenbaum in a private conversation with Jack West 2015 John E (Jack) West 3

4 A Bit of History ISO What s past is prologue W. Shakespeare The Tempest 2015 John E (Jack) West 4

5 History of Yrs. 1986/7 7-8 Yrs Yrs Yrs Yrs Start First Standards Minor Revision Major Revision Two-phase revision process with simultaneous work on 1994 and 2000 revisions John E (Jack) West 5

6 A Bit of History A World of National Standards for QA (non Tariff Trade Barriers) ISO/TC 176 Formed Five versions of 9001 in 35 years Purpose of ISO 9001 has not changed Standards work is ponderously slow 2015 John E (Jack) West 6

7 To improve is to change; to be perfect is to change often. Winston Churchill 2015 John E (Jack) West 7

8 ISO 9001:2015 Certification Transition Timeline September 2015 IS published Sept to Sept year transition period 2015 John E (Jack) West 8

9 Implementation Process Gap Analysis Evaluate Goals Prioritize Improvements Make Changes 2015 John E (Jack) West 9

10 Scope Has Not Significantly Changed 1 Scope 1.1 General ISO 9001:2000 This International Standard specifies requirements for a quality management system where an organization a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements. 1 Scope ISO 9001:2015 This International Standard specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide product or service that meets customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements John E (Jack) West 10

11 Application Statement a Little Different ISO 9001: Application All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion. Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements. ISO 9001:2015 All requirements of this International Standard are generic and are intended to be applicable requirements to all organizations, may regardless not of type, size and product and service provided. No exclusions BUT some apply Must not affect ability or responsibility to ensure the conformity of products and services and the enhancement of customer satisfaction John E (Jack) West 11

12 Benefits What Has Been Improved? 1. More user friendly for service and knowledge-based organizations 2. Addresses organizational knowledge 3. Opportunity for an integrated management system that addresses other elements such as environment, health & safety, business continuity, etc. See ISO 9001 Frequently Asked Questions 2015 John E (Jack) West 12

13 Benefits What Has Been Improved? 3 more that may be more important! 4. Less prescriptive, more flexible documented information 5. Greater leadership engagement: emphasis on planning, setting objectives and management review aligned to organizational results 6. The opportunity for Addresses organizational risks and opportunities in a structured manner See ISO 9001 Frequently Asked Questions 2015 John E (Jack) West 13

14 1. More user friendly for service and knowledge-based organizations The best way to find yourself is to lose yourself in the service of others. Mahatma Gandhi 2015 John E (Jack) West 14

15 User Friendly Less jargon left over from manufacturing and construction Use of product and service BUT Introduces new jargon Some terminological flexibility (Documents and Records vs documented information) 2015 John E (Jack) West 15

16 Use your own terms 2015 John E (Jack) West 16

17 2. Addresses organizational knowledge A good decision is based on knowledge and not on numbers.. Plato 2015 John E (Jack) West 17

18 Understand and Maintain Knowledge for current operations Knowledge you Know You Know Tacit Knowledge you often don t Know you Know 2015 John E (Jack) West 18

19 As Your World Changes, Determine What you Need to Know Next! To know what you know and what you do not know, that is true knowledge. Confucius 2015 John E (Jack) West 19

20 3. Create an integrated management system One organization one management system Improved Management Efficiency Addresses other elements such as environment, health & safety, business continuity, etc John E (Jack) West 20

21 4. Less prescriptive and, more flexible documented information but with greater focus on achieving conforming products and services 2015 John E (Jack) West 21

22 Freedom to Act vs Documented Rules There's a way to do it better - find it. Thomas A. Edison 2015 John E (Jack) West 22

23 Freedom to Act vs Documented Rules 2015 John E (Jack) West 23

24 Whom or What do You Trust? Trust the system: Procedures Automation Rules Documented Information Balanced Approach Trust the people: Leadership Empowerment Communications Alignment 2015 John E (Jack) West 24

25 Implications for Audits Less prescriptive requirements Potentially less documentation of processes Greater need to cross-check the system Potential for debates with 3 rd party auditors Potential for more audit time 2015 John E (Jack) West Audit implies comparison to criteria 25

26 5. Greater leadership engagement: emphasis on planning, setting objectives and management review aligned to organizational results 2015 John E (Jack) West 26

