ISO 9001:2008 QUALITY MANAGEMENT SYSTEMS

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 organizations objectives.
Direction setting Strategic focus Planning, alignment & empowerment Communication Change factor

CUSTOMER FOCUS

Organization depend on their

customers and therefore should understand current and future customer needs and should meet customer requirements and strive to exceed customer expectation.
Meeting Customer Requirements Product & Service Requirements Customer Communication Customer Satisfaction Control of Non-Conforming product and/or service

PROCESS APPROACH

A desired result is achieved more

efficiently when activities and related resources are managed as a process.

Input and output requirements (e.g. specification and resources). Activities within the processes, Verification and validation activities for processes and products, Analysis of process capability Determines the processes needed and their application throughout the organization, Determine the sequence and interactions of these processes

SYSTEM APPROACH

Identifying, understanding and managing

interrelated processes as a system contribute to the organizations effectiveness and efficiency in achieving its objectives.
The processes needed for QMS and their application throughout the organization The sequence and interaction of these processes The criteria and methods needed to ensure effective operation and control of these processes The resources, including information, necessary to support the operation and to monitor the processes

FACTUAL APPROACH

Effective decisions are based on

the analysis of data and information.

Management Review Quality Objectives Use of data analysis Monitoring and measurement of production Maintaining and improving QMS

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.
Top to bottom communication Responsibility and authority Training Empowerment

CONTINUAL IMPROVEMENT

Continual Improvement of the organizations overall performance should be permanent objective of the organization Corrective actions taken to eliminate causes of nonconformity Prevention action taken to eliminate the causes of potential nonconformity. The opportunities for continually improving QMS can be identified through the use of the quality policy, quality objectives, audit results, analysis of data and management review.

SUPPLIER RELATIONSHIP

An organization and its suppliers are

interdependent and a mutually beneficial relationship enhances the ability of both to create value.
Supplier evaluation Supplier re-evaluation Outsourcing Information Requirements Improvement Opportunities