What Is ISO 9001:2008 Standard?

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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Automate ISO Compliance

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.

What ISO 9001:2015 Processes Does MasterControl Automate?

  • Tasking, routing, scheduling, follow-up, tracking, escalation, review and approval of all documents-based processes.
  • Revision control, which makes only the most recent version of a document available.
  • Assignment and monitoring of training tasks.
  • Notification, delivery, escalation and approval of corrective and preventive action (CAPA).
  • Planning, scheduling and executing audits.

ISO 9001 Software Validation

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.

Differences Between ISO 9001:2008 and ISO 9001:2015

  • The new version follows the same High-Level Structure as other ISO standards, making it easier to use multiple management systems.
  • A new focus on risk-based thinking that prioritizes risks and opportunities more than preventative action.
  • Top management now has to take responsibility for the effectiveness of the QMS.
  • A quality manual is no longer required, but the quality management system (QMS) scope still must be determined and documented.
  • There are less rigid documentation requirements that allow organizations to determine the format and information included in documentation.

MasterControl ISO Software Solutions

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.

MasterControl & The FDA

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.