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REGISTERED. They are excerpts from www.iso.org, the International Organization for standardization website.
The following text is an integral reproduction of the content of the brochure "ISO 9000 Selection and use". The ISO 9000 family of international quality management standards and guidelines has earned a global reputation as the basis for establishing quality management systems. This brochure has been developed by ISO Technical Committee ISO/TC 176, Quality management and quality assurance, which is responsible for developing and maintaining the ISO 9000 family. The brochure has been updated to take into account the revisions of several of the core series standards in the ISO 9000 family which were published on 15 December 2000 by ISO (International Organization for Standardization). These revised standards are identified by the "2000" in their designation. The purpose of this brochure is to provide you with a general perspective on the ISO 9000 family of standards with emphasis on the features of the revised versions. It presents an overview of the standards and demonstrates how, collectively, they form a basis for continual improvement and business excellence. In particular, you will see how to distinguish between the various documents in the ISO 9000 family and how they may be utilized to your maximum benefit. The familiar three standards ISO 9001, ISO 9002 and ISO 9003 have been integrated into the new ISO 9001:2000. This brochure provides you with general information on how to use the revised standard together with other documents in the ISO 9000 family to meet your specific requirements. ISO 9001:2000 specifies requirements for a quality management system for any organization that needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements and aims to enhance customer satisfaction. ISO 9001:2000 has been organized in a user-friendly format with terms that are easily recognized by all business sectors. The standard is used for certification/registration and contractual purposes by organizations seeking recognition of their quality management system. The greatest value is obtained when you use the entire family of standards in an integrated manner. It is suggested that, beginning with ISO 9000:2000, you adopt ISO 9001:2000 to achieve a first level of performance. The practices described in ISO 9004:2000 may then be implemented to make your quality management system increasingly effective in achieving your own business goals. ISO 9001:2000 and ISO 9004:2000 have been formatted as a consistent pair of standards to facilitate their use. Using the standards in this way will also enable you to relate them to other management systems (e.g. environmental), many sector specific requirements (such as ISO/TS/16949 in the automotive industry) and will assist in gaining recognition through national award programmes.
ISO 9000 AND ISO 14000 IN BRIEF The ISO 9000 and ISO 14000 families are among ISO's most widely known standards ever. ISO 9000 and ISO 14000 standards are implemented by some 610 000 organizations in 160 countries. ISO 9000 has become an international reference for quality management requirements in business-to-business dealings, and ISO 14000 is well on the way to achieving as much, if not more, in enabling organizations to meet their environmental challenges. The ISO 9000 family is primarily concerned with "quality management". This means what the organization does to fulfil: - the customer's quality requirements, and - applicable regulatory requirements, while aiming to enhance customer satisfaction, and - achieve continual improvement of its performance in pursuit of these objectives. The ISO 14000 family is primarily concerned with "environmental management". This means what the organization does to: - minimize harmful effects on the environment caused by its activities, and - to achieve continual improvement of its environmental performance. The vast majority of ISO standards are highly specific to a particular product, material, or process. However, the standards that have earned the ISO 9000 and ISO 14000 families a worldwide reputation are known as "generic management system standards". "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. "Generic" also signifies that no matter what the organization's scope of activity, if it wants to establish a quality management system or an environmental management system, then such a system has a number of essential features for which the relevant standards of the ISO 9000 or ISO 14000 families provide the requirements. "Management system" refers to the organization's structure for managing its processes - or activities - that transform inputs of resources into a product or service which meet the organization's objectives, such as satisfying the customer's quality requirements, complying to regulations, or meeting environmental objectives. Latest update September 2003.
