What is ISO 17025?
ISO 17025 (or, to give it its full title, ISO 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories) is an internationally recognized standard that sets out the requirements for a Testing and Calibration Laboratory Management System (TCLMS). This Standard is the revision of the previous ISO/IEC 17025:2005 version.
The ISO 17025 standard lays out the general requirements for proving the competence, impartiality, and consistent operations of laboratories that perform testing, sampling, and calibration.
Its guidelines apply to all types of laboratories- private and public- and include a wide range of organizations from academic institutions to research centers and government regulators.
What is the purpose of ISO 17025?
The purpose of the Standard is to specify the general requirements for the competence, impartiality, and consistent operation of laboratories.
It enables laboratories to demonstrate that they operate competently and generate valid results, thereby promoting confidence in their work nationally and worldwide.
Test reports and certificates can be accepted from one country to another without the need for further testing, which, in turn, reduces costly duplication of effort and improves international trade.
For more, see the ISO publication ISO/IEC 17025 Testing and Calibration Laboratories.
What is ISO 17025 Accreditation and the Scope of that accreditation?
Certification to ISO 17025 by a Certification Body is not possible as the assessment of laboratory management systems is exclusively in the hands of national accreditation bodies. From such national accreditation bodies, like UKAS, INAB, RvA, and ANAB, one receives accreditation and not certification.
Different titles but essentially the same thing – proof through independent third-party auditing of compliance with requirements. The Scope of Accreditation is a critical consideration. Only those tests listed in the scope statement given on the accreditation body website page for the accredited organization are included in the accreditation.
These often are defined as types of tests rather than specific, individual tests, and so are not too restrictive. Unless the test in question is included in their accreditation scope, a test laboratory report or a calibration laboratory certificate cannot carry an accreditation body logo.
Does ISO 17025 Accreditation cover all Test Laboratory services?
No. And some offer reports with a variety of logos. Check these carefully. Remember that those reviewing tender documents are unlikely to be inexperienced. They will recognize a poor Accreditation Certificate instantly.
And your offer will go directly into the rubbish bin with the hard work you’ve expended to develop Laboratory or calibration services you are proud of will be totally wasted when an ISO Auditor finds such a bogus Certificate.
Does ISO 17025 Accreditation cover all Calibration Laboratory services?
See the previous answer. Some Calibration Laboratories still offer ISO 9001 Certification and claim that it is an ISO 17025 equivalent. This statement is untrue.
ISO 9001 is not equivalent to the detailed sampling, testing, and reporting requirements of ISO 17025. Therefore, wherever possible, you should seek out laboratories accredited to ISO 17025.
Do You Need ISO 17025 Certification?
Yes. A claim of compliance with the Standard is meaningless and of no commercial value without accreditation. You receive test laboratory reports or calibration laboratory certificates that do not have accreditation body logos in addition to the Laboratory’s logo, you should always ask why.
The use of ISO 17025 is so widespread globally nowadays that you should expect to see accreditation body logos on all test laboratory reports or calibration laboratory certificates.
What is ISO 17025 Training?
ISO 17025 training will equip you with the necessary knowledge and skills to audit testing and calibration laboratories and ensure that they meet Testing and Calibration Laboratory Management System Standards (TCLMS). The current edition of the standard is ISO 17025:2017. For an overview of the Standard published by the ISO click here to learn more.
What’s new in the ISO 17025 2017 Standard?
The main changes included in the 2017 standard include the following.
- The ISO 17025 standard used to be composed of 5 parts. Now, it comes with 8 parts (with Parts 4 to 8 auditable).
- There’s now more focus on competence instead of Qualification and Monitoring.
- Requirements for and Monitoring of Product and Service Providers have been expanded.
- It now features a more robust complaint process.
- Risk Identification and Handling have been improved.
- That goes for better opportunity identification and handling as well.
- Confidentiality Requirements are also now more detailed.
- New requirements for Impartiality have been introduced.
- Handling Decision Rules and their inclusion in Statements of Conformity have also been improved.
- The functionality of LIM Systems is to be established.
- Similarly, calibration (Metrology) requirements have been expanded and clarified.
- Finally, proficiency testing is now mandatory.
What Are My Options for ISO 17025 Training?
There are 6 Auditor Courses to choose from.
Usually, classroom-based ISO 17025 Courses limit you to one choice, a 2-day Internal Auditor Course. This can make selecting an appropriate ISO 17025 auditor course a bit challenging.
The good thing is, there is no such limitation when it comes to our e-learning-based courses.
Because there’s a wide array of courses, it means you can get a course that directly matches your needs.
