Clinical trial sites should consider becoming certified in ISO 9001—Quality Management Systems to help implement a quality framework that is GCP compliant.

Implementing ISO 9001 principles can help sites make the best use of resources, says David Borasky, WCG’s vice president of IRB compliance. “The benefits begin with a rigorous review of current practices and identifying potential areas for improvement. I also think that the larger the site, the greater the benefit, as ISO helps improve processes; in larger sites there can be a lot of processes and moving parts and that can lead to inefficiencies.”

Unlike ICH E6(R2), ISO 9001 provides advice on how to build and manage a QMS, focusing on processes rather than output, and “can provide an infrastructure for a risk-based QMS that is GCP-compliant,” says Dan Middleton, a former investigator with the FDA’s Bioresearch Monitoring program. The standard focuses on minimizing risks and identifying points at which risk may be further reduced and processes improved on an ongoing basis.

“Research facilities rely on creating and following SOPs to meet GCP requirements, but this is not necessarily enough in this context,” Middleton tells CenterWatch Weekly. “Having a bunch of SOPs is not the same as having a comprehensive, risk-based quality management system.”

ISO 9001 requires compliance with statutory and regulatory requirements, such as GCP. And it complements the risk-based quality management (RBQM) systems that the FDA and other regulators are increasingly emphasizing.

Among the chief benefits that ISO 9001 can offer to sites is better organization of critical processes, greater efficiency for common procedures and continuous improvement of all quality-related tasks, Middleton says.

The standard details what exactly is required for an effective QMS that will function in an RBQM environment, including the responsibilities of upper management, as well as investigators, coordinators and other staff directly involved in clinical trial conduct. It also describes how organizations can best manage resources that may be shared across clinical trials, including not only funding, but also human resources, technology, equipment, facility space, and materials and supplies.

Most importantly, Middleton says, the ISO standard explains how research organizations can measure and analyze performance to further the goal of continuous process improvement, which is critical to compliant RBQM. The GCP requirements provide the targets to be met, and the ISO 9001 approach to QMS helps researchers develop processes that allow clinical trials to reliably hit those targets.

These concepts are familiar to the pharma and medical device manufacturing world. But even though they are applicable to clinical studies, the research sector has trailed the manufacturing industry in adopting ISO 9001 approaches for quality management procedures.

In contrast to the ICH GCP guideline, ISO 9001 provides for certification by an accredited body. And while ISO 9001 certification is rare among U.S. sites, Middleton says, since the standard’s last update in 2015, some international research institutions have applied it to their operations.

The Human Tissue Bank of the Ribeirão Preto Clinical Hospital at the University of São Paulo (USP) in Brazil implemented and gained ISO 9001 certification for a new QMS. According to researchers at the Ribeirao Preto Medical School and Ribeirao Preto Nursing School, GCP compliance was easier due to the standardization and process improvements included in the new QMS.

The University of Padua Laboratory of Clinical Bioethics (LCB) also obtained ISO 9001 certification for its clinical ethics consultation and training services. ISO 9001 application can formalize the procedure for clinical ethics consulting and training, including controlled management of documents and data.

LCB achieved several results as a result of completing ISO 9001 certification, including a clearer enunciation of its mission and quality policy, drafting of procedures for providing clinical ethics consulting, formalized measuring and documenting of staff skills, and adoption of new risk-critical processes and outcome indicators.

Additionally, fulfillment of the formal procedures, as required by ISO 9001, promotes sharing of methodologies and tools to ensure consistent quality throughout an organization and across research sites and clinical trials.

CROs also see ISO 9001 certification as a way to demonstrate the validity of their in-house QMS. In announcing its 9001 certification, Mamta Hunt, Biorasi’s vice president of quality and pharmacovigilance, said the CRO’s certification “speaks to the importance of quality assurance at all levels” within an organization. In particular, Hunt said, ISO 9001 encourages researchers to focus on areas of key significance to individual clinical trials, as well as ensuring consistency and GCP compliance.

Routine internal auditing is also a feature of QMS management under ISO 9001. These audits are key to continuous improvement, says Middleton, ensuring that the organization detects and addresses any issues, including GCP compliance, patient safety issues, protocol or SOP deviations, and data quality issues.