To determine compliance with ISO 9001 clause 8.4.2, it’s essential to verify that the organization effectively manages and controls outsourced processes within its Quality Management System (QMS). Evidence of compliance would include a clear framework that outlines how the organization controls each outsourced process to ensure alignment with its quality standards. This may involve examining documented procedures that specify the level and type of control applied to outsourced activities, taking into account the nature and significance of each outsourced process and its impact on product conformity.

Additionally, compliance can be confirmed by reviewing how the organization monitors the performance and effectiveness of each outsourced process. This includes assessing whether there are documented records or reports showing that controls, such as audits, inspections, or periodic reviews, are applied consistently to external providers. These controls should ensure that outsourced processes do not negatively affect the organization’s ability to meet customer requirements and regulatory standards. Records should demonstrate that the organization evaluates the potential impact of each outsourced process and implements suitable monitoring to manage any risks.

Finally, verifying compliance requires confirming that the organization maintains clear communication with external providers regarding the requirements and standards that apply to outsourced processes. Documentation should show that the organization has communicated quality expectations, criteria for process approval, and any verification or validation activities to external providers. This ensures that both parties are aligned and that the outsourced processes remain under the control of the QMS, helping the organization consistently deliver products and services that meet specified requirements.