Selling SOPs is big business. You can buy templates for thousands of dollars from highly respected consultants or for under 50 quid from shadowy companies on Etsy (BTW - this is not recommended).
If you are trying to build a DIY QMS using Google Docs or Microsoft tools, a discounted bundle that promises to deliver ISO 13485 compliance might seem the answer to building out your quality documentation, but as the saying almost goes, beware of ‘geeks bearing gifts’.
For companies under pressure to launch, scale, or meet compliance milestones like passing ISO 13485 audits or securing FDA 510(k) clearance, the appeal of downloadable, bundled SOPs is clear:
But here’s the thing—SOPs are not just paperwork. They are the documented embodiment of how your company operates. And that’s where the problems with bundled SOPs begin.
WATCH: Quality Consultant, Sam Shelley, talk about the risk of buying in bundled procedures;
As Sam Shelley puts it:
“I’m often asked, ‘Why don’t I just buy this set of ISO 13485 procedures off the internet for £500?’ Because those procedures are going to be generic. And what you actually need is to reflect how you as an organisation will comfortably and consistently carry out these processes.”
In other words, buying SOPs is not the same as building a quality management system. At best, you’re buying a starting point. At worst, you’re buying a false sense of security.
ISO 13485 and FDA QMSR don’t just require you to have procedures—they require that those procedures be established, maintained, and followed. Templates must be tailored to match your company’s actual structure, product risk classification, technologies, roles, and responsibilities.
If the SOPs describe processes that don’t reflect what your teams are doing - and the system itself isn’t connected and maintained with appropriate workflows, you’re not compliant—you’re vulnerable.
A £53 bundle from a 1-star shop categorised under "party decor" on Etsy doesn’t exactly scream “FDA audit ready.” Many cheap bundles are incomplete, outdated, or written in vague terms that won’t withstand regulatory scrutiny.
The biggest myth around buying SOPs is that they’re ready to use. In reality, extensive review, editing, validation, implementation, training, and ongoing maintenance are still required. You’re not skipping work - you’re shifting it.
Auditors don’t care whether you wrote your SOPs from scratch or bought them. They care that your procedures match your practices - and that your employees can follow them. Using a template that describes a generic process you don’t actually follow is a sure way to fail an audit.
Even if you use templates, someone in your organisation must understand the regulations well enough to assess and adapt them. Templates might save drafting time, but they don’t replace regulatory knowledge or strategic oversight.
Purchasing bundled SOPs isn’t always a bad idea. Here’s when it might make sense:
Even then, due diligence is key. Vet your vendor carefully. Ask for samples. Check for domain-specific expertise (e.g. SaMD vs. hardware). Make sure you understand what’s included - and what’s not.
Paying for a bundle of procedures might feel like a shortcut - but it won’t make you compliant with ISO 13485.
Because compliance isn’t just about having procedures. It’s about living them—proving that your teams follow them, that they’re reviewed, updated, and linked to training, risk, and quality outcomes. A static folder of SOPs, no matter how well-written, can’t do that.
But the right eQMS can.
A LEAN eQMS platform (such as Cognidox) gives you the flexibility to:
It’s worth noting, that not every eQMS system will give you the flexibility to do this, some systems will force you to use their own set of SOP templates linked together in specific ways in their own digital system.
These SOPs are hard to change and adapt to fit your way of working. If you want to bespoke those SOPs to reflect existing procedures, it may take considerable time and money.
As Sam Shelley puts it, your documented SOPs should be:
All this means moving beyond shortcuts and investing in systems that can grow with your company. Paying for a bundle of procedures without implementation guidance and support from a consultant or eQMS supplier may prove a profound waste of time and money.