Certifications in clinical research

A certification is an examination or proof of compliance with certain requirements or standards. Private persons, companies or organisations can be certified for products or services. Certification is usually carried out by independent certification bodies or notified bodies such as TÜV or DEKRA, or foundations such as the "Health On the Net" foundation. Certifications are issued for a limited period of time after an audit and are usually verified by surveillance audits.

The services that are certified in companies in connection with clinical research are often quality management (the most common and most recognised is ISO 9001), information management, security systems or, in areas with high data processing requirements, data protection.

In order to ensure quality management, EN ISO 9001 is an international standard that defines principles and standards. They were first defined by the International Organization for Standardization (ISO) in 1987 and have been updated several times since then. At present, audits are being carried out according to ISO 9001:2008, and an update to ISO 9001:2015 will be valid from autumn 2015. For successful certification, proof of systematic management and control of processes and the organization must be provided. The principles of ISO 9001 are:

• Quality Management
• Responsibility of management and customer orientation
• Management of resources and involvement of people involved
• Product realization and process orientation
• System oriented management
• Continuous improvement and monitoring, measurement and control of processes
• Factual decision making