Implementing Clause 8.4

First, determine which external processes, products, or services are relevant to your organization's quality management system. These can include suppliers, contractors, outsourced processes, and other external parties. You don’t need to include everything.

Then, establish a process for selecting and evaluating external providers. This may involve supplier audits, performance assessments, and risk assessments to ensure that external providers meet your quality requirements.

Clearly define your organization's requirements for externally provided processes, products, or services. Document these requirements and communicate them effectively to external providers (may be in specification sheets, may be in design documents or projects)

Develop formal contracts, agreements, or purchase orders that clearly specify the quality-related requirements, responsibilities, and expectations between your organization and external providers.

Implement a system to monitor the performance of external providers. This can involve regular quality checks, inspections, and key performance indicators (KPIs) to measure their compliance with your requirements.

Assess and manage risks associated with external providers. Identify potential risks that could impact the quality of your products or services and implement mitigation strategies.

Establish effective communication channels with external providers to ensure that they are aware of your quality requirements and any changes in those requirements

Maintain documentation related to the control of externally provided processes, products, and services. This includes contracts, records of performance evaluations, and any corrective actions taken.
 

You can find more information in the following links:

• Article - How to evaluate supplier performance according to ISO 9001:2015 
• Article - How to control outsourced processes using ISO 9001 
• Purchasing in QMS - The Process & the Information Needed to Make it Work