27 Leadership Engagement Leadership is QMP 2 From ISO9000:2015 Clause Statement of the Leadership principle Leaders at all levels establish unity of purpose and direction and create conditions in which people are engaged in achieving the organization s quality objectives. Rationale Creation of unity of purpose and the direction and engagement of people enable an organization to align its strategies, policies, processes and resources to achieve its objectives John E (Jack) West 27

28 Summary of Leadership Requirements Clause 5.1 top management leads by: Accountability for QMS effectiveness Ensuring quality policy, quality objectives, and a QMS compatible with organization s context and strategic direction Ensuring integration of the QMS requirements into organization s business processes 2015 John E (Jack) West 28

29 Summary of Leadership Requirements Clause 5.1 Continued promoting use of the process approach and riskbased thinking Ensuring availability of resources needed for the QMS Communicating the importance of effective QM and of conformity to QMS 2015 John E (Jack) West 29

30 Summary of Leadership Requirements Clause 5.1 Continued Ensuring the QMS achieves intended results Engaging, directing and supporting contributions to the effectiveness of the QMS Promoting improvement Supporting other relevant management roles to demonstrate their leadership 2015 John E (Jack) West 30

31 Measure Process Parameters That Drive Process Output Results Y Response Variable Sweet Taste Independent Variable Amount of Sugar 2015 John E (Jack) West 31

32 6. The opportunity for Addresses organizational risks and opportunities in a structured manner 2015 John E (Jack) West 32

33 Risk-based Thinking Risks and Opportunities..the only strategy that is guaranteed to fail is not taking risks. Mark Zuckerberg 2015 John E (Jack) West 33

34 Risk-based Thinking Risks and Opportunities Risk comes from not knowing what you're doing. Warren Buffett 2015 John E (Jack) West 34

35 Why use risk-based thinking? improve governance establish a proactive culture of improvement assist with compliance assure consistency of quality of goods and services improve customer confidence and satisfaction 2015 John E (Jack) West 35 35

36 How do I do it? Identify your risks it depends on context Use risk-based thinking to prioritize the way you reduce risk of failure while capitalizing on opportunities Note that: ISO 9001:2015 does not require formal risk assessments ISO Risk management Principles and guidelines may be a useful reference but its use is not a requirement John E (Jack) West 36 36

37 Conclusions Risk-based thinking is not new: you may do it but informally & inconsistently is ongoing ensures greater knowledge of risks and improves preparedness increases the probability of reaching objectives reduces the probability of negative results makes prevention a habit 2015 John E (Jack) West 37 37

38 What s new? A sampler Difference Example New Words for old concepts Risk-based thinking vs preventive action Documented information vs documents and records Expanded expectations Greater emphasis on leadership Expansion of interested parties Change in look and feel New format; common text 2015 John E (Jack) West 38

39 Summary of issues Failure to use ISO 9000 indispensable to users of 9001 Interested parties Is there a conflict with the Scope of 9001 Context of the organization how far do you go Challenge of engaging top management talk $ Degree to which we talk about customer satisfaction and the minuscule coverage in 9001 making it real Integration of QMS into overall management system Affect on the audit process, internal and external 2015 John E (Jack) West 39

40 The most important thing is to THINK Consult registrar consider timing Identify changes Learn: ISO 9001, Requirements ISO 9000, Fundamentals and vocabulary THINK make any needed changes to system YES Process Change mgmt. to system?? Focus? NO THINK THINK Identify processes Identify processes & establish make needed changes process management Implement & audit revised processes 2015 John E (Jack) West Apply for registration 40

41 Think Thinking is the hardest work there is, which is probably the reason why so few engage in it. Henry Ford 2015 John E (Jack) West 41

42 For More Information Go To

43 Books by Cianfrani and West Jack and Charlie are Co-authors of several books published by the American Society for Quality (ASQ) Quality Press including: ISO 9001:2015 Explained (Available soon) SO 9001:2008 Explained & Expanded Unlocking the Power of your Quality Management System - Keys to Performance Excellence How to Audit the Process-Based QMS The ASQ ISO 9000:2000 Handbook Cracking the case of ISO 9001:2008 for Manufacturing Cracking the case of ISO 9001:2008 for Service 2015 John E (Jack) West 43

44 Thank You for your attention 2015 John E (Jack) West 44

45 Any final comments or question? 2015 John E (Jack) West 45

46 The Official Timeline 2015 John E (Jack) West 46