Bridge Design Manual - 2002

Chapter 15 The Quality System ISO 9000

15 THE QUALITY SYSTEM ISO 9000

15.1 GENERAL New construction specifications require quality management from both companies and engineers. The suitable high class Quality System described in this chapter is to be applied with this Manual specifications (see Chapter 2: General Requirements, section 2.1: Design Philosophy) within the Contractor's organization. The Contractors or Consultants who do not have such a Quality System are not pre-qualified for design and construction of Structures. 15.5.1 NEW QUALITY SYSTEM STANDARD The ISO (International Standards Organization) in Geneva, Switzerland has been developing voluntary technical standards over almost all sectors of business, industry and technology since 1947. The ISO 9000 standards are a set of international quality management standards and guidelines. Since their initial publication in 1987, they have earned a global reputation as the basis for establishing quality management systems (QMS). Three of the current standards, ISO 9001, 9002 and 9003, have been used extensively as the basis for independent (third party) quality system certification. This has resulted in the certification of over 211000 organisations world-wide, with many more in the process of setting up and implementing quality management systems. The ISO 9000 quality management systems (QMS) standards have taken on a completely different look under revisions released December 15, 2000. The International Organization for Standardization (ISO) requires all of its standards to be reviewed every five years to determine whether they should be confirmed, revised or withdrawn. ISO 9000, first released in 1987, underwent limited revisions in 1994. A more thorough revision was begun by ISO Technical Committee (TC) 176, Quality Management and Quality Assurance, in 1996, with Subcommittee (SC) 2, Quality Systems, developing the revised standards. The revised ISO 9000 series consists of four primary standards, replacing more than 20 standards and documents. These new standards were preceded by the First Committee Draft (CD1), released in July 1998; the Second Committee Draft (CD2), published in February 1999; the Draft International Standard (DIS), released in November 1999; and the Final Draft International Standard (FDIS), published in September 2000. The four primary standards are ISO 9000, Quality Management Systems - Fundamentals and

Ethiopian Road Authority

Page 15-1

Chapter 15 The Quality System ISO 9000

Bridge Design Manual - 2002

Vocabulary, replacing ISO 9000-1 and 8402; ISO 9001, Quality Management Systems Requirements, replacing ISO 9001, 9002 and 9003; ISO 9004, Quality Management Systems - Guidelines for Performance Improvements, replacing ISO 9004-1; and ISO 19011, Guidelines on Quality and/or Environmental Management Systems Auditing, replacing ISO 10011-1, 10011-2 and 10011-3, as well as the ISO 14010, 14011 and 14012 environmental auditing standards. ISO 9000, 9001 and 9004 were published December 15. ISO 19011 is slated for publication in 2002. Other old ISO 9000 standards and documents are being reviewed by ISO/TC 176 for incorporation into the new standards, withdrawal or reissue as technical reports. The new standards, particularly ISO 9001, are designed to be more generic, follow a processbased structure and be more compatible with the ISO 14000 series of environmental management systems (EMS) standards, allowing for integrated management systems. Under the 2000 revisions, ISO 9001 has become more generic through the new option of being tailored to omit requirements that don't apply to an organization or limiting the scope of application under Section 1.2, Application. This eliminates the need for the less comprehensive ISO 9002 and 9003 standards. In addition, there are no QMS documentation layout or structure requirements. The new process-based structure, similar to that used in ISO 14001, creates a completely different look for ISO 9001. The 20 elements have been replaced by five clauses containing 23 elements. The two standards are more compatible under this approach, making it easier to integrate management systems and combine documentation. ISO 9004, Section 4.3 and ISO 9000, Section 0.2 set forth eight quality management principles, which have been identified as forming a framework for improved performance by an organization. These principles are the basis of ISO 9001. They are:

Customer Focus Leadership Involvement of People Process Approach System Approach to Management Continual Improvement Factual Approach to Decision Making Mutually Beneficial Supplier Relationships

