5.1. A Brief History of ISO 9001:2000
For 40 years, the ISO led the way in establishing standards for consistency, interchangeability, and design. But by the late 1970s, the Western worldEurope and the United Statesbegan to look east: to Japan. For three decades, that country had been quietly taking the lead in quality control. Evidence had begun to surface in distinctive ways, really since the 40s. But in the 1970s, the first transcontinental shockwave was feltin the automobile industry. Japanese car manufacturers like Toyota and Honda began to draw away American buyers by the millions with economical and reliable imports. While American designers embraced the concept of built-in obsolescence, believing that Americans wanted to trade in every four years, the Japanese focused on dependability and value. If you were around at that time, you might remember embarrassments like the Chevy Vega, the AMC Pacer, and the Chrysler Reliant. These cars seemed to roll of the assembly line already rattling. There were no Japanese counterparts to these engineering Frankensteinsnor have there ever been.
What secret had the Japanese uncovered? The ironic note here is that the Japanese were just doing what the Americans and Western Europeans had taught them to do for years.
Think back to the close of World War II. In the late 1940s, Japan was little more than rubble. Literally. Over 60 percent of the country had been flattened. Part of the job of the occupation forces was to rebuild the country's infrastructure. And so the process began. The U.S. helped erect new factories across the land, new factories that featured the latest innovations in manufacturing techniques. Japan was getting the biggest modernization face-lift in the history of the world.
What's more, the people of Japan were taking this fresh start seriously. Their manufacturing leaders, visionaries, and managers began to read and absorb American business school literature: works by people such as Deming, Crosby, and Juran. These quality pioneers introduced such concepts as Total Quality Management zero defects, Continuous Quality Improvement, and promoted the mantra "quality is free." And they gave new definitions to the concept of customer satisfaction. But by the 1960s, in America, these subjectsonce fresh and invitinghad slowly been pulled out of the realm of application, relegated back into the halls of academia. They became interesting concepts, ideas for students to ponder. Meanwhile, American manufacturing (with Europe following lead) concentrated on volume, on turnover.
The Japanese, however, took quality seriously. They were attracted to the ideas of quality and continuous improvement and reliability. They appreciated values of consistency and repeatability. They believed what we preached. And so they began to build their manufacturing techniques around these concepts. They quickly proved adept at getting results.
By the 1980s, Japanese products were known for their superior engineering and solid performance. And not just in the automotive industry. Companies such as Mitsubishi, Sony, Sanyo, Hitachi, and Canon were market leaders. And so the West went East.
We began to send our people over there to find out the secret we had once discovered and then lost. In the mid-1980s, the concept of Total Quality Management attained renewed interest worldwide. The ISO recognized this revitalization, and in the wake of an ongoing technology revolution, it appreciated the need for a new worldwide standard, one that would embrace the ideas of quality and quality controls in manufacturing environments.
5.1.1. ISO 9000
In 1987, the ISO released the first version of its first international quality standard: ISO 9000. ISO 9000 was designed as a generic quality standard. It provided for the implementation of a quality system into just about any manufacturing environment. A coat-hanger factory could implement ISO 9000. A guided-missile plant could implement ISO 9000. A trucking company could do it. Your local pharmacist could, too.
The idea behind ISO 9000 was that in any manufacturing endeavor, there are opportunities in which quality can be controlled. These opportunitiesoften called quality gatescan be identified and then proactively managed so that the production process, once thought of as an unstoppable assembly line, could now become a specimen for fine-tuning. The standard had two basic objectives: to prevent a defective product from getting out the door, and to remedy the missteps that caused the defect in the first place. This was done by continuously examining and measuring the way you created your product.
While the foundation concepts inside ISO 9000 were thematically generic, the ISO realized that different types of manufacturing organizations would probably need different emphases.
Ensuring that coat hangers drop off the assembly line properly twist-tied probably requires a different focus from that of a group that wants to make sure the guidance system of a nuclear warhead operates in subfreezing temperatures. And so ISO 9000 was designed and released as a family of standards. It consisted of five individual but related international standards on quality management and quality assurance. The five standards were known as ISO 9000, ISO 9001, ISO 9002, ISO 9003, and ISO 9004.
