Here are key aspects of IATF 16949:2016:

1. Development: IATF 16949 was developed by the International Automotive Task Force (IATF), which is a group of automotive manufacturers and their respective trade associations. The IATF collaborates with the International Organization for Standardization (ISO) to align this standard with ISO 9001 and to ensure its compatibility.
2. Scope: IATF 16949 is designed for organizations within the automotive supply chain, including manufacturers of automotive parts and components, as well as service providers to the automotive industry. It applies to organizations of all sizes, from large automotive manufacturers to small suppliers.
3. Quality Management System (QMS): IATF 16949 is primarily concerned with establishing and maintaining an effective QMS within the automotive sector. A QMS is a set of policies, processes, and procedures used by an organization to ensure it meets customer requirements and consistently delivers high-quality products or services.
4. Risk Management: IATF 16949 places a strong emphasis on risk management, including the identification and mitigation of risks related to product safety and production processes. This aligns with the automotive industry's focus on preventing defects and ensuring product safety.
5. Customer Focus: The standard emphasizes the importance of meeting customer requirements and enhancing customer satisfaction. Customer-specific requirements are also addressed in the standard.
6. Continuous Improvement: IATF 16949 promotes a culture of continuous improvement through the use of quality tools and methodologies such as Six Sigma, Lean Manufacturing, and Kaizen.
7. Certification: Organizations can seek certification to IATF 16949 through accredited certification bodies. Certification demonstrates an organization's commitment to meeting automotive quality standards and can be a requirement for doing business in the automotive industry.
8. Emergency Response: The FDA plays a role in responding to public health emergencies, such as outbreaks of foodborne illnesses, drug shortages, and other health threats.
9. User Fees: In some cases, manufacturers pay user fees to support the FDA's review of their products. This is common in the pharmaceutical and medical device industries.