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ISO 9000 Introduction

The Who, What, When Where & Why of ISO 

ISO 9000 - Benefits and Problems

ISO LogoISO 9000 has received much publicity. Some managers see it as a prerequisite for conducting business. For others, it substitutes for the difficulties and vagaries of Total Quality Management (TQM). Some see only a needless bureaucratic boondoggle. Depending on the situation, any of these views might be correct.

Sensibly applied, ISO 9000 is a qualifier for international markets or specific domestic customers. Certification can be a valuable marketing tool. The standards are a sound blueprint for a quality system. They can lead the way to the more difficult and sophisticated approaches of Total Quality Management. ISO 9000 can improve a company's cost structure by 5%-20%.

Approached unwisely, ISO 9000 can be costly and unproductive. It may create a quality bureaucracy which adds to the cost structure and slows product development. It can focus people on paperwork instead of customers. It can divert management concentration and energy from more vital issues.

What Is ISO 9000?

The ISO 9000 standards define minimum requirements for business quality assurance systems. These are "consensus standards" promulgated by the International Standards Organization in Europe and the American National Standards Institute (ANSI) in the United States. The ANSI standards are officially titled the "Q90" series. They are identical to the ISO 9000 series and people use the names interchangeably.

Conformance is voluntary. However, many European firms use them as a requirement for suppliers. Within the United States, some firms also use the standards for supplier certification.

ISO 9000 (Q90) is a guideline for selection and use of quality system standards. It provides insight for various situations and conditions as well as definitions and explanations.

ISO 9001 (Q91) defines minimum quality system requirements for design/development, production, installation and servicing. It is the most complete standard. It applies to manufacturing and service businesses engaged in all these activities.

ISO 9002 (Q92) is essentially a subset of 9001. It applies only to production and installation activities.

ISO 9003 (Q93) applies to final inspection and test.

ISO 9004 (Q94) is a guideline for quality system elements. It is like a textbook which describes, explains and recommends.

Requirements

The standards use proven management principles:

  • Policy Definition

  • Clear Responsibility & Authority

  • Appropriate Documentation

  • Corrective Action

  • Capable People & Equipment

  • Adequate Resources

Conformance requires that firms apply these principles to areas which impact quality. It further requires consistent practice which is usually most difficult.

Under section 4.4, for example, ISO 9001 requires that product design projects should be planned, that design input parameters shall be defined and at design completion, the resulting design is confirmed as meeting the input requirements. It requires that the design, as well as any changes, be documented. The standard also requires that design changes be approved by the organization or persons who made the original design.

Experienced product design engineers recognize these requirements as common sense-- taken for granted in successful design organizations. Product design disasters can usually be traced to violation of one or more of the above requirements.

Certification

The American Society for Quality Control has organized a Registrar Accreditation Board (RAB). This board oversees the training and activities of assessors and certifies conformance. Certification is evidence to customers, potential customers and others that a business meets the standard's requirements.

Assessors typically spend 1-3 days at a site. They examine documents, interview employees and observe processes. They look for evidence to confirm compliance or non-compliance. To obtain certification, a business may contract with an accredited assessor. An important customer may wish to assess as part of their supplier certification. Management may wish a self-assessment for internal evaluation.

Who Should Use ISO?

Any firm whose customers make their buying decisions on quality issues should consider using these standards. Firms whose customers require conformance and certification as a qualifier will need a certificate of conformance from an approved Assessor.

  • Firms who perceive quality as a marketing tool may obtain certification as part of their marketing strategy.

  • In markets where quality is not a dominant issue firms may use the standards as a guide, but not attempt certification.

  • Firms may use the standards for their own suppliers requiring certification as a condition of doing business. 

Implementation

An important implementation issue is speed. Most firms require 18 months or longer to achieve certification. Another issue is the current state of quality. Those with severe quality problems may need a maximum effort.

Is certification necessary for your firm? Is the need urgent enough for a maximum effort? Or should the standards be used internally for their intrinsic value?

The first step is awareness. Management must convince the organization that conformance is important. People within the organization must know the basics.

Special purpose teams are an effective implementation tactic. They establish procedures and practices for various parts of the organization or for certain requirements of the standard. 

An especially important requirement of the standard is ongoing self-assessment. The authors consider self assessment and correction as essential for continuing compliance.

How TQM & Six Sigma Fit

Total Quality Management emphasizes leadership, management, worker involvement, low-level responsibility, process control and continuous improvement.

The standard requires clear responsibility and authority. It emphasizes decision procedures, their documentation and implementation. The standards will enhance and complement either TQM or conventional quality systems.

Conformance does not guarantee world-class quality. An organization can conform and still have a mediocre output quality and a high quality cost.

Your Competitive Edge

ISO 9000 can be many things to many organizations. For sound decisions, management should know what it requires and, equally important, what it does not require. The implementation should consider each firm's size, markets, and current quality position. A knowledgeable and experienced assessor is vital.

For many firms, ISO 9000 can be part of a competitive edge. It can contribute to marketing, reduce costs, and be an qualifier for certain markets or customers. It is a strong foundation for Total Quality Management and Lean Manufacturing .

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