ISO 9001:2000 Awareness Training

Objectives of an organization
Customer Satisfaction - identify and meet the needs and expectations Achieve competitive advantage. Effective and efficient operations. Achieve, maintain and improve overall organizational capabilities.

Concepts related to Quality

Customer Satisfaction
(Customers perception of the degree to which the customers requirements have been fulfilled)

Quality
(Degree to which a set of inherent

Capability
(Ability of an organization, system or process to realize a product that will fulfill the requirements for that product)

characteristics fulfils requirements)

Requirement
(Stated, implied or obligatory)

Concepts related quality management

Quality Management
(Coordinated activities to direct and control an organization with regard to quality)

Quality Planning Quality Management System

(Management system to direct and control an organization with regard to quality)

Quality Assurance Quality Control Quality Improvement

International Organization for Standardization

National Bodies
ANSI

176 (Quality)

Technical Committee

National Bodies
Z1 Auto

ISO
Technical Committee User
ASQ

Committees

Trade Orgs

Stds Orgs

Quality management principles

A quality management principle is a comprehensive and fundamental rule or belief, for leading and operating an organization, aimed at continually improving performance over the long term by focusing on customers while addressing the needs of all other stakeholders.

Quality management principles

1. Customer Focused Organization 2. Leadership 3. Involvement of people 4. Process Approach 5. Systems Approach to Management 6. Continual Improvement 7. Factual approach to decision making 8. Mutually beneficial supplier relationships

Quality management principles

Beneficial applications of Quality Management Principles

For Policy and Strategy formulation For Goal and Target setting For Operational Management For Human Resource Management

Principle 1: Customer-Focused Organization

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

Principle 1: Customer-Focused Organization (Contd)

APPLICATION
Assure conformance to defined customer requirements Understand current and future customer needs and expectations. Measure customer satisfaction & dissatisfaction and act on it

Principle 2: Leadership
Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives.

Principle 2: Leadership (contd)

APPLICATION Set policy and verifiable objectives, deploy policy, provide resources and establish an environment for Quality Establish vision, direction and shared values. Set challenging targets & goals and implement strategies to implement them. Coach, facilitate and empower people.

Principle 3: 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.

Principle 3: Involvement of people (Contd) APPLICATION

Establish competency levels, train & qualify personnel. Provide clear authority and responsibility
Create personal ownership of an organization's targets & goals by using its peoples knowledge and experience and through training achieve involvement in operational decisions and process improvement.

Principle 4 : Process Approach

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

Principle 4 : Process Approach (Contd)

APPLICATION
Establish, control and maintain documented processes

Explicitly identify internal/external customers and suppliers of processes. Focus on the use of resources in process activities, leading to effective use of people, equipment, methods and materials.

Principle 5: Systems Approach to Management

...

Identifying, understanding and managing a system of interrelated processes for a given objective improves the organizations effectiveness and efficiency.

Principle 5: Systems Approach to Management (Contd)

APPLICATION Establish and maintain suitable and effective documented Quality System Identify a set of processes in a system. Understand their inter-dependencies. Align the processes with the organization's goals and targets. Measure results against key objectives.

Principle 6 : Continual improvement

Continual improvement should be a permanent objective of the organization.

Principle 6 : Continual improvement (contd)

APPLICATION Through management review, internal/external audits and corrective/preventive actions, continually improve effectiveness of the quality system Set realistic and challenging improvement goals, provide resources and give people the tools, opportunities and encouragement to contribute to the continual improvement of the processes

Principle 7 : Factual approach to decision making

Effective decisions are based on the analysis of data and information.

Principle 7 : Factual approach to decision making (contd)

APPLICATION Management decisions & actions on the Quality System are based on the analysis of the factual data and information from reports on audits, corrective action, nonconforming product, customer complaints and other resources Decisions and actions are based on the analysis of data and information to maximize productivity and to minimize waste and rework. Effort is placed on minimizing cost, improving performance and market share through the use of suitable management tools and technology

Principle 8: Mutually beneficial supplier relationships

An organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value.

