ISO 9000: 2000

Orientation Training

April 2001

Qimpro Standards Organization

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Session Outline      Background  ISO 9000 : 1994  Need for revision Process model ISO 9000: 2000 concepts ISO 9001: 2000 requirements Implementation approach.

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Background

ISO 9000 : 1994          Quality assurance management system standard First version in 1987, revised in 1994 Internationally accepted Guidelines – 9000, 9004 Family of standards – 9001/2/3 20 clauses, generic in nature Certification agencies and accreditation boards Standardized work methods Implementation improves team work.

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Need for Revision  Need to address limitations of ISO 9000:1994  Documentation worshipped   Silo based approach glorified Reduction of chronic waste marginal   Customer neglected Company-wide involvement not achieved   Inadequate management commitment Inadequate attention to supplier partnership.

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Need for Revision (Contd.)  Continual improvement  Customer satisfaction  Management with total quality principles  Work environment  User friendly documents.

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Revision Summary         Process model – faster, better, cheaper Customer satisfaction addressed Continual improvement essential Human resources enhanced Service industry friendly ISO 9004 : 2000 improved Compatible with ISO 14001: 1996 ISO 9002/3 abolished.

April 2001 www.qimpro.com

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Process Model

April 2001 Process Model

QUALITY MANAGEMENT SYSTEM CONTINUAL IMPROVEMENT Management responsibility Resource management Input Measurement, analysis, improvement Product and service realization QUALITY MANAGEMENT SYSTEM Output

Product/ Service www.qimpro.com

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ISO 9000: 2000 Concepts

8 Basic Principles         Customer focus Leadership Involvement of people Process approach System approach to management Continual improvement Factual approach to decision making Mutually beneficial supplier relationships. April 2001 www.qimpro.com

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Basic Principles (Contd.)  

Customer focus

Organizations depend on their customers, and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations.

Leadership

Leaders establish unity of purpose, direction and the internal environment of the organization. They create the environment in which, people can become fully involved in achieving the organization's objectives.

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Basic Principles (Contd.)    Involvement of people People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organizations’ benefit.

Process approach A desired result is achieved more efficiently when related resources and activities are managed as a process.

System approach to management Identifying, understanding and managing a system of interrelated processes for a given objective contributes to the effectiveness and efficiency of the organization.

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Basic Principles (Contd.)    Continual improvement A permanent objective of the organization is continual improvement.

Factual approach to decision making Effective decisions are based on the logical or intuitive analysis of data and information.

Mutually beneficial supplier relationships The ability of the organization and its suppliers to create value is enhanced by mutually beneficial relationships. April 2001 www.qimpro.com

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New Requirements          Continual improvement Increased emphasis on the role of top management Legal and regulatory requirements Establishment of measurable objectives Monitoring customer satisfaction Increased attention to resource management Determination of training effectiveness Measurements for system, processes, and product Analysis of collected data. April 2001 www.qimpro.com

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Revised Structure  Quality management system (2 elements)  Management responsibility (6 elements)  Resource management (4 elements)  Product realization (6 elements)  Measurement, analysis, and improvement (5 elements).

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ISO 9000: 2000 Requirements

4. Quality Management System 4.1 General requirements 4.2 Documentation requirements 4.2.1 General 4.2.2 Quality manual 4.2.3 Control of documents 4.2.4 Control of records.

Only six documents essential.

April 2001 www.qimpro.com

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5. Management Responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning 5.5 Responsibility, authority and communication 5.6 Management review.

Seek and provide feedback Change authorization and initiation of improvement Continually meet customer needs Quality objectives for each function or process.

April 2001 www.qimpro.com

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6. Resource Management 6.1 Provision of resources 6.2 Human resources 6.3 Infrastructure 6.4 Work environment.

Determine and deploy resources Human, facilities, equipment, etc.

Resources to implement quality system.

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7. Product Realization 7.1 Planning of product realization 7.2 Customer-related processes 7.3 Design and development 7.4 Purchasing 7.5 Production and service provision 7.6 Control of monitoring and measuring devices.

Customer related processes Design , purchasing, production, and service Receipt to delivery processes.

April 2001 www.qimpro.com

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8. Measurement, Analysis and Improvement 8.1 General 8.2 Monitoring and measurement 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement.

Measure and analyze results Internal audit, nonconformity control Continual improvement Process/product/service conformity Data initiates action for continual improvement.

April 2001 www.qimpro.com

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ISO 9000: 2000 Family 

Applicable



9000, 9001, 9004 .



