What is ISO laboratory?
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)..
What are ISO 17025 standards?
ISO 17025 is the international standard for testing and calibration laboratories. It’s a set of requirements those laboratories use to show that they operate a quality management system and that they’re technically competent to do the work that they do.
What are quality standards in a lab?
Quality standards are an integral part of the quality system. They are designed to help laboratories meet regulatory requirements, including local health regulations, and monitor laboratory functions, thereby ensuring laboratory safety and consistency of performance.
Is International a standard?
An international standard is a document that has been developed through the consensus of experts from many countries and is approved and published by a globally recognized body. It comprises rules, guidelines, processes, or characteristics that allow users to achieve the same outcome time and time again.
What is the difference between ISO 17025 and ISO 9001?
For instance, the requirements of ISO 9001:2015 on resources and processes are general for any industry, whereas ISO 17025:2017 is more specific and detailed for testing and calibration laboratories. Similarities are found in clause 8 of ISO 17025:2017 regarding management system requirements.
Who needs ISO 17025?
According to the International Organization for Standardization (ISO), the ISO/IEC 17025:2017 applies to all organizations conducting laboratory activities, regardless of the company size.