Cover all your bases with NATA and educate your staff with a gap analysis.
When you designed your quality management system, you were careful to make sure it met NATA’s requirements from the start. Yet every time NATA visits, they question whether the system is watertight and suggest more changes. So you find yourself adding extra steps to your supplier assessment, more columns in the equipment register, and new procedures for activities you’ve never actually done. All so you have something to put in your response.
The truth is, no matter how hard you work on those responses, you can still end up with unnecessary NATA non-conformances simply because it isn’t clear where or how your quality system addresses certain elements of the standard. This can happen when new staff join the quality or management team, when the system was built with outside help, or when you and your team have looked at the documents so many times that you can no longer see the wood for the trees.
The result is a hotchpotch of overlapping documents that wastes the time and money you’ve already invested. But there is a better way…and that is to start with a gap analysis.
What is a gap analysis?
A gap analysis is a document that shows how your organisation meets its accreditation requirements. It is a clear statement of where your systems are right now, not where you want to be in the future, and not where you think NATA wants you to be.
It describes how you actually do things, sometimes with a link to a policy, procedure, or form (but not always). It also honestly identifies any areas of the standard that your system may not yet address. Developing a gap analysis often involves spending time in the lab observing how things work in practice, not just reviewing what’s written down.
Importantly, you do not need a document for every clause in the lab accreditation standards. ISO 17025 and ISO 15189 are process-based standards, and many clauses simply don’t require a written procedure. As I’ve been saying for years, it’s more important to do quality than to write about it.
When do you need one?
A gap analysis is useful across the full accreditation lifecycle.
When onboarding a new quality or lab manager.
A gap analysis gives them an immediate, accurate picture of how the system works…without having to reverse-engineer it from a pile of documents.
When writing or restructuring your quality manual.
Labs that align their quality manual to the numbering in ISO 17025 or ISO 15189 find it increasingly difficult to write content that makes sense in their own context.
Instead, structure your manual and procedures around your actual business processes, using headings that make sense to your team. A gap analysis then acts as the bridge, showing NATA how that structure maps to the standard…without you having to rewrite everything to match clause numbers.Before the assessment.
Use the gap analysis to educate and prepare your staff, focusing on the sections most relevant to their roles.
During the assessment.
When NATA says, ‘You haven’t covered X in your system’, you have a document that explains exactly how your current processes do address that requirement, rather than scrambling to write something new on the spot. This is especially valuable when multiple team members are speaking with assessors simultaneously and may not all know where a particular requirement is covered.
After the assessment.
Before reacting to every item in the assessment report, check the system-related non-conformances against your gap analysis. You may find that your system already addresses their concerns, and the response simply needs to point NATA to the right place.
How to do a gap analysis
Widen the field of input
One of the most common mistakes quality practitioners make is assuming they already know everything about how their system addresses the standard. That’s why a good gap analysis should bring in perspectives from outside the quality circle.
Create an effective way to record your results
Most people use a table based on the standard you need to meet. It will be long…but resist the temptation to abbreviate the clause text too much, as your shorthand may miss a nuance that someone else has caught. Add columns for: how we meet this requirement, document reference (where applicable), gaps identified, notes and actions.
Don’t do it alone
Bring together your senior scientists, quality team, medical director, and whoever has relevant insight into how your organisation operates in real life. Ask everyone to brainstorm beforehand, jotting down what comes to mind without looking up specific documents so they come to the first session with their ideas ready.
Run the gap analysis more than once
across a series of sessions, working through different sections of the standard each time. Capture all the different ways your organisation meets each requirement and record document references where they exist. Plan for at least three sessions; with a large or engaged team, it may take more.
The payoff
The time you invest in a gap analysis will pay dividends before, during and after every NATA assessment. Your team will feel genuinely prepared — and even confident — talking about how your organisation meets the requirements. You’ll be able to show NATA that you’ve done your homework, and you’ll come away with a much clearer picture of what your lab already does well, where there’s room to improve, and how to get there.
If you’d like help pulling your gap analysis together, get in touch. There’s nothing we enjoy more than helping labs run their systems better.