QMS Templates for
ISO 13485 & GMP
Complete QMS and PQS template sets for medical device and pharmaceutical businesses — procedures, work instructions, forms, templates, training assessments and registers, refined over years of use within QSN and across the industry.
Build your QMS without starting from scratch!
ISO 13485 Medical Device
For medical device manufacturers and sponsors. From US$2,997
GMP Pharmaceuticals
For pharmaceutical manufacturers and sponsors.
From US$2,997.
Built for Teams Who Want to Do It Themselves
Writing a QMS from scratch takes months, and most of that time goes into working out what you need and how to structure it. Our template sets give you that structure on day one.
Each set covers the processes expected by PIC/S GMP or ISO 13485. Every process is captured in a single procedure and supported by the work instructions, forms, templates, training assessments and registers you need to run it. A working Document Register lists every document in the set, so you can track drafting, approval, go-live and then Business As Usual in one place.
And you're never left guessing. Every document includes instructional text that tells the preparer how to complete it, with tips and things to consider along the way. Each set is written in plain language and sized for small and growing companies — what you need for your stage, not a system that buries a five-person team in paperwork.
What's In Every Templates Set
Everything you need to run a working QMS — not just a pile of documents.
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Procedures (SOPs)
One procedure per process, covering everything ISO 13485 or GMP expects — so each process lives in one place, not scattered across documents.
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Work instructions (WIs)
Step-by-step instructions for the tasks that need more detail than a procedure.
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Forms and templates
Ready-made forms and templates so your records are complete and consistent from day one.
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Training assessments
Assessments linked to the procedures, so you can show your team is trained and competent.
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Registers
Registers to track the activities your QMS manages, such as CAPAs, complaints, changes and training.
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Working Document Register
A register listing every document in the set, ready to use to manage drafting, review, approval and go-live of your new QMS.
Instructions built into every document. Each document includes instructional text showing the preparer how to complete it. Follow the guidance, delete the instructions, and your document is ready for review.
Word and Excel files. Delivered as one download, so you can edit them or upload them to your document management system.
The content of every document reflects years of development within QSN and across the pharmaceutical and medical device industries.
How Does It Work?
Choose your set and tier. Pick the set that matches your company and the tier that matches the help you want.
Get access straight away. You'll receive an email with access to our portal, where you can download your full template set and Document Register. Tier 2 and 3 training courses are in the same login.
Tailor to your business. Follow the instructional text in each document to complete it for your company, then remove the instructions. Use the document templates in the set to create the documents unique to your company.
Go live. Track each document through drafting, review and approval in the Document Register, then go live with your new QMS.
Train your team. Tier 2 or 3 include QSN Academy courses, so your people understand the system, not just the documents.
Choose Your Tier
Both sets come in the same three tiers. Start with the templates, add QSN Academy training so your team understands how the systems work, or add QSN consulting time to map and create a first draft your most complex process.
| Tier 1Template Pack | Tier 2Pack + Academy Most popular |
Tier 3Process Mapping and First Draft | |
|---|---|---|---|
| Price | US$2,997 | US$3,597 | US$7,497 |
| What you get | The full template set | The template set plus the QSN Academy courses for your set | Everything in Tier 2, plus 20 hours with a QSN Senior Consultant to map and draft your most complex process |
Prices in US dollars. The same tiers and prices apply to both the ISO 13485 and GMP sets.
Not sure which tier is right for you? Book a free call and we'll help you choose.
Templates give you the documents. Training gives your team the know-how
A QMS only works when your people understand why each procedure exists and how to follow it. QSN Academy's online courses are built to sit alongside our template sets, so your team learns the system as you put it in place. The recommended courses for each set are included in Tier 2.
| Template set | Courses included in Tier 2 |
|---|---|
| ISO 13485 Medical DeviceFor manufacturers and sponsors |
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| GMP PharmaceuticalFor manufacturers and sponsors |
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Prefer Some Expert Help?
Templates suit teams who want to do the work themselves. If you'd like a consultant for your most complex process, Tier 3 gives you 20 hours with a consultant at a fixed price.
Need more than that? Our consultants can tailor your whole system, review your documents, or get you ready for an inspection from a one-off review through to full implementation.
FAQs
What format are the templates in?
Editable Microsoft Word or Excel files, delivered as one ZIP download. Update them in Word or Excel, or upload them into your document management system.
Are the templates ready to use straight away?
They give you the structure and most of the content. You'll still need to tailor them to how your business works — each document includes instructional text that shows you how. You will also likely need to create some procedures that are unique to your company using the document templates within the set.
We're a sponsor and outsource manufacturing. Is this set for us?
Yes. Each set is written for manufacturers and sponsors. Each set's sales page explains how sponsors use it - click through to Find Out More.
What is the Document Register?
A working register listing every document in your QMS set. Use it to track each document as you draft, review and approve it, and to manage the go-live of your new QMS.
Will using these templates guarantee certification or a licence?
No template can guarantee an audit outcome. The templates give you a sound, audit-ready structure. Your result depends on how well the system is tailored, implemented and followed — which is why we recommend pairing your set with training. If you'd like hands-on help, choose Tier 3 or book a call with us.
What regulations do these sets align to?
The ISO 13485 set align with ISO 13485:2016 and Australian TGA medical device requirements including recalls under the TGA's PRAC. ISO13485 is also the basis of the QMS requirements under the EU MDR and FDA's QMSR, although each adds its own nuances for some areas.
The GMP set align with the PIC/S Guide to GMP (excluding specific requirements of Annexes), which is closely aligned with EU GMP and similar to FDA requirements.
Can I buy individual documents?
No. The templates are sold as a complete set, because the documents reference each other.
What if I need help after I buy?
Book a consulting call with us. If you bought Tier 1 and want training contact us to upgrade to Tier 2.
What is your refund policy?
Because the templates and courses are digital and available straight away, we don't offer change-of-mind refunds once access is granted. This doesn’t affect your rights under the Australian Consumer Law. Tier 3 terms are on each set's sales page.
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