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This article is related to the toolkit: Audit Toolkit from MasterControl. To get the full details, please download your free Toolkit. The International Organization for Standardization ISO , the world's leading developer of international standards, is instrumental in boosting interest in quality audits among manufacturers and other types of businesses when it published the ISO standards in Under these standards, audit serves as a mechanism for evaluating and improving quality.


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The same principle is reflected in a number of regulations enforced by the Food and Drug Administration. Under the Quality System Regulation 21 CFR Part , medical device manufacturers are required to conduct audits to ensure that the quality system is compliant Sec. Guidances for the pharmaceutical industry and blood establishments also emphasize the importance of audits.

The "Guidelines for Quality Assurance in Blood Establishments" call for comprehensive audit of the quality assurance program. In general, there must be a basis specific requirements for an audit and a systematic method for gathering facts or evidence. An auditor compares the evidence with the requirements and comes up with observations, which can be either positive or negative. Up to this point, the process is similar to inspection. But an audit entails much more. The auditor analyzes his or her observations for patterns - also called findings - in order to draw conclusions.

The auditor then presents the observations, findings, and conclusions in a report to all parties involved. Going back to the example of the mystery shopper, the focus was customer service in just one store. A product audit of a vacuum cleaner may entail randomly pulling outa box from the assembly line and taking the vacuum cleaner apart to examine it from a consumer's perspective. In bothcases, the audit has a narrow focus.

A process audit focuses on a single activity.

Auditing Beyond Compliance - Auditing Beyond Compliance...

For example, a process audit at an ISO-certified car manufacturing plant might examine the process of welding body panels together, or of installing doors and windows. The audit is likelyto be short but intense. It must be conducted several times in order to analyze patterns.


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This kind of audit is useful in troubleshooting and in solving specific issues. A system consists of related processes with a common goal. Using the example of the car manufacturer, an audit of the quality system will cover not just the process of welding body panels, but all other processes, from design to assembly to safety tests, etc.

This type of audit is longer and broader, covering not only different processes but also their controls. Audits can be categorized by purpose. For audit to be an effective improvement and compliance tool, it must be conducted on an on-going basis. And this can be daunting for companies that rely on a paper-based or a partially electronic system.

The following are some of the biggest challenges faced by such companies. Gone are the days when auditors and auditees treat each other like adversaries. More and more companies now see audit as an occasion for auditors and auditees to work together in achieving a common goal - improved performance. Forward-looking organizations recognize that the audit process is one of the best tools for continuous improvement of the quality system and for making sure that the system is always compliant. Buy with confidence, excellent customer service!.

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