ISO 9001 - Understanding ISO 9001 Requirements

                     Understanding ISO 9001:2000
                 Requirements for Quality Management Systems

Chapter 1

Foreword
The purpose of this e-Book document is to provide a clear and in-depth understanding of the intent and implication of each clause and sub-clause of the ISO 9001:2000 standard. While not intended to serve as an implementation guide, this document should provide sufficient insight for a quality practitioner to develop and implement an effective ISO 9001 based quality management system (QMS).

This document can be used by:
Þ Beginners - to understand and apply ISO 9001 requirements.
Þ QMS managers - to develop a more effective QMS for their organization.
Þ QMS auditors - to conduct more effective QMS audits.
Þ Top management - to gain an understanding of ISO 9001 as a business tool.
Þ Consultants - to provide value-added service to their clients.

The ISO 9001:2000 standard is shown in regular font, whereas the "key points and tips" are provided in blue and in italics. The concepts, principles and requirement of the standard are laid out in paraphrased but precise form, following the exact clause by clause numbering. Where ISO has used the word “shall”, I have replaced with “must”. Wherever possible, I have stated the clauses in the active tense instead of the sometimes difficult to understand passive tense used in the standard.

Below each section, clause or sub-clause of the standard, I provide "key points and tips" to help you better understand the specific concepts, principles and requirements. You will find important explanatory points and tips being repeated or further elaborated in different parts of the standard. Whenever I make reference to ‘you’ or ‘your’ QMS, I mean your organization’s or facility’s quality management system.

In going through the explanatory points and tips, I request that you read each paragraph carefully and sometimes twice to fully grasp the additional interpretation or insight it may convey. By doing so, you might be able to save much time, effort and money in understanding and implementing these requirements or help make your QMS more effective.

0.0 ISO 9001:2000 Standard - clause headings:

0.Introduction
1.Scope
2.Normative Reference
3.Terms and Definitions
4.Quality Management System
5.Management Responsibility
6.Resource Management
7.Product Realization
8.Measurement, Analysis and Improvement

Key Explanation Points and Tips:

The first four clauses (clause 0. Introduction to - clause 3. Terms and Definitions) do not provide any requirements for a QMS. They provide background information as to the purpose; concepts and principles used in the standard (e.g. process approach; PDCA); guidance on the QMS scope; reference to related documents; and key terms and definitions used. These clauses will all be explained in more detail as we go through each section.

The remaining five clauses numbering 4 through 8 provide the control requirements that a QMS must implement. The following is a summary explanation of these 5 major clauses or elements of the ISO 9001:20000 standard. Each major clause has several sub-clauses. Collectively, these 5 clauses set out the requirements for your QMS.

Clause 4- Quality Management System - sets requirements to identify, plan, document, operate and control QMS processes and to continually improve QMS effectiveness.

Clause 5- Management Responsibility - sets requirements for top management to demonstrate its leadership and commitment to develop, implement and continually improve the QMS.

Clause 6- Resource Management - sets requirements to determine, provide and control the various resources needed to operate and manage QMS processes; to continually improve QMS effectiveness; and to enhance customer satisfaction by meeting customer requirements.

Clause 7- Product Realization - sets requirements to plan, operate and control the specific QMS processes that determine, design, produce and deliver an organization’s product and services.

Clause 8- Measurement, Analysis and Improvement - sets requirements to plan, measure, analyze and improve processes that demonstrate product and QMS conformity and continually improve QMS effectiveness.

The overall objective of your QMS must be to enhance customer satisfaction by meeting their requirements. This objective can be achieved by using the ISO 9001 requirements to control your QMS processes and by continually improving QMS effectiveness.

To help you get the most out this e-Book, you might find it useful to follow key themes that the ISO 9001 standard has emphasized. These include:

Þ All QMS processes must be planned, implemented, measured and improved.

Þ ISO 9001 requirements focus on controlling QMS processes, not product.

Þ QMS controls must emphasize prevention of nonconformities rather than detection.

Þ QMS processes must be customer focused. Process personnel must be aware of and
   strive to meet internal and external customer requirements.

Þ You must continually improve the effectiveness of your QMS.



                                                                               TOP