ISO 9001 2008

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(Customer’s perception of the degree to which the customer’s

requirements have been fulfilled)

Capability(Ability of an organization,

system or process to realize a product that will

fulfill the requirementsfor that product)

Quality(Degree to which a set of inherent 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 Management System(Management system to direct

and control an organization withregard to quality)

Quality Planning

Quality Assurance

Quality Control

Quality Improvement

International Organization for Standardization

TechnicalCommittee

TechnicalCommittee

ISO

NationalBodies

NationalBodies

Committees

Trade Orgs

Stds Orgs

ANSI

176 (Quality)

ASQ

Auto

Z1

User

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.


1. Customer Focused Organization2. Leadership3. Involvement of people4. Process Approach5. Systems Approach to Management6. Continual Improvement7. Factual approach to decision making8. Mutually beneficial supplier relationships


Beneficial applications of

Quality Management Principles

For Policy and Strategy formulationFor Goal and Target settingFor Operational ManagementFor 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 (Cont’d)

• APPLICATIONAssure 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 (cont’d)

• APPLICATIONSet 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.

People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.

Principle 3: Involvement of peoplePrinciple 3: Involvement of people

• APPLICATIONEstablish competency levels, train &

qualify personnel. Provide clear authority and responsibility

Create personal ownership of an organization's targets & goals by using it’s peoples knowledge and experience and through training achieve involvement in operational decisions and process improvement.

Principle 3: Involvement of peoplePrinciple 3: Involvement of people (Cont’d)

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 (Cont’d)

• APPLICATIONEstablish, 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 organization’s effectiveness and efficiency.

Principle 5: Systems Approach to Management (Cont’d)

• APPLICATIONEstablish and maintain suitable and effective

documented Quality SystemIdentify 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 (cont’d)

• APPLICATIONThrough 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 (cont’d)

• 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 (cont’d)

• 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


• 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


• 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 non-

conformity.


• 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


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


5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION

5.5.1 RESPONSIBILITY AND AUTHORITY5.5.2 MANAGEMENT REPRESENTATIVE 5.5.3 INTERNAL COMMUNICATION

5.6 MANAGEMENT REVIEW

5.6.1 GENERAL5.6.2 REVIEW INPUT

5.6.3 REVIEW OUTPUT


6. RESOURCE MANAGEMENT6.1. PROVISION OF RESOURCES6.2. HUMAN RESOURCES

6.2.1 GENERAL6.2.2 COMPETENCE , AWARENESS AND TRAINING

6.3 INFRASTRUCTURE6.4 WORK ENVIRONMENT


7 PRODUCT REALIZATION

7.1 PLANNING OF PRODUCT REALIZATION7.2 CUSTOMER RELATED PROCESSES7.2.1 DETERMINATION OF REQUIREMENTS RELATED TO PRODUCT7.2.2 REVIEW OF REQUIREMENTS RELATED TO PRODUCT7.2.3 CUSTOMER COMMUNICATION


7.3 DESIGN AND DEVELOPMENT 7.3.1 DESIGN AND DEVELOPMENT

PLANNING7.3.2 DESIGN AND DEVELOPMENT INPUTS7.3.3 DESIGN AND DEVELOPMENT OUTPUTS7.3.4 DESIGN AND DEVELOPMENT REVIEW7.3.5 DESIGN AND DEVELOPMENT VERIFICATION7.3.6 DESIGN AND DEVELOPMENT VALIDATION7.3.7 CONTROL OF DESIGN AND DEVELOPMENT CHANGES


7.4 PURCHASING 7.4.1 PURCHASING PROCESS

7.4.2 PURCHASING INFORMATION7.4.3 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 TRACEABILITY7.5.4 CUSTOMER PROPERTY7.5.5 PRESERVATION OF PRODUCT

7.6 CONTROL OF MONITORING AND MEASURING DEVICES


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


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 90011994

Internal auditEffectiveness assessed in audit report

Management review

ISO 90012000

Customer satisfaction

Management determines

effectiveness by analyzing all

available data and information

Management review

Internal audit

Other data

Third party registration

Registrar Accreditation Board

Registrar

Company

Course ProvidersAuditors

Customers

hire

assess

certifyaccredit accredit

train

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 (cont’d)

• 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

Competitive

Advantage

Efficient

Quality Management System

Effective

Quality Management System

Business Vision

Performance Excellence

SEI-CMMi

Performance Improvement

ISO 9004:2000

Baseline Performance:

ISO 9001:2000

Conclusion

• Success depends on building two capabilities• Capability in winning orders

• Capability in delivering what is required on time at a competitive price consistently

ISO 9001-2000 Awareness Training

54

Thank You

Documents

ISO 9001 2008