ISO16949: 2009 (Auto)

ISO 16949: 2009 Quality Management System (Automotive)

ISO 16949: 2009 defines the requirements of Quality Management System for the design and development, production, installation, and servicing of automotive-related products. ISO/TS 16949 is an ISO Technical Specification issued by the International Automotive Task Force (IATF) in cooperation with the International Organization for Standards (ISO) TC176 Committee. The IATF consists of an international group of vehicle manufacturers, BMW Group, DaimlerChrysler, Fiat Auto, Ford Motor Company, General Motors Corporation, PSA Peugeot-Citroen, Renault SA and Volkswagen, plus national trade associations, AIAG (US), VDA (Germany), SMMT (UK), ANFIA (Italy) and FIEV (France). This specification aligns previous American (QS-9000), German (VDA6.1), French (EAQF) and Italian (AVSQ) automotive quality systems standards.

ISO 16949 Standard became one of the most critical requirements for doing business between American Automotive producers and their suppliers. Together with ISO 9001:2000, ISO/TS 16949 specifies the quality system requirements for the design/development, production, installation and servicing of automotive related products. It contains provision for the customer specific requirements that are required by individual vehicle manufacturers. With the introduction of ISO16949 Standard, automotive industry requested all submissions of production parts (Off-Tool Sample Submissions) to be prepared in line with PPAP – Production Part Approval Process requirements.  Submission of samples of production parts must contain comprehensive documentation including, where applicable, Process FMEA, Design FMEA, Quality Plan, Process Quality Plan, Gauge R&R, Process Capability Studies, dimensional and attributes inspection results, process validation and verification data, etc.  Proper preparation of PPAP submission is time consuming and requires professional expertise. Submission which fails Automotive customer criteria will have to be resubmitted.

Our services include assistance in:
– pre-assessment and gap analysis in line with the requirements of ISO16949/QS9000 (Automotive)
– preparation of required Manuals, Policies, Procedures, Instructions, Specifications, Forms, etc.
– implementation of Data Management system, related methodologies and records
– PPAP – Production Part Approval Process – preparation of submissions for 1-st article approval
– FMEA – Failure Mode and Effect Analysis
– APQP – Advanced Product Quality Planning
– development of PCPs – Process Control Plans
– Process Validation and Verification
– Process Control Plans (PCP)
– Process Capability (PC or Cpk) Studies
– Gauge R&R studies (Repeatability and Reproducibility)
– other activities related to the implementation of customer-specific ISO16949-compliant QMS

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