IATF 16949:2016

Clause 1: Scope

Defines the scope of the standard, which applies to organizations involved in the design, development, production, installation, and servicing of automotive-related products, including all customer-specific requirements.

Clause 2: Normative References

Refers to ISO 9001:2015 as the basis for the requirements, along with customer-specific requirements applicable to the automotive industry.

Clause 3: Terms and Definitions

References the definitions from ISO 9000:2015 and includes automotive-specific terminology, such as "special characteristics," "control plan," "total productive maintenance," and "error-proofing."

Clause 4: Context of the Organization

This clause requires a focus on understanding the external and internal factors that impact the organization and the stakeholders (e.g., customers, suppliers).

Key sub-clauses:

  • 4.1 Understanding the organization and its context: The organization must evaluate internal and external factors influencing its strategic direction.
  • 4.2 Understanding the needs and expectations of interested parties: Identifying interested parties (including automotive customers and regulators) and their expectations.
  • 4.3 Determining the scope of the QMS: Define the boundaries and applicability of the QMS.
  • 4.4 QMS and its processes: Establish, implement, and maintain the processes required for the QMS, with a focus on process control, risk management, and continual improvement.

Clause 5: Leadership

Leadership is essential for the implementation of the QMS. Top management should ensure customer focus and promote continual improvement.

Key sub-clauses:

  • 5.1 Leadership and commitment: Top management should be committed to customer focus, risk-based thinking, and promoting the QMS.
  • 5.2 Quality policy: The organization should define and communicate a quality policy that supports customer satisfaction and continual improvement.
  • 5.3 Organizational roles, responsibilities, and authorities: Ensuring clear responsibility and authority within the organization to ensure the effectiveness of the QMS.

IATF additions:

  • Corporate responsibility: Includes ethical behavior, anti-bribery policies, employee code of conduct, and whistleblower protection.
  • Customer focus: Requires enhanced customer-specific requirements, including continuous feedback loops and metrics.

Clause 6: Planning

Planning for the QMS should focus on addressing risks and opportunities while meeting customer and regulatory requirements.

Key sub-clauses:

  • 6.1 Actions to address risks and opportunities: Risk-based thinking is required, with actions to minimize risks and exploit opportunities.
  • 6.2 Quality objectives and planning to achieve them: Set measurable quality objectives to meet automotive industry requirements.
  • 6.3 Planning of changes: Manage changes in processes, personnel, or products through a planned, systematic approach.

IATF additions:

  • Contingency planning: Organizations must plan for potential emergencies or disruptions to ensure continued production and delivery of automotive products.

Clause 7: Support

Resources, competence, awareness, communication, and documented information required for the QMS are covered here.

Key sub-clauses:

  • 7.1 Resources: Determine the resources required for product conformity, including infrastructure and environment for operation.
  • 7.2 Competence: Employees should be competent and trained, with records maintained for skills and qualifications.
  • 7.3 Awareness: Ensure employees are aware of their contribution to quality objectives and customer satisfaction.
  • 7.4 Communication: Effective communication within the organization and with external stakeholders.
  • 7.5 Documented information: Maintain and control documents and records that support the QMS.

IATF additions:

  • Internal laboratory and external laboratory requirements: Ensure that laboratories used for testing and measurement are competent and accredited.
  • Second-party audits: Suppliers must conduct audits of their own suppliers to ensure conformance.

Clause 8: Operation

The core of IATF 16949, covering product realization, from customer requirements to product delivery.

Key sub-clauses:

  • 8.1 Operational planning and control: Plan and control processes to meet customer requirements, emphasizing risk management, process monitoring, and traceability.
  • 8.2 Requirements for products and services: Includes customer communication, defining customer requirements, and ensuring conformity.
  • 8.3 Design and development of products and services: Plan and control the design and development of products, including validation and testing.
  • 8.4 Control of externally provided processes, products, and services: Ensure that suppliers meet all customer requirements and control outsourced processes.
  • 8.5 Production and service provision: Plan and implement production and service processes, including control of special characteristics, change control, and process validation.
  • 8.6 Release of products and services: Ensure that products meet customer requirements before being released, with evidence of conformity.
  • 8.7 Control of nonconforming outputs: Identify and control nonconforming products to prevent unintended use or delivery.

IATF additions:

  • Product safety: Requires organizations to define responsibilities for product safety, including special characteristics related to safety.
  • Management of change: Emphasizes changes in production processes, personnel, and suppliers must be controlled.
  • Customer-specific requirements (CSRs): Organizations must comply with any additional requirements set by individual automotive customers.

Clause 9: Performance Evaluation

This clause focuses on monitoring, measurement, analysis, and improvement of the QMS’s performance.

Key sub-clauses:

  • 9.1 Monitoring, measurement, analysis, and evaluation: Define what needs to be measured, analyze trends, and evaluate the effectiveness of the QMS.
  • 9.2 Internal audit: Perform regular internal audits to ensure the QMS conforms to IATF 16949 and is effectively implemented.
  • 9.3 Management review: Top management must review the performance of the QMS and the achievement of quality objectives.

IATF additions:

  • Supplier performance monitoring: Suppliers must be evaluated regularly, including the use of scorecards and metrics.
  • Warranty management: Organizations must address warranty performance and analyze warranty data for continual improvement.

Clause 10: Improvement

This clause focuses on the continuous improvement of the QMS to enhance customer satisfaction and product quality.

Key sub-clauses:

  • 10.1 General: Identify and implement improvements that result in better product quality and QMS performance.
  • 10.2 Nonconformity and corrective action: Address nonconformities by determining the root cause and implementing corrective actions to prevent recurrence.
  • 10.3 Continual improvement: Continuously improve the effectiveness of the QMS by analyzing performance data, customer satisfaction, and internal audits.

IATF additions:

  • Problem-solving: The use of structured problem-solving methods, such as 8D, is required to ensure root causes of nonconformities are identified and corrected.
  • Error-proofing (poka-yoke): Introduce error-proofing methodologies to prevent defects in production processes.