Major clauses of ISO 9001: 2000 are: 4 Quality Management System (2 elements), which states general requirements, along with such documentation requirements as the quality manual, procedures, work instructions and records. It sets the general framework to establish a quality management system, which
Page 15-2 Ethiopian Road Authority

Bridge Design Manual - 2002

Chapter 15 The Quality System ISO 9000

defines and manages processes in order to produce a good product or service and allow for continual improvement. 5 Management Responsibility (6 elements), under which management defines policy, objectives, planning and quality management system requirements, while providing for feedback through management review for change authorization and initiation of improvement. It addresses management's responsibility to establish a system that continually meets customer needs and expectations, even in times of organizational change. This responsibility includes quality objectives at each organizational function and level. 6 Resource Management (4 elements), where necessary resources, such as human resources and facilities, are determined and applied. Theses resources, which include new elements covering infrastructure and work environment, are required to implement and maintain the quality management system. 7 Product Realization (6 elements), under which processes, such as customer-related processes, design, purchasing, and production and service provision, are established and implemented. These processes are needed to manufacture product and/or deliver services from receipt to delivery. Organizations must define and describe their unique business processes, but are not obliged to use the standard's structure. 8 Measurement, Analysis and Improvement (5 elements), where results are measured, analyzed and improved through internal audits, nonconformity control and continual improvement. Organizations are required to measure and monitor processes, and product and/or service conformity. Collected data must be analyzed to initiate corrective and preventive action for continual improvement. 15.1.2 QUALITY MANAGEMENT PRINCIPLES A quality management principle is a comprehensive and fundamental rule or belief, for leading and operating an organization, aimed at continually improving performance over the long term by focusing on customers while addressing the needs of all other stakeholders. With growing global competition, quality management is becoming increasingly important to the leadership and management of all organizations. The Quality Management Principles apply universally to all user groups. This document focuses on the needs of executive managers. The Quality Management Principles shall be incorporated into new or existing documents to satisfy the needs of other user groups. By applying the following eight Quality Management Principles, organizations will produce benefits for customers, owners, people, suppliers, local communities and society at large. Principle 1 Customer-Focused Organization Organizations depend on their customers and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations.

Ethiopian Road Authority

Page 15-3

Chapter 15 The Quality System ISO 9000

Bridge Design Manual - 2002

Principle 2 Leadership Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives. Principle 3 Involvement of People People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization's benefit. Principle 4 Process Approach A desired result is achieved more efficiently when related resources and activities are managed as a process. Principle 5 System Approach to Management Identifying, understanding and managing a system of interrelated processes for a given objective improves the organizations effectiveness and efficiency. Principle 6 Continual Improvement Continual improvement should be a permanent objective of the organization. Principle 7 Factual approach to decision making Effective decisions are based on the analysis of data and information. Principle 8 Mutually beneficial supplier relationships An organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value. 15.2 BACKGROUND OF THE EXISTING QUALITY SYSTEM STANDARD ISO 9000 15.2.1 BASICS With the exception of ISO 9000 and ISO 14000, the vast majority of ISO standards are highly specific. They are documented agreements containing technical specifications or other precise criteria to be used consistently as rules, guidelines, or definitions of characteristics to ensure those materials, products, processes and services are fit for their purpose. It also explains why ISO standards were, before ISO 9000 and ISO 14000, principally of concern to engineers and other technical specialists concerned by the precise scope addressed in the standard. ISO 9000 was published in 1987 followed nearly 10 years later by ISO 14000, which have brought ISO to the attention of a much wider business community. These are very different from the majority of ISOs highly specific standards. 15.2.2 GENERIC MANAGEMENT SYSTEM STANDARDS The vast majority of ISO standards are highly specific to a particular product, material, or process. However, both ISO 9000 and ISO 14000 are known as generic management system standards.

