What Does ISO 9001 Clause 8.4.2 Type and Extent of Control Mean?
ISO 9001:2015 Clause 8.4.2, titled "Type and extent of control," outlines the requirements for ensuring that the organization's capacity to continuously provide its clients with conforming goods and services is not negatively impacted by processes, products, or services that are provided by outside sources.
Clause 8.4.2 Key Points
Ensure Externally Provided Processes Remain within Control:
Define Controls for External Providers and Output:
Consider Potential Impact and Effectiveness of Controls: When deciding on controls, the company should take into account how processes, goods, and services supplied by outside parties may affect its capacity to satisfy client demands and adhere to legal and regulatory obligations. additionally, the efficiency of the safeguards put in place by the outside supplier.
Determine Verification Activities:
Example: How an Organization Might Apply Clause 8.4.2
Scenario: Procurement of a Critical Component. Imagine a manufacturing company that produces medical devices. One critical component of their devices is a specialized sensor. Due to the specialized nature of this sensor, the organization decides to procure it from an external provider and implement the following:
Ensure Externally Provided Processes Remain within Control:
Define Controls for External Providers and Output:
Consider Potential Impact and Effectiveness of Controls:
Determine Verification Activities:
This example illustrates how an organization, especially in industries with critical components or processes, might implement controls over externally provided products to ensure they meet the required standards and do not adversely impact the organization's ability to deliver high-quality, compliant products to customers.
ISO 9001:2015 Clause 8.4.2 Type and Extent of Control
Clause 8.4.2 emphasizes the importance of maintaining control over processes, products, and services provided by external parties to ensure that they align with the organization's quality management system and do not compromise the consistency and conformity of the final deliverables to customers.