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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 updated to take into account the revisions of several of the core series standards. Familiar three standards ISO 9001, ISO 9002 and ISO 9003 have been integrated into the new ISO 9001:2000.
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 updated to take into account the revisions of several of the core series standards. Familiar three standards ISO 9001, ISO 9002 and ISO 9003 have been integrated into the new ISO 9001:2000.
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 updated to take into account the revisions of several of the core series standards. Familiar three standards ISO 9001, ISO 9002 and ISO 9003 have been integrated into the new ISO 9001:2000.
standards The following text is an integral reproduction of the content of the brochure"ISO 9000 - Selection and use". Hard copies of the brochure are available from sales@iso.org. 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 Page 1 of 2 Selection and Use of the ISO 9000:2000 family of standards 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/iso9000/selection_use/selection_use.html?pr... gaining recognition through national award programmes. This brochure provides you with: Examples of typical applications of the documents; A step-by-step process to implement a quality management system; A brief view of the future evolution of the ISO 9000 family.
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Selection and use
Examples of the ISO 9000 standards in use ISO 9001:2000 is used if you are seeking to establish a management system that provides confidence in the conformance of your product to established or specified requirements. It is now the only standard in the ISO 9000 family against whose requirements your quality system can be certified by an external agency. The standard recognizes that the word "product" applies to services, processed material, hardware and software intended for, or required by, your customer. There are five sections in the standard that specify activities that need to be considered when you implement your system. You will describe the activities you use to supply your products and may exclude the parts of the Product Realization section that are not applicable to your operations. The requirements in the other four sections ? Quality management system, Management responsibility, Resource management and Measurement, analysis and improvement? apply to all organizations and you will demonstrate how you apply them to your organization in your quality manual or other documentation. Together, the five sections of ISO 9001:2000 define what you should do consistently to provide products that meets customer and applicable statutory or regulatory requirements. In addition, you will seek to enhance customer satisfaction by improving your quality management system. ISO 9004:2000 is used to extend the benefits obtained from ISO 9001:2000 to all parties that are interested in or affected by your business operations. Interested parties include your employees, owners, suppliers and society in general. ISO 9001:2000 and ISO 9004:2000 are harmonized in structure and terminology to assist you to move smoothly from one to the other. Both standards apply a process approach. Processes are recognized as consisting of one or more linked activities that require resources and must be managed to achieve predetermined output. The output of one process may directly form the input to the next process and the final product is often the result of a network or system of processes. The eight Quality Management Principles stated in ISO 9000:2000 and ISO 9004:2000 provide the basis for the performance improvement outlined in ISO 9004:2000. The nature of your business and the specific demands you have will determine how you apply the standards to achieve your objectives. Here are a few examples: Example 1 A metal parts fabricating company used ISO 9000:2000 to develop a plan to implement their quality management system. When they were ready, they prepared a quality manual and quality system procedures as required by ISO 9001:2000, excluding the requirements covering product design and development because their products are made to designs prepared by their customers. Later, in order to bid on Page 1 of 3 Examples of the ISO 9000 standards in use 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/iso9000/selection_use/examplesofiso9000.ht... the supply of parts to a major automotive company, they adapted their quality system to meet the sector specific requirements of ISO/TS 16949. Example 2 A welfare agency decided to establish a quality improvement strategy. It adopted ISO 9004:2000 as the basis for planning and implementing its system. The agency found that ISO 9000:2000 provided very useful additional guidance and plans to seek certification to ISO 9001:2000 to gain more credibility. Example 3 A washing machine manufacturer had a well-established company culture of continual improvement and effective production control. The management decided to improve the company's development processes and to implement ISO 9001:2000 to obtain certification for commercial purposes. The company used ISO 9004:2000 to guide its improvement processes and ISO 10006:1997 to develop a project management plan. Example 4 A large chemical processing company was required by its major customers to gain registration/certification to ISO 9001:2000. In order to obtain additional benefits, company leadership planned a comprehensive management strategy based on ISO 9000:2000 and ISO 9004:2000. A thorough review of their business processes indicated that all elements of ISO 9001:2000 were applicable to their quality management system. The company used ISO 10013:1999 to guide the development of quality documentation in its various production divisions and ISO 10015:1999 for guidance in the preparation of training plans for their employees. Example 5 A firm of international lawyers wanted to improve their client management processes and to achieve registration/certification to ISO 9001:2000. Their quality management system provides for the design and development of new services such as international tax planning and modifying traditional services to meet the requirements of new or amended legislation. They included purchasing control to cover the selection of computer hardware and software, as well as purchasing the services of specialist lawyers as needed. After successfully implementing ISO 9001:2000, they used the self-assessment guidelines of ISO 9004:2000 to monitor their progress as they improved their quality management system. Example 6 A computer software developer serving a niche market recognized that as their user base expanded they would be faced with issues concerning product management and configuration control. Changes to base products, user hardware and regulatory requirements were compounding customer service issues. ISO 9004:2000 provided the guidance they needed to establish documented procedures to control process change and improvement. ISO 10006:1997 and ISO 10007:1995 provided additional assistance as they managed the project and prepared procedures for configuration management. They later acquired another software developer and were able to use their quality management system to integrate the acquisition into their own structure very quickly with a minimum of disruption to customers. Example 7 Page 2 of 3 Examples of the ISO 9000 standards in use 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/iso9000/selection_use/examplesofiso9000.ht... A bank decided to implement a quality management system for its on-line Internet banking services. They ensured that their quality manual made clear that their other conventional banking services were not included in their quality management system. While adopting the requirements of ISO 9001:2000, the bank obtained guidance from ISO 9000:2000 to interpret words and phrases used in the standard for their application. They applied all the requirements of Clause 7, recognizing that design and development is an important part of creating new service processes. The bank used ISO 10013:1995 to prepare their documentation, which they posted on their internal computer network to ensure current procedures are available to their staff.
