ISO 9001 Clause 8.4.1, titled "Control of externally provided products and services," pertains to how an organization manages processes related to externally sourced products and services, including those provided by suppliers, contractors, or other external entities.
Breakdown of Clause 8.4.1 Key Points
Determining the Externally Provided Processes, Products, and Services: The organization identifies and documents the processes, products, and services that are provided by external parties and are relevant to the quality management system.
Ensuring Conformity:
Supplier Evaluation: The organization establishes and applies criteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers. This involves assessing the external providers' ability to deliver processes, products, and services in line with the organization's requirements.
Communication with Suppliers:
Determining Controls: The organization needs to determine the controls to be applied to externally provided processes, products, and services. This determination is particularly important under the following circumstances:
Incorporation into Own Products and Services: When external products and services are intended to be incorporated into the organization's own products and services.
Direct Provision to Customers: When external providers supply products and services directly to the organization's customers on its behalf.
Decision by the Organization: When the organization decides to have a process or part of a process provided by an external provider.
Control of Outsourced Processes:
Documentation:
Manufacturing Company Example of Clause 8.4.1
Company ABCÂ produces high-end electronic devices. One of the crucial components, a specialized microchip, is externally provided by Supplier XYZ. The microchip is integral to the functionality and performance of ABC's electronic devices.
Evaluation and Selection Criteria:
Monitoring and Performance:
Re-evaluation:
Incorporation into Own Products:
Documented Information:
By applying Clause 8.4.1, Company ABC ensures that the externally provided microchips meet its quality standards, contributing to the overall reliability and performance of its electronic devices. The company's documentation also serves as a record of its commitment to quality and continuous improvement.
ISO 9001:2015 Clause 8.4.1 Control of Externally Provided Products and Services
Clause 8.4.1 emphasizes the need for organizations to have clear and effective (purchasing) criteria, controls, and processes in place for selecting and evaluating external providers to ensure that they meet specified quality requirements and contribute to the organization's overall quality objectives.