IATF 16949:2016 Clause 8.6.5 Statutory and regulatory conformity

Statutory and regulatory conformity in the context of the automotive industry refers to the compliance of appearance items, processes, products, and services with applicable laws, regulations, and standards set by government authorities and relevant regulatory bodies. Adhering to these requirements is essential for ensuring safety, quality, and legal compliance. Statutory conformity pertains to compliance with laws and regulations enacted by governmental bodies. In the automotive industry, this includes adhering to laws related to safety, emissions, environmental protection, labor practices, intellectual property rights, and other relevant legal requirements. For instance, appearance items and automotive parts must meet safety standards established by regulatory agencies to ensure they do not pose hazards to vehicle occupants or the public. Regulatory conformity involves complying with specific regulations, guidelines, or directives issued by relevant industry regulatory bodies. In the automotive sector, regulatory conformity may include adherence to standards set by organizations such as the International Organization for Standardization (ISO), Society of Automotive Engineers (SAE), or the National Highway Traffic Safety Administration (NHTSA). Compliance with these standards helps ensure consistent quality, performance, and safety of appearance items. Certain appearance items, especially those related to safety-critical features, may require certification or homologation to demonstrate compliance with applicable regulations. Certification ensures that the appearance item meets the required quality and safety standards specified by relevant authorities. Organizations must have robust compliance management systems in place to monitor, track, and ensure adherence to statutory and regulatory requirements. This involves conducting regular audits, maintaining documentation, and implementing corrective actions if any non-conformities are identified. Appearance items should also conform to safety and environmental regulations. For instance, paint and coating materials used in appearance items must comply with environmental regulations regarding volatile organic compounds (VOCs) emissions. Compliance also involves proper labeling of appearance items, especially if they contain hazardous materials or have specific usage requirements. Providing clear and accurate documentation ensures that customers, suppliers, and end-users are aware of the product’s compliance status and intended use. Failure to achieve statutory and regulatory conformity can lead to legal consequences, damage to the organization’s reputation, and potential safety risks. Thus, it is crucial for automotive manufacturers to prioritize compliance efforts and integrate them into their quality management systems.

Clause 8.6.5 Statutory and regulatory conformity

Prior to release of externally provided products into its production flow, the organization shall confirm and be able to provide evidence that externally provided processes, products, and services conform to the latest applicable statutory, regulatory, and other requirements in the countries where they are manufactured and in the customer-identified countries of destination, if provided.

The standard requires that all products or materials used in part manufacture satisfy current regulatory requirements applicable to the country of manufacture and sale. The first step in meeting this requirement is to establish a process that will identify all current regulatory requirements pertaining to the part or material. You need to identify the regulations that apply in the country of manufacture and the country of sale. This may result in two different sets of requirements. For example, a part may be manufactured in china and sold in UAE or made in the UK and sold in Qatar. In one case the regulations on recycling materials may be tougher in the country of sale and in the other case there may be restrictions prohibiting the sale of vehicles containing materials from a particular country. It is difficult to keep track of changes in import and export regulations but using the services of a legal department or agency will ease the burden. This illustrates how a quality system can easily involve every department, function, and/or discipline in the company.In order to ensure compliance with this requirement you need to impose on your supplier/contractors, through the purchase order, the relevant regulations; and through examination of specifications and products and by on-site assessment, verify that these regulations are being met. It is not sufficient merely to impose the requirement upon your supplier through the purchase order. You can use the certified statements of authorized independent inspectors as proof of compliance instead of conducting the assessment yourself. However, such inspections may not extend to the product being supplied and therefore a thorough examination by your technical staff will be needed. Once deemed compliant, you need to impose change controls in the contract that prohibit the supplier changing the process or the product without your approval. This may not be possible when dealing with suppliers supplying product to their specification or when using off-shore suppliers where the system of law enforcement cannot be relied upon. In such cases you will need to define accurately the product required and carry out periodic inspections and tests to verify continued compliance.