Page 15-4

Ethiopian Road Authority

Bridge Design Manual - 2002

Chapter 15 The Quality System ISO 9000

Generic means that the same standards can be applied to any organization, large or small, whatever its product including whether its "product" is actually a service in any sector of activity, and whether it is a business enterprise, a public administration, or a government department. Management system refers to what the organization does to manage its processes, or activities. The larger the organization, and the more people involved, the more the likelihood that there are some written procedures, instructions, forms or records. All this is usually collected in a Quality System File, which may consist of 1 to 100 files, depending on the size of the company. To be really efficient and effective, the organization can manage its way of doing things by systematizing it. This ensures that nothing important is left out and that everyone is clear about who is responsible for doing what, when, how, when, why and where. This is usually made by so-called checklists or forms. Management system standards provide the organization with a model to follow in setting up and operating the management system. This model incorporates the features which experts in the field have agreed upon as representing the state of the art. A management system that follows the model or "conforms to the standard" is built on a firm foundation of state-ofthe-art practices. Large organizations, or ones with complicated processes, could not function well without management systems although they may have been called by some other name. ISOs management system standards now make these successful practices available for all organizations. 15.2.3 ISO 9000 AND ISO 14000 IN PLAIN LANGUAGE Both "ISO 9000" and "ISO 14000" are actually families of standards which are referred to under these generic titles for convenience. Both families consist of standards and guidelines relating to management systems, and related supporting standards on terminology and specific tools, such as auditing (the process of checking that the management system conforms to the standard). ISO 9000 is primarily concerned with "quality management". The standardized definition of "quality" in ISO 9000 refers to all those features of a product (or service) which are required by the customer. "Quality management" means what the organization does to ensure that its products conform to the customers requirements. ISO 14000 is primarily concerned with "environmental management". In plain language, this means what the organization does to minimize harmful effects on the environment caused by its activities. Both ISO 9000 and ISO 14000 concern the way an organization goes about its work, and not

Ethiopian Road Authority

Page 15-5

Chapter 15 The Quality System ISO 9000

Bridge Design Manual - 2002

directly the result of this work. In other words, they both concern processes, and not products at least, not directly. Nevertheless, the way in which the organization manages its processes is obviously going to affect its final product. In the case of ISO 9000, it is going to affect whether or not everything has been done to ensure that the product meets the customers requirements. However, neither ISO 9000 nor ISO 14000 are product standards. The management system standards in these families state requirements for what the organization must do to manage processes influencing quality (ISO 9000) or the processes influencing the impact of the organizations activities on the environment (ISO 14000). In both cases, the philosophy is that these requirements are generic. No matter what the organization is or does, if it wants to establish a quality management system or an environmental management system, then such a system has a number of essential features which are spelled out in ISO 9000 or ISO 14000. 15.2.4 THE ISO 9000 FAMILY ISO 9001, ISO 9002 and ISO 9003 may have stolen the limelight, but to get the maximum benefits out of ISO 9000, then the whole family should be used in an integrated manner. The ISO 9000 family consists at present of more than 20 standards and guidelines. A 10-step model for implementing ISO 9000 is a basis for continuous improvement. The particular standards and guidelines appropriate to each step are indicated in the brochure, Selection and use of ISO 9000 (ISBN 92-67-10267-2). ISO 9000, with its main parts ISO 9001, ISO 9002 or ISO 9003, the three quality assurance models against which organizations can be certified works like this: ISO 9001 sets out the requirements for an organization whose business processes range from design and development, to production, installation and servicing; for an organization which does not carry out design and development, ISO 9002 is the appropriate standard, since it does not include the design control requirements of ISO 9001 otherwise, its requirements are identical; ISO 9003 is the appropriate standard for an organization whose business processes do not include design control, process control, purchasing or servicing, and which basically uses inspection and testing to ensure that final products and services meet specified requirements.

