ISO 9000: Examples of Converting and Tailoring International and National Quality Standards to Industry-Specific Standards
This article examines the relationship between ISO 90001 and some of the subsequent industry-specific add-ons or derivatives that it has engendered. The intent is to examine the possibility of adopting, converting, and tailoring one of the derivative documents for use in other industries. Companies that do not presently have or use reliability, maintainability, or other product assurance standards, or are dissatisfied with existing standards as written, may also want to consider working within their industries to either adopt and/or modify existing standards to meet their needs. With the decline in the availability and use of military standards dealing with reliability, maintainability, and quality, this is an increasingly frequent possibility.
Thus, we will examine the possibility of adopting (either in whole or in part) one or more of these existing industry-specific Quality System derivatives in an industry other than that for which it was written. This approach might be preferable and certainly would be more cost effective than creating a new fromscratch standard for a different industry. Finally, assuming that it is possible to draw upon one or more of the derivatives, we will examine which of these specific add-ons would be a more likely candidate for a given application.
ISO 9000 Background: Why Industry-Specific Derivatives May Be Needed
The ISO 9000 series of documents underwent a radical change from the 1994 version to the 2000 version. In the latter, the emphasis shifted the focus from up-front ISO 9000 certification to actually using the standard to improve quality. Some of the other benefits of ISO 9000:2000 are a more user-friendly language, a smaller set of interlocking documents, and more universal applicability.
ISO 9000 is in reality a family of standards. In the 2000 revision, the number of standards was reduced from 27 to just 4 documents. These remaining documents were then extensively revised, new requirements were added, other requirements were significantly changed, and the scheme for numbering paragraphs was completely revised as shown in Table 1.
ISO 9001:2000, Quality Management Systems Requirements is the key remaining document used for certification (i.e., to assess a producers ability to meet customer and applicable regulatory requirements) and is now used to specifically address and quantify customer satisfaction.
A major new requirement of ISO 9001:2000 is for organizations to actually implement actions necessary for achieving continual improvement of processes and the quality management system. This change has placed a much greater emphasis on the continued improvement of processes, and on the quantitative assessment of product quality.
Table 1. Comparison of ISO 9001 1994 and 2000 Tables of Contents
2. Normative References
4. Required Tasks
(4.1 4.20: Individual Tasks)
2. Normative References
3. Terms and Definitions
4. Quality Management System
5. Management Responsibility
6. Resource Management
7. Product Realization
8. Measurement, Analysis, and Improvement
Thus one important new element in ISO 9001:2000 is the requirement to actually measure processes, products, and quality objectives. The document recognizes that measurements are important, vital in fact, if organizations are going to have any chance of assessing, monitoring, and improving the quality of their product or service.
ISO 9001:2000 therefore implies that these quality objectives must be measurable this is the first basic requirement for an organization. Whatever product and process measurements are applied, however, they must be compatible with that industry and thus lend positive support to the quality objectives.
Measurement needs to be done with clear objectives in mind; the parameters to be measured must be carefully chosen so that both quantitative and qualitative benefits are obtained. A measurement program that shows no tangible evidence of benefit will soon be discarded. At worst, it may be continued by personnel with no clear understanding of what is required, simply because it has become proceduralized. This wastes time and effort and degrades the prime objectives of measurement.
At this time ISO 9001 is the only standard in the ISO 9000 family against which third-party certification are carried out. Note, however, that the focus of this document is on the requirements themselves, and not on details of the actual measurements. Thus concern with the metrics, the identification and actual measurement of specific parameters is one of the prime focal points of these industry-specific derivatives. With the basic parameters and their associated metrics clearly identified for a specific industry, a template for more focused measurement can then be developed.
Overview of Some ISO 9001 Derivatives
Each of the five industry-specific quality system derivatives considered in this article was prepared by a professional organization using industry experts with the intent of addressing perceived weakness in ISO 9001 relative to that specific industry. Thus, one of their goals was to further enhance the certification process within that specific industry. These documents, however, identify with and represent quite diverse industries. Four of these five derivative documents deal with industries producing hardware, while the fifth one deals with software products.
