Introduction to ISO 9000 Series

In this topic we will cover:
ISO 9000 Series
ISO 9000 , ISO 9001 , ISO 9004
Relationship between ISO 9001 and ISO 9004
Compatibility with other standards

ISO 9000 Series

In the year 2000, ISO 9001 series of standards were revised significantly leaving behind the 20 clause structure of describing quality management system requirement. The ISO 9000 series which consisted of over 20 standards was reduced to just three standards, ISO 9000, ISO 9001 and ISO 9004. ISO 9000 was revised in year 2005; ISO 9001 is revised in 2008 while ISO 9004 will be revised in year 2009.
ISO 9000 series of standards are developed by Technical Committee ISO/TC 176, Quality management and quality assurance, Subcommittee SC 2, Quality Systems.

The ISO 9000 (Year 2000 and 2008) family of standards consists of:
1. ISO 9000 Quality Management systems _ Fundamentals and vocabulary.
2. ISO 9001 Quality Management systems _ Requirements.
3. ISO 9004 Quality Management Systems _ Guidelines on performance improvements

An organization will benefit from establishing an effective quality management system (QMS). The cornerstone of a quality organization is the concept of the customer and supplier working together for their
mutual benefit. For this to become effective, the customer-supplier interfaces must extend into, and outside of, the organization, beyond the immediate customers and suppliers.

A QMS can be defined as:
“A set of coordinated activities to direct and control an organization in order to continually improve the effectiveness and efficiency of its performance.”

These activities interact and are affected by being in the system, so the isolation and study of each one in detail will not necessarily lead to an understanding of the system as a whole. The main thrust of a QMS is in defining the processes, which will result in the production of quality products and services, rather than in detecting defective products or services after they have been produced.

ISO 9000

Introduces the user to the concepts behind the management systems and specifies the terminology used.
This standard replaced ISO 8402 (in year 2000) and contains definitions of the terms used in the quality assurance and information on some of the fundamental issues addressed by the revised ISO 9000 series of standards.
ISO 9000 (last revised in 2005 after 2000) is not a certification standard but the ISO 9000 certification is a generic name which represents the entire series. Only ISO 9001 is available for certification.

The standard is divided into two parts:
A. Fundamentals; and
B. Vocabulary (terms and definitions)

A. Fundamentals:

This section of the standard covers "why" and "how" of quality management. It contains guidance on some of the requirements of the ISO 9001. Fundamentals of quality management system covers quality management principles, rationale for quality management systems, the process approach, quality policy and objectives, role of top management, documentation and role of statistical techniques.

B. Vocabulary:

This section contains definitions to terms used in quality management. The definitions are set out in such a way that a term may be replaced by its definition in other definitions to get clear explanation of the terms and issues encountered in quality management.

For example:
The definition of "Specification" is:
Document (3.7.2) stating requirements (3.1.2).
By replacing the terms in bold with their definitions from the standard; specification may be defined as:
Information and its support medium stating need or expectation that is stated, generally implied or obligatory.

Such simplicity was not available in earlier standard (ISO 8402). Get your copy of standard from Bureau of Indian Standard and play with the definitions. You will learn and get in depth knowledge and correct meaning of the terms.

ISO 9001

This sets out the criteria you will need to meet if you wish to operate in accordance with the standard and gain certification.
ISO 9001 sets out the requirements for quality management systems to use where an organization's capability to provide products and/or services that meet customers and applicable regulatory requirements needs to be demonstrated.
ISO 9001 is being revised in 2008, though changes and in the nature of small amendments and addition of notes to various clauses.
A company actually receives a certificate for this standard only.

ISO 9004

This is designed to take you beyond ISO 9001 and considers the needs of all stakeholders, not just customers.
ISO 9004 provides guidance on quality management systems. The guide contains information on the processes for continual improvement that contribute to the satisfaction of an organization's customers and interested parties.
ISO 9004 is currently under revision and will be released in 2009.  ISO 9004 is not intended for certification purpose.

Relationship between ISO 9001 and ISO 9004

The ISO 9001 and ISO 9004 are developed as a consisting pair of quality management system standards.
The two standards are designed to be used together, but may be used independently. The two standards have followed similar structure to set the quality management system requirements.
ISO 9004 goes beyond the requirements set out by ISO 9001 and provides guidance on how a good quality management system could be build in pursuit of continual improvement in performance, efficiency and effectiveness.
ISO 9004 is not intended for certification or contractual purpose, whereas, ISO 9001 sets out the requirements for a quality management system that may be used by the organizations for certification or contractual purposes. The focus of ISO 9001 is directed towards the effectiveness of the quality management system to meet customer requirements.

Compatibility with other Standards

The ISO 9000 family is intended to be compatible with other internationally recognized management system standards.
In particular, ISO 9001 is aligned with ISO 14001 so that the two Standards may be fully integrated into the one management system.
ISO 10011 parts 1, 2, and 3 are replaced by ISO 190011.
ISO 190011 provides guidance on quality and environment management systems auditing. ISO 190011 is only a guidance document; it provides detailed information on planning and implementation of effective auditing. This is of vital importance for certification bodies and also to the organizations carrying out audits of suppliers.
The 2008 edition of ISO 9001 aligns the standard further with other latest versions of standards like ISO 14001, ISO 21000, and ISO 27001 etc.

The Indian equivalent of ISO 9000 series standards are:

IS/ISO 9000 Quality Management systems _ Fundamentals and vocabulary.
IS/ISO 9001 Quality Management systems _ Requirements.
IS/ISO 9004 Quality Management Systems _ Guidelines on performance improvements.

External Document Reference: From ISO (download) 

About ISO - What ISO Offers etc.
ISO Committee on Developing Country - Information on DEVCO