Introduction to ISO 9001:2008

So, What is Quality?

Quality is Fitness for purpose

What is ISO? (1/2)

Head Office situated in Geneva. Internationally Harmonized Standards are released by ISO. More than 200 countries have adopted ISO 9001 as their national standard.
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ISO 9000 family

ISO 9000:2005 Quality Management Systems Fundamental and Vocabulary ISO 9001:2008 Quality Management Systems Requirements

ISO 9004:2000 Quality Management

Systems Guidelines for Performance

What is ISO 9001?

ISO 9001:2008 is an International Standard for Quality Management System Requirements

Certifiable standard

Quality Management Principles

Mutual Beneficial Supplier Relationship Customer Focus

Leadership

Factual Approach to Decision Making

Involvement of People

Continual Improvement System Approach to Management

Process Approach

ISO 9001 : 2008 Process Model

Continual Improvement of the Quality Management System

5.Management Responsibility

Customer

Customer

Satisfaction

6. Resource Management

8. Measurement Analysis and Improvements

Requirements

7. Product Realization

Product / Service

Consumption

Four Pillars of a Quality Management System

Management Support Procedures Internal Audit Corrective Action

ISO 9001 : 2008 Clauses and Sub Clauses 5. MANAGEMENT RESPONSIBILITY

o 5.6 MANAGEMENT REVIEW The Top management should conduct meetings at regular interval and review the performance in various angle Audit results, Customer Feedback, Process Performance and so on The result of meeting should recommend action in improvement, resource need etc. 5.6.1 GENERAL 5.6.2 REVIEW INPUT Information on: results of audits, customer feedback, process performance and product conformity Status of preventive and corrective actions, follow up of actions from previous management reviews, changes that could affect the quality management system, and Recommendations for improvement. 5.6.3 REVIEW OUTPUT Actions related to: improvement of the effectiveness of the quality management system and its processes, improvement of product related to customer requirements, and resource needs.
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ISO 9001 : 2008 Clauses and Sub Clauses 6. RESOURCE MANAGEMENT

o 6.1 PROVISION OF RESOURCES Provide the resources needed to: Implement and maintain the quality management system and continually improve its effectiveness, and enhance customer satisfaction by meeting customer requirements

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What is a Process? (1/2)

Activity that transforms input into output

Control

Input

Activity
Resource

Output

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ISO 9001 : 2008 Clauses and Sub Clauses 8. MEASUREMENT, ANALYSIS AND IMPROVEMENT Procedure (Contd) Required
o 8.2.2 INTERNAL AUDIT
Organisation Should conduct internal audit At defined intervals Ensure unbiased audit Ensure effectiveness of the QMS Responsibility of Planning and Conducting Audit to be defined Corrective audit to the findings are to be taken without delay

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