IATF 16949:2016 Clause Information for external providers

The standard requires that purchasing documents contain data clearly describing the product ordered. You need to document purchasing requirements so that you have a record of what you ordered. This can then be used when the goods and the invoice arrive to confirm that you have received what you ordered. The absence of such a record may prevent you from legitimately returning unwanted or unsatisfactory goods. The standard requires purchasing documents to include, where applicable, the type, class, style, grade, or other precise identification. The product or service identification should be sufficiently precise as to avoid confusion with other similar products or services. The vendor may produce several versions of the same product and denote the difference by suffixes to the main part number. To ensure you receive the product you require you need to consult carefully the literature provided and specify the product in the same manner as specified in the literature. Purchasing documents to include, where applicable, the title or other positive identification, and applicable issue of specification, drawings, process requirements, inspection instructions, and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment, and personnel. If you are procuring the services of a subcontractor to design and/or manufacture a product or service, you will need specifications which detail all the features and characteristics that the product or service is to exhibit. The reference number and issue status of the specifications need to be specified in the event that they change after placement of the purchase order. This is also a safeguard against the repetition of problems with previous supplies. These specifications should also specify the means by which the requirements are to be verified so that you have confidence in any certificates of conformance that are supplied. For characteristics that are achieved using special processes you need to ensure that the subcontractor employs qualified personnel and equipment. Products required for particular applications need to be qualified for such applications and so your purchasing documents will need to specify what qualification tests are required.

You should seek and record evidence that your organization has, where appropriate, communicated not just the products or services they wish to receive but also any processes they want the external provider to undertake on their behalf.To ensure adequacy of specified purchasing information prior to their communication to the supplier, the supplier is usually requested to quote on price and availability. All pertinent purchasing information, as determined by your organization and customer requirements; should be included in the request for a quote (RfQ).The purchase order should be created after the review and acceptance of a supplier’s quote, and must contain the same content as the request for a quote. Describe the product to be purchased by:

  1. Defining product approval requirements, e.g.; certificate of conformity;
  2. Defining intended verification arrangements, e.g.; witness testing or certification;
  3. Defining personnel qualifications and quality, environmental, and safety requirements;
  4. Maintaining records.

Where activities are wholly outsourced, or subcontracted; your organization maintains responsibility for product conformance to all specified requirements. Purchasing information should include acceptance criteria, and where appropriate, state the requirements for the approval of supplier’s procedures, processes, and equipment.Applicable versions of specifications, drawings, process requirements, inspection instructions, traceability, relevant technical data, and requirements for qualification/competence of the supplier’s personnel, and quality management system must be specified and communicated.

The organization to review and approve purchasing documents for adequacy of specified requirements prior to release. Prior to orders being placed the purchasing documents should be checked to verify that they are fit for their purpose. Again this requirement is appropriate to contracts but only if you submit your purchasing documents to your vendors. The extent to which you carry out this activity should be on the basis of risk and if you choose not to review and approve all purchasing documents, your procedures should provide the rationale for your decision. If you enter purchasing data onto a database, a simple code used on a purchase order can provide traceability to the approved purchasing documents. You can control the adequacy of the purchasing data in four ways:

  • Provide the criteria for staff to operate under self control.
  • Check everything they do.
  • Select those orders which need to be checked on a sample basis.
  • Classify orders depending on risk and only review and approve those which present a certain risk.

Ensure that items, which are essential to fulfilling customer requirements and which directly affect the quality of your products and services, are verified upon product receipt or service delivery to verify they conform to:

  1. QMS requirements;
  2. Competency of external personnel;
  3. Purchase orders;
  4. Purchasing specification;
  5. Purchasing agreements;
  6. Delivery notes;
  7. Release certificates;
  8. Certificates of conformity;
  9. Inspection and acceptance tests;
  10. Product specifications;
  11. National or international standards.

On receipt of incoming materials, the receiving personnel must identify and inspect the items, goods and materials and match them against the delivery note. The delivery note is compared to the corresponding purchase order and any related documentation. This inspection should include but not be limited to:

  1. Confirmation of identification using purchase order number, drawing numbers, material markings etc.;
  2. Confirmation of adherence to delivery schedule;
  3. Confirmation of conformance to purchase order requirements;
  4. Confirmation of correct quantities;
  5. Visual examination for obvious defects;
  6. Measurement comparison to drawings where required;
  7. Specified certification/documentation as required.

