ISO9000基础和术语（英文）
Quality management systems – Fundamentals and vocabulary1 Scope
This International Standard describes fundamentals of quality management systems, which form the subject of the ISO
9000 family, and defines related terms.
This International Standard is applicable to the following:
a) organizations seeking advantage through the implementation of a quality management system;
b) organizations seeking confidence from their suppliers that their product requirements will be satisfied;
c) users of the products;
d) those concerned
with a mutual understanding of the terminology used in quality management (e.g. suppliers, customers, regulators);
e) those internal or external to the organization who assess the quality management system or audit it for conformity with the
requirements of ISO 9001 (e.g. auditors, regulators, certification/registration bodies);
f) those
internal or external to the organization who give advice or training on the quality management system appropriate to that organization;
g) developers of related standards.
2 Fundamentals of quality management systems2.1 Rationale for
quality management systems
Quality management systems can assist organizations in enhancing
customer satisfaction.
Customers require products with characteristics that satisfy their needs and
expectations. These needs and expectations are expressed in product specifications and collectively referred to as customer requirements. Customer
requirements may be specified contractually by the customer or may be determined by the organization itself. In either case, the customer ultimately
determines the acceptability of the product. Because customer needs and expectations are changing, and because of competitive pressures and technical
advances, organizations are driven to improve continually their products and processes.
The quality management system approach encourages organizations to analyse customer requirements, define the
processes that contribute to the achievement of a product which is acceptable to the customer, and keep these processes under control. A quality management
system can provide the framework for continual improvement to increase the probability of enhancing customer satisfaction and the satisfaction of other
interested parties. It provides confidence to the organization and its customers that it is able to provide products that consistently fulfill requirements.
2.2 Requirements of quality
management systems and requirements for products
The ISO 9000 family distinguishes between requirements for quality management systems and requirements for products.
Requirements for quality management systems are specified
in ISO 9001. Requirements for quality management systems are generic and applicable to organizations in any industry or economic sector regardless of the
offered product category. ISO 9001 itself does not establish requirements for products.
Requirements for products can be
specified by customers or by the organization in anticipation of customer requirements, or by regulation. The requirements for products and in some cases
associated processes can be contained in, for example, technical specifications, product standards, process standards, contractual agreements and regulatory
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