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ISO 9001:2015 Revision Luis Fonseca 1ISO 9001:2015 Revision, Luis Fonseca,

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Presentation on theme: "ISO 9001:2015 Revision Luis Fonseca 1ISO 9001:2015 Revision, Luis Fonseca,"— Presentation transcript:

1 ISO 9001:2015 Revision Luis Fonseca 1ISO 9001:2015 Revision, Luis Fonseca,

2 1. Introduction 2 Many definitions of Quality; Gurus: Crosby, Deming, Juran, Feigenbaum, Ishikawa, Taguchi, …; ISO 9000 standards; Excellence Models: EFQM, MBA, Deming Prize + 6 Sigma, Lean Six Sigma, Kaizen, etc.; In summary: Ranging from Conformity to Standards (more B2B) to Customer Satisfaction (more B2C). ISO 9001:2015 Revision, Luis Fonseca,

3 1. Introduction 3 Let´s discuss the rationale behind the ISO 9001:2015 revision and the status of this (still ongoing) process; Key Stakeholders have (and are still working) towards a Quality Management Systems with less emphasis on documentation and new/reinforced approaches like consideration of organizational context, (relevant) Stakeholders, risk based thinking and knowledge management; The main question is how far ISO/TC 176 can go without alienating the "traditional" user and at the same time bonding Quality with Management. ISO 9001:2015 Revision, Luis Fonseca,

4 1. Introduction 4 Let´s discuss the rationale behind the ISO 9001:2015 revision and the status of this (still ongoing) process; WARNING! The current version of the standard is the DIS (draft International Standard). Changes might happen to: Content and Publication date- Why do standards change? ISO have a Directive governing the publication of standards All full ISO standards require to be reviewed every 5 years (ISO Directive Part 1, Cl ) The review can confirm that there is no change … but normally not. ISO 9001:2015 Revision, Luis Fonseca,

5 1. Introduction 5 Let´s discuss the rationale behind the ISO 9001:2015 revision and the status of this (still ongoing) process; ISO 9001 change process: –ISO TC 176 – Structure: SC 1: Terms and Definitions, SC2: Quality Systems (WG 23: Implementation Guidance; WG 24: Revision of ISO 9001); SC3: Supporting Technologies ISO 9001:2015 Revision, Luis Fonseca,

6 1. Introduction 6 User Survey: KEY AREAS IDENTIFIED 64% wanted enhancement (7918 responses) Concepts (top 5) –Resource Management –Voice of Customer –Measures –Knowledge Management –Risk Management In addition there were free text comments which concerned (top 5): Top management involvement; Risk assessment; Business continuity / planning; Inclusion of finance: Resources / competence / work environment. ISO 9001:2015 Revision, Luis Fonseca,

7 7 1. Introduction: ISO Certificates wordwide Source: ISO Survey 2012, acceded at ‎ ISO 9001:2015 Revision, Luis Fonseca,

8 8 1. Introduction: ISO Certificates In Portugal Source: ISO Survey 2012, acceded at ‎ ISO 9001:2015 Revision, Luis Fonseca,

9 9 Information from research done by HBS among 1000 organizations, 500 with and 500 without QMS implemented and certified: Turnover 9% higher. Higher profit because of higher turnover. More salary increase (7%). More personnel needed (10%) because of higher turnover increase. In combination with ISO less waste and less incidents. Effects were much stronger in smaller organizations. ISO 9001:2015 Revision, Luis Fonseca, 1. Introduction: ISO Certification value

10 1. Introduction 10 Major Objectives: Performance Related What to achieve rather than “how” Consistently meeting customer requirements Widen appeal SME, services, R&D etc. Adaptive system Not static. Risk based ISO 9001:2015 Revision, Luis Fonseca,

11 Standardization versus Agility (flexibility, Innovation, Speed) - Process Reliability + + Agility-+ Agility Introduction ISO 9001:2015 Revision, Luis Fonseca,

12 1. Introduction 12ISO 9001:2015 Revision, Luis Fonseca, Design Specification: Revised Quality Principles User Survey Wide applicability Simplified language Consistent language Emphasis on Process Approach Meet ISO Directives ISO/TC176/SC2 Vision and Mission ISO/TC 176/SC2 Strategic Objective Annex SL to the ISO/IEC Directive Sanctioned interpretations Frequently Asked Questions, ISO 9001 for small businesses – What to do? Drafts of ISO 14001, Annex A, as available Drafts of ISO Outsourcing Output of Auditing Practices Group

13 2. ISO 9001:2008 versus ISO/DIS 9001: ISO 9001:2015 Revision, Luis Fonseca, Quality Principles:

14 2. ISO 9001:2008 versus ISO/DIS 9001: ISO Directives Part 1, ANNEX SL: Common structure for management systems; Template for common requirements; Allow better integration of MS; POSSIBLY THE MOST MAJOR CHANGE; Annex SL is also called “the high level text”, “the high level structure (HLS)”; No change allowed unless justified. Justification has to be on the basis that the text will not work in the particular context. ISO 9001:2015 Revision, Luis Fonseca,

15 2. ISO 9001:2008 versus ISO/DIS 9001: ISO Directives Part 1, ANNEX SL: 4: Context of the organisation 5: Leadership 6: Planning for the QMS 7: Support 8: Operation 9: Performance evaluation 10: Improvement ISO 9001:2015 Revision, Luis Fonseca,

