Road Map to ISO 9000

Say “ISO 9000” and most U.S. businesses recognize it as a certification to quality system standards, now accepted worldwide and held highly in the European marketplace. The standards, which have been widely adopted by manufacturing companies here and abroad, ensure the consistency of quality in many regulated product industries such as personal protection devices, construction materials, implantable medical devices, gas appliances, simple pressure vessels and toys

The standards provide guidance for non-regulated products and services industries as well. Automotive industry majors have now adopted ISO standards and are requiring their suppliers to be certified under their QS 9000 industry specific standards initiative. Most recently, there has been a great deal of effort into the development of a new series of ISO standards which treat environmental issues on a global basis.

What is ISO?

As many of the independent European countries came to recognize that the numerous existing standards which varied from country to country were acting as barriers to trade, they began to seek out ways to make it easier to use, import and export products.

Born of BS 5750 and CSA Z299, standards widely accepted and in use in the UK and in Canada, respectively, the ISO standards have had great ramifications for the European Community (EC). ISO is playing an important role as these countries implement the standards as part of general harmonization efforts.

The ISO 9000 document is the overall guide of how, and in which situation to use a specific standards document. ISO 9001, 9002, and 9003 are quality system models which deal with quality assurance issues, and treat what happens between a buyer and seller of products and/or services. ISO 9004 recommends that companies utilize their quality management systems within the guidelines of the standard. This standard deals with and focuses on customer satisfaction through standardized quality system.

The ISO 9000 Series Standards:

ISO 9000 – Quality Management and Quality Assurance Standards – Guidelines
ISO 9001 – Quality Systems – Model for Quality Assurance in Design /Development, Production, Installation and Servicing
ISO 9002 – Quality Systems – Model for Quality Assurance in Production and Installation
ISO 9003 – Quality Systems – Model for Quality Assurance in Final Inspection and Test
ISO 9004 – Quality Management and Quality System Elements – Guidelines

Why achieve ISO certification?

ISO, in general, has been look at by businesses as a way of participating in a more global economy through the standardization of quality assurance processes and systems. Attaining ISO certification can translate to an increased competitive advantage and the ability to participate actively in increasingly broadening global marketplace. No longer would a business have to face fighting through a pile of differing standards for each country.

But more than this, the standards can set the stage for real improvements in processes and procedures, enhancing quality and raising the potential gain of more satisfied customers. Moreover, the ISO standards which are dynamic and keep being upgraded, will keep certified companies in-tune with worldwide changes and help them stay competitive.

The ISO standards provide guidelines for management and business practices that are in themselves generic, and have application in many industries. They are now being broadly used for and beginning to provide guidance to the operation of both service firms as well as manufacturing based businesses.

What does it take?

The efforts involved to attain ISO certification can take typically ten months or more. A large amount of time and internal effort and resources is required in the assessing, streamlining and documenting internal processes.

Only after months of preparation, a company will finally be ready to undergo an audit, which in situations is preceded by a preliminary assessment by the chosen registrar. The actual audit focuses on the documentation of the ISO compliant quality system, validation of the system performance through documented evidence of work and several internal interviews.

To maintain certification, the company is audited once every six months in the next two years to check to see if, in practice, the business is still operating in a consistent manner as outlined by its own documented system of policies, procedures and practices.

The Costs of ISO

Just as with any other performance improvement or quality enhancement initiative, undertaking ISO certification represents a significant bottom-line investment. Estimated costs can range from an average of $250,000 for a typical manufacturer with annual revenue of $20-50 million, to well over a million dollars for larger firms. These estimates represent both the actual costs and the costs of internal resources over a three year period, starting with the pre-certification planning and documenting activities, and extending through refinements during the following years of semi-annual audits.

Between 80-90% of the costs involved in this undertaking are internal resource costs. The actual fees for registrars, in fact, have dropped in recent months and are now reported to run from anywhere between $12,000 to $45,000.

The total investment needs to be thought of and balanced against comparable costs of employee training and other performance improvement initiatives and programs. When viewed in this manner, the efforts and rewards of compliance and certification with ISO standards can represent an economical way of achieving direct and lasting results.