California ISO 17025 Certified Company
GL Technologies is a California based ISO 17025 certified company specializing in calibration prevention maintenance procedures.
GL-Tec calibration competency is verified by our accreditation to all the industry standards, including:
ISO/IEC 17025:2017 – a Quality Framework for Device-Independent Calibration
ANSI/NCSL Z540.3 2006
USP41
If you are in need of certification, please use our Request Information form and we will get back to you promptly!
ISO/IEC 17025 Accreditation Explained
ISO/IEC 17025 is the international standard for both calibration and testing laboratories. It was initially known as ISO/IEC guide 25; ISO/IEC 17025 was originally issued by the international organization for standardization in 2000.
The two sections in ISO/IEC 17025 – Technical Requirements and Management Requirements.
The ISO technical requirements will determine the competence of the staff, testing and calibrating equipment / instruments. Within the laboratory, the Management Requirement are related to the effectiveness and operation of the organizations quality management systems.
A laboratory needs to obtain ISO 17025 accreditation in order ot have a documented quality management system that addresse the elements of standard operating procedures. The contents of the manual detail the outline of the ISO 17025 standard.
ISO/IEC 17025:2017
The ISO/IEC 17025:2017 is the most up-to-date version of ISO/IEC 17025, the previous iteration was ISO/IEC 17025:2005. This standard specifies the general requirements for competence, impartiality, and consistent operation of laboratories. This standard applies to all organizations performing laboratory activities, regardless of the number of personnel.
What does ISO/IEC 17025 Measure?
Individual competence of staff to perform.
Use of proper equipment and its maintenance and calibration.
Having in place sufficient quality assurance and quality control processes.
Sampling in place to the appropriate degree.
Procedures in place for their inspection/testing/calibration.
Validated methods for obtaining data.
The ability to report and record accurate data.
Traceability to national standards whenever appropriate.
Proper environmental conditions to perform testing/calibration/inspection
ISO/IEC 17025 vs. ISO 9001
ISO 9001 is applicable to many businesses and industries, while ISO 17025 is specifically valuable for testing and calibration.
While labs can be certified and audited for internal management systems such as teh ISO 9001 (today's standards typically used in manufacturing), ISO 9001 does not evaluate technical competence. In turn this means that evaluation of ISO 9001 won't ensure that testing, calibrating and inspecting data is accurate and reliable. The focus is that ISO and IECE accreditations fill the "gap" of technical competence not addressed by ISO 9001.
Steps Towards ISO 17025 Certification
Achieving ISO 17025 certification involves a series of steps, including:
Gap Analysis: Assess current laboratory practices against ISO 17025 requirements to identify areas needing improvement.
Documentation and Implementation: Develop and implement quality management systems aligned with ISO 17025 standards.
Training and Calibration: Train personnel and calibrate equipment to maintain compliance and accuracy.
Internal Audits: Conduct internal audits to evaluate adherence to standards.
External Audit and Certification: Engage a certification body for an external audit to attain ISO 17025 certification.
ISO 17025 Education
The Roadmap to ISO 17025 Certification in Biopharma
For biopharmaceuticals, precision, accuracy, and reliability are of utmost importance. These principles underscore the development, testing, and manufacturing of drugs and medical products. To verify that laboratories meet these stric standards, the International Organization for Standardization (ISO) has established ISO 17025 certification. This certification not only validates the competence of laboratories but also assures the quality and integrity of their testing and calibration processes.
Quality Control and ISO 17025 Certification in the Biopharma Industry
In the world of biopharmaceuticals, precision, accuracy, and safety stand as the 3 key pillars. The production and distribution of pharmaceuticals necessitate strict quality control measures to guarantee efficacy, safety, and compliance with regulatory standards. ISO 17025 certification plays an important role in assuring the quality and reliability of testing and calibration laboratories within the biopharma sector. Let's dive into the significance of quality control and the role of ISO 17025 certification in the biopharma industry.
Understanding ISO 17025 Certification in Biopharma
In the field of biopharmaceuticals, maintaining strict quality standards is mperative. The pursuit of excellence in this industry involves sticking to rigorous regulatory requirements and industry standards. Among the various certifications for quality and reliability, ISO 17025 stands out as the key to an organization's credibility and competence. This certification, specifically tailored for testing and calibration laboratories, plays a pivotal role in the biopharma sector, ensuring accuracy, reliability, and consistency in testing methodologies.
About GL Technologies
As a full-service company specializing in equipment calibration, repair, and certification services for biopharmaceutical, pharmaceutical, and medical device industries. Our team has extensive experience working with sPRT calibrations along with CMMS software, HPLC OQ validation, and fume hood certifications. Companies of all sizes rely on our team to implement, maintain, and keep their research and manufacturing processes compliant with regulatory standards. Other specialties include building maintenance systems, and mass spectrometry calibrations.
To receive more information or to have ISO consult, please fill out our "Request Information" form or give us a call!
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