The first and last in the familyISO 9000 and 9004served as bookend documents. ISO 9000 was titled "Quality Management and Quality Assurance StandardsGuidelines for Selection and Use." This document explained the purpose and use of the middle three standards and provided guidelines that adopters could use for selecting the appropriate standard for their organization. ISO 9004 was titled "Quality Management and Quality System ElementsGuidelines." This document featured guidelines for understanding and selecting the elements that would go into the quality management system being established.
The middle three documents contained the three independent quality standards that made up the core of the ISO 9000 family. ISO 9001 was titled "Quality SystemModel for Quality Assurance in Design, Development, Production, Installation, and Servicing." ISO 9002 was titled "Quality SystemsModel for Quality Assurance in Production, Installation, and Servicing." And ISO 9003 was titled "Quality SystemsModel for Quality Assurance in Final Inspection and Test."
ISO 9001 was intended for use in organizations that are involved in the full design/production/maintenance life cycle. These companies typically create custom products specific to the needs of their clients (think of Jet Fighters, McDonald's uniforms, or anything having to do with Jennifer Lopez). They create a unique design based on the customer requirements, produce products from this design, and then perform maintenance once that product is installed in the field.
ISO 9002 was intended for organizations that produce full life-cycle products but do not rely on custom designs. They base their products (or service)like the manufacturers of 10 p nails or 5 mg aspirin tabletson generic specifications and uniform requirements common to all customers. These agencies are not required to create and verify unique designs.
ISO 9003 featured the narrowest scope of the three standards. It was intended for organizations, or groups within organizations, that are only concerned with the inspection and final testing of products (or services) prior to shipping. Think of the people who employ "Inspector Number 6."
5.1.2. ISO 9001:2000
Within a few short years of its release, the ISO 9000 family had become one of the world's leading quality standards. There are solid reasons why. It incorporated the latest quality management philosophies, it was supported by a recognized international organization, it was flexible in its implementation, and it was shown to produce results. ISO 9000 became the most widely disseminated and adopted standard in ISO history.
The ISO refined the standard in 1994 and then began almost immediately on a major revision. The impetus was consolidation. After nearly a decade of adoption, implementation, and observation, ISO members had expressed the need for a single consolidated standard. Such a standard would apply to any manufacturing entity by providing a series of truly generic quality practices. These practices would be expressed in a way that allowed for even more openness in interpretation and flexibility in implementation.
The ISO acted on these inputs and organized a major revision effort. In December of 2000, the organization released version 1 of ISO 9001:2000.
ISO 9001:2000 is a single quality standard. It replaces ISO 9000, 9001, 9002, 9003, and 9004 by incorporating the best practices of them all.
People familiar with the ISO 9000:1994 family will instantly recognize the push and focus of the 2000 standard. But its approach has been condensed to harmonize the goal of common application.
If you were to distill the essence of ISO 9001:2000, you would finish with five core directives:
220.127.116.11. 1. Understand the requirements
Like the best quality programs, the ISO 9001:2000 Standard carries a heavy focus on customer satisfaction. Because the term "quality" can be shaped to mean almost anything at any time, the best way to manage it is to tie it to customer satisfaction, or rather customer expectation. The assumption is, if you build what your customer wants, the customer should be satisfied with your work. Build in too little, and the product won't perform; too much, and it may be full of irrelevance. The best way to achieve agreed-upon quality then is to first know what it is your customer needs.
Understanding what your customer wants comes from understanding the requirements. But reaching that point of understanding takes work. You may begin by accepting a set of requirements from your customer. These may appear to be complete and valid, but it's important to confirm that. So you and your team might need to analyze these requirements. Through analysis, you may come up with questions, or you may derive additional logical requirements. You may then want to work closely with your customers to review and discuss, as necessary, this full set of requirements. Once you are both able to agree that you now have a solid benchmark for commencement, you'll be in a good position to design, build, and deliver a quality end product.
