Overview

A nonconformance is any observed deviation or a non-fulfillment of an established requirement. It could be a product, process, or system requirement. For instance, a product out of specification, a procedure not being followed or a customer requirement not being implemented.

ISO, GMP, and other quality standards present strict guidelines that require companies to follow procedures and establish controls surrounding the nonconformance, root cause analysis, and corrective and preventive action processes.

ISOSYSTEM Action gives you one standard location to see all of your non-conformances. Everything from customer complaints to internal audit findings, supplier issues to warranty returns, ISOSYSTEM Action organizes your problems and helps you set corrective actions.

Through its comprehensive workflow management and flexible functional capabilities, ISOSYSTEM Action enables you to improve your quality system and achieve sustained regulatory compliance.

ISOSYSTEM Action incorporates organizational, classification and search tools to provide users easy and instant access to existing nonconformance records. The search results may also be viewed on spreadsheets and comparative charts.

For a complete automated handling of non-conformance and corrective/preventive actions, two worldwide renown methods are used: PDCA (Plan, Do, Check, Act) for problem solving, and 5W2H (What, When, Why, Where, Who, How, How much) for action planning. Therefore, all process steps are electronically handled, reducing your paperwork and saving time.

The integration of the ISOSYSTEM Action with the data environment of ISOSYSTEM provides access to a vast array of information from other areas.

ISOSYSTEM Action management complies with relevant international standards like ISO 9000 series.