Introduction to ISO 9001

In the complex and critical field of virology research, the highest standards of quality are non-negotiable. That’s why Virology Research Services (VRS) is proud to announce our achievement of ISO 9001 certification, the gold standard of quality management.

What is ISO 9001 Certification?

The International Organization for Standardization (ISO) is an independent, non-governmental organization that has developed over 24,700 international standards, providing guidance across various industries. A prominent standard among them, recognized worldwide for its extensive application, is ISO 9001.

ISO 9001:2015, the latest version of this quality management standard, is applicable to organizations of all sizes and fields. According to the ISO’s official description, it emphasizes key quality management principles, including a robust customer focus, the involvement of top management, a process approach, and an emphasis on continual improvement.

Essential Pillars of ISO 9001:2015 Certification

The core elements for achieving ISO 9001:2015 certification include:

• Context: Understanding the organization’s industry sector, products, and services.
• Leadership: Demonstrating the commitment of senior management to upholding the quality management system.
• Planning: Identifying potential business risks and opportunities.
• Support: Providing resources for the execution, maintenance, and improvement of the quality management system.
• Operation: Managing processes related to the delivery of products and services.
• Performance Evaluation: Evaluating performance through customer feedback, internal and external audits, and management reviews.
• Improvement: Implementing practices that ensure continual enhancement of products and services.

Navigating the Path to ISO 9001 Certification

Our journey towards ISO 9001 certification commenced with a thorough study of the ISO 9001:2015 standard. To gain a better understanding of its requirements, we relied on the guidebook “ISO 9001:2015 In Plain English” by Craig Cochran. This resource provided clarity and practical examples that simplified the intricate clauses of the standard.

While we were already following many of the standard’s practices, we recognized the need to develop additional documents, like a formal Improvement Register and a Business Management System Scope.

We partnered with the British Assessment Bureau (BAB), a UKAS-accredited ISO 9001:2015 auditor, to navigate this process more efficiently. This collaboration enabled us to leverage their Activ online business management software, which provided us with helpful templates for building our Quality Management System (QMS). BAB’s support sessions also offered opportunities to interact with auditors, ask questions, and gain insights into the certification process.

How Becoming an ISO 9001 Certified CRO has impacted VRS

ISO 9001 certification is a testament to VRS’s commitment to quality management, customer satisfaction, and continuous improvement. It provides a recognized framework that our clients can relate to and trust. This certification also paves the way for new opportunities, signaling our dedication to maintaining the highest standard of quality in our work.

Are you interested in understanding how our ISO 9001:2015 certification can benefit your organization? Contact us today to learn more about our commitment to quality and how we can help you with your virology research needs.

Blog by Max Handley
Edited by Reckon Better Scientific Editing