QMS Audit Software Solutions

A quality management system (QMS) audit entails reviewing your quality management system to identify potential flaws and new opportunities to improve and optimize your system. This generally involves evaluating your processes, product inputs and outputs, as well as partnerships, including suppliers.

Audits may recur on a regular basis and attempt to review your system from the top down. Or they may be targeted to address singular occurrences and particular areas of your system.

There are three main types of QMS audits.

Internal. This type of audit is performed by quality organizations to evaluate their own adherence to current good manufacturing practices (CGMPs).

External. This type of audit is performed by a third-party inspector. It focuses on regulatory compliance.

Supplier. Quality organizations perform these audits to evaluate potential or present suppliers.

The purpose of the QMS audit will dictate the approach that you take to prepare for and/or complete it. It may recur on a regular basis as you review your quality management system from the top down. Or it may be targeted to address a singular occurrence of particular area of your system.

Prepare in three simple steps:

Address past problems.

Be familiar with current regulations.

Review common citations.