Mandatory documents for ISO 17025.
The laboratories seeking accreditation are assessed in accordance with ISO/IEC 17025:2005 for testing and calibration laboratories and ISO 15189:2007 for medical laboratories. A laboratory wishing to be accredited must have a Quality Manual on its Quality System satisfying the requirements as described in various clauses of ISO/IEC 17025 or ISO 15189 standards. Quality System documentation and its implementation by the laboratories shall be verified by the Assessors for its compliance in accordance with ISO/IEC 17025 or ISO 15189 standard.
All laboratories seeking or maintaining accreditation must comply with all policy and requirements documents listed below.
- All laboratories should have an official copy of ISO/IEC 17025.
- A copy of the General Requirements for Accreditation.
- Conditions for Accreditation.
- Proficiency Testing Requirements and Annex.
- Traceability Policy.
- Advertising Policy.
- If laboratory performs testing and/or calibration at sites other than the permanent laboratory premises additional policies may be applicable such as, Uncertainty for Testing Laboratories and field-specific annexes to the measurement uncertainty policy and Field Calibration Measurement Uncertainty Policy