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The mission of COBE Cardiovascular is to provide superior quality cardiovascular, blood processing, and related diagnostic medical devices, that are used in life saving and life enhancing therapies, with a passionate focus on service leadership and operational excellence.
The COBE Cardiovascular, Inc. Quality Policy is a guide for everyone in the company as to how they should provide products and services to customers, both internal and external.
All of us expect the highest quality health care for our family members and ourselves when we are sick or are in need of emergency care. We trust the skills of doctors, surgeons, and clinicians. We also trust the quality of medical supplies, implants, and equipment they use while caring for us.
Accordingly, our customers expect COBE Cardiovascular employees to deliver error-free products and services that meet customer requirements. Poor quality can seriously affect patient outcomes and can significantly impact our business. Quality is a team effort that involves every COBE Cardiovascular employee. Quality is everyone's job.
The FDA and worldwide regulatory agencies regulate COBE Cardiovascular. We are required by federal law to conduct business with a documented quality system. We will comply with all released procedures.
It is essential that we each identify our customer, whether internal or external, and understand their needs. Understanding the needs, articulating the requirements, planning to meet or exceed the requirements, and executing the plan are all essential activities, whether in manufacturing, product development, customer service, or the many necessary internal service activities. We will focus on customer requirements.
Developing complete and accurate specifications, employing good design practices, and following our procedures can prevent quality problems. Products and processes will be designed for manufacturability. We will involve suppliers early in the design process. Products will be transferred to production only after they have been thoroughly tested to pre-defined requirements. We will emphasize prevention over detection.
We purchase and distribute products built by other companies. No matter what company brand is on the products we sell, quality problems experienced by our customers negatively reflect against COBE Cardiovascular. We expect all products we sell or distribute, whether under the COBE Cardiovascular brand or not, to meet the quality requirements of COBE Cardiovascular.
Customer satisfaction is fundamental to our long-term success. Complaints are considered a serious matter, and they will be handled with priority. In the event of a complaint, COBE Cardiovascular will address the customer’s concerns and communicate our findings appropriately. Problems will be analyzed using effective problem solving techniques so the root cause can be identified and permanently eliminated. We will give customer complaints the highest priority.
People are the most important element of our quality system. We can have the best procedures, best equipment, best designs, and still build defective products if our people are not vigilant in making sure their work is error-free. COBE Cardiovascular will create an environment where people who spot problems will be acknowledged and recognized. We expect zero defects.
Sometimes we may feel rushed to complete a task, make a decision, or finish the build of a product. If rushing means we might make mistakes, then we will be more careful. We will never sacrifice quality.
Following our quality policy, concentrating on prevention, and continuously improving our business processes will ensure that COBE Cardiovascular's products are safe and effective and that we prosper as a company.
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