Quality Management Present and Future Nigel H Croft Chairman, ISO/TC176/SC2 Quality Systems Member, ISO/TC176 Chairman s Strategic Advisory Group Member, ISO/CASCO Chairman s Policy Committee Member, IAF/ILAC/ISO Joint Working Group April 2010 (c) Nigel H Croft 1
OBJECTIVES Present the latest developments in the ISO 9000 family, and plans for the future Present APCER s Interpretation Guide for ISO 9001:2008; Present the main results of the 2008 ISO Survey (published Nov 2009) April 2010 (c) Nigel H Croft 2
Part 1 Latest developments in the ISO 9000 family, and plans for the future April 2010 (c) Nigel H Croft 3
Overall Scenario of TC176 Development of generic QMS standards that have broad application: all market sectors both private and public organizations +/- 1,000,000 worldwide certifications to ISO 9001 Other guidelines produced by ISO/TC 176 assist organizations in improving their quality management processes. ISO 9000 ISO 9004 Others (ISO 10001/2/3; ISO 19011 etc) April 2010 (c) Nigel H Croft 4
ISO 9001 ISO 9004 & others ISO/TC 176 CALG CSAG Automotive TG Spanish Trans TG Arabic Trans TG SC 1 SC 2 SC 3 Interpretations WG WG1 WG2 WG3 WG18 WG1 WG6 JWG April 2010 (c) Nigel H Croft 5
SC2 Organizational Environment. ISO Central Secretariat International Accreditation Forum ISO/ CASCO Technical Management Board P-members, Liaisons, Experts SC1 TC176 SC2 SC3 JTCG* / Other TC s * Joint Technical Coordination Group April 2010 (c) Nigel H Croft 6
Relationship with TC176.. Participate actively in strategy development via CSAG TC176 Strategic Plan TC176 Portfolio Commit to deploy TC176 policies and strategies via active participation in TCOG Liaison with other SC s Liaison with other organizations outside of TC176 CASCO; IAF; Sectors etc April 2010 (c) Nigel H Croft 7
Relationship with other TC s Joint Technical Coordination Group has made considerable progress: Establishing a joint vision for management system standards Developing a high level structure for all ISO management systems standards Identifying identical sub-clause titles under the high level structure Developing a draft generic core vocabulary for management system standards Initiating the revision of ISO 19011 into a generic guideline for auditing all types of (non-financial) management systems Next meeting in Buenos Aires May 3 rd 7 th 2010 Work is expected to be complete by December 2010 April 2010 (c) Nigel H Croft 8
Current SC2 Portfolio and Ecosystem Auditing Practices Group Small Business Handbook Support packages ISO 9001 ISO 9004 Interpretations ISO 10005 ISO 10006 ISO 10007 ISO/TS 16949 (?) Sector standards (ISO and non-iso) IWA s April 2010 (c) Nigel H Croft 9
The story so far 1960 s Defence, nuclear standards on Quality 1979 - BS 5750 1987 ISO 9000 series 1990 TC176 Strategic Plan Vision 2000 1994 Revision to ISO 9000 series 1996 ISO 14000 series published 2000 Major revision of ISO 9000 family 2002 TC176 Strategic Plan Horizon 2010 2004 Revision to ISO 14001 2005 Small revision to ISO 9000 2008 Small revision ( amendment ) to ISO 9001 2009 Significant changes to ISO 9004 2010 New strategic plans being developed (TC176 and TC176/SC2) April 2010 (c) Nigel H Croft 10
ISO 9001:2008 Primary objectives were: to improve the existing ISO 9001:2000 standard; to provide greater clarity and ease of use, to improve compatibility with ISO 14001:2004 April 2010 (c) Nigel H Croft 11
Main changes in ISO 9001:2008 No new requirements (at the macro-level ) Changes to the wording of some clauses ( Micro-level ) Organizations should revisit their QMS to check if better understanding leads to a need for change. The changes are small, but they provide BIG OPPORTUNITIES for organizations to take a step back & look at the overall effectiveness of their QMS April 2010 (c) Nigel H Croft 12
Key inputs for ISO 9001:2008 Web based User Feedback Survey conducted by ISO/TC 176/SC2 ISO/TC 176 approved interpretations See www.tc176.org/ for details Some interpretation requests indicated need for clarification of ISO 9001 text The ISO 9001:2000 Introduction & Support Package set of documents (www.iso.org) ISO 14001:2004 April 2010 (c) Nigel H Croft 13
Impacts and benefits Changes introduced in ISO 9001:2008 focused on high benefit / low impact cases Some high benefit / high impact improvements that were identified are being saved for the next revision cycle April 2010 (c) Nigel H Croft 14
Impact analysis Impact Benefits 1 2 3 High Medium Low 1 Low 1 2 3 2 Medium 2 4 6 3 High * 3 6 9 1-2 Incorporate the change. 3-4 Additional analysis should be conducted prior to making the decision. 6-9 Do not incorporate the change. Note: *3 - high impact x high benefits - No change allowed, but we need to record details of proposed change, to provide input into future revisions. April 2010 (c) Nigel H Croft 15
