Title: Module 7 Overview: Internal Audit Program
Course: PW-Course-Import-Test > Section: Module 7: Internal Audit Programs

Module 7

Medical Device companies are required to maintain a Quality System in order to manufacture and market medical devices in the USA. After the Quality System has been established - the system must be periodically reviewed in order to assess effectiveness and the overall state of compliance.

Internal Audits required by the regulation provide a means for achieving this objective. Internal Audits are not exclusive to the medical device industry. Many other regulated industries also use this process extensively, such as Banking/Finance and State and Federal Government entities.

Competency

After completing this module, you will be able to explain the principles and benefits of internal audits at a medical device industry.

Learning Objectives

- List the applicable regulatory requirements within 820 related to audits
- Recognize the benefits of effective internal audit program
- Sequence the components and procedures for performing effective internal audits
- Recognize the elements of a standard operating procedure for a high-level internal audit program

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