1. What is ISO 9000?
The term “ISO 9000″ can mean several things. Most often, it refers to a documented quality system standard more properly known as ISO 9001 (2008). This is a comprehensive written set of rules (a “standard”) published by the International Organization for Standardization, an international standards writing body. The rules define time-proven, universally accepted business practices for assuring that organizations consistently understand, and meet, the needs of their customers.

ISO 9001 (2008) 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 9000 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 is new. The first edition, published by ISO in 1987, was drawn almost word for word from a British quality system standard. It in turn evolved from a long succession of written quality system specifications that had their ultimate origin in the defence and arms industries. Most of the practices required by ISO 9000 have been in use in industries of various kinds for decades.

One intent of ISO 9000 is to simplify things for organizations. ISO 9000 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 is not meant to supersede customer, legal, or regulatory requirements.)

The bottom line is this. ISO 9000 is a comprehensive set of rules — a business system, really — that can cause the way your organization runs to profoundly change, almost always for the better. What many do not fully appreciate is that implementing ISO 9000 — expensive, exhausting, and annoying as it can be — can also have the salutary effect of improving the performance of your organization. Not just at first, but on an ongoing basis.

2. What functions of the organization are impacted by implementing a quality management system?
The functions impacted the most are those 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 training / human resources. About the only significant part of your organization not generally taken under the quality management system umbrella is finance.

3. What are the benefits of implementing a quality management system?

• Satisfies the demands of current or prospective customer demands for registration.
• Improves customer focus and process orientation within the organization.
• Facilitates continual improvement.
• Creates consistency throughout the organization.
• Strengthens relationships between your organization and its suppliers and customers
• Provides confidence to customers in the capability of your organization to meet quality commitments.
• Improves management decision-making.
• Institutionalises training.
• Reduces dependence upon individuals
• Provides access to markets.

Clearly, most companies registering to ISO 9000 today are doing so because key customers are pressuring them to do so. But, huge though this market is, it is just one market. There are other markets that put great store in ISO 9000 registration, as well. You would do well not to ignore them.

If you make and/or market products covered by EU product directives – or plan to do so in the future – you may be compelled to register and your quality system in order to operate in the European Economic Area.

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 9000 registration would influence their choice of suppliers. If you are like many companies, you are finding that ISO 9000 registration is often an item on supplier surveys.

• Reduces cost of customers’ supplier programs.
• Reduces operating costs.
• Provides competitive advantage.
• Reduces supplier quality assurance (SQA) audits.

A well implemented ISO 9000 system also adds value. Facilities with advanced quality cost tracking controls almost always find that their documented quality system adds value. 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 implementation, measured improvements under ISO 9000 in several different categories.

• On-time delivery increased from 70 to 90%
• Cycle time improved from 15 days to ½ 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

A 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 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 9000 systems improved management control
• 73% felt that ISO 9000 quality systems enabled them to deliver better service to customers and ensured consistency
• 69% reported that ISO 9000 improved productivity and efficiency
• 89% agreed that the internal benefits of ISO 9000 “met or exceeded expectations”

4. Must quality and environmental management systems be separate?
No! The related Standards are constructed very similarly and have many common elements. You can implement a consolidated business management system that addresses quality as well as environmental management – without redundancy or duplication of effort.