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1、ISO 9000 Family Status and Six Sigma Integration Tony Brown MCQIand material provided by Dr. Bill Truscott FCQIISO 9000 Family Status and Six Sigma IntegrationWELCOME GOOD TO BE BACK IN GLASGOW TALKING TO THE WEST OF SCOTLAND BRANCH OF THE CHARTERED QUALITY INSTITUTE ISO9001 Quality management Syste
2、ms StandardBENEFITS Successfully accepted by the World Business Community by creating a common standard Pre-requisite for doing global business Provides an entry point for 3rd world economies Standardises Best Practice quality methods Its not perfect, nor is 3rd Party Accreditation always effectiveI
3、SO9000 Status WORLDWIDE INCREASE IN CERTIFICATIONS TO 780,000 NUMBER OF ECONOMIES USING THE STANDARDINCREASED BY 50% CHINA TOP THE TABLE WITH 144,000 CERTIFICATES UK CURRENTLY HAVE 46,000 WITH SOME DECLINEISO9001 Quality management Systems StandardSURVEY FEEDBACK CRITICAL ISSUES Standard doesnt guar
4、antee product conformity. Variability of 3rd Party accreditation. Poor take up of ISO9004 ISO9001 should prescribe risk managementISO9001 Quality management Systems StandardSURVEY FEEDBACK CRITICAL ISSUES People Aspects not sufficiently covered by the standards ISO9000 Quality management Systems Sta
5、ndardSalient Issues: Management for Sustainability Criteria for changing words Reduction of Ambiguity Input of changes from S/C2 Relationship with ISO9001, ISO9004 and the intended family Add executive summary to the revised ISO9000ISO9000 Quality management Systems Standard Due 2009Salient Issues:
6、Document/data management Add matrix of ISO9000 family of standards Sub-clause 0.2 review Culture of autonomy Review of scope Product Quality v Quality Management SystemISO9000 Quality management Systems Standard Due 2009SUSTAINABILITY How do we make the music in our organisations last ? How do we ke
7、ep the product from fading too fast ? How do we commit ourselves to our customers and keep our own identity How do we not run out of new ideas We know the world is always changing If we can try each day to make things a little better, then, with some good fortune, well survive ! ISO9000 Quality mana
8、gement Systems Standard Due 20093.2.8 Sustainability of an organizations ability or activity to maintain or develop its performance in the long term Sustainability emphasizes the need for a balance between economic-financial interests of an organization and those of the social and ecological environ
9、ment. This is sometimes referred to as the three Ps: profit, people and planet. Sustainability relates to the direct and indirect interested parties (3.3.7) of an organization (such as shareholders, employees, customers (3.4.5), users, pressure groups and communities). ISO9001 Change StatusTo addres
10、s the issues raised by the sanctioned interpretations against 9001, hopefully to remove them Similarly to address the issues detailed in the ISO 9000 Introduction and Support Package guidance documents Improve clarity, remove ambiguity, and ease translation To improve compatibility with ISO 14001 Th
11、e changes are limited to a small amendment, and there are no major changes to any requirementThe target date for publication is Oct 2008ISO9001 Change StatusGeneral The phrases “monitoring“, “measuring“ and “measurement“ are a constant source for questions of defining these terms and distinguishing
12、them from each.General The statement of effectiveness concerning the corrective action, instead of only checking if it was carried out The new requirements about the existence of records (e.g. audit results). The establishment of statutory requirements.ISO9001 Change Status1.1 General This Internati
13、onal Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements The inclusion of the definition of “effectiveness” emphasizes the concept that “OUTPU
14、T MATTERS”, ISO9001 Change Status4.1Proposed change: “The type and extent of controls to be applied to these outsourced processes shall be defined within the quality management system” ISO9004 Managing for Sustainable Success Due 20084.1Interested parties focus 4.2Approaches of managing for sustaina
15、ble success 4.2.1 General 4.2.2 Focus on StrategyISO9004 Managing for sustainable success4.2.3 Process approach4.2.4 Continual Improvement4.3 Management Responsibility4.4 Assessing sustainable success ISO9004 Managing for sustainable success5.0 The organizations environment5.1Changing environment5.2
16、Monitoring5.3Analyzing ISO9004 Managing for sustainable success 6Policy and strategy formulation, planning 5 golden rules for gemba management Ohnos lean organization; JIT and 7 types of waste Taguchis 8 key concepts and novel approach to experimentsPerformance Improvement Initiatives - 2 A current popular, hig
