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Standards: Their value in today’s world with particular reference to the ISO9000 family . Dr Trevor Smith Chair, ISO/TC 176 International Organization for Standardization Committee: Quality Management & Quality Assurance. Dr. Trevor Smith Chair ISO/TC 176
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Standards:Their value in today’s worldwith particular reference to the ISO9000 family Dr Trevor Smith Chair, ISO/TC 176 International Organization for Standardization Committee: Quality Management & Quality Assurance Trevor Smith; Sao Paulo, Aug 04
Dr. Trevor Smith Chair ISO/TC 176 Quality Management & Quality Assurance Worldwide Quality Director Global Manufacturing & Logistics Eastman Kodak Company Trevor Smith; Sao Paulo, Aug 04
Standards – why are they important? • Standards • Documented agreements, customer technical specifications or other precise criteria • To be used consistently as rules, guidelines, or definitions of characteristics • To ensure materials, products, processes or services are fit for their purpose • Standards promote a standard way of operating Trevor Smith; Sao Paulo, Aug 04
Standards – why are they important/relevant today? • Promote trade / global market • But harmonization of standards is critical. Lack of harmonization can in fact introduce technical barriers to trade • Applicable to a wide range of situations: • Multinational organizations to Small & Medium size enterprises (SME’s) • Important for Developing countries Trevor Smith; Sao Paulo, Aug 04
Very often the contribution of standards is invisible or we take it for granted… • Product Safety • Quality • Compatibility with equipment already in use • Reliability • Interchangeability of components • Etc. Trevor Smith; Sao Paulo, Aug 04
Some facts about ISO • NOT an acronym • From Greek “isos” meaning equal • “International Organization for Standardization”. A worldwide federation of national standards bodies (>140 countries) • www.iso.org • ISO Established in 1947 * • To facilitate international exchange of goods and services and to develop cooperation in the spheres of intellectual, scientific, technological and economic activity * infact international standardization began in the electrotechnical field (the IEC was established in 1906) Consensus Agreement is at the core of International Standardization Trevor Smith; Sao Paulo, Aug 04
ISO in figures(Year 2003) • Members • 148 national standards bodies • Technical Committees (for standards in management systems and product standards: engineering tools and materials, food products, gas turbines, photography, etc) • 2981 technical committees (30,000+ experts) • 188 TCs and 546 SCs • 2224 WGs and 23 Ad hoc study groups • Meetings • On average for every day of the year, 12 meetings are in progress • In 2003, meetings were held in 27 countries Trevor Smith; Sao Paulo, Aug 04
Types of standard • Product Standards • System Standards • They define how things should be done • Standards are now “givens” and are fundamental to many areas of our business and personal lives Trevor Smith; Sao Paulo, Aug 04
ISO in figures - continued • Management system certifications • Over 600,000 organizations (QMS & EMS) • 160 countries • Over 90% organizations transitioned from ISO9001:1994 to ISO9001:2000 • Note: certification = registration Accreditation is different … • Procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks (e.g. Laboratory accreditation) Trevor Smith; Sao Paulo, Aug 04
ISO and Management Systems Standards20 years of efforts • 1979: ISO/TC 176 formed • 1986: ISO 8402 published • 1987: ISO 9001-2-3-4 published 1993: ISO/TC 207 formed • 1994: minor revision of 9000 series 1996: ISO 14001 published • 2000: major revision of 9000 series Trevor Smith; Sao Paulo, Aug 04
Demonstrated benefits of Quality Management standards • Improve the quality of products & services • Improve organizational effectiveness • Reduce barriers to trade • Reduce proliferation of company specific quality requirements • Improve coordination between management systems • Reduce overall business costs • Improve communications • Process approach (ISO9000:2000) better aligned with current business approaches Trevor Smith; Sao Paulo, Aug 04
Technical Committee ISO/TC 176 • Responsible for the ISO 9000 family development of generic standards in the field of quality management and quality assurance; and • Advisory role with to other ISO technical committees with regard to quality management systems and principles [ ISO/TC 207 is the parallel committee responsible for the Environmental Management System standards (ISO14000 family) ] Trevor Smith; Sao Paulo, Aug 04
ISO/TC 176 committee • Membership: 131 • includes 95 country members 36 liaison members • TC Committes • SC1 Concepts and Terminology • SC2 Quality Systems • SC3 Supporting Technologies • Working Group (WG) on Interpretations Trevor Smith; Sao Paulo, Aug 04
The ISO9000 family Quality Management Systems ISO9000:2000 Fundamentals & vocabulary ISO9001:2000 QMS specification ISO9004:2000 Guidelines for continual improvement of QMS Quality Management/Environmental Management Systems Auditing ISO19011 common guidelines for quality and environmental auditing Trevor Smith; Sao Paulo, Aug 04
Other Quality Documents & Guidelines ISO/TS 16949:2002 sector guidance ISO9001 in automotive industry ISO 10005:1995* quality plans ISO 10006:2003 quality management in projects ISO 10007:2003 configuration management ISO 10012:2003 measurement/equipment ISO/TR 10013:2001 QMS documentation ISO/TR 10014:1998 economics of quality ISO 10015:1999 QM – Guidelines for training ISO/TR 10017:2003 statistical techniques for ISO9001:2000 ISO 10019* selection of QMS consultants ISO 10001* market based codes of conduct ISO 10002:2004 complaints handling ISO 10003* external dispute resolution handling * New product or revision in progress Trevor Smith; Sao Paulo, Aug 04
CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM Customer Customer Measurement, Management Satisfaction analysis and responsibility improvement Resource Output management Product realization Input Requirements Product Key: Value adding activities Information ISO9001:2000 Model of a process-based quality management system. Trevor Smith; Sao Paulo, Aug 04
PDCA Maintaining and continually improving the process capability can be achieved by applying the PDCA concept at all levels within the organization. Trevor Smith; Sao Paulo, Aug 04
Quality Management Principles • Customer focus • Leadership • Involvement of people • Process approach • System approach to management • Continual improvement • Factual approach to decision-making • Mutually beneficial supplier relationships Trevor Smith; Sao Paulo, Aug 04
Process approach • « From procedures to processes » • Identify processes needed for the QMS • Demonstrate the ability of processes to achieve planned results and monitor, measure, analyze and improve them • Develop information on characteristics and trends of processes • Top management to review process performance and improve effectiveness Trevor Smith; Sao Paulo, Aug 04
TC 176 – Strategic Plan “Horizon 2010” Mission : • Identify and understand the needs of society, users, and of their customers. • Develop, support and improve generic or sector QMS standards. • Safeguard the integrity of its standards in their use, including conformity assessment activities. • Minimize proliferation of QMS standards. • Contribute to the compatibility of management system standards (MSS). Trevor Smith; Sao Paulo, Aug 04
“Horizon 2010” Strategies and Intents : • Ensure market relevance for TC 176 products • Enhance compatibility of Management Systems Standards • Actively manage liaison relationships • Improve internal processes TC176 activity parallels the full ISO Central Secretariat visioning consultation & plan Trevor Smith; Sao Paulo, Aug 04
Issues of “Value” of standards… what do you think ?? • Time to market • Integrated systems • Alignment of wording between similar standards • Social systems • Broad range of participants in standard development • Others ? Trevor Smith; Sao Paulo, Aug 04
Time to Market • The RIGHT standards at the RIGHT time to the market • Value-added standards for stakeholders • Brief ISO9000 (ISO/TC 176) history • TC 176 “Horizon 2010” • Applying the ISO9000:2000 principles to internal committee processes Trevor Smith; Sao Paulo, Aug 04
TC 176 standards committee and the Process Approach The TC has started the implementation of the Process Approach for its own work, covering 6 key processes: • Maintain relevance of TC products • Identify needs and trends • Manage relationships • Manage resources • Develop products efficiently • Manage sector-specific issues Trevor Smith; Sao Paulo, Aug 04
Process Owners • Process implementation teams with Process Owners • Developing country involvement • Focus on the work before the organizational structure is altered • Measure, monitor, improve Trevor Smith; Sao Paulo, Aug 04
Roadmap to a customer focused standard • Importance of a Vision: • Vision 2000 (1994) • Horizon 2010 (2000) • Member body engagement • User surveys • Interpretations Process • Committee Structures to enable progress (adding value!) Trevor Smith; Sao Paulo, Aug 04
TC 176 – Interpretations Working Group • Purpose is to provide interpretations on ISO 9001 using ISO member body input • WGI Convenor and Secretariat – Brazil • Many requests have been processed by the WGI • Now an operational entity – results are posted on the TC 176 website Trevor Smith; Sao Paulo, Aug 04
Global relevance of ISO standards (all standards)“required characteristic of an International Standard that it can be used/implemented as broadly as possible by affected industries and other stakeholders in markets around the world” Alan Bryden ISO Secretary-General 2004 – Two very different examples • Printer Technology • (ISO/IEC 19752:2004) Information technology – method for the determination of toner cartridge yield for monochromatic electophotographic printers and multi-function devices that may contain printer components • Social Responsibility • ISO to develop and International Standard giving guidelines for the social responsibility of organizations Trevor Smith; Sao Paulo, Aug 04
ISO/TC 176 : Horizon 2010Key strategies (summary): • Improving internal processes • Process Approach to Standards development work • Ensuring market relevance of ISO/TC 176 products • Developing & improving TC 176 products • Enhancing compatibility of MSS (generic management system standards) • Be a resource for new standards development in area of management systems • Actively managing liaison relationships (interested party organizations and groups within and outside the ISO structure) Trevor Smith; Sao Paulo, Aug 04
The Future • Coordination with the development of management systems standards in the ISO community • Vision and revision cycle alignment with ISO14001 • Improve implementation tools • Manage issues related the credibility of the ISO 9001 standard and conformity assessment TC 176 annual plenary meeting in Kuala Lumpur, Malaysia November/December 2004 Trevor Smith; Sao Paulo, Aug 04
Obrigado ! trevor.smith@kodak.com Trevor Smith; Sao Paulo, Aug 04