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Selection and use
Implementing your ISO 9001:2000 quality management system 1. Identify the goals you want to achieve Typical goals may be: Be more efficient and profitable Produce products and services that consistently meet customer requirements Achieve customer satisfaction Increase market share Maintain market share Improve communications and morale in the organization Reduce costs and liabilities Increase confidence in the production system 2. Identify what others expect of you These are the expectations of interested parties (stakeholders) such as: Customers and end users Employees Suppliers Shareholders Society 3. Obtain information about the ISO 9000 family For general information, look to this brochure For more detailed information, see ISO 9000:2000, ISO 9001:2000 and ISO 9004:2000 For supporting information, refer to the ISO Web site For implementation case studies and news of ISO 9000 developments worldwide, read the ISO publication ISO Management Systems. 4. Apply the ISO 9000 family of standards in your management system. Decide if you are seeking certification that your quality management system is in conformance with ISO 9001:2000 or if you are preparing to apply for a national quality award. Use ISO 9001:2000 as the basis for certification Use ISO 9004:2000 in conjunction with your national quality award criteria to prepare for a national quality award Page 1 of 3 Implementing your ISO 9000:2000 quality management system 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/iso9000/selection_use/implementing.html?pr... 5. Obtain guidance on specific topics within the quality management system These topic-specific standards are: ISO 10006 for project management ISO 10007 for configuration management ISO 10012 for measurement systems ISO 10013 for quality documentation ISO/TR 10014 for managing the economics of quality ISO 10015 for training ISO/TS 16949 for automotive suppliers ISO 19011 for auditing 6. Establish your current status, determine the gaps between your quality management system and the requirements of ISO 9001:2000 You may use one or more of the following: Self assessment Assessment by an external organization 7. Determine the processes that are needed to supply products to your customers Review the requirements of the ISO 9001:2000 section on Product Realization to determine how they apply or do not apply to your quality management system including; Customer related processes Design and/or development Purchasing Production and service operations Control of measuring and monitoring devices 8. Develop a plan to close the gaps in step 6 and to develop the processes in step 7 Identify actions needed to close the gaps, allocate resources to perform these actions, assign responsibilities and establish a schedule to complete the needed actions. ISO 9001:2000 Paragraphs 4.1 and 7.1 provide the information you will need to consider when developing the plan. 9. Carry out your plan Proceed to implement the identified actions and track progress to your schedule 10. Undergo periodic internal assessment Use ISO 19011 for guidance in auditing, auditor qualification and managing audit programmes 11. Do you need to demonstrate conformance? Page 2 of 3 Implementing your ISO 9000:2000 quality management system 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/iso9000/selection_use/implementing.html?pr... If yes, go to step 12 If no, go to step 13 You may need or wish to show conformance (certification/registration) for various purposes, for example: Contractual requirements Market reasons or customer preference Regulatory requirements Risk management To set a clear goal for your internal quality development (motivation) 12. Undergo independent audit Engage an accredited registration/certification body to perform an audit and certify that your quality management system complies with the requirements of ISO 9001:2000. 13. Continue to improve your business Review the effectiveness and suitability of your quality management system. ISO 9004:2000 provides a methodology for improvement.
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Selection and use
Maintaining the benefits and continual improvement Most new users obtain measurable benefits early in the process of deploying the standard requirements in their operations. These initial benefits are generally due to improvements in their organization and internal communication. The benefits must be strengthened through effective internal auditing and management review of system performance. Like all systems, it either improves or becomes less effective. It does not remain static for long. When you adopt ISO 9001:2000, you must strive for the satisfaction of your customers and the continual improvement of your quality management system. Continual improvement is a process of increasing the effectiveness of your organization to fulfill your quality policy and your quality objectives. ISO 9001:2000 requires that you plan and manage the processes necessary for the continual improvement of your quality management system. ISO 9004:2000 provides information that will be helpful in going beyond ISO 9001:2000 to improving the efficiency of your operation. It is recommended that you obtain data from various sources, both internal and external, to assess the appropriateness of your quality system goals. This information can also be used to improve the performance of your processes. Some organizations may expand their management systems by extending the ISO 9001:2000 structure to include the requirements of ISO 14001:1996, Environmental management systems. The structural and organizational requirements of the two management systems have been designed to be compatible.
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Selection and use
The future evolution of ISO 9000 In order for the ISO 9000 family to maintain its effectiveness, the standards are periodically reviewed in order to benefit from new developments in the quality management field and also from user feedback. ISO/TC 176, which is made up of experts from businesses and other organizations around the world, monitors the use of the standards to determine how they can be improved to meet user needs and expectations when the next revisions are due in approximately five years' time. ISO/TC 176 will continue to integrate quality assurance, quality management, sector specific initiatives and various quality awards within the ISO 9000 family. ISO's commitment to sustaining the ISO 9000 momentum through reviews, improvement and streamlining of the standards guarantees that your investment in ISO 9000 today will continue to provide effective management solutions well into the future.
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Iso 9001: 2015 Back to the Future: A Review of the New Iso Annex Sl Structure for Certification Standards Using the Draft Iso 9001: 2015 to Explain the Changes.
The ISO 9000 Family of Standards Is Related To Quality Management Systems and Designed To Help Organizations Ensure That They Meet The Needs of Customers and Other Stakeholders