Implications of ISO 9001:2008 Changes were very small (but not trivial ) Some changes could not be incorporated due to potentially large impact TC176/SC2 formed Task Group to look at Future Concepts for possible incorporation into ISO 9001 Long-term Strategic Planning for ISO/TC176 and TC176/SC2 underway, looking at entire portfolio and architecture April 2010 (c) Nigel H Croft 16
SC2 Task Group on Future Concepts for ISO 9001 now looking at. Integration of risk management Enhanced focus on product conformance Financial resources of the organization Maintenance of infrastructure Alignment with business management/ practice April 2010 (c) Nigel H Croft 17
Other concepts for possible inclusion / enhancement Process Management Knowledge management Results/Improvement/Effectiveness Life cycle management (LCM) QM Principles / Leadership April 2010 (c) Nigel H Croft 18
Other concepts for possible inclusion / enhancement Competence Supply Chain Management (and Outsourcing) Use of Quality Tools Communication Improvement and innovation April 2010 (c) Nigel H Croft 19
Other concepts for possible inclusion / enhancement Structure of QMS and Relationship with Work of JTCG Time/Speed/Agility and Related Aspects Impact of Technology and Changes in Information Management Role of Top Management in the QMS Expanding the concept of Customer April 2010 (c) Nigel H Croft 20
ISO 9004:2009 Very different from ISO 9004:2000, both in structure and content. Basis is still the eight quality principles but with additional ideas incorporated: Vision/mission/strategy development, innovation and learning. Guidelines for self-assessment have evolved into a Self-assessment tool (Annex A). Guidance on two levels: one for top management and the other at an operational level. Risks are treated in a more visible way than before. No more direct ISO 9001 quotations ( ISO 9001 boxes ) in the text. (c) ISO 2010 - All rights reserved ISO/TC176/SC2/N891
Some topics addressed in ISO 9004:2009 Understanding organization s business environment Strategic management Strategic planning Mission, Vision, Policy and Objectives Risk management Knowledge management Natural resources and life-cycle management Key performance indicators Learning, improvement and innovation Oct 2009 (c) Nigel H Croft 2009 22
Relation between ISO 9001 and ISO 9004 Maturity Sustained success Effective And Efficient Effective ISO 9001 (minimum) ISO 9004 ( Stepping stones ) Customers Realization processes (c) ISO 2010 - All rights reserved ISO/TC176/SC2/N891 All interested parties All processes 23
Messages I m hearing about ISO 9001.. From many users We want NO CHANGE From High-tech (high risk) and/or mature users. We want MORE! ( We want to show we re BETTER! ) From Low-tech (Low risk) and/or immature users and SME s* We want LESS! ( We want an easier option ) * NOTE I don t agree that this is a function of SIZE From the Future Concepts for ISO 9001 TG Risk Management ; Output matters etc From the TC Chair CMM! From some sectors User-friendly GUIDANCE April 2010 (c) Nigel H Croft 24
My personal ideas for ISO 9001 and ISO 9004 over the next 10 years*.. * Still to be discussed and agreed within TC176/SC2! ISO 9001:2008 (Small changes) ISO 9001:201x Part 1 ( Big changes/ reductions ) ISO 9001:201x Part 2 (Relatively small changes) ISO 9001:202x Parts 1, 2 & 3 (Small changes) ISO 9001:201x Part 3 ( Big changes) ISO 9004:2009 (Big changes) ISO 9004:201x (Small (or no) changes) ISO 9004:202x (Big changes) April 2010 (c) Nigel H Croft 25 (Re-align publication dates)
ISO 9001:201x Part 1 Would be aimed at low-risk / low criticality organizations Many SME s will come into this category (but not necessarily!) Part 2 Default would be a continuation of ISO 9001:2008 with relatively small changes Basis for regulatory requirements, sector schemes etc Part 3 Would be aimed at high-risk / high criticality organizations Plus mature organizations seeking a differential April 2010 (c) Nigel H Croft 26
Possible additions for ISO 9001:201x Part 3 Long-term strategic planning Organizational environment/mission/vision Policy deployment Extra focus on resource management More use of statistical methods Systematic problem solving Customer satisfaction measurement etc April 2010 (c) Nigel H Croft 27
Pro s and con s Pro s Re-aligned revision dates (but out of phase ) allows for beta-testing using ISO 9004 Allows for differentiation (step towards CMM-type). Customers decide which is required! Opportunity to re-gain lost confidence in certification (Avoid repeating mistakes of past, particularly re Part 3 ) Continuity provided in Part 2 Introduce new audience to ISO 9001 ( Part 1 - entry level) Con s Potential to confuse the market Possibility of devaluing existing product Perceived to be a return to the old ISO 9001/2/3 IT S NOT!! A lot more work for SC2!! Could be perceived as favouring consultants and CB s April 2010 (c) Nigel H Croft 28
High-Level Timing for ISO 9001 Systematic Review Justification Study Design Specification Standards Drafting Process Publication 6 Mos. 3 Mos. 9 Mos. 3 Years End 2010 2011 Q1/Q2 2012 2015?? TG Concept Papers SC2 Strategic Plan TC 176 Strategic Plan April 2010 JTCG Work (c) Nigel H Croft 29
