ISO 9001:2015 Clause 8.4.3, titled "Information for external providers," falls under the broader category of "Operation" in the standard, specifically within the context of controlling externally provided processes, products, and services. This clause is pivotal in ensuring that any external entity that supplies your organization with goods, services, or processes understands and aligns with your quality requirements, thereby ensuring the consistency and reliability of what you offer to your customers.
Here's a detailed breakdown of the elements and implications of Clause 8.4.3:
1. Purpose and Scope
- The primary aim of this clause is to specify the type of information that an organization must communicate to its external providers. This information ensures that external providers are fully aware of the organization’s requirements and expectations regarding the products, services, or processes being outsourced.
2. Requirements for External Providers
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Specifications: The organization must clearly define and communicate the specifications for the products, services, or processes that are to be externally provided. This includes detailed descriptions, drawings, or technical documents that the external provider will need to fulfill the order.
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Approval Processes: Details regarding the approval process of products, services, processes, or equipment must be communicated. This includes any specific requirements for testing, verification, or validation that the external provider must perform.
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Competency and Qualification: The clause mandates that organizations specify the necessary competence of personnel, including needed qualifications, that external providers must ensure. This ensures that the personnel handling the organization’s products or services are capable and qualified.
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Quality Management System Requirements: External providers must be informed of the relevant quality management system requirements. This may include specific procedures they need to follow, quality control measures they need to implement, or any quality objectives they need to meet.
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Monitoring and Measurement Requirements: The organization should specify how the products, services, or processes will be inspected and tested before acceptance. This includes any specific monitoring or measuring devices that need to be used and any specific requirements for these devices.
3. Communication and Documentation
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Effective communication channels must be established to ensure that all these requirements are clearly understood and agreed upon by the external provider. This might involve contractual agreements, purchase orders, specifications, or quality agreements.
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Documentation provided to external providers should be controlled and reviewed regularly to ensure its continued adequacy and relevance.
4. Integrating External Providers into the QMS
- The organization must consider how external providers are integrated into its quality management system. This includes considering the impact of externally provided processes, products, and services on the organization’s ability to consistently meet customer and regulatory requirements.
5. Outcome
- By adhering to this clause, organizations can foster a mutually beneficial relationship with their external providers, ensuring that the externally provided processes, products, and services contribute positively to the overall quality objectives.
ISO 9001:2015 Clause 8.4.3 is about establishing a clear, effective communication framework with external providers to ensure that externally provided products, services, or processes meet the organization's requirements. It emphasizes the need for precise, detailed information exchange to maintain the integrity and quality of the final outputs, reflecting the organization’s commitment to quality and customer satisfaction.