18.104.22.168. 2. Establish processes to meet the requirements
The next core directive in the quality standard is to establish processes to meet the requirements. This is the functional heart of ISO 9001. As with any quality standard, the program is built upon documented, repeatable processes. These processes guide the many different activities your teams may have to undertake in the production regimen.
The use of common processes is important for three reasons. First, it externalizes the knowledge of the organization. Look at shops that work without processes. You'll see that they are commonly pretty ad hoc places. The success of their work is almost exclusively dependent upon the skills of the people performing the work; the organization provides little guidance. So your strongest team members will be able to produce as needed. But your weaker team members may fall behind, or produce inconsistently. Without a balance between these two, the success of a project on the whole may be unpredictable. By creating processes that reflect your most efficient work paths, you externalize the expertise in the organization, transferring it from inside the domain of individuals into the realm of the group.
Second, processes add visibility to the production activities. Effective managers and team members see value in this visibility. When an organization prefers to blindly throw components over wallsfrom team to teamit experiences a fragmentation of effort. Activities become micro-focused on bounded sets of actions. The big picture of what the end product should be can easily become lost. A well-balanced process program helps prevent this. With the walls down, all teams can understand how the components move through the system, and what value the system should add at each step. This harmonizes and consolidates the energy of a project team.
Third, processes provide for effective management of budgets, schedules, resources, and functionality. They're a mechanism to plan, predict, monitor, and control.
When the design of the process program is geared to meeting the requirements, you reap all these benefits. The processes are then able to shepherd project activities to create components that effectively meet the customer requirements. Such processes can help you control designs. They can help you assemble appropriately. They can help you test thoroughly. Ergo, quality.
22.214.171.124. 3. Provide resources to run the processes
In point 2, processes are designed to fulfill the requirements: to help focus project activities on meeting the requirements. Here, from this third directive, you make a formal commitment to the process program by providing resources to run the program. In other words, the organization provides the overhead necessary to put the program to work. These resources typically include several elements. To begin with, the program will need people to disseminate, use, and monitor the processes. It may require that you provide office space, desks, and computers for these people. It may require that you publish guides and process flows, and perhaps create training materials for the various teams who will use the processes. Providing adequate resources gives life to the process program.
126.96.36.199. 4. Monitor, control, and measure the processes
What makes quality programs (and the standards they spring from) effective is management's insistence that they not remain still, that they don't stagnate. The idea of continuous quality improvement therefore is woven throughout ISO 9001. No single process program starts out in perfect form. And no process program will probably ever evolve into a perfect methodology. But when a program is implemented in such a way that it is regularly monitored, its efficiencies observed, and its effectiveness measured, management then has the means to refine the program, to make it more effective, to make it more efficient, to make it better able to meet the goals of the organization.
Measurement is the key to this kind of real improvement. Measurement provides datahard numbersthat can be used to make decisions with quantitative support. Often, organizations make decisions on how business processes are governed or on how process activities are undertaken based on instinct, gut feel, intuition. Such moves may turn out to be effective, but that is not really the best way to chart a course. Data is a much more precise way to understand, shape, and direct. It's the foundation for intelligent, fact-based decision-making.
188.8.131.52. 5. Improve continuously based on the results
The final directive built into the structure of ISO 9001 is to use the measurements and data that come from regular monitoring of the quality program to make improvements in the program. This captures what is essential to the success of any quality program: the commitment to long-term adoption. Implementing a quality program should never be viewed as a quick fix.[*] Quality programs require time to become institutionalized, to saturate an organization's culture, to become refined, and for their benefits to become recognized.
For this reason, the ISO Standard provides requirements and recommendations that promote continuous measurement, analysis, and actions, all aimed toward improvement.
These five traits make up the core focus of ISO 9001:2000. The requirements, structural elements, and recommendations contained in the Standard are all designed to promote these traits and, in doing so, promote effectiveness and, in the end, tangible results.