Withdrawn



8402, 9002, 9003.

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Registration/Certification 

Permissible exclusions on line with QS 9000



Three year transition



Early transition recommended.

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Implementation Approach

Approach           Senior management interaction Baseline assessment Gap analysis and action plan Senior management training Orientation and awareness training Change process – document and implement Internal auditor training Audits Reviews and improvements Certification.

April 2001 www.qimpro.com

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Senior Management Interaction     Understand requirements Seek and gain management support Explain budgetary estimates 1 to 2 days – pre proposal stage.

April 2001 www.qimpro.com

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Baseline Assessment        Detailed assessment of systems Interview with key personnel Assessment of existing efforts Assessment of training needs (ISO related) Core team formation Management representative 2 to 3 days - post contract.

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Gap Analysis and Action Plan          Adequacy analysis based on ISO 9000 : 2000 Review by expert panel at Qimpro Initial recommendation report Time frame estimation Revision of time and budgetary estimates Action plan – draft and final Responsibility – RACI Resources 3 days.

April 2001 www.qimpro.com

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Senior Management Training          ISO 9000 : 2000 basics Senior management role Review mechanism Role as auditor Project management roles Role as trainer Publicity responsibility Seek commitment as auditor, trainer, and coach 1 day.

April 2001 www.qimpro.com

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Orientation and Awareness       Company-wide training Train the trainer concept Course material copyrights Material developed internationally (QCI, DHI…) Detailed input on ISO 9000 : 2000 2 days per batch.

April 2001 www.qimpro.com

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Change Process        Visits – facilitation and guidance Guidance on documentation Hands-on help on implementation Continued training sessions Project review with management representative Review with senior management eGuidance .

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Internal Auditor Training         Quality Council of Indiana and David Hutchins In-house program ISO 9000 : 2000 interpretations Auditing skills Report writing skills Review skills Behavioral skills/ interdependent paradigm 3 days per batch.

April 2001 www.qimpro.com

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Audits       Qimpro team to facilitate audits Audit simulation Operational and skill support Areas for improvement Reports Pre-certification audit.

April 2001 www.qimpro.com

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Review and Improvement        Review by core team Review by senior management Identify improvement actions Assign responsibility – RACI Review and record improvement Positive constructive involvement eGuidance.

April 2001 www.qimpro.com

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Certification        Shortlist agencies Select agency Submit documents Seek results of desk/adequacy audit Confirm audit dates Audit Recommendation for certification.

April 2001 www.qimpro.com

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Time Scales        Don’t rush it!

Change takes time 4-6 months is expected Include slack in project schedule Review vigorously Demonstrate sincerity Be involved!

April 2001 www.qimpro.com

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Qimpro

Qimpro  Established in 1987 by Suresh Lulla April 2001 www.qimpro.com

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Qimpro Specialization

Input

World Class Management Infrastructure for WCM Process Management for WCM Customer Focus for WCM Systems for WCM Tools for WCM Professionals for WCM

April 2001 www.qimpro.com

Model

IMC - RBNQA IQRS QC 3 Valency ISO 9000 : 2000 QMC Tool Box ASQ Certification

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Qimpro Principals / Partners        Indian Merchants’ Chambers, Mumbai Det Norske Veritas, Norway ORG-MARG, Mumbai Dhi, UK GOAL/QPC, USA QCI, USA Aptech, Mumbai.

April 2001 www.qimpro.com

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Qimpro Reach  Sectors Serviced  Manufacturing  Service  IT.

 Geographical Coverage  India  Thailand, Malaysia, Singapore  Pakistan, Oman, Kenya.

April 2001 www.qimpro.com

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Qimpro Benefits

Cumulative Savings

Rs 4000 Crores in terms of COPQ

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www.qimpro.com

        Knowledge Park Qimpro Quarterly Online eXpert eView Quality Dictionary Quality Headlines Careers Global Events Calendar Quality Newsletter.

April 2001 www.qimpro.com

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Online Education ISO 9000 : 2000     Qimpro College on www.OnlineVarsity.com

Forthcoming courses developed by Qimpro  Free orientation tour   4 hours awareness 16 hours implementation  24 hours auditing skills Opportunity to train in volumes Affordable and convenient.

April 2001 www.qimpro.com

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Qimpro Advantage          Consulting and eConsulting Auditing Training and eTraining 500 man-years of professional experience International authorities as sources of know-how Collaboration with specialists in India Conventions Awards www.qimpro.com.

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Thank You

www.qimpro.com [email protected]