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Supplier Quality

Quality has been an integral part of our Mission since co-founder Earl Bakken penned by in 1960. One of the six tenets of our Mission is:

To strive without reserve for the greatest possible reliability and quality in our products; to be the unsurpassed standard of comparison and to be recognized as a company of dedication, honesty, integrity, and service.

We consider our suppliers a key component in our pursuit of quality for our customers, and the patients who depend on our products and therapies

We can never be content with what we achieved last year, last quarter, or even yesterday. That's why we're training our key suppliers on the importance of quality to our products and the patients who use them.

The following key elements of supplier quality are included in our Supplier Quality & Excellence Manual, which we expect suppliers to read and comply with:

Process Control

Our approach considers quality and cost as important factors, and their optimization start with design – of products/components/services, processes, and control plans. We believe that ongoing assurance and continuous improvement of quality occurs best within the process of creation – not through downstream inspection.

Your Role as a Supplier

  • Collaborate with us tunderstand how design requirements influence manufacturability processes, and identify improvements for issues and risks.
  • Work with us tdevelop control plans where necessary; embed them as a standard part of your quality system, and train your organization on their effective creation and use.
  • Ensure control plans and their ongoing execution address the following elements:
    • Design risk and identification of critical features
    • Process risk
    • Measurement capability
    • Process monitoring

Change Control

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 when possible.
  • Review timeliness of change notification and establish an effective process for triggering notification.
  • Define a proactive process to identify changes from your suppliers in a timely manner.

Sub-tier Selection and Management

Our expectation is that as a supplier, you will extend and ensure compliance with our requirements to your suppliers (tier 2) and beyond, both in their selection and ongoing management.

Your Role as a Supplier

  • Make supplier management an active part of your quality system, including all the elements listed here.
  • Provide input to the risks your sub-tier suppliers pose to finished products.
  • Agree on which sub-tier suppliers should be managed based on end-user risk.
  • Actively manage your suppliers.

Risk Management

We have employed detailed and predictive supply base risk management processes. It is through these processes we prioritize areas for immediate focus or continuous improvement.

Your Role as a Supplier

  • Formalize a risk mitigation strategy within your business for Medtronic products.
  • Collaborate with us to proactively address the risks you identify.

Auditing

We have the right to audit suppliers to ensure the effectiveness of your quality systems and compliance with agreement terms. These audits will be coordinated across Medtronic divisions.

Your Role as a Supplier

  • Provide focused support from your company for audits, ensuring the process is completed as a ‘win’ for all.
  • Drive timely investigation and closure of any corrective and preventive actions (CAPA) items identified.

Corrective and Preventive Actions (CAPA)

We collaborate with suppliers as part of a collective effort to continuously improve and have more preventive processes in place.

Your Role as a Supplier

  • Engage in timely resolution when action is required.
  • Dedication to quality and timeliness standards.
Last updated: 23 Jan 2013

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Additional information

Supplier Quality and Excellence Manual

Supplier Quality and Excellence Manual

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Our Comprehensive Quality Approach

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