Eng R. L. Nkumbwa-2010 Copperbelt University 1 ISO 9001 - 2008 Quality Management Systems

Eng R. L. Nkumbwa-2010 Copperbelt University1

ISO 9001 - 2008 Quality Management

Systems


Agenda

General Introduction

Quality Management Principles

Process Approach

Compatibility with Other Management Systems


Introduction

ISO recently released the latest revision: ISO 9001 – 2008.

This part of the training session will cover an introduction to the ISO standard, 2008.


Overview

ISO 9001:1994 was the last revision prior to the 2000 release and now we have the 2008 version.

The standard tells a company what they have to do, but not how to do it.


Advantages of Becoming ISO Certified (QMS) Our customers want it Reduce expenses/variability – Optimization of

costs and resources Lower costs and shorter cycle times through

effective use of resources Focused and prioritized improvement

opportunities Repeat business and referrals Performance advantage through improved

organizational capabilities


Vocabulary

ISO - International Organization for Standardization

QMS - Quality Management System

Supplier Organization Customer


CAPA – Corrective Action and Preventive Action

PMT – Process Management Team

Process – any activity or set of activities, that uses resources to transform inputs to outputs.


General

ISO 9000 describes fundamentals of a QMS.

ISO 9001 specifies the requirements for a QMS.

ISO 9004 provides guidelines to consider for the QMS.

ISO 19011 provides guidance for auditing QMS and Environmental Systems.


General (Cont’d) Adoption of a quality management system should be a

strategic decision of an organization.

The QMS requirements specified in the standard are complimentary to requirements for products.

This standard can be used by internal and external parties.

The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this standard.


Quality Management Principles

Eight quality management principles have been identified that can be used by top management to lead the organization towards improved performance.


Quality Management Principles (Cont’d)

Customer focus

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


Quality Management Principles (cont’d)

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.



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 organization’s benefit.



Process Approach

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



System approach to management

– Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives.



Continual Improvement

– Continual improvement of the organization’s overall performance should be a permanent objective of the organization.



Factual approach to decision making

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



Mutually beneficial supplier relationships

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


Process Approach

Determining the needs and expectations of customers and other interested parties

Establishing the quality policy and objectives of the organization

Determining the processes and responsibilities necessary to attain the quality objectives

Determining and providing the resources necessary to attain the quality objectives


Process Approach (Cont’d)

Establishing methods to measure the effectiveness and efficiency of each process

Applying these measures to determine the effectiveness and efficiency of each process

Determining means of preventing nonconformities and eliminating their causes

Establishing and applying a process for continual improvement of the quality management system


Model of a Process-based Quality Management System

ManagementResponsibility

ResourceManagement

Measurement,Analysis andImprovement

ProductRealization

Customers(and otherinterestedparties)

Requirements Product

Customers(and otherinterestedparties)

Satisfaction

Input Output

Continual Improvement ofthe quality management system

Key Value -added activities Information flow

NOTE: Statements in parentheses do notapply to ISO 9001


Compatibility With Other Management SystemsThis International Standard had been

aligned with ISO 14001: 2004 to enhance compatibility

Does not include requirements specific to other management systems, but enables organizations to integrate other systems (such as environmental, OHSA, or financial mgmt.)


Key Changes to the 2008 StandardCustomer Satisfaction must be measured

Outsourced processes– Must be able to demonstrate control over

process– Must be in quality manual and other public

documents


Key Changes to the 2008 Standard (Cont’d)Process Management

– PMT (Process Mgmt. Team) that meets regularly– Process map that shows steps and functions– Customer driven measures– Training and Communication Plan– Methods for monitoring and measuring– Methods for solving problems (CAPA)


Key Changes to the 2008 Standard (Cont’d) Structure of a QMS

– Communicate to rest of company– How much documentation is enough?

Customer Property – Must have process for controlling.

Internal Auditing – has changed, special training required.


Summary

ISO 9001 : 2008 is a process approach system.

This standard is aligned to work with other management systems.

Other processes (such as out sourcing) must be controlled.

Documents

Eng R. L. Nkumbwa-2010 Copperbelt University 1 ISO 9001 - 2008 Quality Management Systems