ISO/IEC 17025:2017 was developed jointly by ISO and the International Electrotechnical Commission (IEC) under the responsibility of the ISO committee on conformity assessment (CASCO). The certified companies producing valid results that are widely trusted is at the heart of laboratory activities: allows laboratory to implement sound quality and demonstrate that they are technically competent and able to produce valid and reliable results.
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ISO 17025 - General Requirements for The Competence of Testing and Calibration
It is the international reference for laboratories carrying out calibration and testing activities around the world.
The scope has been revised to cover testing, calibration and sampling associated with subsequent calibration and testing.
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ISO 15189:2012 - Quality and Competence for Medical Laboratories
ISO 15189:2012 specifies requirements for quality and competence in medical laboratories.
ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers and regulating authorities.
ISO 15189 guidelines help laboratories to establish an effective quality management system (QMS). Adherence to the guidelines leads to more accurate test results and fewer errors in the laboratory. It also boosts stakeholder’s confidence in the value of your lab testing.
The ISO 15189:2012 international standard is based on ISO/IEC 17025 and ISO 9001. It applies to all medical laboratories and is becoming the most widely accepted standard for accrediting the competence of clinical laboratories. ISO 15189 requirements are intended to help lab staff.