So, an organization chooses that its quality system be certified against ISO 9001, ISO 9002 or ISO 9003 according to the business processes covered by the quality system. There is no difference of quality ranking between the three standards. As mentioned in subchapter 15.1: General all of these three will be changed to only one - ISO 9001 in the near future.

Page 15-6

Ethiopian Road Authority

Bridge Design Manual - 2002

Chapter 15 The Quality System ISO 9000

15.2.5 TECHNICAL COMMITTEE NO 176 - QUALITY MANAGEMENT AND QUALITY ASSURANCE In the ISO system, standards are developed by national delegations of experts from business, government and other relevant organizations. They are chosen by the national standards institutes participating in the technical committee concerned and they are required to present a consensus position based on the views of stakeholders in their country. In 1979, a new ISO technical committee was approved: ISO/TC 176, Quality management and quality assurance. Today, the number of countries participating in ISO/TC 176 is more than 50, with around another 20 as observers. The new committee set to work and, in 1986 completed its first standards. Published in the early part of 1987, these standards were known as the ISO 9000 series. When ISO/TC 176 embarked on the development of generic quality management standards for worldwide application, it was able to take advantage of a substantial base of national experience, notably in the United Kingdom and in Canada. Other countries with welldeveloped quality management practices, such as Japan, also took a keen interest in the work of the new committee. 15.2.6 CERTIFICATION AND REGISTRATION The next concrete steps towards a Quality System are certification, registration and finally accreditation. These steps however require more detailed manuals from ISO - see subchapter 15.3: Information Publications on Quality System below. Contact the Quality and Standardization Authority of Ethiopia for details. The maintaining of the Quality System will often be made by means of regular inspections by the Authority. The result of the inspection shall be corrected and/or added to the Quality System in order to keep the Certificate for the future. If the company is unable to maintain a high quality, the Certificate will be withdrawn by the Authority and the company deleted from the registration list. 15.3 INFORMATION PUBLICATIONS ON QUALITY SYSTEM 15.3.1 GENERAL ISO brochure: Compatible technology worldwide An easy-to-read introduction to ISO and the world of international standardization. Answers the most common questions asked by newcomers to the field, press and public. 1994, 20 p., free, ISBN 92-67-10205-2 ISO in brief. 1997, 16 p., free, ISBN 92-67-10250-8 ISOs long-range strategies 1999-2002: Raising standards for the world Long-range strategic plan for improvement developed by ISO for the three-year period (full version). 1998, 18 p., free, ISBN 92-67-10285-0

Ethiopian Road Authority

Page 15-7

Chapter 15 The Quality System ISO 9000

Bridge Design Manual - 2002

NOTE A summary of the full version exists, in the form of a small brochure entitled: ISO in the New Century. 1998, 12 p., free, ISBN 92-67-10290-7 15.3.2 ACCESS TO INTERNATIONAL STANDARDS ISO Catalogue List of all published ISO standards; updated quarterly by cumulative supplements. Annual, 1138 p., price group M, CHF 95,50, ISBN 92-67-10291-5 ISO Technical Program Information on the titles and stages of development of all draft standards. Biannual, 264 p., bilingual, price group A, CHF 32,50, ISBN 92-67-01111-1 15.3.3 COLLABORATION WITH OTHER INTERNATIONAL ORGANIZATIONS ISO Liaisons Detailed list of the International organizations in liaison with ISO. 1995, 8th ed., 180 p., bilingual, price group G, CHF 65,50, ISBN 92-67-01087-5 ISO Development Manuals A leaflet that presents the manuals intended specifically for developing countries. 1998, 16 p., free, ISBN 92-67-10286-9 Development Manual 1 Establishment and management of a national standards body Outline advice for new standards authorities, including examples of national standards acts. 1994, 2nd ed., 96 p., price group B, CHF 37,50, ISBN 92-67-10204-4 Development Manual 2 Conformity assessment The objective of this development manual is to introduce interested persons in developing countries to the basic concepts of conformity assessment and to indicate which International guides and technical documents they should refer to in order to obtain full information on this important subject. 1998, 114 p., price group A, CHF 32,50, ISBN 92-67-10277-X Development Manual 3 Training of technical staff national level and company level Essentials of training for the various functions of national and company standardization activities, and some pertinent technical material. 1985, 130 p., price group D, CHF 49,00, ISBN 92-67-10110-2 Development Manual 4 Teaching of standardization in institutions of higher learning in developing countries Includes introduction, types of standards, organization and elaboration of standards, metrology, quality assurance/certification and standards in production planning. Curricula for two courses (short and long) are tabulated with reference to appropriate chapters. 1987, 114 p., price group B, CHF 37,50, ISBN 92-67-10132-3

