ISO certification means that a company’s quality management system (QMS) conforms with the requirements of the International Organization for Standardization (ISO). The most common reason for not attaining ISO certification is an inadequate document control system or quality management system.
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An ISO certified company has demonstrated its commitment to providing quality products that go beyond consumer expectations. This provides a competitive advantage that non-certified companies lack. ISO standards are also used by regulatory bodies around the world, making the path to compliance simpler for companies that are ISO certified.
ISO certification is obtained by a certification body after a company demonstrates that it meets the requirements set forth by ISO. A certification body can obtain ISO accreditation from a third party as an independent verification of competence. ISO itself does not offer certification, but it does offer guidelines for selecting a certification body.
MasterControl helps companies obtain ISO certification by providing them with software solutions that are interconnected and keep all documentation in a centralized location. Different MasterControl modules help companies pass audits, disseminate training, track standard operating procedures (SOPs), and more.
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.