ISO 9000 Standards

ISO 9000 standards are quality standards for both products and services that are recognized and followed by industries around the world. These industries include manufacturing companies of all kinds, in addition to life science companies (pharmaceutical, medical device, blood/tissue and laboratory organizations).

Please see the following downloads, all of which are all relevant to ISO 9000 standards.

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Foundation of ISO 9000 Standards

The standards associated with ISO 9001 2000 reflect certain aspects of a successful quality system framework, and are the foundation for the family of ISO 9000 standards. Faster compliance, greater compliance control and a higher rate of success with ISO 9001 2000 can be achieved with the use of automated compliance solutions.

How to Streamline Processes Required by ISO 9000 Standards

MasterControl, a provider of document control, quality audit and GxP process software solutions, enables life science companies-- and manufacturing companies of all kinds-- to automate and streamline processes required by ISO 9000 standards. Examples of processes required by ISO 9000 standards include: change control, CAPA management, and customer complaint handling. Other examples of processes required by ISO 9000 standards include:

  • MasterControl Deviations™ Management
  • MasterControl Nonconformance™ Management
  • MasterControl Training™
  • MasterControl Submissions™ (for pharmaceutical companies)
  • MasterControl Bill of Materials™ (for medical device companies)
  • MasterControl Batch Records™ (for pharmaceutical companies)
  • MasterControl Corporate and Supplier Compliance™ (for medical device companies)
  • MasterControl Corporate and Supplier Compliance™ (for pharmaceutical companies)

MasterControl solutions also help companies comply with ISO 9000 standards prescribed by international regulatory bodies and organizations.

MasterControl Software Helps Assure Regulatory Compliance with ISO 9000 Standards

In addition to helping companies meet the requirements of ISO 9000 standards (as well as any other ISO standard), MasterControl solutions can help companies comply with standards prescribed by international regulatory bodies and organizations.

For More Information on ISO 9000 Standards

To learn more about automating processes essential to ISO 9000 standards, or to other ISO standards (e.g., ISO 13485 standards), please feel free to contact a MasterControl representative.