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ISO/IEC 17025 Certification

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The ISO/IEC 17025 is a universally used laboratory accreditation standard that outlines requirements for the competence of testing and calibration laboratories. There are many commonalities with the ISO 9000 (9001, 9002) standard, but ISO 17025 adds the concept of competence to the equation and it applies to those organizations that produce testing and calibration results. Updates to ISO 17025 have introduced greater emphasis on the responsibilities of senior management, and clear requirements for continual improvement of the management system, and communication with the customer. Laboratories use ISO 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. Since the standard is about competence, accreditation is simply a formal recognition of a demonstration of that competence. A prerequisite for a laboratory to become qualified is to have a documented quality management system. Regular internal audits are expected to specify opportunities to make the test or calibration better than it was. The laboratory is also expected to keep abreast of scientific and technological advances in relevant areas.

There are two main sections in ISO/IEC 17025:

Management Requirements- Management requirements are primarily connected to the operation and effectiveness of the quality management system within the laboratory.

Technical Requirements- Technical requirements address the competence of staff, methodology, test/calibration equipment and the test methods. Full validation of test methods and proof of proficiency set this standard apart from ISO 9001 or 9002.

There are five basic elements that make up the review process for ISO 17025 certification:

  1. Scope: The area of the lab being evaluated that will represent the lab as a entire like mechanical equipment, environmental conditions.
  2. Normative References: Documents that give the most recent information about every area of the process and equipment standards.
  3. Terms and Definitions: The labeling of all equipment, employees, work stations, instruments, and defining instructions, protocol, procedure, and safety measures.
  4. Management Requirements: Example- document control, service to clients, contract reviews, preventative actions, internal audits, management reviews, etc.
  5. Technical Requirements: Example- functional equipment, Safe working conditions, and proper calibration of devices, result reporting, handling of tests and substances, etc.

Benefits of ISO/IEC 17025

Accreditation to the ISO 17025 provides both laboratory and business benefits:

  • ISO 17025 is an effective marketing tool to submit tenders for testing and/or calibration.
  • Improving the image of the laboratory.
  • It enables the assessment of relative quality and capability of other recognized laboratories.
  • The data quality and effectiveness is continually improved.
  • Provides a fundamental for other quality systems related to laboratories like Good Manufacturing Practices and Good Laboratory Practices.
  • It protects the laboratory’s data integrity in case of legal implications.
  • It is the recognition of testing competence.
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