16949 QM

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7.6 Control of Monitoring and Measuring Devices

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8.1 Measurement, Analysis and Improvement, General

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8.2.1 Customer Satisfaction

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8.2.2 Internal Audit

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8.2.3 Monitoring and Measurement of Processes

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8.2.4 Monitoring and Measurement of Product

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8.3 Control of Nonconforming Product

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8.4 Analysis of Data

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8.5.1 Continual Improvement

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8.5.2 Corrective Action

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8.5.3 Preventive Action

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Appendix A List of Key QMS Documents

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Appendix B Terms and Definitions

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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):