For large numbers of identical items, visual and dimensional checks should be undertaken on a minimum of 5% of the total quantity. No material is released for further processing until receiving inspection has been completed and goods accepted. All accepted materials passing immediate inspection can be allocated a storage area.Any non-compliant goods must be placed in a separate area, and clearly identified. Further investigating should determine whether the items, materials or goods are to be:

  1. Scrapped;
  2. Returned to Supplier;
  3. Reworked to a useable condition.

When inspecting materials that include specified certification or documentation should only be accepted when such certification and documentation has been viewed and approved by the Quality Manager or the Purchasing Manager.

Clause Information for external providers

In addition to the requirements given in ISO 9001:2015 Clause 8.4.3 Information for external providers, Clause 8.4.3 requires that the organization passes down all applicable statutory and regulatory requirements and special product and process characteristics to their suppliers and require the suppliers to cascade all applicable requirements down the supply chain to the point of manufacture.

Please click here for ISO 9001:2015 Clause 8.4.3 Information for external providers

The organization must passes down all applicable statutory and regulatory requirements to their suppliers.Passing down all applicable statutory and regulatory requirements to suppliers is a crucial aspect of maintaining compliance and ensuring that the products or services provided by the suppliers meet the necessary legal standards. Here’s how the organization can effectively communicate these requirements to their suppliers:

  1. Identify Relevant Requirements:The organization should identify all the relevant statutory and regulatory requirements that apply to their products or services. This includes laws, regulations, industry standards, and any specific customer requirements.
  2. Incorporate Requirements into Contracts:Ensure that contracts or agreements with suppliers explicitly state their obligation to comply with all applicable statutory and regulatory requirements. This should include a reference to the specific laws or standards that are relevant.
  3. Provide Documentation:Supply suppliers with relevant documentation that outlines the specific requirements they need to meet. This could include copies of laws or regulations, industry standards, or the organization’s own quality standards.
  4. Conduct Training and Workshops: Organize training sessions or workshops for suppliers to familiarize them with the applicable requirements and explain their importance.If necessary, offer guidance on how to interpret and implement the requirements in their processes.
  5. Establish Communication Channels:Maintain open and regular communication channels with suppliers to address any questions or concerns they may have about the requirements.Encourage suppliers to report any potential compliance issues promptly.
  6. Perform Audits and Assessments:Conduct periodic audits or assessments of the suppliers to ensure they are meeting the required standards.During these audits, verify their compliance with statutory and regulatory requirements, as well as the organization’s specified quality standards.
  7. Encourage Continuous Improvement:Promote a culture of continuous improvement among suppliers to drive ongoing compliance with statutory and regulatory requirements.Recognize and reward suppliers that demonstrate strong compliance practices.
  8. Monitor and Review:Continuously monitor changes in relevant laws and regulations and update the requirements communicated to suppliers accordingly.Regularly review the effectiveness of the communication process and make improvements as needed.
  9. Address Non-Compliance:If a supplier is found to be non-compliant with statutory or regulatory requirements, work with them to implement corrective actions promptly.If repeated non-compliance occurs, consider reevaluating the supplier relationship or providing additional support to improve compliance.

By effectively passing down statutory and regulatory requirements to suppliers and ensuring their compliance, the organization can maintain its reputation, reduce legal risks, and deliver high-quality products or services to its customers.

Special product and process characteristics

Passing down all special product and process characteristics to suppliers is essential to ensure that the suppliers understand the unique requirements and specifications of the products or processes they are responsible for. This communication is crucial for maintaining consistent quality and meeting customer expectations. Here’s how the organization can effectively communicate these special characteristics to their suppliers:

