What is ISO/IEC 17025?
ISO/IEC 17025 is one of the internationally recognized lab management system standard published by International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) that specifies all the requirements for the competence of testing and calibration laboratories. The most updated version of ISO 17025 standard is ISO 17025:2017 and is applicable to all the organizations having labs that involves first, second and third-party laboratories where testing, calibration, inspection and product certification is done.
ISO/IEC 17025 standard can be applied to any organization involved in testing and calibration, regardless of its size, product(s) or service(s).
Why is ISO/IEC 17025 important?
Overall management system of a lab like quality, administration, technical operations (testing, calibration, sampling and inspection) can be established with the right implementation of ISO 17025 standard. Having set parameters for a lab operation can make your organization stand out from the crowd.
What are the benefits of ISO 17025?
Once in place, the lab management system complying with ISO/IEC 17025 standard will result in swift resolution of issues in case of any personnel or equipment matters, conforming to the quality standards of clients and boost in your laboratory business. Some benefits of ISO/IEC 17025 implementation are as follows:
- Efficient management of all procedures and adequate documentation.
- A thorough working management system will ensure saving valuable time and money.
- A well-maintained testing environment will ensure legitimacy and appropriate calibration of equipment.
- Quality awareness and confidence in the calibrated or tested data.
Adherence to appropriate lab management principles will aid your organization in achieving business objectives and goals, whereas poorly designed lab management system might result in huge overall deterioration of the organization’s structure.
ISO/IEC17025:2017 specifies the general requirements for the competence to carry out the tests and/or calibrations and sampling for a Test/Calibration Laboratory. It covers testing and calibration performed using standard methods, non-standard methods, Laboratory defined methods.
- ISO 17025 governs the quality of results provided by test/calibration, ISO 9001:2015 does not govern the quality of the product but the process.
- ISO 17025 emphasis on the technical requirement of the Lab, ISO 9001 does include the technical requirement of the organization.
- ISO 17025 is accreditation, ISO 9001 is certification.
- ISO 9001 is the ability to demonstrate the ability of an organization to provide products or services to meet customer requirements. ISO 17025 is a demonstration of competency in performing the test/calibration per the scope.
- ISO 17025 is for developing the quality of the Laboratory, administration, and technical system that governs the operation of testing or calibration lab.
- ISO 17025 does not directly provide continuous improvement, ISO 9001 provides the foundation for continuous improvement.
The benefit of ISO 17025 Accreditation is not limited to:
- Establish confidence in management and customers on your test /calibration results as well as test /calibration reports and increase customer trust as well.
- It will give a better image of the company as a Quality producer in the Global Market.
- Provide hot tips on the analysis of data as well as to measurement the uncertainty and integrity of data and records.
- Provide guidelines and better control for maintenance of Instruments, environment control, protection of test records, etc.
The principles of good laboratory practice should be applied to all type of test /calibration laboratory whether private or in- house and in any manufacturing unit for testing/calibration:
- To establish quality in testing/calibration and reliability
- To prevent risk
- To detect deviations
- To correct errors
- To improve efficiency
While considering ISO certification it is very critical to understand the various costs incurred.
These costs include:
- 1st Year Cost
- Create and Charter ISO project (Quality Manager)
- External Registrar Cost+ Logistic Cost
- Proficiency Testing & Measurement Uncertainty Calculations
- Consultant Support( if external consultant used)
- 2nd Year Cost
- Surveillance Audit and Logistics cost.
- Soft Cost associated with Internal Audit, Reporting and Maintenance of the QMS
- Recertification cost( every 2 years): External Audit and Logistics cost
Impartiality, as defined in section 3 of the standard, is freedom from bias, prejudice, fairness. Confidentiality in regard to conflict of interest and resolution of issues to prevent their impact on the quality of results reported. Many Laboratories are part of a bigger organization and have shared resources or have internal customers(Sales, Product Launch Managers, Marketing, Production).
These benefits can present challenges like undue pressure to report specific values, perform test/ calibration to meet the organizational targets and so on.
This undermines Laboratories’ competence and credibility. Hence at the Laboratory level implementing safeguards and protocols /rules to ensure that personnel is able to perform their work and report information accurately, without repercussions.