WHITE PAPER:

JiT (Just in Time) Certification for ISO 13485

ECM’s laboratory authorization program allows test results from approved external laboratories to be considered through ECM Certification schemes. The program is offered for both manufacturers’ laboratories and independent laboratories and may cover one or more testing areas, such as Safety and EMC.

Benefits for the authorized laboratories:

  • Streamlined handling of certification projects at ECM
  • Predictable outcome of projects due to common practices and understanding
  • Improved market access opportunities for the laboratory’s customers
  • Access to standards subscription service, as well as international interpretations
  • Opportunity to be updated on current and coming product standards and access to ECM’s up-to-date knowledge of testing practices
  • Access to organized proficiency/comparative test programs
  • Cost efficiency

Overview of main requirements:

  • Quality system according to the relevant parts of ISO/IEC 17025
  • Qualified testing personnel with knowledge of standards and test methods
  • Necessary test facilities and equipment with proper characteristics and tolerances
  • Calibration procedures traceable to national or international reference standards with regular calibration intervals