Another item that is required by both 21 CFR 820 and ISO 9001 is the Quality Policy. Though it is jointly written by management and quality experts, the process of writing a Quality Process is a beneficial exercise for management as it has them focus on systems and how the company operates. This document is written with a long-term scope, typically 10 years. It should state the objectives of the company with regard to production of a medical device that meets the customer’s expectations. Therefore, it is considered a commitment from the top management to ensure compliance with the Quality Management System, and to ensure continuous increase in customer satisfaction. Management should ensure that all employees are not only aware of, but fully understand the objectives stated through the Quality Policy. The Quality Policy defines your company’s quality goals, what processes are in place to meet these needs, a commitment to meeting them, and a promise that you will employ continuous improvement.
The Quality Policy needs to describe the commitment of management to maintain the standards of their company’s product. It should identify the ownership and involvement of all employees within the company to maintain the quality of the product. Identification of how quality will be monitored should also be captured. The Quality Policy should note that the processes involved in producing the product will be reviewed periodically to ensure they remain effective in meeting customer requirements. As the Quality Policy is meant to be a brief statement, make sure it is concise and does not exceed one page in length. This document is signed and dated by the individual responsible for overall quality control.
Let’s talk biological indicators!
Talk with one of our experts to get your questions answered and see how we can help you solve your BI pain points.