What is ISO/TS 16949?

ISO/TS 16949 is a technical specification, as denoted by the TS. It is a sector scheme of ISO 9001. (See What is ISO 9001?) TS 16949 applies specifically to organizations in the automotive industry (or, “sector”). It includes all of the requirements of ISO 9001, yet TS 16949 has been expanded to include automotive sector-specific requirements. Roughly, TS 16949 is ISO 9001 for organizations in the automotive supply chain.

The precursor to ISO/TS 16949 was QS 9000. The Big Three American auto companies introduced QS 9000 in 1994, thus establishing sector-scheme requirements for the American supply chain. QS 9000 died in 2006, four years after its international equivalent was released in 2002 (TS 19649:2002).

Beyond the basic requirements of ISO 9001, TS 16949 requires organizations in the automotive supply chain to have additional or enhanced controls over various facets of their operations, including:

• A process to ensure the timely review, distribution, and implementation of customer engineering standards/specifications,
• TS 16949 requires a business plan that contains quality objectives and measurements used to deploy the quality policy,
• TS 16949 contains slightly enhanced requirements for responsibilities for quality across all shifts,
• A customer representative is required to address customer quality requirements (e.g., special characteristics, design approvals, corrective and preventive action processing, etc.),
• Enhanced requirements apply to the monitoring of system performance, including the evaluation of the cost of poor quality,
• The requirements for competence are significantly enhanced. Personnel responsible for design require particular skill qualifications with selected tools and techniques, records of task-specific training, and on-the-job training requirements. Finally, TS 16949 also requires a process for employee motivation and empowerment,
• Infrastructure requirements are expanded to include plant, facility, and equipment planning and layout. Contingency plans are also required to ensure operations in case of emergencies,
• Work environment requirements include personnel safety and cleanliness of the premises,
• The requirements for planning product realization have been significantly enhanced in TS 16949. These requirements pertain to: product acceptance criteria, confidentiality, and change controls, as well as more definite realization controls as follows,
• The review of customer requirements must consider any identified special characteristics, while organizations are required to investigate manufacturing feasibility,
• Additional design requirements pertain to manufacturing process design, the control of special characteristics, design/process failure mode effects analyses (FMEAs), a prototype program, and a product approval process,
• TS 16949 requires organizations to develop their suppliers (urging them toward systemic quality management and certification). Requirements also pertain to suppliers who are customer-approved sources. Requirements also specify acceptable methods for assessing incoming product quality and supplier monitoring,
• In production, TS 16949 contains several additional requirements, including a control plan, work instructions, verification of job set-ups, preventive and predictive maintenance, management of tooling, and production scheduling. Additional servicing requirements also exist to ensure process for responding to service feedback information and for abiding by servicing agreements. Requirements pertaining to customer-owned production tooling are also included, as are requirements pertaining to product storage and preservation,
• In addition to the calibration requirements of ISO 9001, TS 16949 contains provisions to address internal and external laboratory facilities. Requirements for calibration records are also more specified in TS 16949,
• TS 16949 requires the identification of statistical tools and techniques, further requiring knowledge of basic statistical concepts throughout organizations,
• Performance indicators reflecting customer satisfaction levels are specified in TS 16949,
• Beyond the requirements for internal auditing in ISO 9001, TS 16949 includes requirements pertaining to: TS 16949 compliance, manufacturing process audits, product audits, internal audit plans, and internal auditor qualifications,
• The process monitoring requirements of ISO 9001 are expanded in TS 16949 to include process capability, customer part approval process requirements, control over significant process events, reaction plans for unstable processes, etc.,
• Product measuring requirements are also expanded, to include: layout inspection and functional testing, as well particular requirements for appearance items,
• Additional controls pertaining to nonconforming product including its classification and control of any rework. TS 16949 requires customers to be informed of released nonconforming product. It also contains requirements pertaining to customer waivers and concessions.
• The analysis of data required of ISO 9001 must include trend analyses in TS 16949,
• Where ISO 9001 requires continual improvement, TS 16949 requires a defined process for it, including manufacturing process improvement, and finally
• TS 16949 contains enhanced requirements pertaining to corrective action, including: a defined process for problem solving, use of error-proofing methods, corrective action impact and application, and rejected product testing and analysis.

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