09 May 2022

NunaBio is awarded ISO9001 certification

NunaBio is proud to announce our successful certification to ISO 9001:2015, an internationally recognised Quality Management Standard which ensures that our products and services meet the needs of our clients through an effective Quality Management system.

We have developed and implemented this system in order to improve our overall performance, maintain a high-level of quality and strong customer service, and provide a sound basis for sustainable development initiatives. Our decision to work towards ISO 9001 certification demonstrates a commitment to providing high-quality and consistent products and services to our clients and our ongoing investment in technology and development.

The ISO 9001 certification is the assurance that we have robust, clearly defined procedures in place in all our business areas including R&D, production, supply chain management, risk management, handling of documents and data, and strong business continuity processes. It also ensures 100% traceability of our supply chain and helps us by converting customer feedback into project tasks for our R&D team.

CEO Joe Hedley comments ‘ISO9001 is the basis of all of the ISO quality standards. To have achieved certification at such an early stage of the company’s development shows that we are operating in the right way to satisfy all regulatory requirements as we develop exciting new products.’

Working with NunaBio

We work through detail design, integration and initial testing, repeating this process to optimise the design before verification testing.

Our work is fully documented and a package of data and specifications can be assembled to allow scale up manufacture to start smoothly.  

We have extensive experience in Process Validation, Project Management to Phase 2 Manufacturing Criteria, Change Management and Quality Assurance to Regulatory standards (MHRA; FDA). 

Our operations management is led by a Lead Auditor qualified in Quality Management (ISO9001), Medical Devices (ISO13485), Laboratory Testing (ISO17025), Information Security (ISO27001), and Environmental Management (ISO14001).  

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