ISO 17025 Calibration Processes
ISO 17025 is an international standard governing most of the important aspects of calibration processes. Laboratories who meet this standard should operate a quality control system, be technically competent and be capable of producing technically valid results. The intention of ISO 17025 is to provide a functional system or hierarchy of calibration laboratories in which we can have confidence. Any calibration performed by an ISO 17025 accredited lab should:
- Be performed by competent technicians in a controlled environment
- Use reference instruments or materials in which we can have confidence
- Operate an administrative quality system similar to ISO 9001.
ISO 17025 maximises confidence in reference instrument and materials by requiring that they are traceable to SI (System Internationale) units defined by international agreements at the BIPM in Paris.
17025 CALIBRATION is our guarantee of confidence in our calibration results through internationally recognized technical auditing of a laboratory’s competence. ISO 17025 is virtually now the only Internationally Recognized Calibration System. Traceable Calibrations from Non ISO 17025 Accredited Calibration Sources are now generally technically questioned. To quote from the ISO Standard, “Certification against ISO 9001 and ISO 9002 does not of itself demonstrate the competence of the laboratory to produce technical valid data and results.”
In the United Kingdom, UKAS Calibration is the only Accreditation Body who Test & Calibration Laboratories to ISO 17025. For instance, National & International Technical Trade Barriers for your company’s products and services become transparent when all your calibrations to the ISO 17025 standard.
A Background to ISO 17025
ISO 17025 addresses every element of laboratory management. It is not exclusive to the laboratory manager, assistant laboratory manager, or quality manager. The standard involves all laboratory staff whose functions relate to the quality of laboratory data generated. It replaces NAMAS M10 and laboratories, which are currently accredited to M10, have until 30th June 2002 to meet the requirements of ISO 17025 if they are to retain their certification.
The ISO management system will provide a defined, ordered process for operating all facets of a laboratory. Besides, the laboratory community throughout the world has expressed, through the International Organization for Standardization, the essential elements for a laboratory management system in the text of ISO 17025. That document also provides the nucleus for most laboratory accreditation programs today. ISO 17025 provides the framework for a Quality Management System for a testing or calibration laboratory.
The Transition Management Tool gives the following benefits:
- Clear identification of the new requirements in ISO 17025
- Simple workbook format
- Addresses every clause and sub-clause of the standard
- Cuts through the jargon of the standard
- Breaks the standard down into manageable chunks
- Identifies the gaps in the existing system
- Fully costs the transition project
- Assigns responsibilities for all the key project tasks
What is driving accreditation?
- The automotive standards QS 9000 and 16949 require testing and calibration laboratories to be accredited.
- Laboratories may need a quality system that is recognized internationally.
- The marketplace – laboratories must also keep up with competitors who are becoming accredited.
- Internal motives – laboratories can improve their internal systems.
- Transition Tool – for companies accredited to NAMAS M10