Other things happening in TC176.. Guidance documents for ISO 9004:2009 out for comment to be published mid-2010 ISO 9001 Small Business Handbook recently updated ISO 19011 being revised (includes other management systems) ISO/TS 10004 in preparation (Guidelines for monitoring and measuring Customer Satisfaction) April 2010 (c) Nigel H Croft 30
Part 2 Presentation of the APCER Interpretation Guide for ISO 9001:2008 April 2010 (c) Nigel H Croft 31
APCER - ISO 9001:2008 Interpretation Guide Aim of the guide: To provide a common platform for organizations, consultants, trainers, and auditors to understand: Intent of each clause of ISO 9001 Interpretation of the clause Typical evidence that might be expected in order to demonstrate conformity To highlight the changes and opportunities introduced in the ISO 9001:2008 version April 2010 (c) Nigel H Croft 32
Contents of the interpretation guide. Background to the development of ISO 9001:2008 Inputs Design specification Concept of benefit versus impact Focus on high benefit / low impact for 2008 Details of other standards and guides produced by ISO/TC176 The role of CT80 in Portugal Use of the 8 QMP s, and PDCA Cycle Clause-by-clause analysis of ISO 9001:2008, with highlight on the changes introduced. A few examples... April 2010 (c) Nigel H Croft 33
Clause 0.1 Clause 0.1 now refers to the organizational environment, changes in that environment and associated risks. Check to ensure that your QMS continues to be relevant to the changing business environment in which you are operating. As you grow, your situation may change new technologies, market opportunities, consumer demands, threats etc. Is the level of detail of your QMS and associated processes still appropriate to the risks involved in your activities? In the current financial climate, you should be looking to your QMS to guide you through troubled times Ensure that despite cutbacks etc, your product or service quality (and with them your reputation) does not suffer. April 2010 (c) Nigel H Croft 34
Clause 0.2 Text added to clause 0.2 to emphasize the importance of processes being capable of achieving desired outcomes. Probably one of the most subtle but important changes introduced in the new standard. Emphasizes that the QMS should be achieving its primary objective - consistent, conforming products Did we all forget this?? Too much focus on documents and records, rather than on managing processes to achieve desired results. Take a long, hard look is your system really producing the desired outcomes for you, your customers, and your employees? If not, then why not? What needs to be changed? April 2010 (c) Nigel H Croft 35
Clause 4.1 Clause 4.1 (e) now clarifies that process measurement may not be applicable in all cases (though all processes must be monitored). Do you know the difference between monitoring and measuring? In some cases, you may have been induced by consultants and/or auditors to come up with process measurements that are not practical, meaningful or useful, simply because ISO 9001 was understood to require them. You might wish to re-evaluate the need for such measurements, and to ensure that any measurements that are necessary really do add value to your organization April 2010 (c) Nigel H Croft 36
Clause 4.1 Notes have been added to explain more about outsourcing what is meant by an outsourced process and what controls might be appropriate Review the way you manage your outsourced processes... Are they being carried out in line with the requirements of ISO 9001:2008? Can you introduce greater efficiencies by considering alternate sourcing or imposing more meaningful monitoring initiatives? Are there any indications of customer dissatisfaction with these processes? Could you benefit from outsourcing other processes? Might it be appropriate to bring some outsourced processes back in-house? April 2010 (c) Nigel H Croft 37
Clause 6.2 ISO 9001:2008 makes an important clarification that competence requirements relate not only to personnel whose work directly affects product quality, but also where it indirectly affects product quality via the operation of the QMS (e.g. purchasing, supplier evaluations, internal audits etc). If you have previously limited your attention to competence requirements for personnel directly involved in production or service delivery processes, you should assess where you may need to include other activities such as those mentioned above, among others. This might mean an extra work-load in the short-term, but it is likely to bring long-term benefits. April 2010 (c) Nigel H Croft 38
Clause 6.3 This clause now recognizes the importance of information technology (IT) in modern organizations and the effect that information systems can have on product conformity. Not a new requirement, but the specific inclusion of IT as an example of infrastructure provides you with an opportunity to review your dependence on IT Risk analysis of potential problems should a failure occur (system crash, computer virus, loss of confidential data, file corruption etc). No requirement to use IT in your QMS (many organizations can operate quite effectively without it), but where it is used, the risks must be understood and mitigation measures put in place as appropriate. April 2010 (c) Nigel H Croft 39
