Quality in Action: How Phage Australia at Westmead Achieved ISO9001:2015 certification
Carina Lauter, Stephanie Lynch, Ruby Lin and Phage Australia at Westmead team
Back in 2021, Phage Australia was launched with support from MRFF Frontiers Stage 1 and OHMR (Office of Health and Medical Research), NSW Health funding, with a bold vision to establish phage therapy as a transformative solution for antimicrobial resistance. One of the program's foundational pillars was to build a robust and scalable phage manufacturing and supply system to support the STAMP trial (1) and future clinical applications.
Today, we are proud to announce that Phage Australia at Westmead has achieved ISO9001:2015 certification - a major milestone in our journey to inspire confidence in phage therapy as a third major intervention in infectious diseases, alongside antibiotics and vaccines.
This certification reflects our commitment to quality, safety and operational excellence. It strengthens our ability to deliver therapeutic-grade phage products, streamlines our processes across research and manufacturing, and positions us to expand access to life-saving phage therapies for patients across Australia. We are now registered by INTERTEK SAI Global as conforming to the requirements of ISO 9001:2015. The management system is applicable to the provision of biobanking, genomics, development, production, distribution and monitoring of therapeutic phages. This prestigious certification reflects our commitment to maintaining the highest quality standards in the development and production of phage therapies.
Achieving this milestone was a true team effort. Here, we share some insights from our ISO journey and highlight how this achievement supports our broader mission to professionalise and scale phage therapy for global impact.
What is ISO 9001:2015?
ISO 9001:2015 is an international standard that specifies requirements for a Quality Management System (QMS), enabling organisations to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements. In simple terms, it’s a structured framework for businesses, laboratories, and even non-profits to systematically manage their processes and make sure they consistently deliver high-quality work, meet customer needs, and ensure conformity to legal requirements. This framework ensures our operation is well-organised, traceable and reliable while promoting continual improvement throughout the organisation.
Our ISO 9001:2015 journey had strengthened our existing processes from phage matching through to product delivery to the hospital, building our own ISO9001:2015 system boosted our operation to the next level and an even higher quality of standards. “This helps build trust with hospitals and patients, ensuring our phage products are safe and ready for clinical use.” stated Professor Jon Iredell, Director of Phage Australia.
Reflection prior to ISO 9001:2015
It is interesting to think about where we were 1 year ago when we embarked on this ISO9001 journey. At the time, the foundations of a QMS were already taking shape – partly in our collective team thinking, and partly embedded in our protocols, databases, and day-to-day processes. Dr Stephanie Lynch had already established a robust lab recording system, and Carina Lauter had implemented a structured biobanking documentation framework – both critical building blocks that set the stage for formalisation. The decision to fully implement a QMS, led by our Director, Professor Jon Iredell, was the catalyst that transformed these early efforts into a coordinated, organisation-wide commitment to quality. One of the most important lessons we have learned is that QMS implementation is not a top-down directive - it is a whole-team endeavour.
Implementing a QMS is not just a technical upgrade – it is a cultural shift. Success hinges on full-team engagement, from senior management to lab technicians and everyone in between. We have concluded that quality is not a check box; it is a shared value. Another key lesson we have learned is that when every team member understands why quality matters, the system transforms from being compliant to becoming truly resilient.
“Identifying the right quality management partner required thorough evaluation and careful consideration,” said Adjunct Professor Ruby Lin, Deputy Director. We chose SmartQMS because of their proven expertise in ISO9001:2015 certification for complex, mixed-purpose laboratories – where research excellence must coexist with clinical-grade quality systems. Their understanding of the nuanced needs of labs like ours – where part of this shared lab space requires ISO compliance while others remain research-focussed – was instrumental in helping us build a tailored, scalable QMS that support both innovation and operational rigour.
The scoping document took more than 2 months to finalise, and it remains a living document. Dr Stephanie Lynch spearheaded a weekly writing huddle focussed on refining lab protocols and laboratory procedures (LPs), which became a cornerstone of our documentation culture. These sessions fostered collaboration across small working groups – particularly within the lab (Dr Stephanie Lynch, Carina Lauter, Clare Fisher, Dr Jackie Chan, Dr Rabeya Rahmatullah), biobanking (Carina Lauter, Dr Stephanie Lynch, Dr Ruby Lin) and genomics (Drs Jackie Chan, Nouri Ben Zakour, Jenny Draper, Claire Elek) teams – enabling us to iterate on genomic pipelines, general documentation and the risk register (Dr Ruby Lin, Karen Swensen). Upon reflection, this grassroots approach to quality strengthened not only our QMS but also cultivated a shared language and mindset around continual improvement [Note: data dictionary]. Given the integrated and bespoke nature of our phage therapy operations, our ISO implementation was far from a cookie-cutter exercise - it demanded thoughtful consultation and adaptation across every level of the organisation. [Note: read between the lines – there were a lot of meetings].
