Supplier quality

Medtronic expects suppliers to develop and maintain highly capable processes that produce quality Products and Services. We expect suppliers to have systems in place that define and maintain manufacturing processes to ensure that Products conforms to the specifications.
 

Your role as a supplier
 

• Collaborate with us to understand how design requirements influence manufacturability and identify improvements to reduce risks.
• Work with us to develop process control plans and embed them as a standard part of your quality system. Ensure control plans identify critical features of processes and repeatable methods to measure and monitor them.

We recognize that continuous improvement efforts may require changes to manage cost, quality, delivery, and technology. However, implementation of unapproved changes can have unintended effects on our products and therapies, our operations and, more importantly, our customers and patients. Suppliers must notify Medtronic of changes made to materials, products, or processes.
 

Your role as a supplier
 

• Provide adequate advance notification of the change by submitting a request through Medtronic’s Supplier Change Request.
• Define a proactive process to identify and manage changes from sub-tier suppliers.

Suppliers are expected to manage sub-tier suppliers to ensure that Product(s) manufactured utilize only specified material and meet all requirements of the Specification.
 

Your role as a supplier
 

• Make supplier management an active part of your quality system.
• Identify and mitigate risks that sub-tier suppliers pose to finished products.
• Manage sub-tier supplier changes and notify Medtronic as applicable.

We expect our suppliers to have a robust risk management process to identify, prioritize and mitigate risks. The risk management process should include a business continuity plan to facilitate rapid response and recovery in the event of disruptions.
 

Your role as a supplier
 

• Formalize a risk mitigation strategy within your business for Medtronic products.
• Collaborate with us to proactively address and eliminate or minimize risks identified.

Medtronic may choose to audit the supplier or sub-tier supplier’s manufacturing and Quality Systems to ensure compliance to quality requirements.
 

Your role as a supplier
 

• Provide access to your facility and focused support for the duration of the audit.
• Provide timely response to all findings and implement corrective and preventive actions where applicable.

Suppliers are expected to establish and maintain a Corrective and Preventive Action (CAPA) process.

Your role as a supplier
 

• Engage in timely resolution when action is required.
• Conduct robust investigation and root cause analysis to identify actions to correct and prevent reoccurrence.
• Verify the actions taken were effective and did not adversely affect the product or service.