Understanding ISO/IEC 17025:2017
ISO/IEC 17025 is a standard for calibration and testing laboratories, jointly developed by ISO (The International Organization for Standardization) and IEC (The International Electrotechnical Commission). It covers all aspects of laboratory management, including quality management and technical requirements. The standard applies to any organization that performs testing or calibration activities, from sample preparation, proficiency in test analysis, record-keeping, and reporting. The standard emphasizes various elements, such as laboratory quality systems, document control, corrective and preventive actions, facilities and environmental conditions, equipment suitability, measurement uncertainty estimation, sample management, and more.
Why is ISO/IEC 17025:2017 Important?
In the industrial sector, particularly in manufacturing, specialized equipment such as factory instruments, scales, machinery, and other tools are used for calibration or laboratory testing. These tools must undergo “calibration” to ensure accuracy and reliable measurement results, preventing “measurement errors.” Ensuring that equipment is tested and verified for accuracy under standardized international testing and calibration methods is crucial.
Laboratories certified under the ISO/IEC 17025 standard demonstrate that their test results are accurate, precise, and reliable, adhering to scientific principles. Results from such certified laboratories are accepted both domestically and internationally. This is particularly beneficial for manufacturers exporting goods, as products tested and certified under ISO 17025 do not need re-testing in the importing country, thus reducing costs for both exporters and importers.
Industries We Consult and Implement ISO/IEC 17025:2017 Standards
The ISO/IEC 17025:2017 standard is applicable to any organization performing calibration and/or testing activities. TIBD offers consultation and implementation services for the health and beauty industries.
- Cosmetics Industry
- Food Supplement
- Food Industry
- Pharmaceutical Industry
- Medical Equipment Industry
- Organizations seeking to build confidence in operational efficiency and safety to enter international markets.
- Businesses/Organizations requiring laboratory calibration certification.
- Businesses/Organizations with plans for expansion.
- Organizations looking to access new markets.
- Businesses/Organizations wanting to ensure quality and safety for partners and consumers.
- Enhances the capabilities of laboratories, gaining acceptance both domestically and internationally.
- Builds confidence in the quality and reliability of test or calibration results from certified laboratories.
- Reduces trade barriers by eliminating the need for re-testing by trading partners, facilitating international trade.
- Lowers costs associated with certification for exporting goods to global markets.
- Promotes continuous improvement and efficient management systems, enhancing the organization’s reputation.
- Consulting Services: To improve and develop standard production and quality control systems for calibration-required tools.
- Coaching: Guidance in creating, developing, improving, and reviewing organizational systems to meet ISO 17025:2017 requirements.
- System Management Planning: Proper factory layout design and planning.
- System Implementation and Documentation: Customized system setup and documentation to meet ISO 17025:2017 standards.
- Internal Quality Audits: Conduct internal audits as per ISO 17025:2017 standards.
- Pre-Audit Preparation: Preparation for certification audits to ensure readiness.
