For some companies, quality assurance audits are mandatory. Pharmaceutical companies, for example, must allow the FDA to audit their quality systems and processes. Other companies have clients who insist on audits as part of a contract and will not do business with you unless you allow them to audit your quality systems and procedures.

Even if your company doesn't require quality assurance audits by law or as apart of a contract, they can be an important part of your overall quality management.


A quality assurance audit is a systematic inspection of a quality management system to ensure it complies with quality requirements. Those requirements could be the company's quality requirements, those set by a customer or those set by the government.

The Three Components of Quality

While quality assurance and quality control are often used interchangeably, they are actually two different aspects of a quality management system.

  • Quality Management (QM): How you ensure your products and services meet specified criteria for excellence. This includes quality policies, quality assurance, quality control and quality improvement. 
  • Quality Assurance (QA): The activities and systems within your company that are put in place to ensure your products or services meet your quality requirements. 
  • Quality Control (QC): Includes activities and systems that check or inspect your products or services to ensure quality assurance systems are working. 

As a basic illustration of a quality management system, suppose you made chocolate and wanted to ensure every box contained 12 pieces of chocolate without fail, so you tell the packager to pause and look at each box before putting the lid on (QA). Then, once an hour, the manager opens a random box to make sure it is actually full (QC).

Quality Assurance Audits

A quality assurance audit is an independent process for examining and evaluating your QA systems, procedures and policies to ensure they produce the quality levels expected. With rare exceptions, the terms quality assurance audit, quality management audit and quality control audit usually mean the same thing, unless they are components of a quality assurance audit.

There are three kinds of quality assurance audits:

  1. Process audit: Examines processes, including the resources used and defined requirements within those processes, like weights, times and measurements. It also examines work instructions, flow charts and worker training. 

  2. Product audit: Examines products or services to determine if they meet quality requirements. 

  3. System audit: Examines the quality management system to ensure it meets requirements, such as internal company policies, regulatory requirements or commitments made in a customer contract.

If an audit is done by an employee or manager, it's known as an internal audit. If it's performed by an outside agent, like a consultant, client or a government body like the FDA, it's called an external audit.

Benefits of Quality Audits

The benefits of quality audits are numerous. At a minimum level, for companies that have no choice but to open themselves to audits by government bodies like the FDA, the audit ensures that quality standards set by law are being met and the company can remain open for business — provided it passes the audit, of course.

Customers benefit from quality in audits in that they can rest assured that the products or services they buy will meet the quality levels the company promises. In the business-to-business (B2B) sector, customers may insist on quality audits as part of a contract.

Finally, the company itself benefits from the audit. Customers are more satisfied, returns and complaints decrease and employee morale should improve. In addition to increased sales from satisfied customers, there are direct long-term cost-savings because less time and money is spent replacing or fixing inferior products and services.