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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.

ISO 17025: An Overview

ISO 17025 is an international standard that outlines the general requirements for the competence of testing and calibration laboratories. Accreditation to this standard demonstrates a laboratory's proficiency in generating accurate and reliable results. In the biopharma industry, adhering to ISO 17025 is not just a preference but a necessity to maintain the highest standards of quality control and assurance.

The Certification Process

Achieving ISO 17025 certification in the biopharma sector involves a systematic approach that integrates various steps and considerations.

Understanding the Standard

This standard sets forth rigorous requirements making sure these facilities demonstrate technical competence, impartiality, and consistency in their operations. Understanding this certification involves a strict adherence to its comprehensive framework, including a wide spectrum of elements such as management requirements, technical processes, equipment calibration, testing methods, personnel competency, and the handling of test and calibration items. Laboratories seeking this accreditation must document their procedures, show a commitment to continuous improvement, and undergo regular assessments by accreditation bodies to maintain compliance with the criteria laid out by ISO 17025.

Gap Analysis

The gap analysis is an evaluative procedure done to identify the disparities between the laboratory's existing processes and the  ISO 17025 requirements. This analysis involves a comprehensive assessment of quality management systems, personnel competence, equipment calibration, testing methodologies, and documentation practices. It serves as a roadmap, showing the areas needing improvement and alignment with the standard's strict criteria. Through a methodical and systematic approach, the gap analysis paves the way for an informed and structured implementation strategy, guiding laboratories towards achieving ISO 17025 accreditation

Development of a Quality Management System (QMS)

The development of a comprehensive QMS necessitates a systematic approach, encompassing meticulous documentation of procedures, well-defined processes, calibrated equipment, competent personnel, and stringent quality control measures. The certification process typically involves a thorough evaluation by accredited auditors who assess adherence to ISO 17025's strict requirements.

Training and Competence Development

Key to this accreditation is the emphasis on training and competency development, where adherence to strict standards creates a culture of continuous improvement. This process involves mapping out personnel competencies, establishing comprehensive training programs, and assessing proficiency levels to meet the strict requirements of ISO 17025. By focusing on ongoing skill improvement, knowledge transfer, and proficiency evaluation, laboratories can create a workforce equipped with the expertise necessary to uphold the requirements set by ISO 17025, fortifying the credibility and accuracy of testing and calibration activities.

Implementation and Documentation

Implementation of ISO 17025 requires planning, execution, and documentation adherence. To start, an organization intending to acquire certification must assess its existing procedures and practices against the standard's requirements. This involves creating a roadmap for compliance, allocating resources, and defining roles and responsibilities within the laboratory. Documentation plays a pivotal role throughout the process, demanding the creation of quality manuals, procedures, work instructions, and records that align with ISO 17025 stipulations. Rigorous documentation not only provides transparency but also facilitates continuous improvement and effective audits.

Internal Audits and Corrective Actions

Integral to this process are internal audits and corrective actions that serve as important checkpoints in maintaining compliance and quality standards. Internal audits involve thorough evaluations of the laboratory's operations, procedures, and documentation to identify discrepancies or non-conformities with the ISO 17025 requirements. These audits are conducted by trained personnel within the organization to systematically assess adherence to protocols, pinpoint areas needing improvement, and validate the effectiveness of implemented procedures. Upon finding any issues or ares of discrepancies, the laboratory initiates corrective actions, a step aimed at addressing the identified issues, preventing their recurrence, and continuously improving the quality management system.

External Assessment and Accreditation

Commencing with an application, the process includes a comprehensive evaluation by an accredited certification body. This evaluation includes an in-depth scrutiny of the laboratory's quality management system, technical competence, equipment calibration, personnel proficiency, and adherence to testing methodologies. External assessors conduct thorough on-site inspections, examining procedures, records, and the laboratory's ability to produce accurate and reliable results. Upon successful assessment, accreditation is granted, affirming the laboratory's compliance with ISO 17025 standards, bolstering trust in its capabilities, and validating its commitment to precision, competence, and reliability in testing and calibration endeavors.

Benefits of ISO 17025 Certification

Obtaining ISO 17025 certification offers numerous advantages to biopharma laboratories:

Increased credibility and trustworthiness in the industry
Improved quality of testing and calibration processes
Increased customer confidence in laboratory services
Compliance with regulatory requirements
Facilitation of international recognition and acceptance of test results

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 softwareHPLC 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.


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