The ISO 9000 series of standards was first issued in 1987. Within a short period, these standards gained worldwide acceptance – unprecedented in the history of standardization – and started a powerful quality movement in industrialized nations as well as developing countries. According to the normal policy of ISO, all standards are reviewed at least every five years to ensure that they reflect the current state of the art.
Accordingly, the core standards, initially issued in 1987, underwent their first revision in 1994 on the basis of the experience gained during their implementation worldwide. This revision is being treated as a phase 1 revision because another major revision of these standards is already in process. Scheduled to take effect in phase 2, the revision to be completed in 1997-1998. The salient features of the phase 1 revision in core standards are briefly explained in this chapter.
Changes in ISO 9000-1:1994
ISO 9000-1:1994, quality management and quality assurance standards – Part 1 : Guidelines for selection and use is the first standard in this series, and the whole series is also commonly called the ISO 9000 series. This standard is a “roar map” for the ISO 9000 family of standards, and has undergone major changes in the 1994 revision. It has been greatly expanded and includes concepts that are fundamental building blocks for modern quality systems. These concepts are described below :
Clause 4 : Principal concepts
This clause describes the following basic concepts of quality :
Key objectives and responsibilities for quality :
The clause has acquired a strong emphasis on improving the quality of products and operations. On providing confidence that quality requirements are being met. This builds on the objectives in the 1987 version which focused on achieving and sustaining product quality.
Stakeholders and their expectations :
Stakeholders include employers, owners, customers, sub suppliers and society at large.
Distinction between quality-system requirements and technical product requirements.
The subject of the ISO 9000 standards is the quality system itself, which is applicable to organizations and not to products. This crucial distinction was not clear in the 1987 version, leading to many misunderstandings in practical use.
Generic product categories :
This sub clause classifies suppliers into four categories, namely, hardware, software, processed materials and services. The quality-system requirements for all categories are essentially the same but the terminology and management system details may differ.
Facets of quality :
The following four facets are presented as key contributors to product quality : quality due to definition of needs for a product, quality due to product design, quality due to conformance to product design and quality due to product support throughout its life cycle.
Process orientation :
In line with the contemporary use of quality concepts, emphasis is placed on preventing non-conformance rather than on inspecting the product against its specification. Operationally, this implies that the processes in an organization must be controlled in the broadest sense of the term. Sub clause 4.6 defines “process” and discusses related concepts, such as the following :
- All work is accomplished by a process.
- Processes involve people and other resources and apply to products in all generic product categories.
- Process inputs and outputs can be products or information.
Sub clause 4.7 states that every organization accomplishes its work through a network of processes. This network must be identified, organized and managed to provide consistent output. Sub clause 4.8 discusses the quality system in connection to the network of jobs.
Guidance on the use of quality-system standards
In addition to the concepts mentioned above, ISO 9000-1 : 1994 provides guidance on the following concepts :
Evaluating quality systems :
The ISO 9000 series is intended as a means of evaluating the effectiveness of a quality system, but the standards have not previously given a “big-picture” view of this role. Sub clause 4.9 presents three areas to be addressed for every process being evaluated.
- Process documentation and definition
- Process implementation and deployment
- Process effectiveness
This clause also clarifies the roles of management review and quality-system audits in the evaluation.
Value of documentation
Clause 5 stresses the importance of documentation, which is important for :
- Achieving the required (product) quality
- Evaluating quality systems
- Quality improvement
- Maintaining the improvements
Quality system situations
Clause 6 of the ISO 9000-1 standard identifies and clarifies the four situations in which the ISO 9000 series is intended to be used :
- Guidance for quality management
- Contractual agreements between first and second parties.
- Second-party approval or registration
- Third-party certification or registration
Selection and use of ISO 9000 standards on quality
Clause 7 of the standard replaces and expands the information in clauses 6 and 7 of the 1987 version. It is now a definitive source of guidance for selecting appropriate standards from the growing ISO 9000 family. The five revised core standards are described with 10 additional standards that have been published since 1987.
Clause 8 on the selection and use of international standards for external quality assurance, gives explicit attention to quality system situations calling for contractual agreements, second-party approval and registration. The clause emphasizes that both customers and suppliers must benefit from the standard selected and applied. With third-party registration, the selection of the quality-assurance standard should be agreed upon by the supplier and the third-party certification body or registrar, taking into account customer needs and supplier objectives. Typical means of demonstrating conformance to requirements and explicit additional considerations in contractual situations are discussed.
Three annexes have been added to ISO 9000-1, Annex A contains terms and definitions taken from ISO 8402, quality management and quality assurance – vocabulary. Annex B discusses product and process factors that should be considered in applying the ISO 9000 standards. Annex C provides information and guidance on the types of standards that are appropriate in the international, regional and national implementation domains, as well as industry/economic sectors. This guidance is provided with a view to minimizing the proliferation of standards that create non-tariff trade barriers.
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