The Internal Audit Program is a key component to a robust Quality Management System (QMS). Internal Audits are a regulatory requirement, but they are also an essential tool to drive a QMS to a higher level. There are several reasons why a strong Internal Audit Program is important to the health of the QMS. A strong Internal Audit Program can drive higher efficiency. Auditors conduct an in-depth examination of processes to assess their effectiveness. During these thorough evaluations, auditors actively seek out opportunities for improvements and gaps in the QMS. These findings will lead to higher efficiency in a QMS.
In addition to promoting efficiency, an Internal Audit Program will also help verify that all processes in the QMS are compliant with the relevant standards and regulations. This is very important in ensuring that the organization meets both the internal and external requirements. Internal audits also play a role in locating potential risk within the QMS, by finding gaps within processes. This allows organizations to address vulnerable spots before they become a major problem. When changes happen to a process Internal audits are also a great tool to verify that these changes are working effectively and that there is no additional risk to the QMS because of these changes.
Finally, internal audits are a powerful tool in encouraging continuous improvement. Auditors will find opportunities for improvement, while subject matter experts will be reviewing their processes in a different way as they prepare for the audit. The effort from both parties will help find inefficiencies and will drive improvement for the QMS. All life science businesses should be conducting internal audits because it satisfies a regulatory requirement and acts as an important tool to enhance a QMS. If you need help developing or implementing an internal audit program for your life sciences business, EMMA International’s team of experts can help. Give us a call at 248-987-4497 or email info@emmainternational.com
