How to Achieve NATA Accreditation

What is NATA accreditation (and why do people care)?

NATA accreditation is independent confirmation that your organisation is competent to perform specific activities (within a defined scope) and that your system supports reliable, defensible outputs. And yes, sometimes it’s commercially essential: certain customers, industries, and regulators may require accredited results for specific work.

People care because it changes what your results mean to the outside world:

• ISO/IEC 17025: Validity and reliability of test/calibration results.
• ISO/IEC 17020: Independence, impartiality, consistent inspection decisions.
• ISO 15189: Quality and competence for medical laboratories within the Australian pathology context.

If your customers, regulators, or stakeholders need confidence, NATA accreditation is one of the clearest ways to demonstrate it.

First things first, understand your “why”

Before you contact NATA, be clear on why you want accreditation. Is it because certain customers are asking you about your organisation’s accreditation status? Is it because the regulatory environment has changed and now NATA accreditation is a “must have”? Is it because you want to showcase how good you believe your organisation to be? Is it because you like challenges and want to improve the way things are done in your organisation?

Knowing the answer to the question of “why” helps you to work out the tests/ methods/ materials that must be covered by the scope of accreditation. If it’s customers and regulators driving the decision, what tests are they asking for? That might take a bit of research, especially when it comes to meeting regulators’ demands. So spend some time looking at regulations, codes of practice and Standards.

MAS Tip: You don’t have to be accredited for EVERYTHING you do. It can be time-consuming and expensive to go down that pathway.

Once you know more about the methods and materials to be covered by your NATA accreditation, then you can delve into the maze of documents on the NATA website for the various sectors that have been designated by NATA. NATA’s sector names can be confusing. For example, environmental testing sits under the Life Sciences sector.

Now you’re ready to launch!

The official “big picture” steps

NATA describes the accreditation process as typically taking up to six months (depending on your readiness), and outlines these stages:

• Readiness and eligibility
• Advisory visit
• Application and document review
• Initial assessment
• Addressing findings (submission process)
• Granting of accreditation

Let’s unpack what those steps mean in real life.

Step 1: Readiness and eligibility (your foundations)

This stage is where the smoothest projects are won or lost. These foundations must be solid with four key outcomes

1. Define your scope

   Be specific about what you want accredited: which tests/calibrations/sampling activities, which methods, which sites, which matrices, which ranges. Scope drives everything: competence needs, equipment, validation, uncertainty, QC, PT/ILC, staff authorisations, reporting.

2. Understand the criteria you must meet

   NATA expects you to meet the relevant Standard (e.g. ISO/IEC 17025) plus applicable NATA requirements and criteria. This is a good time to contact NATA for a discussion of the work you do and intend to have covered by accreditation. They will be able to assist in pointing you in the direction of the relevant criteria and they will provide you with a cost estimate.

   MAS tip: save your sanity and don’t try to read every document ever written. Start with the criteria that apply to your industry program and scope.

3.  Build your systems and the evidence of implementation

   If you already have some documents or records, that’s a great start! Now would be a good time to do a gap analysis to find out what other things need to be done to meet the criteria. We can help with that task and build an action plan with you for the next steps.

   Remember, you’re not only writing procedures. And Assessors don’t accredit documents; they accredit controlled operations and processes. As well as having some documented policies and procedures, you must also be able to show records that prove:

   • staff competency and authorisations
   • method validation/verification and ongoing QC
   • equipment calibration/maintenance and traceability
   • handling of items/samples
   • participation in proficiency testing or interlab comparisons, in accordance with your schedule
   • reporting controls and review
   • document and record control
   • nonconformity and corrective action
   • internal audits are being completed, as scheduled and drive improvement. Don’t be afraid if the audits find real issues – it’s the perfect time to test out the non-conformity and corrective actions systems
   • management review that covers all of the listed topics, drive improvement and deal with risks

   Understanding whether your processes, people and procedures are up to scratch is important and helps to put you in the best light before getting to the formal accreditation process. That’s where a gap analysis is essential!

   For each of the accreditation standards, the technical aspects listed below are often the areas that organisations often fall short.

   • 17025: staff competence, including qualifications, method validation/verification, traceability, equipment control, QC/PT/ILC participation as applicable, reporting controls, and (where required) uncertainty and decision rules.
   • 17020: independence/impartiality controls, conflict-of-interest management, consistent inspection criteria, and inspector competence and monitoring.
   • 15189: end-to-end control across pre-analytical, analytical and post-analytical phases, result review, and appropriate alignment with Australian pathology requirements where applicable.

