The ISO TS 16949 Standard: General Requirements

General Requirements of the ISO TS 16949 Standard

ISO TS 16949 is a technical specification that brings together the US, French, German, and Italian automotive quality system standards at the global level. It sets out the quality system requirements for the design, development, production, assembly, and servicing of automotive-related products.

The general requirements of the standard are set out below.

• Processes and activities must be defined.
• The sequence and interactions of the processes must be defined.
• Principles and methods that keep the processes effective and under control must be established.
• The resources and information needed to operate and monitor the processes must be provided.
• Processes must be measured, monitored, and analysed.
• Actions must be taken to reach coordinated results and to keep improving the processes.
• Where a process that affects product conformity is outsourced, that process must still be under the organisation's control.

Documentation Requirements

• Quality policy and quality objectives
• Quality manual
• The procedures the standard requires

Preventive Action

• The documents needed to plan, implement, and control the processes
• The records the standard requires
• Quality manual
• The quality manual contains:
• Details of excluded clauses and the reasons for exclusion
• Scope of the quality management system
• Documented procedures or references to them
• Description of the interactions between processes

Document Control Requirements

1. Adequacy check before issue

• Review, update where required, and re-approval
• Current revisions of documents available at the points of use
• Documents kept legible
• Obsolete documents flagged to prevent unintended use

2. Engineering Specifications

Customer engineering specifications and the changes they trigger must be:

• Reviewed within two working weeks
• Put into effect

3. Management Responsibility

• Operating the management system
• The quality management system
• Developing it
• Implementing it
• Management commitment to continually improving its effectiveness

4. Customer Focus

• Increasing customer satisfaction
• Identifying customer requirements
• Meeting those requirements

5. Quality Policy

• Aligned to the organisation's purpose
• Includes commitment to meeting the quality management system requirements and to continuous improvement
• Provides the framework for quality objectives
• Communicated and understood across the organisation
• Reviewed for continuing suitability

6. Planning

• Aligned to meeting product requirements
• Established for the relevant parts and levels of the organisation
• Measurable
• Consistent with the quality policy

7. Authority and Responsibility

• Defined
• Communicated across the organisation
• Quality responsibilities
• Where the product or process fails to meet requirements, corrective action is triggered
• Managers with authority and responsibility are notified immediately

8. Management of Resources

• Implementation of the quality management system
• Its application
• Its maintenance
• Continuous improvement of its effectiveness

9. Product Realisation

• Requirements accepted by the customer, including delivery and post-delivery activities
• Product requirements not specified by the customer but necessary for use
• Statutory and regulatory requirements related to the product
• Additional requirements defined by the company

Any formal inspection requirement that cannot be met must be confirmed with the customer.

Manufacturing feasibility of the products covered in the contract review process.

Design and development outputs must be documented in a form that allows verification against the input requirements, and they must be approved before release. Purchasing process.

• Conformity of the purchased product to the defined purchasing requirements must be ensured.
• The type and extent of control must reflect the effect of the purchased product on product realisation and on the final product.
• Service and Production
• Service, production, and their control must be ensured
• Information describing the product characteristics must be available
• Work instructions must be available
• Suitable equipment must be used
• Monitoring devices must be used

• Measurement, analysis, and improvement processes must be planned and implemented
• To demonstrate product conformity
• To ensure conformity of the quality management system
• To continuously improve the effectiveness of the quality management system
• The method and scope of statistical techniques must be determined and their use documented
• The statistical approach must be described

• As one of the performance measures of the quality management system, customer satisfaction must be monitored.
• Methods for collecting and using customer satisfaction information must be defined.

• Product that does not meet the defined requirements must be identified and unintended use or delivery prevented
• The controls, responsibilities, and authorities related to this must be described in a documented procedure

• Continuous improvement
• Continuous improvement of the effectiveness of the quality management system must be ensured
• The following sources must be used for continuous improvement
• Quality
• Objectives
• Audit results
• Analysis of findings
• Preventive and corrective actions
• Management review

• A problem-solving process for identifying and removing the causes of nonconformities must be defined
• Where the customer specifies a particular problem-solving method, that method must be used.

Preventive action to remove the causes of potential nonconformities must be initiated. The documented procedure for preventive action must cover the following:

• Identification of potential nonconformities and their causes
• Analysis of the actions that will prevent the nonconformities from occurring
• Definition and implementation of the preventive actions
• Recording the results of the actions

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