ISO 17025 certification standard is general requirements for the competence of testing and calibration laboratories. This standard specifies the general guidelines for the competence, impartiality and consistent operation of laboratories. ISO 17025 standard was revised and released on 30th November 2017.
Benefits of being ISO 17025 certified:
- Increase lab credibility
- National and International recognition
- Public and Industry acceptance
- Provide global equivalence
- Decision makers can rely on test results
- Engagement of employees and staff motivation
- Saves money by getting it right at first time.
Why ISO 17025 standard was revised?
Earlier version of ISO IEC 17025 was the second edition which was published in 2005 after that market conditions have changed the shared aspects among ISO international standards has lead the need for further organization among other international documents which are current which contributed to development of the third edition of the standard. It has been developed jointly by ISO and IEC and the committee on conformity assessment (CASCO). The process approach of the document now matches that of numerous standards such as ISO 9001, ISO 15189 and ISO IEC 17021-1. Key changes in 17025 various terms have been updated. Example:
- Definition for laboratory has been included
- Guidelines for processes and procedures
- Documented information and organizational responsibilities have more flexibility now
A new chapter has been added on risk based thinking which lead to reduction of the standards strict guidelines and have been replaced by performance based guidelines in test report date of issue of a report is required, the process approach now matches that of numerous standards such as ISO 9001 Quality Management System, ISO 15189 Quality of Medical Laboratories and ISO IEC 17021-1 requirements for certification bodies.
More about ISO 17025 certification – Testing and Calibration Laboratories
The scope now covers all the laboratory activities including calibration, testing and the sampling associated with subsequent calibration and testing. The revised standard puts the importance on the results of a process, instead of the detailed description of its tasks and steps, term outsourcing is replaced by external provision, certification body has been replaced by the laboratory, new standard have the use of computer systems, electronic records and the production of electronic results and reports which have modernized the document. A new structure has been adopted to align this standard with the other existing ISO IEC conformity assessment standards such as the ISO IEC 17000 series on conformity assessment. Clause 8 is aligned with ISO 9001 QMS importance on impartiality and confidentially, word quality manager or technical manager is removed. ISO 17025 previous version it had five elements that are scope, normative references, terms and definitions, management requirements and technical requirements. While in ISO 17025 latest version it has eight elements that are scope, normative references, terms and definitions, general requirements, resource requirements, process requirements and management system requirements. ISO 17025 previous version’s scope included organizations performing tests and calibration. While in ISO 17025 latest version’s scope is applicable for all organizations performing laboratory activities.