![]() ![]() The internal role of QA involves management, while QA’s external role pertains to the customer, government, agencies, regulators, notified bodies, and third parties. In the QA stage, all activities involved in your quality management plan should verify that your product is ready to be approved and get through the manufacturing process.Īssurance has two purposes: internal and external. ![]() The quality assurance process is part of the organization’s overall quality management. In short, QA is a pre-planned process that defines the product in its development stage and determines whether it meets the necessary requirements. Quality Assurance consists of a series of activities carried out by the organization's QMS in order to confirm the product meets quality standards. ![]() If you're a medical device company, you've probably known or already implemented the ISO 13485 Quality Management System within your organization however, other life science organizations might implement ISO 9001, which is another QMS standard. To effectively manage your quality processes-including Quality Assurance and Quality Control activities-you need to implement a QMS according to ISO standard requirements. Understanding the roles of QA and QC can help your organization improve each process and deliver the best possible products. ![]() QA activities mostly focus on providing assurance that quality requirements will be fulfilled, while QC activities focus on actually fulfilling quality requirements. According to ISO 9000:2015 – Quality management systems – Fundamentals and vocabulary, QA and QC are both part of the QMS yet focus on different subjects. As such, it’s good to know the difference between these two processes. Elements of the QMS may not be specifically composed of QA or QC activities and responsibilities, but instead involve a combination of the two.īoth QA and QC play vital and distinct roles in the health of life sciences companies. However, while these processes feature some overlap, it’s essential to note that they are two separate entities and take place at different times. QA and QC processes are inseparable parts of the overall Quality Management System (QMS), and they are often used interchangeably. ![]()
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