Iso

JIYO
EJ DIPLOMA 2ND BATCH
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
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
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.
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
* in fact international standardization began in the electro technical field (the IEC was established in 1906)
Consensus Agreement is at the core of International Standardization

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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 12
Meetings

On average for every day of the year, meetings are in progress In 2003, meetings were held in 27 countries
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
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)
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

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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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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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Membership:
131
includes 95 country members 36 liaison members
TC

Committees
SC1 Concepts and Terminology SC2 Quality Systems SC3 Supporting Technologies Working Group (WG) on Interpretations
12
The ISO9000 family Quality Management Systems

ISO9000:2000 ISO9001:2000 ISO9004:2000 QMS Fundamentals & vocabulary QMS specification Guidelines for continual improvement of
Quality Management/Environmental Management Systems Auditing

ISO19011 common guidelines for quality and environmental auditing
13
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* 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
ISO 10001*
ISO 10002:2004 ISO 10003*
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.
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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
17
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 OFPROCESS PROCESS== Ability Abilityto toachieve achieve desired desiredresults results (Focus of (Focus ofISO ISO 9001:2000) 9001:2000)
Input
(Includes Resources)
PROCESS
(Set of interrelated or interacting activities)
Output
PRODUCT
(Result of a process)
EFFICIENCY EFFICIENCYOF OF PROCESS = PROCESS = Results Resultsachieved achieved vs vsresources resourcesused used (Focus (Focusof ofISO 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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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).
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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 ?
22
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
23
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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Trevor Smith; Sao Paulo, Aug 04
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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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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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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 ISO to develop and International Standard giving guidelines for the social responsibility of organizations
Social Responsibility
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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)
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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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THANK YOU
32

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JIYO

EJ DIPLOMA 2ND BATCH

promote a standard way of operating

trade / global market

to a wide range of situations:

often the contribution of standards is invisible or we take it for granted

Consensus Agreement is at the core of International Standardization

148 national standards bodies

Committees (for standards in management systems

2981 technical committees (30,000+ experts)

Standards System Standards

1993: ISO/TC 207 formed

1994: minor revision of 9000 series

2000: major revision of 9000 series

includes 95 country members 36 liaison members

The ISO9000 family Quality Management Systems

Quality Management/Environmental Management Systems Auditing

Other Quality Documents & Guidelines

market based codes of conduct

From procedures to processes

Identify processes needed for the QMS

MONITORING AND MEASUREMENT OPPORTUNITIES

Strategies and Intents :

Improve internal processes

of Value of standards what do you think ??

Applying the ISO9000:2000 principles to internal committee processes

Trevor Smith; Sao Paulo, Aug 04

implementation teams with Process

Measure, monitor, improve

Vision 2000 (1994) Horizon 2010 (2000)

TC 176 Interpretations Working Group

2004 Two very different examples

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