Scope

Overall, it covers the scope of the system according to the requirements of ISO 9001 and incorporates automotive specific constraints, such as the types of products or services included, as well as the relevant manufacturing processes.

Context of the Organization

The organization must understand its business context and operating environment, define the scope of its QMS, identify customer specific requirements, and address management processes related to product safety and manufacturing processes.

Leadership

This section discusses the role of top management, who must be involved in defining the responsibilities and authorities related to the QMS, including process owners, those responsible for customer-specific requirements, as well as various quality management policies.

Planning

This includes identifying opportunities and risks, conducting risk analysis related to product recalls, audits, or other product issues, implementing preventive actions to avoid recurrence of nonconformities, planning for changes (Change Management), and preparing contingency plans to ensure product delivery during emergencies which we will discuss in detail in this article.

Support

This section addresses the provision of various resources needed for the QMS to achieve its objectives, such as skills, personnel, infrastructure, and the operational environment. It also includes specific topics such as Measurement System Analysis (MSA), control of measurement data and verification records for measuring equipment used in quality inspection, and requirements for both internal and external testing laboratories.

Operation

This is the largest section of IATF 16949, as it relates to all operational activities involved in producing the organization’s products and services from receiving customer orders, design, production planning, and supplier control, to delivering products that are safe and of high quality. The main topics include the following:

Organization Manufacturing Feasibility

This is the process in which the organization verifies whether it truly has the readiness and capability to produce products according to customer requirements covering quality, quantity, timing, cost, and necessary resources. The goal is to confirm that the manufacturing process can support customer demands consistently and reliably. This goes beyond basic process testing; it also includes assessing risks, evaluating process capability, confirming supplier readiness, and ensuring long-term production stability, to guarantee that the products are safe and meet international automotive quality standards.

Design and Development

In the automotive industry, this refers to the product development process from concept to readiness for mass production. Although each OEM may have different specific requirements, IATF 16949 defines common core elements that every organization must follow. These ensure that the design is safe, meets customer requirements, is manufacturable on a large scale, includes systematic risk assessments, and applies strict change control. All of this helps ensure that the developed products meet international automotive quality and reliability standards. The key tools used to support quality control include:

1. Advanced Product Quality Planning (APQP)
2. Production Part Approval Process (PPAP)
3. Failure Mode and Effects Analysis (FMEA)
4. Measurement System Analysis (MSA)
5. Statistical Process Control (SPC)
6. Control Plan

Supplier Management

In the automotive industry, this refers to the strict management and control of suppliers, as component suppliers play a more critical role in the quality and value of a vehicle than in many other industries. Therefore, specific processes are required, such as supplier capability assessments, control of external processes, quality oversight of parts, use of Core Tools, and regular audits. These ensure that suppliers can manufacture and deliver parts in accordance with standards for quality, safety, and on‑time performance.

Production Control) and Product Approval

Production control focuses on tightly managing the manufacturing processes using standardized tools and methods such as Control Plans, Process Flows, PFMEA, and process audits, ensuring production stability and reducing the risk of defects. Product approval, on the other hand, refers to the process of approving the product and the manufacturing process before mass production begins (such as PPAP), to confirm that the parts, processes, measuring instruments, and supporting documents have all been thoroughly verified and are ready for large‑scale production.