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 gaining recognition through national award programmes.
This brochure provides you with:
- A list of the ISO 9000 quality management standards and guidelines;
- 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.
The ISO 9000 family
The standards, guidelines and technical reports which make up the ISO 9000 family and which are listed below are available separately, or as collections. The ISO 9000 Compendium presents the ISO 9000 family in hard copy form.
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Standards and guidelines |
Purpose |
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ISO 9000:2000, Quality management systems - Fundamentals and vocabulary |
Establishes a starting point for understanding the standards and defines the fundamental terms and definitions used in the ISO 9000 family which you need to avoid misunderstandings in their use. |
|
ISO 9001:2000, Quality management systems - Requirements |
This is the requirement standard you use to assess your ability to meet customer and applicable regulatory requirements and thereby address customer satisfaction.
It is now the only standard in the ISO 9000 family against which third-party certification can be carried. |
|
ISO 9004:2000, Quality management systems - Guidelines for performance improvements |
This guideline standard provides guidance for continual improvement of your quality management system to benefit all parties through sustained customer satisfaction. |
|
ISO 19011, Guidelines on Quality and/or Environmental Management Systems Auditing (currently under development) |
Provides you with guidelines for verifying the system's ability to achieve defined quality objectives. You can use this standard internally or for auditing your suppliers. |
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ISO 10005:1995, Quality management - Guidelines for quality plans |
Provides guidelines to assist in the preparation, review, acceptance and revision of quality plans. |
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ISO 10006:1997, Quality management - Guidelines to quality in project management |
Guidelines to help you ensure the quality of both the project processes and the project products. |
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ISO 10007:1995, Quality management - Guidelines for configuration management |
Gives you guidelines to ensure that a complex product continues to function when components are changed individually. |
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ISO/DIS 10012, Quality assurance requirements for measuring equipment - Part 1: Metrological confirmation system for measuring equipment |
Give you guidelines on the main features of a calibration system to ensure that measurements are made with the intended accuracy. |
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ISO 10012-2:1997, Quality assurance for measuring equipment - Part 2: Guidelines for control of measurement of processes |
Provides supplementary guidance on the application of statistical process control when this is appropriate for achieving the objectives of Part 1. |
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ISO 10013:1995, Guidelines for developing quality manuals |
Provides guidelines for the development, and maintenance of quality manuals, tailored to your specific needs. |
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ISO/TR 10014:1998, Guidelines for managing the economics of quality |
Provides guidance on how to achieve economic benefits from the application of quality management. |
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ISO 10015:1999, Quality management - Guidelines for training |
Provides guidance on the development, implementation, maintenance and improvement of strategies and systems for training that affects the quality of products. |
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ISO/TS 16949:1999, Quality systems - Automotive suppliers - Particular requirements for the application of ISO 9001:1994 |
Sector specific guidance to the application of ISO 9001 in the automotive industry. |
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.
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 the supply of parts to a major automotive company, they adapted their quality system to meet the sector specific requirements of ISO/TS 16949.
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.
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.
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.
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.
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.
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.
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
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?
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.
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.
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.
www.iso.org
www.tc176.org
www.bsi.org.uk/iso-tc176-sc2
Information on the ISO 9000 standards is also available from ISO's national member institutes or from the ISO Central Secretariat ISO 9000 enquiry service. Sales enquiries should also be directed to the ISO members or to the ISO Central Secretariat sales department.
ISO publishes the bimonthly ISO Management Systems, which provides updates on these families of standards and news on their implementation around the world. A Spanish-language edition is published by the Spanish national standards institute, AENOR.