San Diego ISO 17025 Certification Company

GL Technologies is a San Diego based ISO 17025 certified company specializing in calibration prevention maintenance procedures.

ISO 17025 certification is a globally recognized standard that specifies the requirements for the competence of testing and calibration laboratories. This standard is widely used in the biopharmaceutical industry to verify and validate testing and calibration results. GL Technologies is an ISO 10725 certified company that works with biopharmaceutical and related industries throughout the San Diego region. Our team of professionals works closely with our clients to maintain certification requirements in the manufacturing and research industries.

To speak with the experts about your ISO 17025 certification needs, please fill out our online form or give us a call!

858-202-1408

What is ISO 17025 Certification?

ISO 17025 certification is an international standard that specifies the general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. This certification ensures that the laboratory is capable of producing accurate and reliable test results, and that it has implemented a quality management system to continuously improve its processes and operations.

ISO 17025 Certification for Biopharma

GL Technologies has been helping biopharmaceutical and related industries throughout the San Diego region with ISO 17025 certifications and industry compliance needs. Here are a few benefits the ISO certification the GL Technologies team can provide for your organization and laboratory:

Compliance with Regulatory Requirements

Because the biopharmaceutical industry is highly regulated, ISO 17025 certification provides documentation that the laboratory is capable of producing accurate results. The certification will demonstrate to these agencies that your facility and laboratory have implemented a quality management system that meets domestic and international standards.

Improved Quality Management System (QMS)

As part of the ISO 17025 certification process, it requires that the laboratory implements a quality management system that provides reliable calibration and testing results. The system should include procedures for sample handling, test methods, instrument calibration, and data analysis that is also documented. Quality management systems can help research facilities reduce the risk of errors.

Access to New Markets

As a globally recognized standard, the ISO 10725 certification can help biopharmaceutical and medical related research organizations to gain access to new international markets. Again, it will demonstrate that the laboratory has implemented a QMS that also meets international standards and can compete in global markets.

Improved Customer Satisfaction

ISO 17025 certification can improve customer satisfaction by showing that the laboratory is capable of producing accurate test results along with medical devices. This certification demonstrates to customers that the laboratory has implemented a quality management system that can verify the consistency and reliability of test results.

The Certification Process

The ISO 17025 certification process holds significant importance within the biopharmaceutical and pharmaceutical industries, serving as a quality benchmark for laboratories engaged in testing and calibration activities. For these organizations, achieving ISO 17025 accreditation shows a commitment to strict quality standards and technical competence in conducting tests related to pharmaceutical products, medical devices, biological materials, and more. The certification process involves a thorough assessment of the laboratory's management system, technical proficiency, equipment calibration, and the validity of testing methods employed. Adhering to ISO 17025 standards verifies that laboratories operating in these sectors maintain accurate, reliable, and consistent testing practices, vital for product safety, efficacy, and compliance with regulatory requirements.

To obtain ISO 17025 certification in the these industries, laboratories undergo a series of steps. The process cstarts with an internal audit and the establishment of quality management systems aligning with ISO standards. An external assessment is conducted by an accredited certification body like GL Technologies, which includes a comprehensive evaluation of documentation, procedures, personnel competence, equipment calibration, and testing methodologies. This assessment looks at every party of laboratory operations to show conformity with ISO 17025 requirements. Upon successful completion of the evaluation, the laboratory receives accreditation, signifying its compliance with international standards, increasing its credibility, trustworthiness, and competitiveness. Continuous adherence to these standards through periodic audits and quality improvement initiatives remains imperative for maintaining ISO 17025 certification and upholding quality standards in biopharma laboratory operations.

ISO 17025 Education

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.

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.

Why GL-Tec for ISO 17025?

Obtaining ISO 17025 certification is a pivotal milestone for any company committed to maintaining the quality and reliability of its testing and calibration processes. By adhering to the rigorous standards set forth by ISO 17025, GL Technologies not only demonstrates its technical competence but also underscores its dedication to accuracy, consistency, and continual improvement. This certification serves as a testament to our unwavering commitment to meeting the needs and expectations of our clients while upholding the highest standards of integrity and professionalism. With ISO 17025 certification, GL-Tec stands poised to improve customer confidence, strengthen market credibility, and create long-term partnerships built on trust and excellence.

