What most labs do wrong
When I review labs, the most common problem I notice isn’t the equipment or the processes; it’s usually the quality manual and procedures. They’re often full of jargon, copied standards or outdated references that no one reads or uses. You need to search for the content you’re looking for, because the headings don’t make sense in the context of the lab.
How long does it take to find the section you’re looking for?
It feels like it was written to tick boxes for NATA (or another certifying body), not to help the people working in the lab. And that means that there’s a clear disconnect between what’s on paper and what actually happens.
Why poor quality manuals exist
A manual full of NATA-speak
Believe me, I understand how this happens. When you have an accreditation or certification visit, the assessors find things wrong with your quality manual, and you have to fix them to pass the assessment. Often, the easiest way to do this is to add a new section to the quality manual and send it to NATA. You add more and more pages, even though literally NOBODY (except external assessors) ever reads the manual again afterwards.
Generic statements
Most often, you end up with these generic statements when you get a consultant to write your “quality system” for you. They have standard documents they use, which they base very closely on the relevant clauses from the standard. They replace “the laboratory shall” with the name of your organisation. Of course, they don’t (usually) quote ALL the words from the standard, but often it reads like that!
There’s no point giving a manual like this to a new staff member – they won’t learn anything from it. Even the section headings make no sense to your staff.
Focus on your audience
If you want a quality manual to ONLY explain to NATA (or your certifying body) how you meet their requirements, that’s your call.
But why not make your quality manual a multi-purpose document that helps a range of different people?
A great quality manual can help you pass your NATA accreditation assessment. But it can also be used to orient new staff (or those moving into different roles). They can use it to get an overview of which tests are performed, who the clients are, which methods and equipment are used, and even how samples are received and labelled.
This means they start to see how accreditation standards support the work they do, rather than being a separate, intimidating compliance exercise.
You can also use a quality manual to show your clients how you work and how you meet quality standards.
Thinking about how you might make better use of this document and who might benefit from reading it HAS to be a better outcome than creating a very expensive doorstop.
Creating high-quality manuals
My consulting career started by helping small labs remove the ‘NATA told us we had to’ content from their documents and replacing it with content that described what they actually did.
I was able to show them how their current processes met the accreditation requirements, whether that was ISO 17025, ISO 15189, or ISO 9001. Pretty soon, they had quality manuals that were meaningful for both staff and assessors.
Translating requirements into real language
A big part of what we do now is help labs bridge the gap between ‘accreditation-speak’ and their laboratory processes. And I love it. Because honestly, auditing to ISO 17025 and ISO 15189 requirements is easy. Explaining why it matters and showing how your team already does it? That’s where the real value lies. Staff ownership grows when people understand the intent behind the requirement, not just the words on a page.
When staff understand why things are done, compliance becomes less an intimidating external thing and something more integrated into their daily work. Over the years, I’ve watched confidence grow, errors drop, and entire teams start taking greater ownership. The manual stops being a chore and starts being a source of clarity for everyone involved.
It also becomes much simpler to keep up to date if you write in active language and explain what you do, instead of relying on long quotes from the standards.
Here are some more ways to make your documents relevant.
Case studies: turning quality manuals into usable tools
Bob’s lab is a perfect example. They’d been sold an off-the-shelf Quality Management System for ISO 9001 and another for ISO 45001, and were overwhelmed by hundreds of documents that needed updating for each NATA assessment. Their documents didn’t even really reflect their core business – collecting samples and testing them.
They considered hiring a full-time quality manager to keep up. Together, we identified which documents they truly needed, translated and streamlined them, creating a system the lab manager could easily maintain. For a one-off fee, they saved themselves from hiring extra staff and went through a fault-free NATA assessment.
Perfect Pathology had a 40-page quality manual for a team of just two, filled with every requirement NATA had ever raised during reassessments. The lab manager struggled to update it, often asking, ‘Why is this section here? NATA told us to include it years ago, but it doesn’t really apply to us, and we’re not sure if we can delete it.’
We worked with them to highlight information genuinely useful for staff orientation (tests, methods, equipment, sample handling) and were able to withdraw some procedure documents entirely. The manual suddenly became a tool people could actually use.
Get in touch
If you suspect your quality manual isn’t doing your team any favours, we can help. Just imagine how you’ll feel knowing you’ve turned that dreaded door stop into a tool that supports your work!