ISO 9001:2008 is a standard from the International Organization for Standardization (ISO) designed to ensure the best quality management system (QMS) for any organization. ISO regularly reviews its standards every five years to determine if revisions are required, and in 2015, this standard was updated.
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MasterControl has studied and researched ISO standards and has developed associated software solutions that streamline the quality processes that allow companies to quickly achieve ISO certification. Because ISO standards are continually fine-tuned they can become difficult to manage. However, with automated software solutions, managing these changes is easier.
Software validation for ISO 9001 is one of the core factors under consideration when a company is looking to implement new software solutions, such as a QMS. In addition to meeting the requirements of ISO 9001, a QMS should be easy to validate. With the right validation tools, documentation and resources, companies can save significant amounts of time when validating.
Becoming ISO 9001 certified is considerably easier with software solutions that automate quality management processes. And if the company producing those software solutions is itself ISO 9001 certified, all the better. In November 2015, MasterControl became ISO 9001:2015 certified by using its own software solutions for quality management. Our certification has prepared us to help other companies achieve certification, and our QMS is designed with that goal in mind.
Organizations all over the world use MasterControl software solutions to ensure compliance – including organizations that enforce compliance. The U.S. Food and Drug Administration (FDA) became a MasterControl customer in 2009. Since then, the FDA has expanded its use and now multiple divisions of the agency use MasterControl software solutions.