Previous Page of 28Next Page

16949 QM

spinner.gif

d0. Table of Contents

SECTION TITLE Page 

0 Table of Contents 

1 Scope 

2 Reference Documents 

3 Terms and Definitions 

4.1 Quality Management System, General Requirements 

4.2.1 Documentation Requirements, General 

4.2.2 Quality Manual 

4.2.3 Control of Documents 

4.2.4 Control of Records 

5.1 Management Commitment 

5.2 Customer Focus 

5.3 Quality Policy 

5.4 Quality Management System Planning 

5.5 Responsibility, Authority and Communication 

11 

5.6 Management Review 

13 

6.1 Provision of Resources 

14 

6.2 Human Resources 

15 

6.3 Infrastructure 

16 

6.4 Work Environment 

17 

SECTION TITLE Page 

7.1 Planning of Product Realization 

18 

7.2.1 Identification of Product Requirements 

20 

7.2.2 Review of Product Requirements 

21 

7.2.3 Customer Communications 

22 

7.3 Design and Development 

23 

7.4.1 Purchasing Process 

26 

7.4.2 Purchasing Information 

27 

7.4.3 Verification of Purchased Product 

27 

7.5.1 Control of Production and Service Provision 

28 

7.5.2 Validation of Production/Service Provision Processes 

31 

7.5.3 Product Identification and Traceability 

31 

7.5.4 Customer Property 

32 

7.5.5 Preservation of Product 

32 

7.6 Control of Monitoring and Measuring Devices 

33 

8.1 Measurement, Analysis and Improvement, General 

35 

8.2.1 Customer Satisfaction 

35 

8.2.2 Internal Audit 

36 

8.2.3 Monitoring and Measurement of Processes 

37 

8.2.4 Monitoring and Measurement of Product 

38 

8.3 Control of Nonconforming Product 

40 

8.4 Analysis of Data 

41 

8.5.1 Continual Improvement 

42 

8.5.2 Corrective Action 

43 

8.5.3 Preventive Action 

44 

Appendix A List of Key QMS Documents 

45 

Appendix B Terms and Definitions 

46 

 

1. Scope

1.1 General

The automotive industry requires its supply base to participate in the design and development of the components and systems that compose an OEM vehicle. This shift in responsibility to the supply base for complete or partial responsibility for engineering, research, and development has been coined as Full Service Suppliers (FSS). IsoQual, Inc. has based the Quality Management System (QMS) described in this manual to demonstrate our FSS capability (see Section 5.4.1.1), to consistently provide products/services that meet customer and applicable regulatory requirements, and to operate with increased effectiveness and efficiency with the overall aim of enhancing customer satisfaction.

Our QMS utilizes the process approach and quality management principles contained in the international standards: ISO 9000:2005, ISO/TS 16949:2009 and ISO 9004:2000 to enhance our ability to continually improve. (Note: you must obtain a complete copy of the official versions of the latest ISO standards; use the links contained in this document, check with the accrediting body in your country, and/or contact ISO directly.)

Our QMS was also developed in accordance with the following four additional types of documents containing recommended automotive industry practices, examples, illustrations and explanations, to further facilitate continual improvement by emphasizing defect prevention and the reduction of variation and waste:

• International Automotive Task Force (IATF) Guidance to ISO/TS 16949:2009 

• Quality System Assessment Checklist to ISO/TS 16949:2009 (The "QSA Checklist" is obsolete as an IATF document, effective 1 June 2004 and is no longer available; however, you can utilize our QSA Checklist and Audit Guide as an internal audit tool, especially useful in conducting documentation reviews against the TS standard) 

• ISO/TS 16949:2009 Automotive Certification Scheme-Rules for Achieving IATF Recognition 

• Customer-specific requirements and guidance documents

1.2 Application

Our QMS complies with all applicable requirements contained in ISO/TS 16949:2009, covers the design and provision of all company products, and encompasses all operations at our facility located at 10903 Hobbs Station Road, Louisville, Kentucky, USA 40243 (?). The following table identifies ISO/TS 16949:2009 requirements not applicable to our organization and provides a brief narrative justifying their exclusion from the scope of our QMS (exclusions are limited to clause 7.3, Product Design and Development only; note: clause 7.3 of ISO/TS 16949:2009 always applies as applicable to Manufacturing Process Design and Development requirements):

ISO/TS 16949:2009 Requirements EXCLUSION TABLE

Clause or Sub-clause Exclusion Justification 

None

Previous Page of 28Next Page

Comments & Reviews (2)

Login or Facebook Sign in with Twitter


library_icon_grey.png Add share_icon_grey.png Share

Who's Reading

Recommended