Greenfield ISO13485 Medical Device Reprocessing
Supporting the Global Standard for Reusable Medical Device Reprocessing
A greenfield facility, a first-in-the-world process, and a path to ISO 13485 accreditation.
Client: International medical device manufacturer
Sector: Surgical / reusable medical devices
Project type: Greenfield facility and process development, QMS build and integration with rest-of-business, validation support and ongoing audit partnership
Standards: ISO 13485 • AS 4187 • ISO 9001
Outcome: ISO 13485 accreditation achieved, with QSN retained for ongoing pre-inspection audits
The Challenge
Our client had developed a bespoke process — the first of its kind anywhere in the world — for reprocessing and sterilising a highly sensitive class of surgical devices. A pilot facility, built around AS 4187 requirements, had proven the concept worked. The next step was harder: turning that pilot into a fully compliant, purpose-built production facility capable of meeting ISO 13485, and integrating it seamlessly with the client's existing ISO 9001-certified business.
Because no equivalent process existed anywhere else, there was no established playbook to follow. The client needed a partner who could provide compliance support for the facility build, equipment and process validation, the supply-chain process and the quality systems behind it — and be ready to prove all elements to a notified body for ISO13485 accreditation.
Our Approach
QSN embedded with the client's project and QARA teams from pilot through to handover prior to accreditation, providing hands-on quality and compliance support at every stage of the project.
Pilot Development and Operations
Facilitated internal workshops, process mapping and Gemba walks to trial and refine the pilot facility
Mapped product, material and personnel flows, and integrated the new process with the client's wider ISO 9001-compliant business systems
Verified the end-to-end reprocessing process met IFU requirements across the full device range
Developed protocols for early-stage end-to-end studies, transport and logistics studies, and process and equipment validation
Provided QA representation throughout sterilisation validation
Greenfield Facility Design and Build
Facilitated the facility's User Requirements Specification ahead of architectural planning and fit-out
Developed the facility's environmental monitoring program
Completed facility vendor qualifications as the QA representative
Conducted Gemba walks and internal audits throughout construction and commissioning
ISO13485 Quality Management System
Built the facility's QMS from the ground up — close to 200 documents — including batch instructions and records, packaging and labelling requirements, and numerous bespoke procedures, instructions and forms
Aligned every document to ISO 13485
Managed integration of the new QMS with the client's existing corporate QMS, including change control, document approval and routing
Audit Readiness and Accreditation
Supported the client through audit readiness activities, training delivery and a mock inspection ahead of their ISO 13485 accreditation assessment
Continues to deliver mock and internal audits to ISO 13485 ahead of each re-accreditation cycle with the notified body.
The Outcome
ISO 13485 accreditation achieved — the client's greenfield facility is certified and operating the world's first process of its kind
A ~200-document QMS built and embedded, fully aligned to ISO 13485 and integrated with the client's existing ISO 9001 business systems under compliant change-control and approval process
An ongoing audit partnership — QSN continues to perform mock and internal audits ahead of each re-accreditation cycle, keeping the client inspection-ready year after year
Building something the world hasn't seen before?
Whether you're planning a greenfield facility, transitioning to ISO 13485, or preparing for your next audit, QSN can help you get there — and stay there.
Check out our relevant services - Site Licensing and Accreditation or QMS.
Or check out our retainer options for Audit4Life and Compliance4Life.