ISO 9000 3 – Engagement of people Principle 4 – Process approach Principle 5 – Improvement Principle 6 – Evidence-based decision making Principle 7 – Relationship management ISO 9001:2015 Quality management systems — Requirements is a document of approximately 30 pages which is available from the national standards organization in each country. Only ISO 9001 is directly audited against for third party assessment purposes. Contents of ISO 9001:2015 are as follows: Essentially the layout of the standard is similar to the previous ISO 9001:2008 standard in that it follows the Plan, Do, Check, Act cycle in a process-based approach, but is now
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