What are the main changes to the standards? The main changes that have been introduced in the consistent pair of quality management system standards are: - A new process-oriented structure and a more logical sequence of the contents - A continual improvement process as an important step to enhance the quality management system - Increased emphasis on the role of top management, which includes its commitment to the development and improvement of the quality management system, consideration of legal and regulatory requirements, and establishment of measurable objectives at relevant functions and levels. - The concept of "Application" of the standard has been introduced (in clause 1.2) as a way to cope with the wide spectrum of organizations and activities. - A requirement for the organization to monitor information on customer satisfaction as a measure of system performance. - Significant reduction in the amount of required documentation. - Terminology changes/improvements for easier interpretation. - Increased compatibility with the environmental management system standard ISO 14001 - Specific reference to quality management principles. - Consideration of the benefits and needs of all interested parties. - Addition of the concept of organizational self-assessment as a driver for improvement (ISO 9004:2000) [FAQ 014, March 2001]
What new requirements have been introduced into the revised ISO 9001 standard? The main new requirements include: - Continual improvement - Increased emphasis on the role of top management. - Consideration of statutory and regulatory requirements. - Establishment of measurable objectives at relevant functions and levels. - Monitoring of information on customer satisfaction as a measure of system performance. - Increased attention to resource availability. - Determination of training effectiveness. - Measurements extended to system, processes, and product. - Analysis of collected data on the performance of the quality management system [FAQ 015, March 2001]
Why has the requirement for monitoring of customer satisfaction been included in ISO 9001? "Customer satisfaction" is recognized as one of the driving criteria for any organization. In order to evaluate if the product meets customer needs and expectations, it is necessary to monitor the extent of customer satisfaction. Improvements can be made by taking action to address any identified issues and concerns. [FAQ 016, March 2001]
Will the revised standards improve customer satisfaction? The quality management system described in the revised standard is based on quality management principles that include the "process approach" and "customer focus". The adoption of these principles should provide customers with a higher level of confidence that products will meet their needs and increases their satisfaction. [FAQ 017, March 2001]
What is a process? Any activity or operation, which receives inputs and converts them to outputs, can be considered as a process. Almost all activities and operations involved in making a product or providing a service are processes.
For organizations to function, they have to define and manage numerous inter-linked processes. Often the output from one process will directly form the input into the next process. The systematic identification and management of the various processes employed within an organization, and particularly the interactions between such processes, may be referred to as the process approach to management. The revised quality management system standards are based on just such a process approach, in line with the guiding quality management principles. [FAQ 018, March 2001]
What is meant by "continual improvement"? "Continual improvement" requires an organization to focus on continually increasing the effectiveness and/or efficiency of its processes, to fulfill its policies and objectives. Continual improvement (where "continual" highlights that an improvement process requires progressive consolidation steps) responds to the growing needs and expectations of customers and ensures a dynamic evolution of the quality management system. [FAQ 019, March 2001]
How will the implementation of the new standards help my organization to improve its efficiency? ISO 9001:2000 aims at guaranteeing the effectiveness (but not necessary the efficiency) of the organization. For improved organizational efficiency, however, the best results can be obtained by using the new ISO 9004:2000 in addition to ISO 9001:2000. The guiding quality management principles are intended to assist an organization in continual improvement, which should lead to efficiency throughout the organization. [FAQ 020, March 2001] How will the revised standards improve the perception of ISO 9001 certification/registration? By demonstrating to organizations that the process of certification based on the new ISO 9001 standard adds value to their own business goals, a market-wide improvement in the perception of ISO 9001 certification should be developed. The rationale behind the revision process places great emphasis on making quality management systems closer to the processes of the organization and on continual improvement. As a result, the revised standards (ISO 9001:2000 and ISO 9004:2000) are directed to the achievement of business results, including satisfaction of customers and others.
There is confidence that management of the organization will be able to adopt the quality management system standards not only for certification purposes, but also as a profitable investment. [FAQ 021, March 2001]
Certification, registration and accreditation Your organizations management system has been independently audited and confirmed as being in conformity with ISO 9001:2000 or ISO 14001, for which you have been issued a certificate. In announcing this, which is the correct term to use: certification, registration or accreditation? Lets take the first two. According to the standardized definitions*, they are not quite the same thing. In the context of ISO 9001:2000 or ISO 14001, certification refers to the issuing of written assurance (the certificate) by an independent external body that has audited your management system and verified that it conforms to the requirements specified in the standard. Registration means that the auditing body then records your certification in its client register. So, your organizations management system has been both certified and registered. For practical purposes then, in the ISO 9001:2000 and ISO 14001 contexts, the difference between the two terms is not significant and both are acceptable for general use. Certification seems to be the term most widely used worldwide, although registration (from which registrar as an alternative to registration/certification body) is often preferred in North America, and the two are used interchangeably. On the contrary, using accreditation as an interchangeable alternative for certification or registration is a mistake, because it means something different. In the ISO 9001:2000 or ISO 14001 contexts, accreditation refers to the formal recognition by a specialized body an accreditation body that a certification body is competent to carry out ISO 9001:2000 or ISO 14001 certification in specified business sectors. In simple terms, accreditation is like certification of the certification body. Certificates issued by accredited certification bodies and known as accredited certificates may be perceived on the market as having increased credibility.
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