ISO 9000: An Aerospace Engineer's Handbook for Implementing the International Standards for a Quality System
Roy M. Chiulli
Chapter 1: Introduction
The ISO 9000 Series, issued in 1987 by the International Organization for Standardization (ISO), is a set of international standards on quality and quality management. The standards are generic and not specific to any particular product. They were adopted by the American Society for Quality Control (ASQC), now American Society for Quality, and issued in the United States as the ANSI/ASQC Q90 Series (revised in 1994 as the ANSI/ASQC Q9000 Series). ISO 9000:2000 is the most recent revision of the standards.
Fundamentals of ISO 9000
ISO 9000 represents an evolution of traditional quality systems rather than a technical change. Whereas traditional quality systems rely on inspection of products to ensure quality, the ISO 9000–compliant quality system relies on the control and continuous improvement of the processes used to design, produce, inspect, install, and service products. In short, ISO 9000 represents a systemic tool for bringing quality processes under control. Once processes are controlled, they can be continuously improved, resulting in higher-quality products.
ISO 9000 represents a significant step beyond ensuring that specific products or services meet specifications or industry standards. It certifies that a facility has implemented a quality system capable of consistently producing quality products. That is, ISO 9000 does not certify the quality of products; it certifies the processes used to develop them.
Thus ISO 9000 is a process-oriented rather than a results-oriented standard. It affects every function, process, and employee at a facility, and it stresses management commitment to quality. But above all, it is customer-focused: It strives to meet or exceed customer expectations.
ISO 9000 is not a prescriptive standard for quality. The requirements section (ISO 9001), which covers all aspects of design, development, production, test, training, and service, is less than 10 pages long. For example, when addressing the product design process, ISO 9000 focuses on design inputs, outputs, changes, and verification. It is not meant to inhibit creative thinking.
ISO 9000 is a system quality standard that provides requirements and guidance on all aspects of a company's procedures, organization, and personnel that affect quality—from product inception through delivery to the customer. It also provides significant requirements and guidance on the quality of the output delivered to the customer. Pertinent questions are: What benefits will the proposed changes to the procedures, organization, and personnel provide to the customer? Will the proposed changes help to continuously improve product delivery schedules and product quality and reduce the amount of variance in product output?
ISO 9000 does not require inspection to verify quality, nor is it the preferred method. ISO requires that the output be verified according to documented process-control procedures. ISO 9000 does not mandate that specific statistical processes be used; it requires the user to implement appropriate statistical processes. ISO 9000 mandates product-control methods such as inspection only when process-control methods are neither practical nor feasible.
ISO 9000 does not provide industry-specific performance requirements. It provides a quality model that can be applied to virtually every industry procurement situation and is being used worldwide for commercial and, recently, government procurements.
Many suppliers already have a quality system in place, be it simple or elaborate. ISO 9000 does not require a supplier to add new or redundant requirements to an existing quality system. Rather, it requires that the supplier specify a basic, common-sense, minimal quality system that will meet the quality needs of the customer. Thus, many suppliers find that their operative quality system already meets some or all of the ISO 9000 requirements. They only need to show that their existing procedures correspond to the relevant sections of ISO 9000.
ISO 9000 provides suppliers with the flexibility of designing a quality system for their particular type of business, market environment, and strategic objectives. It is expected that management, aided by experienced internal quality personnel and, if necessary, external ISO consultants, will determine the exact set of supplier quality requirements. To ensure the overall success of the quality program, however, the specific work procedures should be created by those actually doing the work rather than by management or ISO consultants. Although an organization's documentation of work procedures may be ISO 9000 compliant, if employees do not follow the procedures, the organization may not attain ISO 9000 certification. Drawing upon employee expertise and keeping employees involved in the process when improving and controlling procedures are critical to attaining ISO 9000 compliance.
Developing a quality system is not a sprint, but a journey, and because processes are continuously being improved, it is a journey without an end. ISO 9000 does not mandate the use of short-term motivational techniques to foster employee enthusiasm for a supplier's quality system program. Attempting to motivate employees by promising lower overhead or greater market share is not likely to be successful. Instead, it is recommended that employees be educated on how ISO 9000 standards will help them perform their jobs better and faster.
ISO 9000 emphasizes that for any quality system to be successful, top-management commitment and active involvement are essential. Management is responsible for defining and communicating the corporate quality policy. It must define the roles and responsibilities of individuals responsible for quality and ensure that employees have the proper background for their jobs and are adequately trained. Management must periodically review the effectiveness of the quality system. It should not back the effort to comply with ISO 9000 during its inception and then back down when the scope and cost of the effort is fully realized. When employees sense that management commitment has diminished, their own commitment slackens. Employees typically want out of a costly project not backed by management.
ISO 9000 does require that an organization have documented and implemented quality procedures that ensure personnel understand the quality system, that management maintain control of the system, and that internal and external audits be performed to verify the system's performance. Because ISO 9000 affects the entire organization, all employees should be given at least basic instruction in the ISO 9000 process and its specific implementation at their facility. Training should emphasize goals, benefits, and the specific responsibilities and feedback required of each employee. ISO 9000 uses customer satisfaction as its benchmark. But the "customers" of ISO 9000–compliant processes include not only the obvious end-users of the product, but also an organization's product designers, manufacturers, inspectors, deliverers, and sales force.
Improving the processes that produce a quality product can provide an additional benefit: When the processes are well-defined and constant and when employees are well trained to perform these processes, employee safety typically improves significantly. Also, during the course of improving its processes, a company often finds after close inspection that many of its processes and procedures are ineffectual and can be eliminated. Thus, while ISO 9000 requires preparation and maintenance of a formidable set of documents and records, the total paperwork of a company implementing ISO 9000 may decrease significantly in the long run. Other benefits of ISO 9000 compliance are a decrease in product defects and customer complaints and increased manufacturing yields. A final but very important by-product of implementing ISO 9000 is a heightened sense of mission at a company and an increased level of cooperation between departments.
