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:

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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

Sub-tier Selection and Management

Risk Management

Auditing

Corrective and Preventive Actions (CAPA)