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Document: ISO/TC 176/SC 2/N 544R2(r)
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Secretariat of ISO/TC 176/SC 2 Date: 13 May 2004

ISO 9000 Introduction and Support Package:
Guidance on the Concept and Use of the Process Approach for management systems

In conjunction with the publication of the International Standards ISO 9001:2000 and
ISO 9004:2000, ISO/TC 176/SC 2 haspublished a number of guidance modules:

N524 – Guidance on ISO 9001:2000 clause 1.2 'Application'
N525 – Guidance on the Documentation requirements of ISO 9001:2000
N526 – Guidance on the Terminology used in ISO 9001:2000 and ISO 9004:2000 _1)
N544 – Guidance on the Concept and Use of the Process Approach for management
systems
N630 – Guidance on 'Outsourced Processes'

(1) This modulewas developed jointly with ISO/TC 176/SC1/WG2. ISO/TC 176/SC1 was responsible for the development of ISO 9000:2000 Quality management systems - Fundamentals and vocabulary)

Together these are being made available as the ISO/TC 176/SC 2 'ISO 9000 Introduction and Support Package.

Feedback from users of the standards will be used to determine whether additional modules should be developed, orif these published modules should be revised.

The modules, and further information on the year 2000 ISO 9000 standards, may be downloaded from the following web sites:

www.iso.org
http://www.bsi.org.uk/iso-tc176-sc2

C Corrie
for BSI Secretariat
ISO/TC 176/SC 2

1) Introduction

Key words: management system, process approach, systemapproach to management

Content

1. Introduction 2
2. What is a process? 3
3. Types of processes 3
4. Understanding the process approach 4
5. Implementing the process approach 6
5.1 Identification of processes of the organization (system approach to management) 6
5.2 Planning of the process 8
5.3 Implementation and measurement of the process 10
5.4 Analysis of the process 105.5. Corrective action and improvement of the process 10

1. Introduction

This guidance document provides an understanding of the concepts, intent and the application of the “process approach” to the ISO 9000 family of Quality Management System standards. The guidance may also be used to apply the process approach to any management system regardless of the type or the size of organization. Thisincludes but is not limited to management systems for:

- Environment (ISO 14000 family),
- Occupational Health and Safety,
- Business Risk,
- Social Responsibilities.

This guide also aims to promote a consistent approach to the description of processes and use of process related terminology.

The purpose of the process approach is to enhance an organization’seffectiveness and efficiency in achieving its defined objectives.

Benefits of the process approach are:
• Integration and alignment of processes to enable achievement of planned results.
• Ability to focus effort on process effectiveness and efficiency.
• Provision of confidence to customers, and other interested parties, about the consistent performance of the organization.
•Transparency of operations within the organization.
• Lower costs and shorter cycle times, through the effective use of resources.
• Improved, consistent and predictable results.
• Provision of opportunities for focused and prioritized improvement initiatives.
• Encouragement of the involvement of people and the clarification of their responsibilities.

2. What is a process?

A“Process” can be defined as a “Set of interrelated or interacting activities, which transforms inputs into outputs”. These activities require allocation of resources such as people and materials. Figure 1 shows the generic process.

A major advantage of the process approach, when compared to other approaches, is in the management and control of the interactions between these processes and the...