Automotive Industry Standard ISO/TS16949:2016 is the Quality Management System Standards for the Automotive Industry. Specific requirements for the application of ISO 9001:2008 for the production of the parts and assemblies intended for the automotive applications require organizations management systems are developed and designed to incorporate the auto industry codes and conventions as well as a disciplined approach to the specifications within the ISO9001:2015 standard.
In addition to the requirements detailed in ISO9001:2015 the automotive industry has additional requirements derived from the high expectations of the customers for motor vehicle reliability and performance. These include:
Cost of poor quality
Discussion of business planning
Preparation of contingency plans
Discussion of product safety
Cleanliness of the premises
Use of statistical tools and data
Control and measurement of manufacturing processes
TS16949 has a number of product-specific additional technical requirements including:
Review of engineering specifications;
Assignment of a customer representative; field failures;
Failure mode and effects analysis (FMEA);
Use of control plans;
Duplication of manufacturing processes
Process consistency and repeatability
The requirements for product design and development processes are extensive including a number of additional stipulations and impositions including:
Multidisciplinary Approach in the design planning process
Product Design Input must be documented
Selection of Manufacturing Process to be a design consideration
Special Characteristics must be included in the control plan
Product Design Outputs includes requirement for verification and validation
Manufacturing Process to be verified and validated
Monitoring must include a program of reporting design stages
Validation must include performance to customer requirements
Prototype Program required to include prototype submission
Product Approval Process to be agreed and recognized with customer
Purchasing requirements include a detailed and highly prescriptive specification for providing more information and detail to suppliers regarding all quality control requirements and procedures for monitoring.
Note: Preference is strongly advocated for use of suppliers compliant with TS 16949 with concession to use those registered to
ISO 9001:2015 where TS16949:2016 is not available.
Measurement system requirements, calibration/verification records, and laboratory requirements have a number of enhanced requirements. Calibration authorities’ accreditation to ISO 17025 is preferred but not mandatory.
TS16949 inspection and test activities are more demanding and significantly expanded with the control of nonconforming product being highly prescriptive. In addition, the Internal Audits are expanded to include:
Quality management system audits,
Manufacturing process audits,
Product audits, and an annual audit plan
Specified requirements for improvement include the additional prescriptions for problem-solving, error proofing, and analysis of the impact of corrective actions to other areas of the operation with filter down impositions to suppliers.
Advice and assistance from Q-Share is strongly recommended before engaging in this automotive industry quality program.