The ISO standards were developed by the International Organization for Standardization (ISO) to help create best practices for public and private sector businesses. The ISO procedures can be found within the standard and are what a company must follow to comply.
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ISO quality standards consist of general guidelines, rather than stringent requirements. These guidelines help companies develop, implement, and improve their quality management system. Generality is preferable in these standards so they can be applied in organizations across multiple industries, although there are some ISO quality standards that are industry specific.
Depending on the source, ISO procedure may refer to the steps necessary in an ISO standard or it may refer to the standard operating procedures (SOPs) required by an ISO standard. The SOPs are documentation that demonstrate a company is following the requirements found in the ISO standards and must match the actual practices of a company.
MasterControl can help your company comply with any ISO standard. We provide process management, document control, and risk-based validation solutions. We also provide a variety of services that comply with both FDA and ISO standards. At MasterControl, we automate compliance so you don’t have to worry about it.
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.