What does IQA stand for?

In addition, they found no objective evidence available for review to demonstrate that the company had conducted an internal quality audit since its last FDA inspection in April 2005.

Biolase also established an internal quality system audit schedule that "is currently being diligently followed," and a second internal quality audit was ongoing, the response letter stated.

For example, the areas for design controls and device tracking were not covered in the Au gust 2006 internal quality audit.

The elements also cover, among other things, training requirements, how quality records are to be kept and how internal quality audits are to be conducted.

ISO 9002 Targets ISO 9002 demands documented quality procedures in the following areas: Management Responsibility Quality System Contract Review Document Control Purchasing Purchaser Supplied Product Product Process Control Inspection and Testing Inspection, Measuring/Test Equipment Inspection and Test Status Control of Non-Conforming Product Corrective Action Handling, Storage, Packaging, Delivery Quality Records Internal Quality Audits Training Statistical Techniques

The Surviving an FDA Audit Conference is taking place from July 11-12, 2005, at the Radisson Hotel at Cross Keys, Baltimore, MD, and will allow delegates to understand the key components of current FDA Audits, and approaches to internal quality audits, to avoid the high costs of regulatory non-compliance.

In addition, they found no objective evidence available for review to demonstrate that the company had conducted an internal quality audit since its last FDA inspection in April 2005.

Specifically, there were no QS internal quality audits performed from September 2004 until February 2006; and, the firm's design-output procedures did not allow for adequate evaluation of conformance to design-input requirements.