Principle 8: Mutually beneficial supplier relationships (contd)

APPLICATION Adequately define and document requirements to be met by sub-contractors. Review and evaluate their performance to control the supply of quality products and services Establish strategic alliances or partnerships, ensuring early involvement and participation in defining requirements for joint development and improvement of products, processes and systems. Develop mutual trust, respect & commitment to customer satisfaction and continual improvement

ISO 9001:2000 Requirements

ISO 9001:2000 Approach and structure

Business-oriented Process Approach Easier to understand requirements Increased emphasis on customer satisfaction and continuous improvements

Compatibility with EMS and other management systems

ISO 9000: 2000 Family of standards

The year 2000 version of this series comprises of only three standards. ISO 9000: 2000 Quality management systems - Fundamentals and vocabulary. ISO 9001: 2000 Quality management systems - Requirements. ISO 9004: 2000 Quality management systems - Guidelines for performance improvements ISO 10011 is the auditing standard and work is on to develop a common standard for use by both QMS and EMS auditors.

ISO 9000: 2000 Definitions

Quality: Degree to which a set of inherent characteristics fulfills requirements. Requirement - need or expectation that is stated, generally implied or obligatory. Quality Policy: Overall intentions and direction of an organisation related to quality as formally expressed by the top management Quality Objective: Something sought or aimed for, related to quality

ISO 9000: 2000 Definitions (contd)

Quality Management: Coordinated activities to direct and control an organisation with regard to quality Quality Planning: Part of quality management focused on setting quality objectives and specifying necessary operational processes and related resources to fulfill the quality objectives

ISO 9000: 2000 Definitions (contd)

Quality Control: Part of quality management focused on fulfilling quality requirements. Quality Assurance: Part of quality management focused on providing confidence that quality requirements are fulfilled Quality Improvement: Part of quality management focused on increasing ability to fulfill quality requirements

ISO 9000: 2000 Definitions (contd)

Non conformity Non fulfillment of a requirement Defect: Non fulfillment of a requirement related to an intended or specified use. Correction: Action taken to eliminate a detected nonconformity.

ISO 9000: 2000 Definitions (contd)

Corrective action: Action taken to eliminate the cause of a detected non-conformity or other undesirable situation. Preventive action: Action taken to eliminate the cause of a potential non-conformity or other undesirable potential situation.

ISO 9000: 2000 Definitions (contd)

Quality Manual: Document specifying the Quality Management System of an organization. Document: Information and its supporting medium
Record: Document stating the results achieved or providing evidence of activities performed.

ISO 9001: 2000

Quality management system-requirements
1. SCOPE 1.1 GENERAL 1.2 APPLICATION

2. NORMATIVE REFERENCE
3. TERMS AND DEFINITIONS 4. QUALITY MANAGEMENT SYSTEM 4.1 GENERAL REQUIREMENTS

4.2 DOCUMENTATION REQUIREMENTS

ISO 9001: 2000 Quality management system-requirements

4.2 DOCUMENTATION REQUIREMENTS 4.2.1 GENERAL 4.2.2 QUALITY MANAUAL 4.2.3 CONTROL OF DOCUMENTS 4.2.4 CONTROL OF RECORDS

ISO 9001: 2000 Quality management system-requirements

5. MANAGEMENT RESPONSIBILTY
5.1 MANAGEMENT COMMITMENT

5.2 CUSTOMER FOCUS

5.3 QUALIY POLICY

5.4 PLANNING 5.4.1 QUALITY OBJECTIVES 5.4.2 QUALITY MANAGEMENT SYSTEM PLANNING

ISO 9001: 2000 Quality management system-requirements

5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION 5.5.1 RESPONSIBILITY AND AUTHORITY 5.5.2 MANAGEMENT REPRESENTATIVE 5.5.3 INTERNAL COMMUNICATION
5.6 MANAGEMENT REVIEW

5.6.1 GENERAL 5.6.2 REVIEW INPUT 5.6.3 REVIEW OUTPUT

ISO 9001: 2000 Quality management system-requirements

6. RESOURCE MANAGEMENT 6.1. PROVISION OF RESOURCES 6.2. HUMAN RESOURCES 6.2.1 GENERAL 6.2.2 COMPETENCE , AWARENESS AND TRAINING 6.3 INFRASTRUCTURE 6.4 WORK ENVIRONMENT

