ISO 9000-1 Guidelines Translated into Plain English

Guidelines for Selecting and Using ISO Concepts and Publications

Society for the Advancement of Material and Process Engineering

This section summarizes ISO 9000-1. It highlights the main points.
It does not present detail. If you need a detailed and complete interpretation
of the ISO 9000-1 standard, please consider purchasing our hardcopy version.

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

• 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.

• ISO distinguishes between four types of products: hardware, software, processed materials, and services. Notice that a service is a product.

• The quality of your product depends on:
  • Whether you routinely update it to meet changing market
    requirements and opportunities.
  • Whether you design into your product the characteristics
    the marketplace 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.

• All work is a process.
  • Every process is a transformation.
  • Every process has inputs and outputs.
  • Every process transforms inputs into outputs.

• 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 how well this network of processes works.
  • Therefore this network must be routinely monitored and analyzed.
  • Therefore the continuous improvement of this network must be
    a high priority.

• 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.

• When evaluating a quality system process, you must 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 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 process is documented by writing procedures.
  • Your quality system should be documented by writing 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.

• Documents provide objective evidence that:
  • A process has been defined.
  • Procedures have been approved.
  • Procedural changes are under control.

As we indicated earlier, ISO refers to ISO 9000-1 as a "roadmap" for the ISO family of publications. It provides a quick "tour" by briefly explaining what each ISO publication is about. That's what the following material will now do.

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

• Use ISO 9000-2 if you need some help implementing ISO 9001,
  ISO 9002, or ISO 9003.

• Use ISO 9000-3 if you are in the software business and you want to use ISO 9001 to set up a quality system.

• Use ISO 9000-4 if product dependability is important. Dependability means reliability, maintainability, and availability.

• Use ISO 9001 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 the appropriate quality system.

• Use ISO 9002 if you produce, install, and service products. ISO 9002 presents a Quality Assurance Model that will help you to develop the appropriate quality system.

• Use ISO 9003 if product quality can be assured through final inspection and testing. ISO 9003 presents a Quality Assurance Model that will help you to develop the appropriate quality system.

• Use ISO 9004-1 if you intend to develop a quality system. ISO 9004-1 lists the elements that make up a quality system.

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

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

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

• 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.

• Use ISO 10011-2 to develop your internal quality audit program. It describes the qualifications that your internal auditors should have.

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

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

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