ISO 9000 is not product-quality oriented. It does not provide criteria for separating acceptable output from defective output. Instead, it is a strategy for continuous improvement where employees meet and exceed customer quality requirements and, in doing so, continuously improve the quality of the product.
ISO 9000 recognizes that when a customer is looking at a specific part of a product (e.g., car, stereo system), he is often looking at an item (e.g., engine, stereo cabinet) provided by a subcontractor. Hence, ISO 9000 requires that a company verify that its subcontractors are providing quality items. Today, organizations with excellent quality systems often partner with their subcontractors. ISO 9000 provides an excellent framework for such a relationship, with subcontractors providing the raw materials and components of the final product.
The ISO 9000 family is a set of "quality system management" standards, the first in a set of evolving management system standards. Standards for environmental management are in place; standards for occupational safety, health management, and energy management will soon follow. These new standards will affect the space and aircraft industries just as they affect other industries.
In summary, ISO 9000 compliance provides customers with the assurance that approved raw materials for a product have been purchased and that the product has been manufactured according to the correct specifications, assembled by trained employees, properly inspected and tested, adequately packaged for preservation, and transported in a manner that prevents damage to it en route. Overall, ISO 9000 compliance helps generate quality awareness among a company's employees, an improved competitive position for the company, an enhanced customer quality image, and increased market share and profits.
Components of the ISO 9000 Series
The ISO 9000 Series includes three standards:
- ISO 9000:2000 Quality Management Systems—Fundamentals and Vocabulary
- ISO 9001:2000 Quality Management Systems—Requirements
- ISO 9004:2000 Quality Management Systems—Guidelines for Performance Improvement
Table 1.1 provides the general applicability of ISO 9000.
Applicability of the ISO 9000 Series
| Standard | Applicability |
|---|---|
| ISO 9000:2000 Quality Management Systems— Fundamentals and Vocabulary |
General guidelines for choosing the appropriate quality system. Includes guidelines on how to apply the standard. |
| ISO 9001:2000 Quality Management Systems— Requirements |
Used for all ISO 9001 certification audits. Only this document specifies mandatory requirements. |
| ISO 9004:2000 Quality Management Systems— Guidelines for Performance Improvement |
Guidelines for improving the quality system beyond ISO 9001. |
Note: ISO 9002:1994 and ISO 9003:1994 were discontinued in the ISO 9000:2000 family of standards. Organizations that do not have design or manufacturing responsibilities (and were previously certified using ISO 9002:1994) will now have to use ISO 9001:2000 for certification. These organizations are allowed to exclude design and manufacturing requirements in ISO 9001:2000 based on the rules for exception given in Clause 1.2, Permissible Exclusions.
ISO Facts
The International Organization for Standardization (ISO), founded in 1946, is a global federation of national standards organizations that includes some 130 member nations:
- ISO is based in Geneva, Switzerland.
- ISO's mission is to develop standards that facilitate trade across international borders.
- In 1979, the Technical Committee 176 (ISO/TC 176) was established to create international standards for quality assurance.
- Representatives from the United States and many other countries served on the committees responsible for developing ISO 9000.
- Early in the 1990s, the chair of the consortium was a U.S. citizen from American Telephone & Telegraph (AT&T).
- The U.S. standards organization within ISO is the American National Standards Institute (ANSI).
- The American Society for Quality (ASQ) has published a U.S. version of the ISO 9000 standards under the name Q9000.
- ISO serves only as a disseminator of information on system quality.
- ISO 9000 certificates are not issued on behalf of ISO.
- ISO does not monitor the activities of ISO 9000 accreditation bodies. Monitoring is done by accreditation boards within member nations.
Philosophy of ISO 9000
ISO 9000 places the responsibility for the establishment, performance, and maintenance of a quality system directly with a company's top management:
- ISO requires the top management to define a quality policy, provide adequate resources for its implementation, and verify its performance.
- Top management must demonstrate how its employees acquire and maintain awareness of its quality policy.
The ISO 9000 process strives for generic applicability:
- No specific methods, statistical processes, or techniques are mandated.
- Emphasis is on the overall objective of meeting customer expectations regarding the output of the system quality process.
- ISO has said that it will never issue industry (product-specific) quality guidelines.
ISO 9000 strives to achieve a quality system by employing the following practices for continuous improvement:
- Prevention rather than detection by inspection
- Comprehensive review of critical process points
- Ongoing communication between the facility, its suppliers, and its customers
- Documentation of processes and quality outcomes
- Management commitment at the highest levels
ISO 9000 provides a clear definition of the management style required to achieve a "world-class" quality system:
- Formal organization that delineates responsibilities
- Documented, authorized, and enforced procedures for all key activities
- Full set of archived but periodically analyzed quality outcome records
- Set of periodic reviews to track system quality performance and plan and implement corrective actions
- Philosophy of regulating, but not eliminating, individual initiative in achieving system quality
ISO 9000 provides a facility with a formal management style leading to system quality. The measure of success in implementing system quality is determined by well-organized, well-planned, and well-executed periodic internal and external audits of the processes and quality outcomes of the facility.
The majority of ISO member nations will not mandate the adoption of the ISO 9000 standards in the foreseeable future. To date, only Australia mandates adoption of the standards.
How well the ISO standards facilitate trade in the international marketplace will determine how widespread their use becomes.
