ISO 17025 is an international standard that specifies the scope, objective, competence, impartiality, the structure of a quality management system, and guidance to ensure the consistent operation of calibration or testing laboratories. ISO/IEC 17025 standard is widely accepted and used by calibration and testing labs to define resource requirements, technical competence, process requirements, and quality management system requirements.
What is ISO/IEC 17025:2017?
ISO 17025:2017 standard is the third edition of the ISO 17025 standard which mainly focuses on risk-based thinking, performance-based requirements, increased flexibility in attaining requirements for processes, & procedures of calibration and testing laboratories.
ISO/IEC 17025:2017 standard developed jointly by International Electrotechnical Commission (IEC) & International Organization for Standardization (ISO). ISO/IEC 17025 certification is essential for any lab to issue a calibration certificate or test report to prove the technical competency of the calibration lab/testing facility.
The following graphical table helps you to understand the overview of ISO 17025:2017.
ISO 17025 requirements:
The following requirements (requirements for ISO 17025) are covered in the ISO 17025 standard,
|Section||Requirements||Sub-Requirements / Clause|
|1||Scope||General requirements of laboratory technical competence, confidentiality, impartiality and consistent operation|
|4||General Requirements||4.1 Impartiality|
|5.1 Legal Entity|
5.2 Management responsibility
5.3 Range & Scope of laboratory
5.4 Laboratory activities inline with customer and regulatory requirements
5.5 Organization Structure
5.6 Authority and resources needed
5.7 Laboratory management system
|6||Resource Requirements||6.1 General|
6.3 Facility and Environment
6.5 Metrological Traceability
6.6 Externally Provided Services
|7||Process Requirements||7.1 Tender and Contract Review|
7.2 Selection and Verification of methods
7.4 Handling of tools/equipment
7.5 Technical Records
7.6 Measurement Uncertainty
7.7 Validity of results
7.8 Reporting of results
7.10 Non-conforming work
7.11 Control of Data and information management
|8||Management System Requirements||8.1 QMS (Option A / Option B)|
8.2 Management System Documentation
8.3 Control of management system documents
8.4 Control of Records
8.5 Actions to address risk and opportunities
8.7 Corrective Actions
8.8 Internal Audits
8.9 Management Reviews
Refer to ISO/IEC 17O25:2017 standard for more details of each clause and sub-clause.
What is 17025 calibration and test lab?
As explained in the previous paragraph, ISO 17025 certification is mandatory in various countries. ISO 17025 standard not only provide general requirements but also technical competence requirements.
ISO 17025 requirements help to build the technical competence of the laboratory and ensure compliance to international or national standards.
ISO 17025 calibration and test lab follows are requirements which are specified in ISO 17025 standard. In India, NABL (National Accreditation Board for Testing and Calibration Laboratories (NABL) is authorized to certify calibration and test labs as per ISO 17025 standard, whereas in the United States of America, the ANSI National Accreditation Board grants ISO 17025 certification to calibration and test lab.
Benefits of ISO 17025 certification and accredited calibration and testing lab.
- Accurate and Precise calibration or testing.
- Calibration and testing as per national or international standard
- Accredited labs are more potential to get access to the internal market
- The standard way of working across all labs in-country and in international markets.
- Internationally accepted calibration and test method acceptance level.
- A standardized way of lab operational control across regions/countries.
- The right method for calibration or testing is being utilized by labs eventually it will help manufacturer to ensure compliance.
- Accreditation bodies do conduct regular audits at calibration / testing labs on regular basis as a surveillance / re-accreditation audit.
ISO 17025 accredited labs list
ISO 17025 covers a wide variety of calibration and testing labs. Please refer to the following list to understand different types of calibration and testing labs.
|Calibration Labs||1. Mechanical lab (pressure, vacuum, weight, mass)|
2. Electro-Technical lab
3. Fluid Flow Lab
5. Radiological Lab
|Testing Labs||1. Software & IT system testing laboratories|
2. Drinking water testing laboratories
3. Food and food material testing laboratories (FSSAI)
10. Forensic Science
13. Diagnostic Radiology QA Testing
14. Textile and Fabric testing
Let’s understand each sub-types of lab category. The following table will help you to understand different categories of lab
|Mechanical Lab||1. Dimensional lab|
2. Weighing scale and balance
3. Calibration of the universal tensile machine (UTM)
4. Torque-sensing device calibration
5. Torque generating device calibration
6. Pressure and Vacuum gauge calibration
7. Calibration of hardness tester machine (metal and rubber)
8. Calibration of push-pull tester
9. Calibration of the force measuring device
|Fluid Flow Lab||1. Differential pressure flow meter|
2. Pitot Tube
5. Magnetic / Turbine Fluidic
|Electro-Technical Lab||1. A/C current|
2. D/C current
3. Time & Frequency
4. EMC / EMI
5. RF & Microwave
|Thermal Lab||1. Pyrometer (infrared radiation thermometer)|
2. Environment Chamber
3. Cold Room
7. Liquid bath
Conclusion about ISO/IEC 17025 standard:
We hope this high-level overview of ISO/IEC 17025 requirements helps you to understand the importance of ISO/IEC 17025 certification for calibration and testing laboratories. For more detailed information, please do refer to ISO/IEC 17025 standard, you can download the same from ISO standard webpage.
Stay tuned, our next blog post will be related to ‘How to implement ISO 17025 requirements in calibration or testing laboratories’.