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ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hanson Training Course using the EudraVigilance System Duration:3 dislocation:AGES, Vienna, AustriaOVERVIEW The European Medicines Agency
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Identify the specific ISO standard that is required to be followed.
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Who needs mandatory use of iso?

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Organizations seeking to improve their quality management systems
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Companies operating in industries where ISO standards are commonly required or expected
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The mandatory use of iso refers to the requirement for certain companies to adhere to international standards set by the International Organization for Standardization (ISO) in their operations.
Companies in specific industries or sectors that are mandated by regulatory bodies to comply with ISO standards are required to file mandatory use of iso.
To fill out mandatory use of iso, companies must provide detailed information about their implementation of ISO standards, practices, and compliance measures.
The purpose of mandatory use of iso is to ensure that companies maintain high quality standards, adhere to best practices, and meet regulatory requirements set by governing bodies.
Companies must report on their adherence to specific ISO standards, implementation of quality management systems, and any measures taken to maintain compliance.
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