ISO 9000-1 Guidelines for Selecting and Using ISO 9000 Concepts and Standards

This web page is based on the ISO 9000-1:1994 Quality Standard
published by the International Organization for Standardization.
It presents a detailed and comprehensive interpretation of this
standard using language that is clear and easy to understand.

ISO refers to ISO 9000-1 as a "road map" for the ISO 9000 family of
standards. It provides a quick "tour" by briefly explaining what each
ISO 9000 standard is about. But it also discusses some concepts and
makes some general theoretical points. This is where we will begin.


Quality objectives	ISO believes that organizations should: Improve the quality of their products. Improve the quality of their services. Improve the quality of their operations. Prove to customers that quality is important. Prove to employees that quality is important. Prove that quality improvements are being made.
Quality requirements	ISO distinguishes between quality system requirements and product quality requirements. Quality system requirements are characteristics or properties that systemic elements should have. Product quality requirements are characteristics or properties that products or services should have.
Types of products	ISO distinguishes between four types of products: Hardware Software Processed materials Services
Product quality	The quality of your product depends on: Whether you routinely update it to meet changing requirements and opportunities. Whether you design into your product the characteristics the market needs and wants. Whether every instance of your product precisely conforms to your product design. Whether you provide customer support throughout the life cycle of your product.
Product value	Your customers are likely to place a higher value on your products if: You have established a good reputation in the marketplace. Your financial performance meets market expectations. You are committed to the well being of employees.
Work is a process	All work is a process. Every process is a transformation. Every process has inputs and outputs. Every process transforms inputs into outputs.
Organizations are made up of processes	An organization is a network of processes. Organizations must identify, organize, and manage this network of processes. The link or interface between each process must be clearly defined and well managed.
Product quality depends on process	Product quality depends on how well this network works. Therefore this network of processes must be routinely and regularly monitored and analyzed. Therefore the continuous improvement of this network of processes must be a high priority.
Quality systems are made up of processes	A quality system is a network of processes. These processes must be well integrated and properly coordinated. The link or interface between each process must be clearly defined and well managed.
Process evaluations	When you evaluate a quality system process, ask: Have you developed procedures to control this process? Are the procedures that control this process both documented and well defined? Are the procedures that define this process completely deployed and implemented? Are the procedures that define this process able to generate the necessary results?
Quality system evaluators	Quality systems are evaluated by: Executive managers. Quality auditors. Internal auditors. First party auditors (your employees). External auditors. Second party auditors (your customers). Third party auditors (independent bodies). A third party audit is usually designed to gain or maintain certification or registration.
Quality system documents	A process is documented by writing procedures. Your quality system should be documented with written procedures. If you document your current quality system procedures, changes in quality are easier to detect and to measure because they can be compared with the way things were done in the past.

Documentary evidence

Documents provide objective evidence that:

A process has been defined.
Procedures have been approved.
Procedural changes are under control.

Why quality
systems are
developed

Quality systems are set up in order to:

Meet the quality demands of all customers.
Meet the contractual demands of some customers.
Demonstrate to second party customer appointed auditors that quality requirements are being met.
Demonstrate to third party external auditors that quality requirements are being met.
Maintain or achieve a competitive advantage.
Achieve senior management's quality objectives.
Take advantage of emerging market needs and trends.

