Laboratory Competence
ISO/IEC 17025
ISO/IEC 17025 is the international standard used to assess the competence, impartiality and consistent operation of testing and calibration laboratories.
Technical authority
Standards, accreditation and metrology authority pages
Browse 14 educational authority pages explaining calibration standards, accreditation terms, regulatory marks, measurement uncertainty, traceability, validation and verification.
Laboratory Competence
Laboratory Competence authority pages
Medical Electrical Safety
Medical Electrical Safety authority pages
Medical Electrical Safety
IEC 60601
IEC 60601 is a standards series addressing safety and essential performance expectations for medical electrical equipment.
Medical Electrical Safety
IEC 62353
IEC 62353 is commonly referenced for recurrent testing and testing after repair of medical electrical equipment.
Quality Management
Quality Management authority pages
Quality Management
ISO 13485
ISO 13485 is a quality management system standard for organizations involved with medical devices.
Accreditation
Accreditation authority pages
Accreditation
NABL
NABL is India's National Accreditation Board for Testing and Calibration Laboratories, assessing laboratories against recognized requirements such as ISO/IEC 17025.
Healthcare Accreditation
Healthcare Accreditation authority pages
Healthcare Accreditation
NABH
NABH is a healthcare accreditation framework used by hospitals and healthcare organizations to improve quality, safety and documentation systems.
Regulatory and Standards Bodies
Regulatory and Standards Bodies authority pages
Regulatory and Standards Bodies
BIS
BIS, the Bureau of Indian Standards, is India's national standards body and publishes Indian Standards for many products, systems and technical areas.
Regulatory and Standards Bodies
FDA
FDA commonly refers to the United States Food and Drug Administration, a regulator for medical devices, drugs, food and other regulated products in the US market.
Regulatory and Standards Bodies
CE
CE marking indicates that a product placed on the European market meets applicable EU requirements declared by the manufacturer.
Metrology Concepts
Metrology Concepts authority pages
Metrology Concepts
Measurement Uncertainty
Measurement uncertainty expresses the doubt associated with a measurement result and helps users interpret calibration results.
Metrology Concepts
Traceability
Traceability links measurement results to recognized references through an unbroken documented chain of calibrations.
Calibration Process
Calibration Process authority pages
Calibration Process
Calibration Procedure
A calibration procedure defines how equipment is identified, prepared, measured, recorded and reported against defined requirements.
Quality and Qualification
Quality and Qualification authority pages
Quality and Qualification
Validation
Validation provides documented evidence that equipment, a process or an environment performs as intended for a defined use.
Quality and Qualification
Verification
Verification checks whether equipment, results or records meet specified requirements.