The documents themselves, QS 9000 (Automotive industry), AS 9000 & AS 9100 (Aerospace industry), TL 9000 (Telecommunication industry), and TickIT Guide (Software industry) are very different. Although these five industry-specific derivatives all claim to be quality system add-ons to ISO 9001, the basic layout formats that they utilize to address these perceived weaknesses are very different.
Of these various derivative documents, AS 9100, Quality Systems Aerospace Model for Quality Assurance in Design, Development, Production Installation and Servicing, published by the Society of Automotive Engineers (SAE), is the newest. It is also the easiest and most straight forward to work with. It retains the identical ISO 9001 paragraph titles and numbering scheme (see Table 1) and reproduces, within the document itself, the text from the applicable paragraphs of two different ISO 9001 versions (i.e., the current version ISO 9001:2000 and the earlier version ISO 9001:1994). The two ISO versions are then addressed in two distinct sections; thus, each one details the specific (Aerospace) changes within the context of the original ISO requirement. This format itself is a significant advantage for a potential new user.
AS 9000, Aerospace Basic Quality System Standard, also published by the SAE, is essentially an older version of AS 9100, and for the purposes of this article can be considered to have been replaced by the newer document.
TL 9000, published by Quality Excellence for Suppliers of Telecommunications (QuEST) Forum, takes a slightly different approach. It starts out by breaking out the subject material into two separate documents, the first document dealing with requirements and the second dealing with measurements. Consequently, the user needs two separate documents.
The first TL 9000 document, Quality Management System Requirements Handbook, likewise retains the identical ISO 9001 paragraph titles and numbering scheme (see Table 2). It reproduces, within the document itself, the text from the applicable paragraphs of ISO 9001:2000 and details the specific (Telephone industry) changes within the context of the original ISO requirements.
The second TL 9000 document Quality Management System Measurements Handbook does not follow this approach; instead, it defines a minimum set of performance measurements unique to the telecommunication industry. The measurements are then selected to guide progress and evaluate results of quality management system implementation.
TickIT Guide, published by the British Standards Institute (BSI), is intended to be used as a Software Sector Quality Certification Scheme by the software community. It provides a clause-byclause correlated guide (rather than a specification) for software developers. It also contains specific certification procedures relate directly to ISO 9001:2000. Where specific requirements of this standard are implied, the applicable portions of ISO 9001:2000 are likewise reproduced in full within this document. However, since this document was prepared specifically for dealing with the unique considerations within the software industry, application to a hardware-based industry would appear to be somewhat more limited.
QS-9000, Quality System Requirements, published by the Automotive Industry Action Group (AIAG), takes an entirely different organizational approach. This is the earliest of the industry-specific derivatives, originally published in 1994. It has not been updated to the ISO 9000:2000 version. Furthermore, it does not reproduce the text from either ISO 9001:1994 or ISO 9000:2000. It only refers to the applicable ISO 9000 paragraph numbers. This can create an immediate problem because the entire paragraph numbering scheme, as shown in Table 2, was changed radically between ISO 9001:1994 and ISO 9001:2000.
QS-9000 consists of two major sections Section I: ISO 9000
Based Requirements and Section II: Customer-specific Requirements. Unfortunately Section I is based upon the older version ISO 9001:1994 (see Table 2) rather than on the current version ISO 9001:2000. This makes QS-9000 extremely difficult to compare with the current version of ISO 9001. It is this authors opinion that this fact alone would make QS-9000, although almost certainly the best known and currently the most widely used, the last choice among the possible add-on specification choices. Section II dealing with customer-specific requirements is not directly correlated in any way with ISO 9001 requirements.
Table 2. ISO 9000:1994 Elements Versus ISO 9000:2000 Elements
Guidelines for selection and use
ISO 8402: Vocabulary
|ISO 9000: Quality management systems -- Fundamentals and vocabulary
| ISO 9004-1: Guidelines for managing quality system elements
Guidelines for managing the quality of service activities
Guidelines for managing the quality of processed materials
Guidelines for creating quality improvements
Quality management systems -- Guidelines for performance improvements
Quality assurance -- Design, manufacturing, installation, and servicing systems
ISO 9002: Quality assurance -- Production and installation
Quality assurance -- Final product inspection and test
Quality management systems -- Requirements
PRISM. One real world application of this analysis was recently made in the RACs PRISM Reliability Prediction Tool. Within the PRISM tool an assessment is made regarding the quality level that can be anticipated from a given producer. This assessment is compiled based upon answers to a series of specific questions regarding the producers quality program, methods, and documentation. Initially only QS-9000 was recognized as a valid measure of product/process quality. After considering the other derivative documents it was concluded that all four of the hardware industry-specific derivatives could be considered effectively equivalent for the purpose of identifying and quantifying the Part Quality assessment. Also TickIT certification was also recognized as a significant enhancement beyond just ISO 9001 certification in the software arena.