   MAS tip: If your system “exists” only in one person’s head (or only in a Quality Manual nobody opens), you will feel pain later. Build a system your team can run on a busy Tuesday. These tips on writing documents will help.

4. Confirm your records match your procedure

   If your procedures say one thing and your job files show another, you are not ready. Think about what the criteria for records are in the relevant standard and NATA requirements, and those of any standard methods (if you’re using these). Adjust any procedures or practices to match those requirements.

Step 2: Advisory visit (a reality check that saves time)

To start, submit an enquiry via NATA, then provide the key system documents they request (typically your management system overview or manual and supporting procedures/records), along with the completed Accreditation Information Document.

Think of an advisory visit as feedback before the high-stakes assessment.

How to get value from it:

• Prepare your “this is how we operate” walkthrough (not a document parade)
• Bring your key records and real job files: recent QC, calibrations and equipment checks, testing/ calibration records, training/competency evidence, internal audit outcomes, management review outputs
• Prepare a short list of questions you genuinely need answered, like scope wording, witnessing expectations, evidence depth
• Be ready to hear gaps without taking it personally (gaps are normal at this stage)

After the Advisory Visit, NATA will send a letter of any issues to be rectified before the next stage of formally applying for accreditation. They will want to see evidence that these issues have been addressed. The timeframe for response is completely up to you.

Timeframes are usually agreed with you, however, momentum matters.

Once NATA is satisfied that the issues have been resolved, then you’ll receive an Application form.

MAS tip: Advisory visits are most useful when you treat them like a learning exercise, not a pass/fail test. You may also receive some advice about how to do things from your NATA Lead Assessor. It’s not mandatory to follow this advice. Remember that NATA cannot consult. That’s why you engage a professional consultant, like MAS Management Systems!

Step 3: Application and document review (make it easy to assess you)

Once you’re ready, you’ll apply and NATA will review documentation as part of the pathway. That means they will want to see more than just your quality manual. Copies of any supporting procedures, measurement uncertainty budgets and proficiency testing/ interlab comparison records should also be submitted to NATA.

Your goal here is to submit a clear, consistent “story” of your lab that matches your scope and shows control.

What often causes delays here is not lack of effort, but mismatch:

• scope says one thing, procedures describe another
• forms reference outdated templates
• records show the process isn’t being followed
• validation/QC doesn’t cover the full scope you requested

MAS tip: A simple internal “application pack review” before you submit can save weeks.

Step 4: Initial assessment (the main event)

NATA’s next step is the initial assessment. But before you get there, there are decisions on acceptability of technical assessors and the date of the assessment. The Technical Assessors are peers from your industry and people from competitors could be nominated by the NATA Lead Assessor. You don’t have to accept everyone nominated. You can raise concerns about proposed technical assessors and request alternatives if there’s a valid conflict or issue.

The initial assessment is where the assessors look for two things:

1. Do you meet the requirements? (both system and technical)
2. Can you demonstrate it with evidence? (records, decisions, controls, competence)

The Technical Assessors commonly focus on technical elements such as method validity, staff competence, traceability, equipment control, sample or item handling, QC, and reporting. The Lead Assessor orchestrates the team (just like a conductor) and also looks at things like document control, records management, how work is accepted, non-conformances and corrective action, risk management, internal audits and management review.

Expect assessors to:

• test the system (control, implementation, decision-making)
• test the technical work (validity, competence, consistency)
• follow evidence trails from scope → method/criteria → job file → result/report
• observe/witness work

Common issues that can arise at the initial assessment are:

• scope does not map cleanly to methods/criteria and job flow
• competence and authorisations do not obviously map to scope (who is authorised for what, and why)
• templates and calculations are not adequately controlled (make sure there is no spreadsheet free-for-all)
• records demonstrate implementation (not “planned” implementation)

At the end of the initial assessment, NATA will leave you with a detailed interim report that includes details of any deficiencies (conditions for accreditation). This will be followed up within a couple of weeks by a confirmed assessment report.

MAS tip: The strongest assessment prep is not “tidying documents.” It’s making sure your team can confidently explain how work is done, why it’s done that way, and where the evidence lives. A pre-NATA audit by an external consultant can help to prepare everyone for the next step and ensure things are where they should be for the big day.

Step 5: Addressing findings (submissions that actually close out)

After the assessment, you’ll respond to findings through the submission process.

This is where many labs accidentally slow themselves down: they jump straight to “fixing the thing” without showing they understand the cause, the risk, and how they will prevent recurrence.

