Your process, your standard, your starting point.
- We map your technical work and certification or accreditation goal
- We identify what already exists before adding new controls
- We surface the real gaps and challenges specific to your processes
QUALITY MANAGEMENT FOR LIFE SCIENCE TEAMS
Build a quality system that works with your team.
SmartQMS designs practical quality management systems for biotech startups, MedTech companies, scientific laboratories, and research organisations looking to improve reproducibility, translation, and commercialisation, and/or obtain ISO certification and accreditation.
20+ years in MedTech & Biotech · Academic & medical research · Startups
20+
years of cross-sector
ISO experience
ISO experience
20+ years
MedTech & Biotech experience
Trusted
by leading Australian research institutes
9001 · 13485 · 17025 · GCP
ISO Certification & NATA Accreditation specialists
Where do you want to start?
Pick the pathway that fits your goal.
System design, advisory, training, and audits - shaped around the standard that matters to you.
I need ISO 9001 certification
Practical QMS design and certification readiness for biotech startups, research, and science-based organisations.
Book a call →I need ISO/IEC 17025 NATA accreditation
Laboratory management systems, technical readiness, and audit support for testing and calibration labs preparing for or maintaining NATA accreditation.
Book a call →I need ISO 13485 for medical devices
Medical device QMS design, implementation, and certification readiness for MedTech companies, device manufacturers, and clinical-grade biotech.
Book a call →I need a clinical quality management system New
Good Clinical Practice-aligned quality systems for clinical trial sites, CROs, and sponsors — trial documentation, monitoring, deviations, and inspection readiness.
Book a call →I need a Fractional Quality Lead
Senior quality expertise on-demand — without the cost or recruitment lead time of a full-time hire. Scaled to your stage, embedded in your team.
Book a call →I'm not sure yet
Take our 5-minute Quality Readiness Check to see where your system stands and which pathway fits.
Start the readiness check →How we work
A QMS your team will be proud of.
In three simple steps.
We build systems around your work, your risks, and your specific needs, together with your team.
Practical processes, documents, and evidence pathways.
- We design controls that fit how your team actually works
- We implement core processes, assign responsibilities, and review cadences
- We develop lean documentation - only what the standard needs and people will use
Processes that your team own.
- We train your team so the system isn't dependent on us
- We conduct pre-audit dry runs, evidence walk-throughs, corrective action coaching
- We implement continual improvement culture and system that doesn't stall after certification
Case Studies
How we have helped teams build
great systems.
RNA Therapeutics Research
A leading Australian research institute pursuing ISO 9001 certification for RNA therapeutics manufacturing.
- QMS design from clinical-grade research operations
- Certification readiness aligned to manufacturing controls
- Audit preparation across documentation, training, and CAPA
Genomics Laboratory
A genomics centre strengthening ISO/IEC 17025 systems for NATA reassessment.
- Method validation, traceability, and result-validity controls
- Internal audit refresh and corrective action discipline
- Lean documentation aligned to lab realities
Recombinant Products Facility
A university-embedded production facility scaling its quality system.
- Risk-based controls for non-routine, project-driven work
- Records and competence pathways for early-career staff
- Quality culture coaching for technical leadership
Biotech Scale-Up
A growing biotech preparing first-time ISO 9001 certification ahead of investor due diligence.
- Lean QMS that doesn't slow R&D
- Investor-ready evidence of process maturity
- Roadmap to clinical-grade quality for trial-ready work
Built for Australian science
ISO 9001:2015
Certification support for biotech, research, and science-based organisations.
ISO 13485:2016
Medical device QMS for MedTech companies, device manufacturers, and clinical biotech.
ISO/IEC 17025:2017
Laboratory management aligned to NATA accreditation requirements.
Clinical QMS
Good Clinical Practice-aligned quality systems for clinical trial sites, CROs, and sponsors.
Research-informed
Deep understanding of the research landscape.
Trusted by Australian science and research leaders.
Trusted across university research facilities, biotech scale-ups, genomics centres, and MedTech founders. Here are a few of the leaders we've worked with.
Click through to read what they had to say.
Her knowledge of the QMS and certification landscape, excellent communication, and organised, pragmatic approach were invaluable. What could have been an overwhelming task was instead a manageable and rewarding effort — we achieved our certification goals within an ambitious timeline.
Thanks to her leadership, we smoothly achieved ISO 9001 certification — and we've just passed our fourth audit with no findings for the fourth consecutive time. With Keren, quality management is not a bureaucratic hurdle but a strategic asset.
She played a crucial role in steering us through the ISO/IEC 17025 accreditation process. Her impressive skill set and unwavering dedication make her a true standout leader. If anyone needs guidance going through NATA or other accreditation, I would recommend you contact Keren.
Keren's calm, considered, and ordered approach, expertise in all things quality, and excellent communication make her a trusted advisor. Under her guidance the Centre successfully obtained and maintained its ISO/IEC 17025 accreditation.
She provides guidance that is proportionate, risk-based, and aligned with commercial reality — ensuring compliance is built properly from the outset without unnecessary overengineering. For early-stage MedTech founders, that balance is incredibly valuable.
1 / 5
Where does your quality system actually stand?
Take the 5-minute SmartQMS Quality Readiness Check. Get a snapshot of your readiness for ISO 9001, ISO 13485, ISO/IEC 17025 NATA, or Good Clinical Practice — and what you need to focus on next
FAQ
How long does ISO 9001 certification take for a small biotech?
Most growing biotech and research organisations can reach ISO 9001 certification in 6-12 months, depending on starting point, technical complexity, and team capacity. We start with a gap analysis to give you a realistic timeline before any commitment.
What's the difference between ISO 9001 and ISO/IEC 17025?
ISO 9001 is a general quality management standard for any organisation. ISO/IEC 17025 is the laboratory-specific standard for testing and calibration competence — required for NATA accreditation. Most science organisations need 9001 for the business as a whole and 17025 for specific lab activities.
When do we need ISO 13485 instead of — or alongside — ISO 9001?
ISO 13485 is the QMS standard specifically for medical device design, manufacture, installation, and servicing. If your product is a medical device or will be submitted for TGA registration, ISO 13485 is the required standard — not ISO 9001. Many MedTech companies hold both: 13485 for their device activities and 9001 for broader business operations. SmartQMS helps you scope and sequence both without duplicating your documentation effort.
Do we need a full-time Quality Manager?
For most small biotech and lab teams, no. SmartQMS provides Fractional Quality Lead support — senior quality expertise scaled to your stage, without the cost or recruitment lead time of a full-time hire.
What does a clinical quality management system cover?
A clinical QMS puts the controls a trial actually runs on into one system: trial documentation and version control, delegation and training records, monitoring, protocol deviations, safety reporting handoffs, and inspection readiness. We build it around Good Clinical Practice for clinical trial sites, CROs, and sponsors — and align it with ISO 9001 where you also hold or want certification, so you are not maintaining two sets of paperwork.
Do you publish pricing?
No. Every quality system is different — scope depends on your current processes, certification or accreditation objective, team size, technical complexity, and timeline. We start with a free consultation so we can recommend the right level of support.
Ready to start
Book a free consultation.
30 minutes with our team. We'll talk through your certification or accreditation goal, where your system stands today, and the next practical step. No obligation. No sales pitch. Just clarity.
Book a free consultation
Or email us: info@smartqms.com.au