Standards: Their value in todays world

with 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 3

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 (SMEs) Important for Developing countries
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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

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ISO in figures
Members
Technical Committees

(Year 2003)

148 national standards bodies

(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
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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
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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 Standards 20 years of efforts 1979: ISO/TC 176 formed
1986: ISO 8402 published 1987: ISO 9001-2-3-4 published

1994: minor revision of 9000 series

1996: ISO 14001 published

1993: ISO/TC 207 formed

2000: major revision of 9000 series

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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
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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) ]

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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
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The ISO9000 family Quality Management Systems

ISO9000:2000 ISO9001:2000 ISO9004:2000

Fundamentals & vocabulary QMS specification Guidelines for continual improvement of QMS

Quality Management/Environmental Management Systems Auditing

ISO19011

common guidelines for quality and environmental auditing

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Other Quality Documents & Guidelines

ISO/TS 16949:2002 ISO 10005:1995* ISO 10006:2003 ISO 10007:2003 ISO 10012:2003 ISO/TR 10013:2001 ISO/TR 10014:1998 ISO 10015:1999 ISO/TR 10017:2003 ISO 10019* ISO 10001* ISO 10002:2004 ISO 10003*
* New product or revision in progress

sector guidance ISO9001 in automotive industry quality plans quality management in projects configuration management measurement/equipment QMS documentation economics of quality QM Guidelines for training statistical techniques for ISO9001:2000 selection of QMS consultants market based codes of conduct complaints handling external dispute resolution handling

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ISO9001:2000
Model of a process-based quality management system.
CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM

Management responsibility

Customer

Customer
Resource management Measurement, analysis and improvement
Satisfaction

Requirements

Input

Product realization

Output

Product

Key:
Value adding activities Information

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PDCA
Act
How to improve next time?

Plan
What to do? How to do it?

Check
Did things happen according to plan?

Do
Do what was planned

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 17

Quality Management Principles

1. 2. 3. 4. 5. 6. 7. 8. Customer focus Leadership Involvement of people Process approach System approach to management Continual improvement Factual approach to decision-making Mutually beneficial supplier relationships
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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
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PROCEDURE*
(Specified way to carry out an activity or a process - may be documented or not)

EFFECTIVENESS EFFECTIVENESS OF PROCESS == OF PROCESS Ability to achieve Ability to achieve desired results desired results (Focus of ISO (Focus of ISO 9001:2000) 9001:2000)

Input
(Includes Resources)

PROCESS
(Set of interrelated or interacting activities)

Output

PRODUCT
(Result of a process)
EFFICIENCY OF EFFICIENCY OF PROCESS == PROCESS Results achieved Results achieved vs resources used vs resources used (Focus of ISO (Focus of ISO 9004:2000) 9004:2000)

MONITORING AND MEASUREMENT OPPORTUNITIES

(Before, during and after the process)
* Note This is the definition of procedure given in ISO 9000:2000. This does not necessarily mean one of the 6 documented procedures required by ISO 9001:2000

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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 21

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
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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 ?

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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
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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
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Process Owners
Process implementation teams with Process Owners Developing country involvement Focus on the work before the organizational structure is altered
Measure, monitor, improve

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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!)
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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

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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 30

ISO/TC 176 : Horizon 2010

Key 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 31

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
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Obrigado !

trevor.smith@kodak.com

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