ISO9001认证如何把握质量三要素
How to grasp the quality certification of ISO9001 three elements
1、首先，把握质量三要素中的“要求”。也就是要及时、正确理解和预测顾客的需求和期望。恰当地把这些需求和期望转化为可操作的、明确规定的对产品（服务）的使用要求。这些要求必须满足ISO9001第7.2条要求。
1, first of all, to grasp the quality of the three factors"". It is timely, correctly understand and predict customer needs and expectations. Appropriately to these needs and expectations into operable, defined on product ( service ) requirements for the use of. These requirements must meet ISO9001 article 7.2 requirements.
2、其次，把握好质量三要素中的“固有特性”。如何把握，分三个层次来讨论：
2, secondly, a good grasp of the quality of the three elements of" inherent characteristic". How to grasp, is divided into three levels to discuss:
a)    产品层次。通过产品的设计和开发过程，把顾客的需求和期望转化成产品中各种固有特性。然后，针对这些特性。层层展开，分别确定各个部件、零件和原材料的要求。通过产品中零部件的作用，使产品具有能满足顾客需求和期望的特性，达到使顾客满意的目的。ISO9001第7.3.3.a）条要求，体现了这个要求。这说明质量是设计进去的。产品固有特性满足顾客要求的程度决定了产品的质量好坏。
A ) product level. Through product design and development process, the customer needs and expectations into a product in a variety of natural characteristics. Then, aiming at these characteristics. Unfolding, respectively to determine the various components, spare parts and raw material requirements. Through the product parts in the role, so that products can meet customer needs and expectations of the characteristics, to achieve customer satisfaction with the purpose of. ISO9001 7.3.3.a) requirements, and reflects the requirements. The quality of design. Product characteristics to meet customer requirements of the product quality is good or bad.
b)  过程层次。产品设计和开发的输出不仅对产品、零部件规定要求之外，凡是对产品质量有影响的过程，根据ISO9001：2000第7.3.3.b和c条《设计和开发输出》要求，设计要给出采购、生产、和服务提供适当的信息。包含或者引用产品合格验收的判别准则。这样做，就从设计角度把握了质量三要素。相当于产品是内部顾客向各该过程（采购、加工、装配、检验等过程）提出了需求和期望。这些过程的固有特性必须满足产品对它们提出的要求，其满足的程度也通常用过程能力指数来衡量，过程能力指数决定了过程的质量好坏。
B ) the process level. Product design and development output only on products, spare parts requirements, usually affecting product quality process, according to the ISO9001: 2000 7.3.3.b and C" design and development output" requirements, design, production, procurement and give service to provide appropriate information. Contain or reference product qualified acceptance criterion. To do so, from the design angle grasp the quality of three elements. The product is equivalent to internal customers to the process ( procurement, processing, assembly, inspection process ) put forward the requirements and expectations. These processes are inherent properties to satisfy the product requirements for them, to satisfy the degree also usually use the process capability index to measure, process capability index determines the process quality.
c) 体系层次。前面这些过程的固有特性都是由人、机、料、法、环、测等因素组成和决定的。这些因素又是各该过程的工作结果。譬如，人员是人力资源提供过程、机器设备是设备维护过程、材料是采购过程……的结果。这些过程我们通常叫支持过程，它们和产品实现过程组成了质量管理体系。这个体系应当满足ISO9001第4.1条要求。用这个体系来控制过程，确保过程始终具有满足产品要求的能力，从而确保产品的质量。同时，要持续改进体系的有效性（实际上，还必须提高效率，才能求得生存和发展）。这就相当于把过程的要求转向变成对体系提出的需求和期望。这些体系的固有特性满足过程要求的程度决定了体系的质量好坏。
System level C ). In front of the inherent characteristics of these processes are the people, machine, material, method, measurement of ring, factors such as composition and decision. These factors are the process of work results. For example, personnel human resources processes, machinery and equipment maintenance process, material procurement process ... ... The results of. These processes we usually call support process, they and the product realization process consisting of a quality management system. This system should meet the requirements of ISO9001 4.1. Use this system to control the process, ensure the process always has the ability to meet requirements for product, thus ensuring the quality of the products. At the same time, to continuously improve the effectiveness of the system ( in fact, we must improve the efficiency, to seek survival and development ). This is equivalent to the process requirements to become on the needs and expectations of. The system 's inherent characteristics to meet the process requirements of system quality.
3、最后，把握质量三要素中的“满足的程度”。以上三个层次（产品、过程和体系）的“要求”和“固有特性”是逐步展开的。顾客的要求由产品的固有特性来满足，产品的固有特性转化为对过程的要求，再由过程的固有特性来满足，过程的固有特性转化为对体系的要求，再由体系的固有特性来满足。它们的满足程度决定了它们的质量水平。同样有三个层次需要把握好。