Why QC Rules On Paper Matter At The Patient’s Bedside
In the world of surgical instruments and sterilisation baskets, you often hear phrases like “industry standard”, “ISO 13485” or “AQL and sampling plans”. For most people in theatre or CSSD, it all blurs into one question: is this just paperwork, or does it actually make a difference to the patient?
At Scala, we look at it in two layers. First, there are the industry standards – the formal rules everyone is supposed to follow. Second, there is what we call the Scala Standard – how we choose to apply and go beyond those rules in real life.
When we talk about industry standards, we mean a set of connected requirements.
On the regulatory side, in the UK we work to UK MDR 2002 for medical devices (post-Brexit, instead of the old MDD 93/42/EEC). This sets the legal framework for placing devices on the market and keeping them there safely.
On the quality management side, ISO 13485 is the main standard for running a medical device business. It sets expectations for documentation, risk management, design, production and post-market surveillance. Used properly, it stops a company from relying on memory and habit, and forces them to define how things are done and improve them over time.
There are also technical and material standards. ISO 7153-1 covers materials for surgical instruments. BS 5194 sets dimensional and performance requirements for surgical instruments. ASTM A967 describes passivation and corrosion-resistance treatments for stainless steel. Together, these define what “good steel”, “good geometry” and “good surface finish” should look like.
Finally, there are sampling and inspection standards. Standards such as ISO 2859-1 guide how many pieces you inspect from each batch and when you should accept or reject that batch, based on defined AQLs. Instead of “check a few and hope for the best”, you get a structured plan for sample size and acceptance criteria.
Taken together, these regulations and standards define what good practice should look like: how you design, manufacture, inspect, clean and trace a reusable instrument. Used properly, they are a very good benchmark.
There are, however, two ways to treat those standards. One way is as a tick-box: something you do once a year to keep a certificate on the wall. The other way is as a toolbox: something you actually use to run and improve your business.
Some organisations do slip into the tick-box mindset. It is possible to have a certificate and still not take quality seriously. At Scala, we work hard to stay in the second camp.
As a co-director, General Manager and Quality Management Representative, I see a real benefit in standards like ISO 13485 and in using sampling principles from ISO 2859-1 properly because they give a clear framework when you are otherwise left to guess how to organise your processes. They force you to document, measure and improve instead of relying on memory and good intentions. They give you a way to learn from mistakes rather than hide them – especially when your sampling and inspection plans are based on real statistics, not “inspect a few and hope for the best”.
We are not perfect. We have made mistakes and we will make more. The point is that the system pushes us to learn from them, not repeat them.
On top of the formal requirements, we have what we call the Scala Standard.
This includes deeper inspection of instruments and baskets, often under magnification or with digital microscopes. A quick glance by eye is rarely enough. Microscopic contamination and early corrosion almost always start in places you do not see at arm’s length: joints, serrations, box locks and contact points where soil and biofilm like to hide. We design our inspection approach with that reality in mind.
We focus on CSSD and theatre use, not just factory conditions. Instruments live a hard life in real hospitals. We think about how they are handled, how they are loaded in baskets, how they are washed, and how that links to patient recovery and infection risk.
We also maintain close relationships with our manufacturing partners, many of whom are working by hand. A single instrument can pass through 70 to 120 pairs of hands from forging to final finish. Respecting that craft means putting proper quality checks at every stage, not just at the end.
When needed, we support custom development. Sometimes a surgeon needs a specific pattern that does not exist in a catalogue. We create drawings, refine them with the customer, develop the instrument and work through the inevitable tweaks. It might take months, but the aim is a tool that really does the job the surgeon has in mind.
Our goal is not to claim we are flawless. It is to say: we take the official standards seriously, and then we build our own expectations on top of them. We have been told more than once that our quality exceeds traditional German benchmarks. Whether you agree or not, that is the standard we are aiming for.
Most people working in theatre, decontamination or procurement are not going to memorise ISO numbers – and you should not have to. What you care about is whether the instruments are safe, reliable and fit for purpose; whether we are doing everything reasonably possible to reduce infection risk and rework; and whether your supplier will be honest with you, fix issues and keep improving.
Industry standards such as UK MDR 2002, ISO 13485, ISO 7153-1, BS 5194, ASTM A967 and sampling standards like ISO 2859-1 give a solid baseline. The Scala Standard is our promise to treat that baseline as a starting point, not the finish line – so the product can do the talking: better instruments, better baskets, better support, backed up by a system that keeps learning.
If you would like to go deeper into any part of this – whether it is sampling, decontamination practice, microscopes or instrument design – please get in touch or explore the other articles in our Information Hub.