ISO 9000-1 1994 Guidelines in Plain English

Guidelines for Selecting and Using ISO 9000 Concepts and Standards 

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.

ISO 9000-1: 1994

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

Use ISO 9000-1 (this one) if you need to clarify concepts 
and to see which publications you should study.

ISO 9000-2:1993

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

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

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

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

Use ISO 9004-2 if customer service is important to your organization. It discusses elements and concepts.

ISO 9004-3:1993

Use ISO 9004-3 if your organization processes solids, 
liquids, or gases as part of your production process.

ISO 9004-4:1993

Use ISO 9004-4 if you need to generate quality system 
improvements. It discusses concepts and methods.

ISO 10011-1:1990

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

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

Use ISO 10011-3 to develop your internal quality audit program. It describes how a program should be managed.

ISO 10013:1995

Use ISO 10013 to develop a quality manual.

ISO 10012-1:1992

Use ISO 10012-1 to ensure that your quality assurance measuring equipment meets ISO's requirements.

ISO 9000-1: 1994

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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