How ISO/TS Developed

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1 ISO/TS16949 Documentation Structure 3 rd Party Certification Requirements Role of Top Management- for Implementation TS defines the Quality Management System requirements for the design and development, production and, when relevant, installation and service of automotive-related products. TS is applicable to sites of the organization where customer-specified parts, for production and/or service, are manufactured. TS can be applied throughout the automotive supply chain How ISO/TS Developed World Wide OEM Acceptance of ISO/TS BMW Compliance Daimler Chrysler Required Fiat New Certification/Renewal Ford Required Nissan Optional/Compliance PSA Required Renault Required Volkswagen Optional Honda - Compliance GM Required Hyundai is Certified to ISO/TS16949 Rationale for ISO/TS16949 Enhances customer satisfaction Encourages Analysis of customer requirements Definition of processes Process control Provides a framework for continual improvement Provides confidence in the ability to provide consistent products and services Goals of ISO/TS16949 Development of a Quality Management System (QMS) that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain ISO/TS16949 Technical Specification document, coupled with customer-specific & industry specific requirements that apply, defines the fundamental QMS requirements Avoids multiple certification audits and provide a common approach to the QMS Application of the Eight Management Principles Customer focused organization Leadership Involvement of people

2 Process approach System approach to management Continual Improvement Factual approach to decision making Mutually beneficial supplier relationship(s) Typically, customer needs and expectations gathered will effect both business and product related processes Business expectations will be along the lines of cost, delivery, technology, ethical, psychological, timing, and many other expectations Product expectations will be in terms of product characteristics, tolerances, reliability, and functionality

3 Alignment of Strategy : Align the organization with a shared sense of purpose Data Driven Quality Operating System

4 Process Focus Versus Department Focus : Sequence & Interaction of Processes not Departments Drive Performance

5 System Approach to Management Identifying, understanding and managing interrelated processes as a system contributes to the organization s effectiveness and efficiency in achieving its objectives. Key Benefits Integration and alignment of key processes Ability to focus on key processes Provide confidence as to consistency, effectiveness and efficiency Applications Structuring a system to achieve objectives Understanding interdependencies of processes (sequence & interaction) Structuring approaches to synchronize processes to work towards common goals Continually improving the system through measurement and evaluation Sequence & Interaction of Processes - Process Map (LEVEL 1 Example)

6

7 Example Standardize Documentation- Level 2 (example) Flow charts are a practical and convenient way to document processes Simple to create and easy to understand

8 Who does what and when at a glance 3 rd Party Certification Requirements The Initial Certification audit is divided into two stages : Stage 1 Readiness review Stage 2 Site audit The Initial Certification audit is divided into two stages : Stage 1 Readiness review Stage 2 Site audit 3rd party auditors use the process approach The entire quality management system must be assessed at a minimum once every three years. The audit cycle is based upon the dates of the initial certification audit The Role of Top Management-for Implementation Choose Strategy for QMS Implementation Set QMS Implementation Structure Establish Implementation Objectives Allocate Resources Believe in the QMS and communicate your support Scope of ISO/TS 16949:2009

9 ISO/TS 16949, in conjunction with ISO9001, defines the Quality Management System requirements for the design and development, production and, when relevant, installation and service of automotive-related products Automotive-related parts means parts that are actually installed on the vehicle by automotive OEM s TS16949 is applicable to sites of the organization where customer-specified parts, for production and/or service, are manufactured TS16949 can be applied throughout the automotive supply chain Definitions Site location at which value-added manufacturing processes occur Manufacturing process of making or fabricating production materials, production or service parts, assemblies, or heat treating, welding, painting, plating or other finishing services 3.1 Terms and definitions for the automotive industry from ISO/TS16949: nd edition Exclusions to the Standard Where the organization is not responsible for product design and development, the only permitted exclusions related to elements of 7.3-Product Design Manufacturing process design is the responsibility of the organization and is not a permitted exclusion Who is not eligible for ISO/TS16949:2009 Certification Automotive Aftermarket Manufacturers Automotive Retailers Automotive Repair Centers Distribution Centers Warehouses However, Supporting functions, on site or remote, ie., engineering, contract review, purchasing, warehouses are audited as they support the manufacturing site but cannot achieve independent certification Diagram of Support Functions- remote or at the manufacturing site example

10 Headquarters-Purchasing Engineering Center Manufacturing Site Warehouse Sales Center

11 Criteria for 3 rd party certification audit Meet the scope eligibility requirements for ISO/TS16949:2009 Greater than 12 months of manufacturing at the site Organization is on an active bid list for an automotive customer Entire internal audit completed of the Quality Management System 12 months of customer satisfaction and internal/external process performance trend data Management review of the entire Quality Management System Criteria for 3 rd party letter of conformance audit Meet the scope eligibility requirements for ISO/TS16949:2009 New site- less than 12 months of manufacturing at the site Organization can demonstrate it is on an active bid list for an automotive customer requiring ISO/TS16949:2009 certification or compliance Entire internal audit of the Quality Management System Appropriate level of customer satisfaction and internal/external process performance trend data to demonstrate a trend Management review of the entire Quality Management System

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