Clause 7.1 ISO 9001:2008 now strengthens the requirement for product realization planning to include measurement (as appropriate). Need to think about and define what measurements you need to make in order to ensure control over your processes and conformity of the resulting product. All processes have to be monitored, but it is not always feasible, meaningful or cost-effective to establish measurements for everything. Think about the reasons measurements might be needed (eg for evidence of conformity to requirements, or to provide process control data for subsequent action) and the potential consequences of not making measurements for every process. April 2010 (c) Nigel H Croft 40
Clause 7.2.1 The standard now clarifies that post-delivery activities may include actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal. Need to think about the whole range of characteristics of your product that can affect customer satisfaction. These might include characteristics that are not traditionally identified as being related to product quality. As global environmental awareness increases, considerations such as unnecessary packaging or end-of-life product disposal (particularly for electronic and electrical items) become a concern Take a positive and proactive approach to these issues, and you will not only be meeting the intent of ISO 9001:2008 you may be able to use them as a strategic marketing tool to gain an advantage over your competitors. April 2010 (c) Nigel H Croft 41
Clause 8.2.2 This clause now expects management responsible for the area being audited to ensure that both correction and corrective actions are addressed as appropriate with respect to detected nonconformities. You must consider the need for correction of detected nonconformities and recognize that it might not be necessary or appropriate to take corrective action for all nonconformities found during internal audits. After a root cause analysis of the situation and based on a number of factors, including the risk and probability of a recurrence you might decide that it s sufficient simply to correct the problem, without the need for corrective action. April 2010 (c) Nigel H Croft 42
Clause 8.5.2 & 8.5.3 The standard now makes it clear that it is the effectiveness of the corrective and preventive action that must be reviewed, not just the action itself. You need to look carefully at the actions you have initiated, and to make sure they are achieving the intended results. If the actions are to address specific real or potential nonconformities (in product, process or the quality management system), have they successfully eliminated (or significantly reduced) the problem or risk? April 2010 (c) Nigel H Croft 43
Implications Transition to ISO 9001:2008 should be very simple, but not automatic Organizations should take advantage of the changes to re-assess the value of their QMS and make the most of this BIG OPPORTUNITY Is the QMS really delivering on its promise of consistent, conforming products?? April 2010 (c) Nigel H Croft 44
Part 3 Results of the 2008 ISO Survey April 2010 (c) Nigel H Croft 45
ISO Survey 2008 Carried out by A.C. Nielsen on behalf of ISO Survey based on data from Dec 31 st 2008 Survey now covers the following standards. ISO 9001:2000/2008 (QMS) ISO 14001:2004 (EMS) ISO/TS 16949:2002 (Automotive) ISO 13485:2003 (Medical devices) ISO/IEC 27001:2005 (Information security) ISO 22000:2005 (Food Safety) April 2010 (c) Nigel H Croft 46
ISO Survey 2008 Summary is available for free download from www.iso.org More detailed breakdown of results, including brochure & CD-ROM is available for purchase from ISO April 2010 (c) Nigel H Croft 47
Corrections to 2007 data Correction of previous over-counting has resulted in some distortions in 2008 survey Data now collected directly from CB s to eliminate multiple counting of same cert Result is that some countries have an apparent REDUCTION in number of certs for ISO 9001 Japan (-13 527) Netherlands (-10 890) India (- 10 270) April 2010 (c) Nigel H Croft 48
ISO Survey 2008 (up 3.3%) April 2010 (c) Nigel H Croft 49
Comparisons (ISO 9001).. (CORRECTED) April 2010 (c) Nigel H Croft 50
ISO Survey 2008 (up 22%) April 2010 (c) Nigel H Croft 51
Comparisons (ISO 14001)..
Other standards Standard Certs Countries % Increase 2008 / 2007 ISO/TS16949 39 320 81(Largest are China, USA, Korea) ISO 13485 13 234 88 (Largest are Germany, USA, China) ISO 27001 9 246 82 (Largest are Japan, India, UK) ISO 22000 8 206 112 (Largest are Turkey, Greece, India) 11.7% 1.9% 20.0% 198.6% April 2010 (c) Nigel H Croft 53
THANK YOU nigelhcroft@sapo.pt April 2010 (c) Nigel H Croft 54