NATA has specifically highlighted that cause analysis and corrective action are critical to conformance and maintaining confidence in outputs, and that labs often struggle with things like pinpointing causes, resourcing, data gaps, and verifying effectiveness. Read our article which gives tips this common barrier to success with NATA submissions.

A practical corrective action structure that works:

• What happened? (clear, factual description)
• What is the cause? (not just the symptom)
• What is the risk/impact? (on validity, customer outcomes, compliance)
• What did we do immediately? (containment/correction)
• What changed to prevent recurrence? (system improvement to address the root cause)
• How will we verify effectiveness? (checks, audits, QC trends, review)

If your response can’t answer “how do you know this won’t happen again?”, it’s not finished.

MAS tip: “We retrained staff” is rarely a complete corrective action on its own. It might be part of the solution, but assessors will look for system control and deeper root cause investigations. If you want help at this stage, we can assist. We also have a half-day training course on Root Cause Analysis so you and your staff can sharpen these skills.

Step 6: Granting of accreditation (and what changes after that)

Once findings are addressed, NATA moves to granting of accreditation. That can be a slow process as you wait nervously for the good news. It often takes 4 weeks (or more) to get the happy news that you “passed” and accreditation has been granted. Cue the champagne!

After approval, you can apply the NATA endorsement correctly to accredited reports and communications.

At that point, you transition from a project mindset (“get accredited”) to an operational mindset (“stay accredited, improve, and grow”).

What changes:

• Your accredited scope becomes your boundary and your protection. Assessments focus on the scope, so keep it accurate and don’t imply work is accredited when it isn’t.
• Changes to documents/methods/equipment/software/staff authorisations need structured control.
• Internal audit and management review become your early warning system, not a yearly ritual.

Common pitfalls (and how to dodge them)

• Scope creep: trying to accredit “everything we might do one day”

Start with the scope your customers actually need and you can competently support.

• Documents without implementation

Assessors look for records and consistent practice, not only beautifully formatted procedures. Ensure the records are up to scratch and practice aligns with procedures.

• Corrective actions that don’t close the loop

Show the root cause, and evidence of system changes and effectiveness checks in your response to the NATA communications post-assessment.

• Underestimating the time factor
  NATA notes the pathway may take up to six months depending on readiness. But if you put the timeframes stated in NATA’s Accreditation Service Commitment together (and allow for a couple of rounds of assessment follow-up, as is typically the case), you’ll find it adds up to 9 months. In fact, it’s not unusual for new accreditations to take 9-12 months to reach completion.

Explain to NATA (in writing) of any urgency in gaining accreditation. Plan backwards from customer/regulatory deadlines with these extended timeframes and let them know where your organisation is in the accreditation process.

Costs and maintaining accreditation (what people forget to plan for)

If you only budget for the assessment visit, you’re budgeting incorrectly.

There is an application fee, and all activities up to granting accreditation are charged on a fee-for-service basis (including the advisory visit, document review, initial assessment and post-assessment follow-up). Pro rata annual fees apply from the date accreditation is granted.

Accredited facilities (NATA Members) are charged annual fees, calculated based on the scope of accreditation. Routine scheduled assessments are covered by those annual fees. The timing and nature of these assessments depend on which standard your organisation is accredited to. Non-routine or unscheduled activities, such as changes to the scope of accreditation, are typically charged on a fee-for-service basis.

MAS tip: Budget for more than the assessment visit. Budget for staff time, technical work (validation, uncertainty, QC), equipment calibrations and certified reference materials, internal audits, and the “submission energy” after the assessment.

Whilst you might give yourself and your team a chance to celebrate your achievement, now is not the time to take the foot off the pedal. Those systems you have need to be tended like a garden, nurturing those green, healthy shoots and weeding out the unwanted or unsuitable “pests”.

Experiencing success at future assessments takes some planning. Our tips for reaching this state of utopia are covered in this article.

How MAS can help (without turning your lab into a paperwork museum)

If you’d like support, MAS can help you:

• define a scope that matches customer needs and reduces rework
• run a practical gap analysis against the relevant criteria
• build simple, usable systems your team will actually follow
• prepare for advisory visits and assessments with confidence
• advocate for your organisation and interpret the NATA babble during advisory visits, assessments and post-assessment.
• respond to findings with strong cause analysis and corrective action
• set up an ongoing “maintenance rhythm” so accreditation becomes part of business-as-usual

If you’ve been thinking, “We’re close, but we’re stuck,” reach out. A short conversation often saves weeks of circular work later.