Introduction	As we indicated earlier, ISO refers to ISO 9000-1 as a "roadmap" for the ISO 9000 family of standards. It provides a quick "tour" by briefly explaining what each ISO standard is about. This tour is presented below.
ISO 9000-1:1994 (now obsolete)	Use ISO 9000-1 (this one) if you need to clarify concepts and to see which publications you should study.
ISO 9000-2:1993 (now obsolete)	Use ISO 9000-2 if you need some help implementing the 1994 versions of ISO 9001, ISO 9002, or ISO 9003.
ISO 9000-3:1997 (now obsolete)	Use ISO 9000-3 if you are in the software business and you want to use ISO 9001:1994 to set up a quality system.
ISO 9000-4:1993 (now obsolete)	Use ISO 9000-4 if product dependability is important. Product dependability means reliability, maintainability, and availability.
ISO 9001:1994 (now obsolete)	Use ISO 9001:1994 if you design, develop, produce, install, and service products, and if your customers need to be satisfied that product nonconformities will be avoided. ISO 9001 presents a Quality Assurance Model that will help you to develop a quality system.
ISO 9002:1994 (now obsolete)	Use ISO 9002:1994 if you produce, install, and service products. ISO 9002 presents a Quality Assurance Model that will help you to develop a quality system.
ISO 9003:1994 (now obsolete)	Use ISO 9003:1994 if product quality can be assured through final inspection and testing. ISO9003 presents a Quality Assurance Model that will help you develop a quality system.
ISO 9004-1:1994 (now obsolete)	Use ISO 9004-1 if you intend to develop a quality system. It lists the elements that make up a quality system.
ISO 9004-2:1991 (now obsolete)	Use ISO 9004-2 if customer service is important to your organization. It discusses elements and concepts.
ISO 9004-3:1993 (now obsolete)	Use ISO 9004-3 if your organization processes solids, liquids, or gases as part of your production process.
ISO 9004-4:1993 (now obsolete)	Use ISO 9004-4 if you need to generate quality system improvements. It discusses concepts and methods.
ISO 10011-1:1990 (now obsolete)	Use ISO 10011-1 to develop your internal quality audit program. It explains how to verify the existence of quality elements and how to verify that your quality objectives are being met.
ISO 10011-2:1991 (now obsolete)	Use ISO 10011-2 to develop your internal quality audit program. It describes the qualifications that your internal auditors should have.
ISO 10011-3:1991 (now obsolete)	Use ISO 10011-3 to develop your internal quality audit program. It describes how a program should be managed.
ISO 10013:1995 (now obsolete)	Use ISO 10013 to develop a quality manual for your organization.
ISO 10012-1:1992 (now obsolete)	Use ISO 10012-1 to ensure that your quality assurance measuring equipment meets ISO's requirements.


Introduction	We conclude this section with some comments about how to select a quality assurance standard and some notes about how to demonstrate that your quality system complies with the standard you have chosen.
Three Quality Assurance Models	According to ISO, you can choose from the following list of quality assurance standards: The ISO 9001 1994 quality assurance model (now obsolete). The ISO 9002 1994 quality assurance model (now obsolete). The ISO 9003 1994 quality assurance model (now obsolete).
How to select your Quality Assurance Model	According to ISO, you should consider the following points when you select which standard to use. If you intend to develop a quality system because your customers expect you to do so, then you and your customers should formally agree on which standard should be used. If you wish to be certified or registered by an external auditor or third party registrar, then you and your auditors should agree on which standard should be used. Choose the ISO 9001 1994 standard if you design, develop, produce, install, and service products (standard is obsolete). Choose the ISO 9002 1994 standard if you produce, install, and service products. This standard is now obsolete. Choose the ISO 9003 1994 standard if you assure product quality through final inspection and testing (this standard is obsolete).
Creating a customized quality system	You don't have to meet all requirements. You may deviate from the official ISO 9001:1994, ISO 9002:1994, and ISO 9003 1994 quality standards if some of the existing requirements do not apply and if your customers agree. If you have the agreement of your customers, you may delete certain requirements, modify existing ones, or add new ones to suit your unique situation. This agreement should be specified in a contract. The customized quality system should be routinely audited to ensure that it meets requirements.
How to demonstrate compliance	You must be prepared to demonstrate that your quality system complies with the quality assurance standard you have chosen. You may: Formally declare that your quality system meets all quality assurance requirements. Use documentary evidence to prove that your quality system meets all requirements. Prove that customers accept your quality system. Agree to have your quality system audited by your customers or someone appointed by them. Agree to have your quality system audited by an external third party auditor (a registrar). Present third party audit certificates that show that your quality system meets all requirements.

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Updated on November 28, 2014. First published on June 6, 1997.
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ISO 9000-1 1994 in Plain English