Achieving ISO/IEC 17025 accreditation represents a significant milestone for testing laboratories operating within regulated environments. The standard establishes rigorous requirements for technical competence, data integrity, and quality management systems (QMS), ensuring the reliability and reproducibility of laboratory results. At Quality Systems Now (QSN), we specialise in supporting therapeutic goods manufacturers, testing laboratories, and biotechnology companies in achieving and maintaining compliance with such standards.

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This case study presents a detailed examination of a laboratory accreditation project involving a facility specialising in peripheral blood mononuclear cells (PBMC), cryopreservation, ELISA, and multiplex assay techniques. The laboratory supported international clinical trial testing and required accreditation to ISO/IEC 17025 through the National Association of Testing Authorities (NATA). The project encompassed the full lifecycle of QMS development, implementation, training, audit readiness, and post-accreditation support.

Initial State and Project Scope

At project initiation, the laboratory had established its physical infrastructure and core technical capabilities. Some procedural elements were in place; however, the organisation lacked a formalised and integrated QMS. This created significant gaps in governance, traceability, and compliance with ISO/IEC 17025 requirements.

The absence of a structured QMS limited visibility across laboratory operations. Critical processes such as sample handling, data review, equipment qualification, and deviation management were not consistently standardised or documented. While the laboratory demonstrated strong technical capability, the lack of system-level control presented a substantial barrier to accreditation.

QSN was engaged to design and implement a comprehensive quality framework, ensuring alignment with ISO/IEC 17025 while supporting the laboratory’s operational objectives.

Development of a Comprehensive Quality Management System

A foundational component of the project was the development of a QMS from the ground up. This involved the creation of approximately one hundred controlled documents, including standard operating procedures (SOPs), policies, forms, and work instructions.

The development process was conducted in close collaboration with subject matter experts (SMEs) within the laboratory. This ensured that documented procedures accurately reflected operational practices while incorporating compliance requirements. The QMS was structured to address all critical elements of ISO/IEC 17025, including document control, risk management, corrective and preventive actions, and internal auditing.

The resulting system provided a centralised and controlled framework for laboratory operations, significantly improving consistency, traceability, and regulatory alignment.

Establishing Chain of Custody and Sample Management

Given the laboratory’s role in supporting clinical trials, the integrity of sample handling processes was of paramount importance. QSN developed and implemented a robust chain of custody system to manage incoming samples and subsequent test materials.

This system ensured complete traceability from sample receipt through to analysis and reporting. Procedures were established to document each stage of sample handling, including storage conditions, processing steps, and transfer between personnel or locations. Unique identifiers and controlled documentation were used to minimise the risk of misidentification or loss.

By formalising these processes, the laboratory achieved a high level of control over sample integrity, a critical requirement for both ISO/IEC 17025 compliance and clinical trial reliability.

Equipment Validation and Environmental Control

The project included comprehensive support for equipment validation and environmental monitoring. Key laboratory equipment, including cold storage units, incubators, and analytical instruments, underwent qualification to demonstrate fitness for purpose.

Validation activities included installation qualification, operational qualification, and performance qualification, as appropriate. These activities ensured that equipment operated within defined parameters and produced reliable results.

Additionally, temperature-controlled environments were subject to mapping studies. QSN supported the development of protocols and reporting for temperature mapping, ensuring that storage conditions were consistent and compliant with regulatory expectations. These studies provided empirical evidence of environmental control, supporting both data integrity and sample stability.

Data Integrity and Result Management

Data integrity was addressed as a core component of the QMS. Processes were established to ensure that all laboratory data were attributable, legible, contemporaneous, original, and accurate. This included the implementation of structured workflows for data recording, review, approval, and release.

Controls were introduced to manage access to data systems, ensuring that only authorised personnel could create, modify, or approve records. Audit trails and review processes were implemented to detect and investigate any discrepancies.

By embedding data integrity principles into daily operations, the laboratory improved both compliance and confidence in its analytical outputs.

Training and Competency Development

A structured training program was developed to support the implementation of the QMS. This included training in Good Documentation Practices (GDocP), ISO/IEC 17025 requirements, and all newly developed procedures.

Training was delivered through a combination of formal sessions and read-and-understand activities. Competency assessments were incorporated to verify that personnel could apply the requirements effectively in practice.

This systematic approach ensured that all staff were aligned with the expectations of the QMS and capable of maintaining compliance in their respective roles.

Quality Assurance Leadership and System Management

QSN provided ongoing quality assurance (QA) representation for approximately two years, managing all aspects of the QMS. This included oversight of training, change control, deviation management, nonconformances, and internal audits.

The QA function played a critical role in maintaining system integrity and driving continuous improvement. Regular internal audits were conducted to assess compliance and identify opportunities for enhancement. Deviations and nonconformances were investigated systematically, with corrective actions implemented to address root causes.

This sustained involvement ensured that the QMS remained active and effective, rather than becoming a static set of documents.

Audit Readiness and Inspection Support

Preparation for the NATA accreditation audit was a key phase of the project. QSN conducted audit readiness assessments to identify and address any remaining gaps. These assessments simulated the conditions of an external inspection, enabling the laboratory to refine its processes and documentation.

During the NATA audit, QSN led the organisation’s audit activities, providing guidance and support throughout the inspection. This included facilitating interactions with auditors, presenting evidence of compliance, and coordinating responses to any findings.

Post-audit, QSN managed the response to identified deficiencies, ensuring that corrective actions were implemented effectively and within required timelines.

Accreditation Outcome and Ongoing Support

The laboratory successfully achieved ISO/IEC 17025 accreditation, demonstrating compliance with all relevant requirements. This outcome validated the effectiveness of the implemented QMS and the laboratory’s technical competence.

Following accreditation, QSN continued to provide QA and QMS support. This ongoing engagement ensured that the laboratory maintained compliance, adapted to evolving requirements, and continued to improve its systems.

Sustaining accreditation requires continuous effort, and the presence of a structured and well-managed QMS enables organisations to respond effectively to future challenges.

Conclusion

This case study illustrates the complexity and scope of achieving ISO/IEC 17025 accreditation in a regulated laboratory environment. While technical capability is essential, it is not sufficient on its own. A comprehensive and integrated QMS is required to provide the visibility, control, and consistency necessary for compliance.

At QSN, our approach focuses on building systems that not only meet regulatory requirements but also enhance operational effectiveness. By developing robust processes, embedding data integrity, and supporting organisations through every stage of the accreditation journey, we enable laboratories to achieve and sustain high standards of quality and performance.