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ISO 9001 is the international standard for quality management. Properly called ISO 9001:2008, it is also frequently referred to as ISO-9000, ISO9000, and ISO 9001.

Developed and published by the International Organization for Standardization (www.iso.org), an international standards writing body, the ISO 9000 / ISO 9001 standard is a set of requirements, the majority of which are mandatory. These requirements reflect time-proven, universally accepted business practices. The aim of ISO 9001 is to assure that organizations consistently meet customer needs, resulting in customer satisfaction.

To do this, the organization's ISO 9000 / ISO 9001 system controls its processes affecting customer satisfaction (i.e. sales orders, design, production, inspection, delivery, etc.). The scope of ISO 9001 extends beyond these "core" processes to address business support processes like purchasing, training, calibration, maintenance, and performance metrics.

ISO 9000 / ISO 9001 is, intentionally, highly generic. Its rules and principles can be applied to any organization providing any product or service anywhere in the world.

Since "meeting customer needs" is one of the (many) definitions of quality, ISO 9001 is often called a "quality system" or a "quality management" system. But the rules, referred to as "requirements," go beyond "quality" matters as they are traditionally understood. The requirements fall roughly into four types:

  • Requirements that help assure that the organization’s output (whether product, service, or both) meets customer specifications. (Making customers happy, and keeping them that way.)
  • Requirements that assure that the quality system is consistently implemented and verifiable. (We must actually do what we say we are supposed to do. This must be verifiable via independent, objective audit.)
  • Requirements for practices that measure the effectiveness of various aspects of the system. (In God we trust; all others bring data.)
  • Requirements that support continual improvement of the company’s ability to meet customer needs. (We cannot sit still. We must strive to get better all the time, because customers change, and competitors gain strength.)

Nothing in ISO 9000 / ISO 9001 is new. The first edition, published by ISO in 1987, was drawn almost word for word from a British quality system standard. This in turn evolved from a long succession of written quality system specifications that had their ultimate origin in the defense and arms industries. Most of the practices required by ISO 9001 have been in use in industries of various kinds for decades.

One intent of ISO 9000 / ISO 9001 is to simplify things for organizations. ISO 9001 strives to harmonize the sometimes conflicting, sometimes redundant "quality programs" that have traditionally been imposed by major corporations on their suppliers. (Note, however, that ISO 9000 / ISO 9001 is not meant to supersede customer, legal, or regulatory requirements.)

Bottom line: ISO 9001 is more than a comprehensive set of rules. It is in fact a business system. When properly designed (tricky), implemented (exhausting), and maintained (in many firms more taxing than it needs to be), this system can have the salutary effect of improving the performance of your organization. Not just at first, but on an ongoing basis.

Directly impacted are the functions directly involved in the process of meeting customer needs. That means your marketing people, design department, purchasing, production / service delivery, warehousing, transportation, etc. Impacted also are certain support functions, including maintenance, training / human resources, and purchasing. About the only significant part of your organization not generally taken under the quality management system umbrella is finance.

  1. Satisfies the demands of current or prospective customers for registration.
  2. Improves customer focus. We focus controls on management of the processes that enable us to achieve and improve customer satisfaction.
  3. Boost international acceptance and credibility. ISO 9001 is known, recognized, and accepted without question. ISO 9000 / ISO 9001 is accredited not only by ANAB in the United States, but by accreditation bodies in virtually every country in the world.
  4. Expand / retain markets.In the U. S., certain key industry segments such as automotive, defense, heavy equipment, aerospace, mandate or prefer ISO 9001 registration for their key suppliers.Those that make and/or market products covered by EU product directives -- or plan to do so in the future -- may be compelled to get registered to ISO 9000 / ISO 9001 to operate in Europe.Increasingly, other marketplaces may become less and less friendly to unregistered firms as the number of registrations increases. In a recent survey, more than 80 percent of respondents said ISO registration would influence their choice of suppliers.
  5. Places you in an elite category of businesses. Registration to ISO 9001 puts your organization on the identical level of excellence shared by organizations of all kinds worldwide.
  6. Keeps you prepared for external audits and inspections – i.e. customers, etc.
  7. Facilitates continual improvement.It sounds like a cliche, but it really is true. In today's intensely competitive global market, there is no such thing as a safe, protected market. Your competitors, out to eat your lunch, are striving to improve. You must do so too.
  8. Provides competitive advantage. When you're head-to-head with a competitor for a piece of business -- and you're certified but they're not -- who's going to get the nod?
  1. Transforms your operation from detection mode to prevention mode. Prevention is less work and less expense than detection. With an ISO management system, you prevent product nonconformities.
  2. Creates consistency throughout the organization built around "best practices".
  3. Improves business performance. A well designed, well implemented ISO compliant management system can help improve satisfaction of customers and consumers and boost internal manufacturing and operational efficiencies.
  4. Lessens dependency on key individuals. An ISO management system distributes responsibility and accountability across the work force. More people share more information and accountability for key quality tasks. Result: tasks or processes don't collapse just because one person leaves or changes jobs. Each person carries his or her small share of the load.
  5. Provides blueprint for controlled, disciplined growth. Some organizations see ISO 9000 / ISO 9001 management systems as a way to organize the business, systematize practices, and ensure management accountability as the organization expands.
  6. Ensures consistent training. An ISO system is like a collection of road maps. Each road map provides direction from one end of a process to the other. New people to the process are trained using the road map. They refer to the road map while they're learning. Their performance is tested against the road map. And once they know their process, they don't need to refer to the road map anymore. Except when the process changes, in which case the road map changes and people are retrained to it.
  7. Improves management oversight. An effective ISO management system incorporates monitoring and measurement of key quality performance indicators. This gives management objective data upon which to base decisions. The required self-auditing function is even more powerful. Internal auditing is an "early warning system" to help you spot problems that could impact customer satisfaction or operating efficiency – giving you the chance to address and resolve them before they are detected by others, rather than after. And then management review, closing the loop as we said, provides management with solid data, enabling management to make decisions based on facts and evidence.

Firms with advanced quality cost tracking controls almost always find that their documented quality system adds value by reducing "costs of poor quality."

A major home appliance manufacturer saw its failure rate (defined as claims per year divided by sales per year) drop by 70% in three years. Its warranty cost per unit declined by 76% during the same period.

Dupont, a pioneer in quality improvement and in ISO 9000 / ISO 9001 implementation, measured improvements under ISO 9001 in several different categories.

  • On-time delivery increased from 70 to 90%
  • Cycle time improved from 15 days to ˝ days
  • First pass yield improved from 72% to 92% on a product line
  • One site reduced the number of test procedures from more than 3,000 to 2,000

Lloyd's Register Quality Assurance, the British quality assurance registrar, published a survey of some 400 of its ISO registrants in the United Kingdom. The population was a proportional sample of market sectors and organization sizes. Some of the findings:

  • 67% felt that the ISO 9000 / ISO 9001 approach was essential for creating and maintaining viable quality management systems
  • Most originally sought ISO for external benefits, but discovered that internal benefits were more beneficial.
  • 86% stated that their ISO 9001 systems improved management control
  • 73% felt that ISO 9000 / ISO 9001 quality systems enabled them to deliver better service to customers and ensured consistency
  • 69% reported that ISO 9001 improved productivity and efficiency
  • 89% agreed that the internal benefits of ISO 9000 / ISO 9001 "met or exceeded expectations"

No. The related Standards have parallel construction and many significant elements in common. You can implement an integrated business management system -- either all at once or on an incremental basis -- that addresses quality as well as environmental management and even health/safety management -- without redundancy or duplication of effort.