Behind the Scenes of NATA Accreditation

Following one lab from its first enquiry to receiving accreditation

 

Imagine this…

It’s Monday morning.

Sarah, the Quality Manager of a medium-sized environmental laboratory, has just finished another management meeting.

Their biggest client has made it clear:

“We’ll need NATA accreditation before we can award the next contract.”

Everyone around the table nods. Then someone asks the question nobody can answer.

“So…what actually happens now?”

That simple question marks the beginning of a journey that thousands of Australian labs have taken.

Let’s follow Sarah’s laboratory through the accreditation process.

 

“We’re going for accreditation.”

The excitement lasts about ten minutes. Then reality arrives.

Questions begin flying around.

Do we have enough procedures?

What procedures do we need?

Is our equipment suitable?

Do we need a LIMS?

Have we trained everyone?

How much documentation is enough?

How long will this take?

The lab quickly realises that accreditation isn’t just about creating a quality manual. It’s about demonstrating competence.

 

If this were a pathology laboratory…

ISO 15189 places much greater emphasis on patient care, pre-examination and post-examination processes, clinical communication, and the competence of medical personnel.

 

The first conversation with NATA

Sarah contacts NATA. She’s expecting an application form. Instead, she receives a pile of guidance documents and a daunting form to complete.

Questions are asked about:

• the scope
• methods
• locations
• staffing
• standards

The application isn’t the beginning. Getting information to NATA in the format that they expect is. A lot of preparation is where the action really starts. And sometimes lots of questions on how to fill in the form.  We’ve written previously on this.

 

Calibration laboratories

Much of this stage focuses on calibration capabilities, measurement uncertainty, and traceability.

 

Building evidence

Over the next several months, nothing dramatic happens, which is exactly the point.

The laboratory starts generating documents and evidence.

• Internal audits.
• Management reviews.
• Competency assessments.
• Equipment records.
• Quality control.
• Proficiency testing.

Day after day of grinding towards getting the building blocks in place.

Why is this necessary? Because assessors won’t simply ask whether the laboratory has a procedure. They’ll ask whether it works.

 

The application

Finally…

Sarah presses Submit.

Everyone celebrates. Sarah doesn’t – she knows the real work hasn’t started yet.

Unbeknownst to Sarah and the team, this isn’t the formal application. It’s just the pre-application documentation.

 

Somewhere inside NATA…

This is the part laboratories never see.

A customer service person reviews the application. The proposed scope is examined. The relevant sector is identified. The package is forwarded to a Lead Assessor with suitable expertise for further examination.

Then the Lead Assessor contacts Sarah to arrange for an Advisory Visit in about 4 weeks’ time.

 

Stage 1- The Advisory Visit

The Advisory Visit is undertaken by the Lead Assessor. Their task is to confirm that Sarah has a functioning lab and is up to the task of successfully undergoing an assessment.

 

The Lead Assessor is not a technical assessor and has limited knowledge of the testing done by the lab. They will take a tour of the lab but can’t answer all those tricky technical questions Sarah and her team have. They have read through the submitted document package and ask to see things like equipment calibration and verification records, staff records, and test or calibration records to ensure that these are available and complete. They also delve a little into the quality management system records.

Once the visit is done, Sarah receives a report on the outcome. This gives the team some information on what else needs to do be done before any assessment is organised.

The letter says that Sarah will need to respond to this correspondence before she can formally apply for accreditation.

Sarah and her team diligently try to make sense of the requests for action in the letter- it seems to be written in a language other than English. Then they respond.

 

Back at the NATA Ranch….

The Lead Assessor receives the response and puts it in the pile of other correspondence to be dealt with. After a couple of weeks, it rises to the top of the pile.

The Lead Assessor reviews the response and can’t see how the lab has dealt with the issues raised in the letter. There are pieces of evidence missing. So, they write another letter with further requests in the language known as “NATA speak”.

Sarah receives this letter and feels very demoralised. The team really thought they nailed everything. The cycle repeats. Fortunately, Sarah realises that they don’t understand the language and calls the Lead Assessor for some interpretation.

This time, the application can progress to a formal application, and then an assessment is organised.

 

The Assessment Stage

A Lead Assessor is appointed. This is a different person to the Lead Assessor that Sarah dealt with for the Advisory Visit. It’s because the previous Lead Assessor has been moved into a new role. The new Lead Assessor emails Sarah to introduce themselves.

The Lead Assessor selects Technical Assessors who understand Sarah’s testing. Two of the assessors work at a competitor lab and Sarah is uncomfortable with allowing them into the lab. She tells the Lead Assessor.

Finally, assessment dates begin taking shape. In a couple of months’ time. The client is starting to get anxious because it’s already been a few months and the lab isn’t accredited. Sarah contacts the Lead Assessor to explain the urgency of the application.

Apparently nothing can be done to push things forward. Months of planning occur before anyone walks through the laboratory door.