  1. Define Special Product and Process Characteristics:
    • Clearly define and identify all special product and process characteristics that are critical to the performance, safety, or functionality of the product.
    • These characteristics could include specific dimensions, tolerances, materials, surface finishes, critical control points in the manufacturing process, or any other attributes that significantly impact product quality.
  2. Incorporate Requirements into Contracts:
    • Ensure that contracts or agreements with suppliers explicitly state their responsibility to adhere to all special product and process characteristics.
    • Include detailed descriptions and references to relevant technical documents or specifications.
  3. Provide Detailed Documentation:
    • Supply suppliers with comprehensive documentation that outlines the special characteristics in detail.
    • This documentation may include engineering drawings, technical specifications, process control plans, quality requirements, and any other relevant information.
  4. Hold Supplier Meetings:
    • Organize meetings or conferences with suppliers to discuss the special characteristics face-to-face.
    • Allow for a two-way communication process where suppliers can seek clarifications and provide feedback.
  5. Conduct Supplier Training:
    • Offer training sessions or workshops to help suppliers understand the importance of the special characteristics and how to meet the specified requirements.
    • Train suppliers on measurement and testing methods to verify compliance with these characteristics.
  6. Perform Audits and Assessments:
    • Conduct periodic audits or assessments of the suppliers to verify their adherence to the special characteristics.
    • Evaluate their manufacturing processes to ensure that they have effective controls in place to meet the requirements.
  7. Provide Support and Feedback:
    • Offer continuous support to suppliers as they implement and maintain compliance with the special characteristics.
    • Provide feedback on their performance and collaborate on improvement initiatives.
  8. Monitor and Review:
    • Continuously monitor changes in product or process requirements and communicate updates to suppliers promptly.
    • Review the effectiveness of the communication process and adjust it based on feedback and results.
  9. Encourage Continuous Improvement:
    • Encourage suppliers to identify opportunities for process improvement and better ways to meet the special characteristics.
    • Recognize and reward suppliers for achieving and sustaining compliance with these requirements.

By effectively passing down special product and process characteristics to suppliers and ensuring their understanding and compliance, the organization can maintain consistent quality, reduce defects, and enhance customer satisfaction.

The suppliers to cascade all applicable requirements down the supply chain to the point of manufacture.

Requiring suppliers to cascade all applicable requirements down the supply chain to the point of manufacture is a critical step in ensuring that the entire supply chain operates in compliance with the necessary standards and regulations. This practice helps maintain consistent quality, regulatory compliance, and accountability throughout the entire production process. Here’s how the organization can encourage and ensure that suppliers effectively cascade these requirements:

  1. Include Contractual Agreements:
    • Establish clear contractual agreements with suppliers that explicitly state their responsibility to ensure that all requirements are passed down the supply chain to the point of manufacture.
    • Include clauses that hold suppliers accountable for any non-compliance within their supply chain.
  2. Communication and Collaboration:
    • Maintain open communication channels with suppliers to discuss the importance of cascading requirements and the expectations for compliance.
    • Foster a collaborative approach where suppliers are encouraged to seek guidance and support in implementing these requirements within their supply chain.
  3. Documented Requirements:
    • Provide suppliers with comprehensive documentation that outlines all applicable requirements they need to pass down the supply chain.
    • This documentation should be clear, detailed, and easily understandable.
  4. Regular Training and Education:
    • Offer training sessions or workshops to suppliers to help them understand the significance of the requirements and how to effectively communicate them to their sub-suppliers and manufacturers.
    • Provide guidance on how to train their own suppliers and partners.
  5. Supplier Assessments and Audits:
    • Conduct regular assessments and audits of suppliers to verify that they are indeed cascading the requirements down the supply chain.
    • Evaluate the effectiveness of their communication and monitoring mechanisms.
  6. Encourage Transparency:
    • Encourage suppliers to be transparent about their supply chain and disclose information about the manufacturers and sub-suppliers they work with.
    • Request regular updates on their progress in cascading requirements and address any challenges they face.
  7. Shared Responsibility:
    • Emphasize that ensuring compliance within the supply chain is a shared responsibility among the organization and its suppliers.
    • Acknowledge and appreciate efforts made by suppliers to maintain compliance.
  8. Incentives and Penalties:
    • Consider offering incentives to suppliers who consistently demonstrate effective cascading of requirements and maintain high levels of compliance.
    • Establish penalties or consequences for suppliers who repeatedly fail to ensure compliance within their supply chain.
  9. Continuous Improvement:
    • Encourage suppliers to continuously improve their supply chain processes and systems to enhance the efficiency of cascading requirements.

By implementing these strategies, the organization can foster a culture of compliance throughout the supply chain, minimize risks, and ensure that all parties involved in the manufacturing process are aware of and adhere to the applicable requirements.

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