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Quality and Regulatory Compliance

Global Business Practice Standards Manual

Baxter's reputation is built on the quality of our products and services. Quality within Baxter is important from many perspectives. As a company, we are a global leader in delivering critical therapies for life-threatening conditions. This truly makes what we do at Baxter unique from many other companies and industries.

 

Quality is not just a manufacturing plant responsibility. The quality of our products and services starts with understanding the requirements of our customers, defining those requirements, and designing products and services to meet or exceed those requirements.

 

Our "Quality Policy" states:

 

      "We are committed to providing safe, effective quality products, and services by

  • Reaching agreement on requirements with our customers,
  • Meeting those requirements and the needs of patients, and
  • Implementing continuous improvement."

 

Defect-free work does not mean perfection, but it does mean meeting requirements every time, all the time.

 

Baxter has a quality manual that details the quality standards and the system for administering the quality process. To ensure consistency in product research and development, production, and performance across the company, each business unit must establish and maintain a quality system that conforms to the Baxter Corporate Quality Manual and all applicable laws and regulations. All Baxter employees and others performing work on behalf of Baxter, including those involved in basic research as well as clinical and non-clinical studies, must carry out their work precisely, accurately, and in conformance with the Baxter Corporate Quality Manual.

 

Once our products are cleared or approved by the applicable regulatory agency, quality becomes even more important and involves each and every employee in the process. The quality system covers all aspects of the process including:

  • Design and control procedures for manufacturing processes.
  • A supplier quality program so purchased products and services comply with specifications and regulatory requirements.
  • Procedures to control nonconforming products, to investigate reasons for nonconformance, and to take corrective and preventive action.


When our products are delivered to our customers, our quality and service standards ensure that our customers receive the right products at the right time. When we bill our customers, the invoices should accurately reflect what the customer ordered and what was shipped. If our customers have questions or problems, we must be responsive and solve those problems as rapidly as possible.

 

Every day, we must remember that the work we do has an impact on products which someday may be used on us or our loved ones.

 
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