 

Assessment Day

8:15 am.

The assessors arrive. They’re early!!!

Everyone is nervous.

The opening meeting begins. But the assessment actually started several minutes earlier.

The assessors noticed:

• Is the laboratory organised?
• Who greeted them?
• Were staff expecting them?
• Does management appear engaged?
• What information is posted on the wall of the lab?

Experienced assessors begin building an overall picture almost immediately.

 

Watching the work

A technical assessor stands beside an analyst performing a test.

They’re not hoping something goes wrong. They’re asking themselves:

• Does this person understand why they’re doing this?

They ask the analyst

• What would they do if QC failed?
• How do they know this balance is suitable?
• Where is the uncertainty considered?

The assessment isn’t about catching mistakes. It’s about understanding competence.

 

Inspection bodies

For ISO/IEC 17020, assessors spend much more time evaluating professional judgement, decision-making, impartiality and the consistency of inspection outcomes than they do reviewing laboratory-style testing activities.

Lunch

The assessors disappear.

Staff assume they’re eating the sandwiches. Actually…they’re comparing notes.

• “Did you notice…”
• “I’m thinking that might become a finding…”
• “What evidence have you seen?”

Assessment findings rarely belong to one assessor. They’re usually discussed by the whole team.

Once they’re done, then everyone can join them for the sandwiches and hopefully some light conversation.

 

The assessment continues

Sarah and the Lead Assessor are bunkered down delving into the quality management system.

Records of staff training and competency, internal audits, management review, corrective actions, document control and equipment calibrations and checks are sifted through and discussed. There are a couple of things to tidy up after the assessment.

The Technical Assessor continues discussion with the analysts, reviewing methods and reports and some calibration records.

 

Another assessor conclave

Once the Lead and Technical Assessors have completed their interrogations interviews, they adjourn to write up the assessment report. Here they again compare notes and decide if the findings are conditions for accreditation and against which clauses these conditions might appear. The Lead Assessor types the assessment report.

The Lead Assessor comes to see Sarah with a few more questions

Sarah and her team wait nervously for what seems to be hours until the “white smoke” appears in the form of the Lead Assessor announcing they’re ready for the closing meeting.

 

The closing meeting

Sarah braces herself.

The Lead Assessor begins.

“We’d like to thank everyone for the assistance given to the team today…..”

The assessment findings follow. Some are expected. Some aren’t. They are all negative findings.

Sarah and her team feel like they have nothing positive coming out of the assessment because the report only gives the negatives. Besides, nobody enjoys receiving nonconformances. But Sarah remembers something she’d been told months earlier.

Findings don’t mean you’ve failed.

They mean you’ve identified where evidence wasn’t sufficient.

 

The quiet part

The assessors leave. Most people think it’s over.

In reality, another important phase begins.

The laboratory investigates root causes. Corrective actions are implemented. Evidence is submitted.

Assessors review responses. Questions may come back. Again, it’s in that “NATA speak” language. But Sarah knows how to handle that now.

Eventually…

A recommendation is made to grant accreditation. And off it goes to what seems like a black hole. In that place are the sector managers and the Accreditation Advisory Committee. They sometimes have questions that you’ll need to answer, just when you thought EVERYTHING had been covered in the assessment and post-assessment phase!

 

Accreditation

Several months after that first meeting…Sarah opens an email. It’s been a month since she heard anything, and everything seems to have gone into a black hole.

Accreditation has been granted. The laboratory celebrates.

Then someone asks…”When’s the next assessment?”

Everyone laughs. Sarah knows the answer. She is now an experienced leader.

The journey isn’t over. It has simply entered its next chapter.

 

Accreditation Isn’t a Destination

The laboratories that benefit most from accreditation don’t see it as a project. They see it as the way they operate every day.

The assessment simply confirms what they’ve already built. And perhaps that’s the biggest surprise of all.

Accreditation isn’t about impressing assessors. It’s about giving customers, regulators and your own staff confidence that your laboratory consistently delivers reliable results.

And if you want to know how to be in top condition for future assessments, then read our tips here.

FAQs

How long does NATA accreditation usually take?

It depends on the laboratory’s readiness, the complexity of the scope being sought, and scheduling of the assessment. Laboratories with well-implemented management systems generally progress more smoothly than those still developing documentation or evidence of implementation. It can take anywhere from a few months to a couple of years.

What happens during a NATA assessment?

Assessors review both the laboratory’s management system and its technical competence by examining records, observing activities, interviewing personnel and verifying that accreditation requirements are being consistently implemented.

What happens if nonconformances are raised?

Most assessments identify at least some nonconformances. The laboratory is expected to investigate the root cause, implement corrective actions and provide objective evidence before accreditation can be recommended.

Does accreditation end after approval?

No. Accredited laboratories undergo ongoing surveillance and periodic reassessment to demonstrate continued compliance and technical competence.