Data integrity: requirements set in the accreditation standards

Abstract

The requirements for the competence of laboratories are described in two standards, namely ISO/IEC 17025 and ISO 15189. The former applies to all laboratories except medical laboratories where the latter is the most appropriate. The requirements of both standards include specific references to data and other related terms, their protection and integrity. The recently revised ISO/IEC 17025 introduces additional provisions for the control of data and information management compared to those of the 2005 edition. Both standards include provisions for the use of laboratory information management system(s) for the collection, processing, recording, reporting, storage or retrieval of data. ISO 15189 addresses these issues in more detail in order to meet the particular needs of the sector dealing with personal data of the patients. This article presents the requirements for data integrity and the control of relevant components of the management system set by the standards for laboratories as well as for some other conformity assessment bodies of importance for laboratory work, namely reference materials producers (ISO 17034) and proficiency testing providers (ISO/IEC 17043). Some additional regulatory requirements recently implemented are also discussed.