Confirming and providing evidence of conformity to the latest applicable statutory, regulatory, and other requirements is a critical step in ensuring the quality and compliance of externally provided processes, products, and services in the automotive industry. This process helps organizations verify that the appearance items and related components meet the necessary legal and customer-specific standards. Here’s how an organization can implement this process:

  1. Supplier Evaluation: Thoroughly assess and evaluate external suppliers to ensure their capability to meet the organization’s requirements and comply with relevant statutory and regulatory requirements. This evaluation includes verifying their compliance with applicable laws in the countries where they operate.
  2. Contractual Agreements: Establish written contracts or agreements with external suppliers that clearly state the quality requirements, regulatory compliance obligations, and applicable standards. These agreements should also address the requirements of customer-identified countries of destination, if provided.
  3. Compliance Documentation: Request evidence of compliance from external suppliers, such as certificates, test reports, or documentation demonstrating conformity with statutory and regulatory requirements. This documentation should be kept on record as evidence of compliance.
  4. Inspection and Testing: Perform inspection and testing on externally provided processes, products, and services to validate their conformity to specified requirements. This may involve conducting quality checks on incoming appearance items to ensure compliance before they are used in production.
  5. Legal Compliance Monitoring: Regularly monitor changes in applicable laws, regulations, and standards in the countries where the appearance items are manufactured and the customer-identified countries of destination. Stay updated with the latest requirements to ensure ongoing compliance.
  6. Customer-Identified Requirements: Pay close attention to any specific requirements identified by customers for appearance items destined for particular countries. This may include unique labeling, certification, or packaging needs.
  7. Records and Traceability: Maintain detailed records of all the evidence and documentation demonstrating compliance with statutory, regulatory, and customer-identified requirements. Ensure that the traceability of appearance items and components can be established from the supplier to the final product.
  8. Continuous Improvement: Use feedback from customers, internal audits, and supplier assessments to identify areas for improvement and enhance the overall compliance process.

By adhering to this process, organizations can confidently release externally provided processes, products, and services into their production flow, knowing that they meet the latest applicable statutory, regulatory, and customer-specific requirements. This proactive approach not only ensures legal compliance but also fosters customer satisfaction and strengthens the organization’s reputation in the automotive industry.

Identifying the latest applicable statutory and regulatory requirements

Identifying the latest applicable statutory and regulatory requirements in the supplier country and customer country is crucial for ensuring compliance and meeting legal obligations. Here are some steps you can take to identify these requirements:

  1. Research Government Websites: Visit the official websites of the government authorities in the supplier country and customer country. Look for relevant departments or agencies responsible for regulating the automotive industry. These websites often publish updates on laws, regulations, and standards applicable to various industries, including automotive.
  2. Regulatory Bodies and Industry Associations: Identify regulatory bodies and industry associations related to the automotive sector in the supplier country and customer country. These organizations often publish guidelines, codes of practice, and updates on regulatory changes affecting the industry.
  3. Consult Legal and Compliance Experts: Seek advice from legal and compliance experts who specialize in the automotive industry. They can help interpret complex legal requirements and provide guidance on meeting compliance obligations.
  4. Trade Publications and News Sources: Monitor trade publications, industry journals, and reputable news sources for updates on regulatory changes in the automotive industry. These sources often highlight legislative developments and their potential impact on businesses.
  5. Collaborate with Suppliers: Engage in open communication with suppliers to understand the local regulatory landscape. Suppliers are likely to be aware of the latest requirements in their respective countries and can share information about compliance challenges.
  6. Consult with Customers: Collaborate with customers to understand their specific requirements for appearance items and any additional regulatory standards they may demand in their country. Customers may provide insights into localized requirements and certifications necessary for the products they receive.
  7. Attend Industry Conferences and Seminars: Participate in industry conferences and seminars where regulatory updates are often discussed. These events offer opportunities to network with experts and gain insights into the latest compliance trends.
  8. Use Regulatory Databases: Access regulatory databases or subscription services that provide updates on relevant laws and regulations. These databases can be valuable resources for staying current with the latest legal requirements.
  9. Regular Reviews and Audits: Conduct regular reviews and audits of your compliance management system. Ensure that your organization has a process in place to keep track of regulatory changes and update internal policies and procedures accordingly.
  10. Regional and International Standards Organizations: Check regional and international standards organizations, such as the International Organization for Standardization (ISO) or the United Nations Economic Commission for Europe (UNECE), for harmonized standards applicable to the automotive industry.

By actively seeking information through these channels, your organization can stay informed about the latest applicable statutory and regulatory requirements in the supplier country and customer country. This proactive approach helps in maintaining compliance, mitigating risks, and building trust with suppliers and customers alike.

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