Norma Iso/Ts 16949

TECHNICAL SPECIFICATION

ISO/TS 16949
Third edition 2009-06-15

Quality management systems — Particular requirements for the application of ISO 9001:2008 for automotive production and relevant service part organizations

Reference number ISO/TS 16949:2009(E)

© ISO 2009

Introduction
0.1 General

ISO 9001:2008, Quality management systems — Requirements Introduction 0.1 GeneralThe adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization's quality management system is influenced by a) b) c) d) e) f) its organizational environment, changes in that environment, and the risks associated with that environment, its varying needs, its particular objectives, the products it provides, its size andorganizational structure. the processes it employs,

It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation. The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding orclarifying the associated requirement. This International Standard can be used by internal and external parties, including certification bodies, to assess the organization's ability to meet customer, statutory and regulatory requirements applicable to the product, and the organization's own requirements. The quality management principles stated in ISO 9000 and ISO 9004 have been taken intoconsideration during the development of this International Standard.

0.2 Process approach ISO 9001:2008, Quality management systems — Requirements 0.2 Process approach

This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.For an organization to function effectively, it has to determine and manage numerous linked activities. An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next. The application of a system of processes within an organization,together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach”. An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction. When used within aquality management system, such an approach emphasizes the importance of a) b) c) d) understanding and meeting requirements, the need to consider processes in terms of added value, obtaining results of process performance and effectiveness, and

continual improvement of processes based on objective measurement.

The model of a process-based quality management system shown in Figure 1 illustratesthe process linkages presented in Clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements. The model shown in Figure 1 covers all the requirements of this InternationalStandard, but does not show processes at a detailed level.
NOTE In addition, the methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all processes. PDCA can be briefly described as follows. Plan: establish the objectives and processes necessary to deliver results in accordance with

customer requirements and the organization's policies. Do: implement the processes. Check:...