TABLE OF CONTENTS
1.1 General
1.2 Application
4.1 General Requirements
4.2 Documentation requirements
5. Management's Responsibility
5.1 Management commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.5 Responsibility, authority and communication
5.6 Management review
6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.4 Work environment
7.1 Planning of product realization
7.2 The processes associated with customers
7.3 Design and development
7.4 Purchasing
7.5 Production of products and services
7.6 Control of monitoring and measuring
8. Measurement, analysis and improvement
8.1 General
8.2 Monitoring and measurement
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
Applications
A - correspondence between ISO 9001 : 2000 and ISO 14001 : 1996
B - the correspondence between ISO 9001:2000 and ISO 9001:1994
Bibliography
Foreword
International Organization for Standardization (ISO) is a worldwide federation of national standards bodies (ISO member bodies bodies). Work on the preparation international standards is carried out by the ISO Technical Committees. Each national ISO member body interested in the area for which it was created by an appropriate technical committee has the right to be represented on that committee. International organizations, governmental kA, and non-governmental, are in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) in all areas of electrotechnical standardization.
International Standards are drafted in accordance with the rules laid down in ISO / IEC Directives, Part 3.
Draft International Standards adopted by the technical committees are forwarded to the national bodies of ISO members for voting. Published as an International Standard requires that the decision is adopted at least 75% of the national bodies of ISO members eligible to vote.
It must be borne in mind the possibility that some elements of this International Standard may be associated with patent rights. ISO is not responsible for the identification of (partial or complete) of such patent rights.
International Standard ISO 9001 was prepared by subcommittee SC 2, "Quality Systems" Technical Committee ISO / TC 176 "Quality management and quality assurance."
This third edition of ISO 9001 cancels and replaces the second edition (ISO 9001:1994) together with ISO 9002:1994 and ISO 9003:1994. It is a technical revision of these documents. Thus the organization, which was used in the past, ISO 9002:1994 and ISO 9003:1994 can use this International Standard by excluding from it the relevant requirements in accordance with section 1.2.
This edition of ISO 9001 has changed the name, which no longer includes the term "quality assurance". This reflects the fact that the quality management system requirements contained in this edition of ISO 9001, in addition to quality assurance of products also aim to improve customer satisfaction.
Annexes A and B to this international standard are purely informational.
Introduction
0.1 General Provisions
The adoption of quality management system should be a strategic decision of the organization. Design and implementation of quality management system are determined by the changing needs, specific goals, products, processes used, the size and structure of the organization. This International Standard does not imply uniformity in the structure of quality management systems or documentation.
Quality management system requirements specified in this International Standard are complementary to product requirements. Information marked "NOTE" is a guide to understanding and explaining the requirements.
This International Standard can be used by internal or external parties, including authorities on certification to assess the organization's ability to fulfill customer requirements governing the (normalized) bodies and their own organization's requirements.
In the development of this International Standard have been included quality management principles stated in ISO 9000 and ISO 9004.
0.2 Process approach
This International Standard promotes the adoption of a process approach when developing, implementing and improving the quality management system to enhance customer satisfaction through the implementation of its requirements.
For an organization to function effectively, it must identify the many related activities and carry out their management. An activity using resources, and managed in order to make possible the transformation of inputs (within cells) into outputs (outgoing elements) can be regarded as a process. Often the output from one process directly forms the input to the next process.
The use of a system of processes within the organization together with the identification and interactions of these processes and their management can be considered as a "process approach".
ISO 9001-2001: Application of the organization of a system of processes, along with the identification and interactions, as well as management processes can be considered a "process approach". ISO 9001:2000 (E): The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the "process approach" |
The advantage of the process approach is the continuity of control that it provides in relation to the connections between the individual processes within a system of processes, as well as with respect to the combination (union, combination) and the interaction of these processes.
This approach, when applied within the quality management system that emphasizes the importance of:
a) understanding and compliance;
b) the need to consider processes in terms of added value;
c) measuring the functioning and effectiveness of processes, as well as
d) continual improvement of processes based on objective measurement.
Model of quality management system based on processes, which is presented in Fig. 1 illustrates the connection between the processes presented in Sections 4-8.
This figure shows that customers play a significant role in defining requirements, considered as an input. Monitoring of customer satisfaction requires the evaluation of information relating to the perception of the consumer as to whether the organization of his claim.
The model presented in Fig. 1 covers all the requirements of this International Standard, but does not show processes at a detailed level.
Note. - Check - Act - PDCA ). In addition to all processes can be applied methodology, known as "Plan - Do - Check - Act» (Plan - Do - Check - Act - PDCA). PDCA methodology can be briefly described as follows:
Schedule: | Set goals and create the processes necessary to deliver results in accordance with customer requirements and policies of the organization. |
Do: | embed processes. |
Check: | monitor the processes and products and measure them against policies, objectives and requirements for the product and report the results. |
Take Action: | take actions to continually improve process performance. |
In Fig. 1. Model of quality management system based on processes
0.3 Relationship with ISO 9004
The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of standards for quality management system, which were designed to complement each other, but that they can also be used independently from each other. Despite the fact that these two international standards have different scopes, they have a similar structure, which facilitates their use as a consistent pair of standards.
ISO 9001 specifies requirements for quality management system, which can be used for internal application by organizations for quality management systems certification or for contractual purposes. It is aimed at quality management system in fulfilling the requirements of the consumer.
ISO 9004 provides guidance on a wider range of objectives of quality management system than ISO 9001, particularly for continuous improvement throughout the organization, efficiency and effectiveness of the organization. ISO 9004 is recommended as a guideline for organizations whose top management in an effort to continually improve performance wants to go beyond the requirements of ISO 9001. However, this standard is not intended for certification of quality management systems or applications in order to contract.
0.4 Compatibility with other management systems
This International Standard has been aligned with ISO 14001:1996 in order to improve the compatibility of these two standards in the interests of the user community.
This International Standard does not contain requirements in relation to other management systems, such as environmental management, management of health and safety, financial management or risk management. However, this International Standard enables an organization to align or integrate its own quality management system with the relevant requirements of other management systems. An organization may adapt (adjust) their existing system (s) of management, to create a quality management system that meets the requirements of this International Standard.
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[...] This document supersedes EN ISO 9001:2000. [...]