ISO 9001: 2000 Quality management system-requirements

7 PRODUCT REALIZATION 7.1 PLANNING OF PRODUCT REALIZATION 7.2 CUSTOMER RELATED PROCESSES 7.2.1 DETERMINATION OF REQUIREMENTS RELATED TO PRODUCT 7.2.2 REVIEW OF REQUIREMENTS RELATED TO PRODUCT 7.2.3 CUSTOMER COMMUNICATION

ISO 9001: 2000 Quality management system-requirements

7.3 DESIGN AND DEVELOPMENT

7.3.1 DESIGN AND DEVELOPMENT PLANNING
7.3.2 7.3.3 7.3.4 7.3.5 7.3.6 7.3.7 DESIGN AND DEVELOPMENT INPUTS DESIGN AND DEVELOPMENT OUTPUTS DESIGN AND DEVELOPMENT REVIEW DESIGN AND DEVELOPMENT VERIFICATION DESIGN AND DEVELOPMENT VALIDATION CONTROL OF DESIGN AND DEVELOPMENT CHANGES

ISO 9001: 2000 Quality management system-requirements

7.4 PURCHASING 7.4.1 PURCHASING PROCESS 7.4.2 PURCHASING INFORMATION 7.4.3 VERIFICATION OF PURCHASED PRODUCT 7.5 PRODUCTION AND SERVICE PROVISION 7.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION 7.5.2 VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION 7.5.3 IDENTIFICATION AND TRACEABILITY 7.5.4 CUSTOMER PROPERTY 7.5.5 PRESERVATION OF PRODUCT 7.6 CONTROL OF MONITORING AND MEASURING DEVICES

ISO 9001: 2000

Quality management system-requirements

8. MEASUREMENT, ANALYSIS & IMPROVEMENT
8.1 GENERAL 8.2 MONITORING AND MEASUREMENT 8.2.1 CUSTOMER SATISFACTION 8.2.2 INTERNAL AUDIT 8.2.3 MONITORING & MEASUREMENT OF PROCESSES 8.2.4 MONITORING & MEASUREMENT OF PRODUCT

ISO 9001: 2000

Quality management system-requirements
8.3 CONTROL OF NONCONFORMING PRODUCT 8.4 ANALYSIS OF DATA 8.5 IMPROVEMENT 8.5.1 CONTINUAL IMPROVEMENT

8.5.2 CORRECTIVE ACTION

8.5.3 PREVENTIVE ACTION

ISO 9001:2000 Certification

Actions towards ISO 9001 certification

Appointment of Management Representative Define quality policy and quality objectives Training in the ISO 9001: 2000 standard Preparation of quality system documentation Training on documentation

Actions towards ISO 9001 certification (contd)

Implementation in all projects and products Train internal quality auditors Conduct internal quality audits Management review of the QMS Identification of certification agency Certification audits

Documentation

Quality Manual Key Process documents Support Process documents Quality System Procedures Guidelines/templates Quality record formats

The Role of Internal audits

ISO 9001 1994 Effectiveness assessed in audit report Management review

Internal audit

Internal audit ISO 9001 2000 Customer satisfaction Other data

Management determines effectiveness by analyzing all available data and information

Management review

Third party registration

Registrar Accreditation Board
accredit hire certify accredit

Registrar

Auditors Company Customers

assess

train

Course Providers

Benefits of ISO 9001 certification

Process orientation towards building quality Design and development on a life cycle approach Defect prevention Project management and monitoring Management review of the system Delivery schedules and project costs under control

Benefits of ISO 9001 certification (contd)

Design and change control Document control Control on sub contract work Customer satisfaction Continuous improvement Better work culture Marketing advantage

ISO 9000:2000 is the foundation for Performance Excellence

Business Vision Competitive Performance Excellence SEI-CMMi Efficient Performance Improvement ISO 9004:2000 Effective Baseline Performance: ISO 9001:2000 Quality Management System Quality Management System Advantage

Conclusion
Success depends on building two capabilities Capability in winning orders Capability in delivering what is required on time at a competitive price consistently

Thank You
ISO 9001-2000 Awareness Training 54