Should you buy bundled ISO 13485 procedures for your med tech QMS?

It’s a fair question - especially when you’re staring down the barrel of an audit, short on time, and knee-deep in product development. If you’re promised ‘off-the-shelf compliance without the cost of consultants or an eQMS platform it can be tempting. But is it too good to be true?

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). 

Beware of geeks bearing gifts

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’.  

The allure of bundled SOPs

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:

• Time-saving: Drafting dozens of standard operating procedures (SOPs), forms, and checklists from scratch is a massive undertaking. Bundled templates promise to shortcut the grunt work.
• Structure and scope: Authored by the same company - the CAPAs, NCRs, equipment calibrations and other documents, should all be easy to link together to create a single system.
• Cost-effective: For a few hundred pounds, you can get a full “QMS in a box.” Compare that to the cost of consultants or full-featured eQMS platforms running into the thousands.
• Expertise: The best templates are written by regulatory experts and have been used in the real world as part of quality management systems that have gained ISO 13485 

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.

The problem with ‘buying in’ quality

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.

The downsides of bundled ISO 13485 SOPs

1. Customisation is non-negotiable

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.

2. Quality varies wildly

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.

3. It’s not plug-and-play

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.

4. Misalignment can result in audit findings

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.

5. You still need expertise

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.

So when does it make sense?

Purchasing bundled SOPs isn’t always a bad idea. Here’s when it might make sense:

• You’re a medical device startup looking for a foundation to build on.
• You need a temporary structure while your full QMS is under development.
• You have internal expertise to adapt and implement the procedures.
• You’re using them as part of an eQMS platform that can manage version control, training, and audit readiness more effectively.

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.

It’s all about your eQMS

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:

• Upload your own SOPs into a digital framework (or start from trusted templates)
• Automate process workflows through digital tools
• Control versions, approvals, and document lifecycle from one place
• Assign training and track who’s read what
• Generate evidence that procedures are understood and followed
• Make the evidence accessible — for every audit or inspection

A word of warning

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.

Why quality can’t be downloaded

As Sam Shelley puts it, your documented SOPs should be:

• Realistic for your size and structure
• Practical for your team to follow
• Integrated with your quality culture and risk controls

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.