Our ISO9001:2015 commitment
Our quality commitment states that ‘We are committed to ensuring that all clients are provided with the highest quality products and services, supporting a national ecosystem that integrates phage biobanking, rapid phage diagnostics, phage production, and clinical trials’.
How did we leverage this commitment to shape our QMS? Here, we examine this process through the lens of laboratory operations and governance structures.
The lab perspective
The creation and execution of a robust QMS heavily rely on the lab team responsible for biobanking, diagnostics, phage production and QAQC of the phage product. Our journey commenced with the identification of essential processes for inclusion in the QMS along with the formalisation of necessary Standard Operating Procedures (SOPs). To note, many of these protocols (e.g., DNA extraction of bacteria and phages) are publicly available in various formats. We, however, take the extra step of refining, customising and standardising them to tailor-fit our unique phage therapy operations. To date, existing SOPs are now uniformly structured, subject to review, approval and managed under a stringent document control protocol, with comprehensive staff training records that are regularly updated.
Furthermore, we enhanced our methods for monitoring equipment, materials, and documentation – a crucial step towards ensuring the consistency and safety of our operations. During this period, “control” and “monitoring” are recurring terms across all laboratory activities, essential for maintaining a robust QMS (and successfully navigate audits!). This was no small feat, for example, tracking down purchasing and calibration records for equipment is never a fun task. There were also a few new words and phrases to learn like ‘non-conformance’ and ‘change management’.
The governance perspective
A major aspect to implementing and sustaining a QMS is having robust governance policies and procedures. This involves formalising critical aspects like the organisational context, internal and external factors such as stakeholders and funding, and the identification of risks (including factors such as climate change!) that pose challenges to the organisation. While we have the foundational elements scattered across various documents and policies, the QMS mandates the meticulous documentation and formalisation of these components, integrating seamlessly into the entire operational framework.
While considerations around data security risks were previously in place, the QMS has elevated our ability to ensure the safety and effective management of all systems. This shift demonstrated a trickle-down effect where management’s commitment cascades through the entire team – providing cohesion, structure and oversight to implement these policies effectively. During this period, “resilience” and “compliance” are recurring terms across all governance activities – essential to foster a culture of continual improvement and ethical conducts.
We are proud to have established a robust, quality-assured framework for delivering therapeutic-grade phages. By systematically integrating our operations – from biobank curation and phage susceptibility diagnostic to GMP-aligned manufacturing – we now meet key standards for consistency, traceability, and clinical readiness. This milestone not only reflects our commitment to excellence but also paves the way for expanding equitable access to phage therapy across Australia.
To date, we have treated >37 patients with phages produced by this team under the STAMP protocol (1).
In total, we have treated >57 patients with phages in Australia since 2017.
Lessons learnt
1. Recognising ISO9001 certification is a strategic asset (secure and assign funding).
2. Preparing the whole group on cultural shift in terms of quality.
3. Harmonising SOPs (e.g., data dictionary) and think about validation early on i.e., pick a case in real time to validate from start to finish).
4. Traceability is crucial for regulatory confidence.
5. Risk-based thinking for processes (and improvements).
6. Cross-functional training (future proof the whole operation).
7. Document control systems must be scalable.
8. Stakeholder engagement.
Acknowledgements
We would like to thank the contributions of SmartQMS Keren Natalia, Shilpa Patil and Yuliana Gunawan; our team members Drs Holly Sinclair, Alicia Fajardo Lubian and Emily Mascord; Westmead Institute, Dr Ying Cao – research coordinator lead, Usman Jawaid – chief information officer, Simon Hall - Chief Operating Officer, and Kevin Johnson - Cyber Security Engineer. We also extend our appreciation to the broader level 4 lab community at Westmead Institute for their understanding and support.
1. Khatami A, Foley DA, Warner MS, Barnes EH, Peleg AY, Li J, Stick S, Burke N, Lin RCY, Warning J, Snelling TL, Tong SYC, Iredell J; Phage Australia Clinical Network. Standardised treatment and monitoring protocol to assess safety and tolerability of bacteriophage therapy for adult and paediatric patients (STAMP study): protocol for an open-label, single-arm trial. BMJ Open. 2022 Dec 9;12(12):e065401. doi: 10.1136/bmjopen-2022-065401.)