Page 15-8

Ethiopian Road Authority

Bridge Design Manual - 2002

Chapter 15 The Quality System ISO 9000

Development Manual 5 Development and organization of a company standards department Helps to provide guidelines for companies towards the establishment of company standards systems and assists them in using standardization achievements effectively. 1988, 66 p., price group A, CHF 32,50, ISBN 92-67-10145-5 Development Manual 6 Application of standards This manual discusses different aspects of the application of standards at all levels and proposes methodologies for the promotion of their application. 1991, 48 p., price group A, CHF 32,50, ISBN 92-67-10167-6 Development Manual 7 Participation in International standardization The purpose of this manual is to encourage developing countries to participate more actively in the technical work of ISO and to commit themselves to implementing International Standards whenever possible in their national standardization systems. 1992, 84 p., price group A, CHF 32,50, ISBN 92-67-10169-2 Development Manual 8 Organization and development of a national standards information centre Provides all the background knowledge, technical regulations, organizational requirements and general advice for setting up a national standards information centre, the central source for key information for traders, manufacturers and exporters on standardization, at the national, regional and International levels. 1993, 74 p., price group A, CHF 32,50, ISBN 92-67-10189-7 Development Manual 9 Establishment of a testing laboratory for a national standards body This manual is intended to provide guidance for those who undertake to plan and set up a new national testing laboratory. It defines the basic rules that should be followed to ensure that this undertaking is carried out in an efficient and orderly manner to achieve the best utilization of financial and human resources available in the country. 1997, 80 p., price group A, CHF 32,50, ISBN 92-67-10259-1 Development Manual 10 Environmental Management and ISO 14000 The purpose of this manual is to introduce the ISO 14000 series of standards to readers from developing countries who wish to obtain an overall idea about the published standards as well as those still in preparation and how they were developed. It can be of interest to any reader who wants to gain insight into those aspects of environmental management dealt with by ISO/TC 207, Environmental management, and its subcommittees. 1998, 137 p., price group D, CHF 49,00, ISBN 92-67-10280-X The role of standardization in economic development The complete proceedings of the International Seminar organized by the World Bank and ISO in 1992; discusses through the various presentations how the inclusion of a standardization component in projects for developing countries significantly increases the chances of success of such projects. 1993, 198 p., price group L, CHF 88,50, ISBN 92-67-10184-6
Ethiopian Road Authority Page 15-9

