TS169492002版英文检查表(1) Checklist to ISO/TS 16949:2002 Last revision 09/10/ 2001 Second Edition, Issued October, 2001 Copyright © 2001 © DaimlerChrysler, Ford Motor Company, General Motors Corp., © ANFIA, © CCFA/FIEV, © VDA, © SMMT FOREWORD The Quality System Assessment Check-List to ISO/TS 16949 Second Edition is based on the content of ISO/TS 16949 and it is effective for the life of ISO/TS 16949, Second Edition. The Quality System Assessment Check-List is to be used as a guide in auditing the requirements of ISO/TS 16949, Second Edition. The requirements column references the clauses in ISO/TS 16949. All italics are ISO 9001: 2000. The "What to look for" column is not mandatory but it is a good guide. It is expected that auditors will supplement this column with their educated and experienced enhancements. Acknowledgements for this effort are due to the IATF membership. ELEMENT 4 – Quality management system Requirements What to look for Assessor notes / Objective evidence 4.1 General Requirements 4.1.1 Has the organization established and documented a quality management system in accordance with the requirements of ISO/TS 16949:2002(E)? (4.1) · Quality manual according to TS 16949 or one with a conversion matrix. 4.1.2 Has the organization implemented and maintained its established quality management system in accordance with the requirements of ISO/TS 16949:2002(E)? (4.1) · Key personnel interview. · Examples of effective implementation. 4.1.3 Is the organization continually improving the effectiveness of its quality management system in accordance with the requirements of ISO/TS 16949:2002(E)? (4.1.1.1) · Examples and status of quality management system continuous improvement projects , not corrective actions. · Management review results. · 4.1.4 Does the organization’s quality management system : a) identify the processes needed for the quality management system and their application throughout the organization? b) determine the sequence and interaction of these processes? c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective? (4.1.a, b, c) · Quality manual according to TS 16949 or one with a conversion matrix. · 4.1.7 Does the organization’s quality management system : a) ensure the availability of resources and information necessary to support the operation and monitoring of the processes needed for its quality management system? b) monitor, measure and analyze the processes needed for its quality management system? c) implement actions necessary to achieve planned results and continual improvement of the processes needed for its quality management system? (4.1.d, e, f) · Review of all the elements of the quality management system to insure its continuing suitability and effectiveness. · Review of quality cost indicators · Management review meeting minutes, attendance and adequate frequency. · Action plans and follow-up. 4.1.10 Does the organization manage the processes needed for its quality management system in accordance with the requirement of ISO/TS 16949:2002(E)? (4.1) · 4.1.11 Does the organization ensure control over outsourced processes that affects product conformity with requirements? (4.1) · 4.1.12 Is the control of the organization’s outsourced processes that affects product conformity with requirements identified within the quality management system? (4.1) · Quality manual according to TS 16949 or one with a conversion matrix. · ELEMENT 4.2 Documentation requirements 4.2.1 General 4.2.1 Does the quality management system documentation include the following: a) documented statements of a quality policy and quality objectives? b) a quality manual? c) documented procedures required by ISO/TS 16949:2002(E)? d) documents needed by the organization to ensure the effective planning, operation and control of its processes? e) records required by ISO/TS 16949:2002(E) (see element 4.2.4)? (4.2.1) · Quality manual according to TS 16949 or one with a conversion matrix. · Adequacy of the procedures to the complexity of the organization. · Quality management system procedures. · Quality records. 4.2.2 Quality Manual 4.2.2 Has the organization established and maintained a quality manual that includes : a) the scope of the quality management system, including details of and justification for any exclusions (see section 1.2 of ISO/TS 16949:2002(E))? b) the documented procedures established for the quality management system, or reference to them? c) a description of the interaction between the processes of the quality management system? (4.2.2) · Quality manual according to TS 16949 or one with a conversion matrix. 4.2.3 Control of documents 4.2.3 Does the organization control the documents