ISO 9000 ISO 9001, and concluded that it was necessary to create a new QMS model for the next 25 years. They subsequently commenced the official work on creating a revision of ISO 9001, starting with the new QM principles. This moment was considered by important specialists in the field as "beginning of a new era in the development of quality management systems." As a result of the intensive work from this technical committee, the revised standard ISO 9001:2015 was published by ISO on 23 September 2015. The scope of the standard has not changed; however, the structure and core terms were
ISO 15189 section on laboratory information management. ISO 15189 ISO 15189 Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardization's Technical Committee 212 (ISO/TC 212). ISO/TC 212 assigned ISO 15189 to a working group to prepare the standard based on the details of ISO/IEC 17025:1999 "General requirements for the competence of testing and calibration laboratories". This working group included provision of advice to medical laboratory users, including specifics on the collection of patient samples, the interpretation of test