Chapter 15 The Quality System ISO 9000

Bridge Design Manual - 2002

Launching a standards initiative Guidelines for developing countries The purpose of these Guidelines is to help developing countries, members of ISO (or IEC), to prepare their proposals for the establishment of International Standards in a way that ensures the maximum chances of success. They prescribe a series of preparatory studies and actions destined to put the proposals for starting an International standardization project on track and to keep it there. 1996, 16 p., free 15.3.4 QUALITY MANAGEMENT AND CONFORMITY ASSESSMENT ISO Standards Compendium ISO 9000 Quality Management This compendium groups together the generic ISO quality management and quality assurance standards. It contains all the International Standards and Final Draft International Standards which collectively make up the ISO 9000, and the associated ISO 10000, series of standards. 1998, 7th ed., 436 p., CHF 280,00, ISBN 92-67-10265-6 ISO 9000 on CD-ROM: The complete collection of International Standards for Quality Management An electronic version for easy reference, with keyword search, glossary and on-line help. 1997, CHF 450,00, ISBN 92-67-10257-5 ISO 9000 and ISO 14000 on CD-ROM: The complete collection of International Standards for Quality Management and Environmental Management An electronic version for easy reference, with keyword search, glossary and on-line help. 1997, CHF 595,00, ISBN 92-67-10256-7 Selection and use of ISO 9000 This brochure gives a general perspective on the ISO 9000 standards and demonstrates how they can form a basis for continuous improvement and business excellence. Advice is given on how to distinguish between the various publications in the ISO 9000 family, and how they can be used for maximum benefit.1998, 12 p., CHF 10,00, ISBN 92-67-10267-2 Certification and related activities: Assessment and verification of conformity to standards and technical specifications A decision-making tool for all those who have to evaluate, choose or operate the various programs used in trade today to demonstrate that products and services measure up to standards and technical specifications. 1992, 172 p., price group J, CHF 76,50 ISBN 92-67-10176-5 The ISO Survey of ISO 9000 and ISO 14000 certificates, Seventh cycle - 1997 The 7th cycle uses exactly the same methodology as previous cycles to produce a country-by-country breakdown of data collected up to and including 1997. There is a large amount of data on ISO 14000 certification, which has grown rapidly during 1997. 1998, 8p free, ISBN 92-67-10284-2

Page 15-10

Ethiopian Road Authority

Bridge Design Manual - 2002

Chapter 15 The Quality System ISO 9000

15.3.5 ENVIRONMENT Development Manual 10 Environmental Management and ISO 14000 The purpose of this Manual is to introduce the ISO 14000 series of standards to readers from developing countries who wish to obtain an overall idea about the published standards as well as those still in preparation and how they were developed. It can be of interest to any reader who wants to gain insight into those aspects of environmental management dealt with by TC 207 and its Subcommittees. 1998, 137 p., price group D, CHF 49,00, ISBN 92-67-10280-X ISO 14000 on CD-ROM: The complete collection of International Standards for Environmental Management An electronic version for easy reference, with keyword search, glossary and on-line help. 1997, CHF 290,00, ISBN 92-67-10258-3 ISO Standards Compendium: ISO 14000 Environmental Management This compendium brings together in one volume all of the published International Standards developed by ISO Technical Committee 207, Environmental Management. It also includes Draft International Standards. 1998, 1st ed., price group XA, CHF 185,00, ISBN 92-67-10266-4 ISO 14000 Meet the whole family! This brochure provides a list of the ISO 14000 family of standards, ongoing work and other ISO 14000 publications. It describes two approaches to implementation, and gives an outline of their application at the organizational level and to products and services. Business benefits of ISO 14000 are also explained. 1998, 8p., CHF 10,00, ISBN 92-67-10283-4 15.3.6 INFORMATION AND DOCUMENTATION International Classification for Standards (ICS) Serves as a structure for catalogues of International, regional and national standards and other normative documents, and as a basis for standing-order systems. 1999, 4th ed., 90 p., price group B, CHF 37,50, ISBN 92-67-10289-3 SI Guide The SI Guide covers the basics of: the historical background, the principles of the SI, the base units, derived units, multiples and sub-multiples, additional units, printing rules, space and time, periodic phenomena, mechanics, heat, electricity and magnetism, light, acoustics, physical chemistry, atomic and nuclear physics activity, ionizing radiations, characteristic numbers, and it ends with conversion tables. 1998, 32 p., A6 format sold in packs of 10 for CHF 32,50, plus postage and packing, ISBN 92-67-10279-6.

Ethiopian Road Authority

Page 15-11