Canadian Experience ISO 9000 versus QS-9000. A study2 recently published by the Standards Council of Canada Information and Research Services found some interesting facts comparing ISO 9000 registration versus its industry-specific derivative QS-9000 registration.
These findings were the result of nearly 3,000 telephone interviews with Canadian private-sector businesses conducted between November 1998 and January 1999. It was the first largescale, multi-sector study of Canadas experience with ISO 9000 and QS-9000 and provides an objective, statistically representative review of Canadian firms relationship with the standards.
Within a section titled: Comparative analysis: ISO 9000 registered versus QS-9000 registered, this study found that:
Organizations registered to ISO 9000 were generally smaller than those registered to QS-9000. QS-9000 registered organizations came from a much narrower range of industry sectors.
Exports were particularly important to QS-9000 registered companies. Almost all exported their goods and services and derived a significant proportion of their revenues from export sales.
QS-9000 registered organizations were significantly more likely than ISO 9000 registered organizations to have had a quality management system before implementing and registering the current system.
While motivating factors were fairly similar between ISO 9000 and QS-9000 registered organizations, customers and competitors consistently represented a stronger influence in the case of QS-9000.
Levels of satisfaction with the registration process were generally similar. The only notable difference was that QS-9000 registered organizations appeared to be more satisfied with their ability to find information and assistance.
Almost all respondents in both groups noted a variety of benefits from using or registering to the standards, including greater quality awareness, greater self-discipline, improved management practice, and increased quality.
Registered organizations had a positive attitude toward both series of standards. Significant majorities believed that they help an organization to compete globally, and that they are worth considering for any organization.
The conclusion was that the survey paints a generally positive picture of Canadas experience with both ISO 9000 and QS-9000. It shows that both standards are widely recognized, accepted and respected, that they provide genuine benefits to the organizations that use them, and that their implementation and registration is, despite the costs involved, generally a positive experience.
NASA. A few years ago a goal was set for NASA Headquarters and all of the NASA Centers to obtain and maintain ISO 9001 registration for all key processes. The NASA HQ ISO 9001 Program Office was to lead this registration process and a HQwide Corrective and Preventive Action/Internal Audit Team was established. The Team was comprised of representatives from each HQ office. On September 17, 1999, NASA Headquarters, all of the NASA Centers, the Jet Propulsion Laboratory and all of NASAs Government Operated Facilities achieved ISO 9001 registration. With this achievement, NASA became the first Government Agency in the World (Federal or State) to have multiple sites under an ISO 9001 registration.
TE-9000. Within the literature, reference is also sometimes (erroneously) made to a TE-9000. TE-9000 is actually a shorthand nomenclature for a supplement to QS-9000. Properly identified as the Tooling and Equipment Supplement, this document applies QS-9000 to suppliers of tooling, equipment, and related products. This Supplement document is an excellent example of the tailoring of an existing industry-specific ISO 9000 derivative to the specific needs of a somewhat different industry.
The RIAC web site http://www.theRIAC.org
has an extensive listing of documents identified in this article and other potential reliability, maintainability, and quality specifications and standards. The web site listing include already recognized national, international, and military documents (found under the heading: R&M Standards) that may potentially be considered for applicability beyond their traditional application. Certainly a great deal of the groundwork has already been performed in the preparation of these documents. Information has already been compiled and assembled by knowledgeable experts into potentially useful formats.
However, it is the authors opinion that, in most instances, ISO 9000 and one or more of the industry-specific derivatives discussed in this article would certainly be the recommended starting point to find, convert or tailor a suitable Quality System specification.