ISO Standards vs. ISO Procedures

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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The Basics of ISO Quality Standards

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.

Popular ISO Standards

  • ISO 9001 Quality Management: Sets out the criteria for a quality management system, which includes a strong customer focus, the involvement of top management, the process approach, and continual improvement.
  • ISO 22000 Food Safety Management: Details what organizations need to do to show their ability to identify and control food safety hazards and ensure that food is safe.
  • ISO 14000 Environmental Management: Explains how to set up an environmental management system, which assures management, employees, and external stakeholders that the company is aware of and improving its environmental impact.
  • ISO 13485 Medical Devices: Lists the requirements for quality management systems for medical devices and how to manage quality through every step of the product’s lifecycle.
  • ISO 31000 Risk Management: Provides guidelines for managing risk to help organizations increase the likelihood of achieving their objectives, and to identify and neutralize threats.
  • ISO 45001 Occupational Health and Safety: Gives companies a framework for reducing the burden of occupational injuries and diseases by improving employee safety and reducing workplace risks to create better, safer work environments.

Standard Operating Procedures (SOPs) vs. ISO Procedures

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.

Benefits of ISO Procedures

  • The key to becoming compliant with ISO standards.
  • Increases consumer confidence in a company’s products.
  • Opens up international markets for businesses.
  • Decreases costs through improved efficiency.

MasterControl Ensures Compliance With ISO Standards

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.

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.