16 2. ISO 9001:2008 versus ISO/DIS 9001: Headlines Consideration of organizational (relevant) Stakeholders; Planning: Actions to address risks and opportunities; Preventive Action: Now covered by Risk Based Thinking Context, Clause 4.1, 4.2 and 4.3; Quality Manual, no specific requirement; Management Representative: Rewritten as clause 5.3, No specific role but same responsibilities; Objectives: More systematic approach; Organisational Knowledge: Knowledge management; Leadership: Better definition of top management responsibilities; Communication: Enhanced requirement ISO 9001:2015 Revision, Luis Fonseca,

17 2. ISO/DIS 9001:2015 Process based QMS System 17ISO 9001:2015 Revision, Luis Fonseca,

18 2. ISO 9001:2008 versus ISO/DIS 9001: Headlines ISO 9001:2015 Revision, Luis Fonseca, ISO/TC 176/SC2 Document N1222, July 2014 “RISK” IN ISO 9001:2015 ISO TS 9002:2015: There will be a guidance document (started 9 June 2014). It is intended to be available when ISO 9001:2005 is published.

19 2. ISO 9001:2008 versus ISO/DIS 9001:2015 Correlation Matrix 19 ISO 9001:2015 Revision, Luis Fonseca,

20 2. ISO 9001:2008 versus ISO/DIS 9001:2015 Correlation Matrix 20 ISO 9001:2015 Revision, Luis Fonseca,

21 2. ISO 9001:2008 versus ISO/DIS 9001:2015 Correlation Matrix 21 ISO 9001:2015 Revision, Luis Fonseca,

22 3 Conclusions 22 What about the feedback from ISO 9001 community? Some like very much the “Annex SL” approach, but other do not. Concerns that some requirements might being soft grading (e.g., Design & Development and Calibration). Concerns about “auditability” of some requirements (I agree this might be a major challenge for Consultants and for Certification Bodies Auditors). Some want more prescriptive requirements (e.g., Automotive Sector). Introduction of the concept of “Relevant Interested parties” and “Risk Based Approach” is a new reality. Elimination of usual terminology and requirements like “Preventive action”; “Management Representative”, “Quality Manual” still not liked by all. ISO 9001:2015 Revision, Luis Fonseca,

23 3 Conclusions 23 What does the author thinks? It should not be a major source of concern for the ISO 9001:2015 should not be a major source of concern, for the more than 1 Million certified organizations and the many Quality Professionals and Scholars that work with it. It will have major benefits for Quality Management Systems with less emphasis on documentation and new/reinforced approaches like consideration of organizational context and (relevant) Stakeholders, risk based thinking and knowledge management. The author thinks one of the major changes will be that organizations have to be clearer about what they say they are going to offer and the main question is how far ISO/TC 176 can go without alienating the "traditional" user. ISO 9001:2015 Revision, Luis Fonseca,

24 3 Conclusions 24 What should you do know? Stay tuned to what’s happening with the revision to ISO Get familiar with the concepts of “Risk-based thinking” and “Relevant interested parties”. Follow into since periodic updates will be made available by ISO/TC176/SC2/WG23. Look into the DIS (Draft International Standard) and start working on understanding and incorporating the changes. DIS will be followed by FDIS (Final Draft Standard) and finally IS (international Standard). ISO 9001:2015 Revision, Luis Fonseca,

25 3 Conclusions 25 What should you do know? Is your organization pleased with your present Quality Management System? Is it really a lean process based system? Does it integrates and supports your business well? Depending on you the answer, some organizations should consider the 2015 ISO 9001 revision as a great opportunity to reviews and reignite theirs systems. If the system is working well, maybe just adjust it to the new ISO changes. ISO 9001:2015 Revision, Luis Fonseca,

26 4 References 26ISO 9001:2015 Revision, Luis Fonseca, ISO TC/176, accessed at ISO Survey 2012, accessed at Boiral, O., 2012, ISO 9000 and Organizational Effectiveness: A Systematic Review, QMJ, Vol 19, and N º 370) Croft, N.H., 2013, ISO 9001:2015, from CD to DIS, DNV Webinar Hadfield R., Fonseca L., 2014, ISO9001:2015, APQ, ANO XLIII, Edição 01,pp32-36 IATF, 2014, accessed at ww.iatfglobaloversight.org. ISO, 2014, ISO/TC 176/SC 2/N 1147, 2013, ISO/CD ISO 2014, ISO/TC 176/SC 2/WG 24/N 112, 2014, ISO/DIS This document is presently under ISO copyright and should not be forwarded to, or made available to, any 3rd Party -This document is a draft circulated for comment and approval. It is therefore subject to change and may not be referred to as an international standard until published as such. Lee, H., L., 2004, Harvard Business Review, October Levine D., Toffel, M.W., 2010, Quality Management and Job Quality: How the ISO 9001 Standard for Quality Management Systems Affects Employers and Employees, Harvard Business School. Nascimento J.C., 2013, Norma ISO 9001:2015, Panorama e tendência da revisão 2015, ABNT, Exponorma. O’Byrne, F., Tighe, J., 2013, NSAI Consultants Forum. Sá, J.G., 2014, Workshop ISO 9001:2015 perspetivas futuras, Ponta Delgada. Karapetrovic, S., 2002, Strategies for integration of management systems and standards, TQM Magazine, 14(1) pp ).

27 27 Q&A and Thanks Luis Fonseca paginas.isep.ipp.pt/lmf/‎ For more details please see full article. Quality: a major source of value. Thank You Very Much Q&A most welcomed ISO 9001:2015 Revision, Luis Fonseca,


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