Frequently Asked Questions

Why is ISO 17025 certification important for laboratories?

ISO 17025 certification serves as a globally recognized benchmark for validating the competence, impartiality, and consistency of testing and calibration services. By adhering to the rigorous standards set forth by ISO 17025, laboratories demonstrate their commitment to delivering accurate and reliable results, which increases customer confidence and facilitates the acceptance of data both nationally and internationally.

What are the key requirements for achieving ISO 17025 certification in biopharma?

Key requirements include maintaining a comprehensive quality management system (QMS) that aligns with ISO 9001 principles, verifying the competency of personnel through appropriate education, training, and experience, implementing validated testing methodologies and equipment calibration protocols, establishing documentation practices for procedures, results, and traceability, maintaining a suitable laboratory environment with adequate facilities and safety measures, and engaging in regular internal audits and proficiency testing to continuously evaluate and improve processes.

How can biopharma laboratories prepare for ISO 17025 accreditation?

Labs need to establish a strong quality management system (QMS) tailored to their specific operations, covering areas including document control, corrective and preventive actions, and internal audits. Implementation of thorough standard operating procedures (SOPs) for all processes, from sample handling to data analysis, is important to maintain consistency and accuracy in results. Calibration and maintenance of equipment to verify accuracy and reliability of measurements is another vital aspect.

What are the benefits of obtaining ISO 17025 certification?

It increases credibility and trust in the quality of testing and calibration services provided, as it signifies compliance with internationally recognized standards. This can lead to increased confidence from customers, regulators, and stakeholders. ISO 17025 certification facilitates access to new markets by demonstrating competence and adherence to global quality, creating international trade opportunities. It also promotes continual improvement and efficiency within the laboratory for processes and workflows to increase overall performance.

How long does it typically take to achieve ISO 17025 certification?

The process can take anywhere from 6 months to over a year depending on the organization. Initial steps involve a gap analysis to identify areas needing improvement, followed by the development and implementation of necessary procedures and documentation. External audits by accredited certification bodies are then conducted to assess compliance with ISO 17025 requirements. Successful certification is achieved upon demonstrating consistent adherence to the standard's criteria, verifying the organization's competence in performing testing and calibration activities.

How does ISO 17025 certification contribute to improving the quality and reliability of biopharmaceutical products?

By sticking to ISO 17025 requirements, laboratories involved in biopharmaceutical testing maintain competence, impartiality, and consistency in their operations, which promotes trust among stakeholders. This certification demands strict quality management systems, proficient staff training, and documentation, all of which contribute to minimizing errors and strengthening the reliability of test results.

How often are biopharma laboratories required to undergo audits to maintain ISO 17025 certification?

Biopharma laboratories are audited annually or biennially to maintain compliance with ISO 17025 standards, which includes various aspects such as competence, impartiality, and quality management systems.

Can ISO 17025 certification be integrated with ISO 9001?

Yes, ISO 17025 certification, which specifies the general requirements for the competence of testing and calibration laboratories, can indeed be integrated with ISO 9001, the international standard for quality management systems. This integration is facilitated by the fact that both standards share common elements such as document control, management review, corrective actions, and continual improvement. By integrating ISO 17025 with ISO 9001, organizations can create a more streamlined and efficient quality management system that addresses both the quality of their products and services as well as the competence of their testing and calibration processes, leading to improved customer satisfaction and confidence in the organization's capabilities.

What are the implications of ISO 17025 certification for data integrity and traceability in biopharma laboratories?

This certification mandates rigorous protocols for documentation, calibration, and validation, enhancing the reliability and credibility of data generated within these laboratories. By implementing robust quality control measures, ISO 17025 certification cultivates a culture of accountability and transparency, mitigating the risk of data manipulation or inaccuracies.

Can ISO 17025 certification help biopharma laboratories meet regulatory requirements?

Given the highly regulated nature of the biopharmaceutical industry, compliance with ISO 17025 not only demonstrates a commitment to producing accurate and reliable results but also streamlines the process of meeting regulatory mandates.

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 speak with the experts about your ISO 17025 certification needs, please fill out our online form or give us a call!

858-202-1408

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