When a lab has their accreditation suspended, it usually comes as a huge shock. But there are warning signs for poor assessment outcomes. You can determine whether there are issues that you should address before NATA comes.

These are some of the things I have observed in laboratories that go on to have a poor assessment outcome or have their accreditation suspended:

  • Senior technical staff have left and not been replaced.
  • Business has expanded and they’re getting lots of new contracts but haven’t had time to train the front-line staff.
  • They are receiving lots of phone calls from customers.
  • There are technical problems that everyone agrees need to be fixed, but for some reason they never do get sorted out.
  • Internal audits have not been done for many months: everyone is too busy to be audited.
  • New NATA requirements, but they haven’t had time to work out how they apply to them.
  • Their business has expanded, but they haven’t increased the resources for quality management and internal audit.
  • Their accreditation covers many different labs, some of which they have never seen nor met the staff members.
  • No one knows where to find a copy of the last NATA assessment/surveillance report.
  • The laboratory has been chronically short-staffed due to illness or other unavoidable factors.
  • Last but not least – if you have had the same NATA lead assessor for many years and now a new one is headed your way.

No one of these problems alone means that your accreditation is doomed, but if you are saying “yes” to a few of them, you need to slow right down and take stock.

How to protect your NATA accreditation

Some labs stumble into having their accreditation suspended without a clue that it is coming, while others may have a fair idea that things are rough around the edges and are just hoping for the best. But there are things you can do to protect your accreditation status.


If you think your laboratory may have a problem, take stock of your whole organisation (the accredited part anyway).  The Management Review clause in ISO17025, ISO15189, and most other “quality” standards is useful for this.  It covers all key aspects of a laboratory quality system. Add in financial indicators and you should have a full review of your operation.  Don’t make up things to put under each category but do try to include any relevant information that you can think of. And don’t forget to record what is going well.

Decide which items need to be actioned and develop plans for each one.  Don’t aim too high – you need a good enough system, not a perfect one. Start with the things that are clear technical problems, affecting the validity of your test results.

Implement the changes one at a time so that you can see how they work.  Involve all relevant stakeholders in the implementation process.

Measure the improvements and keep records.  Make sure you have data from the process both before and after the improvement.  This can help with staff unhappy with the change, management asking about the cost and of course accreditation bodies.

Adopt the changes if you are happy with the results and management approves. Update SOPs/procedures and train staff.

Use your internal audit program to make sure that the improvements “stick”.  Get the auditors to look at the new process in detail. Choose internal auditors who understand NATA’s requirements and will give you frank and fearless advice.

NATA suspension procedures

NATA’s criteria for deciding when a laboratory should be suspended are quite vague.  Based on the Accreditation Procedures and the Rules (mainly 40 and 41), NATA can suspend “an accredited facility” if it “at any time fails to comply with any condition for continuance of its accreditation”.  It sounds scary, but normally the non-conformances have to be quite serious and/or systematic before NATA will move to suspend an accreditation.

There are three main ways that your laboratory or site could have accreditation suspended:

Failing a NATA assessment

Failing a NATA assessment (or surveillance visit) is every lab manager’s nightmare.  Yet it can happen to labs that have always thought themselves to be completely “up-to-scratch” with nothing to worry about, as well as labs that know there are problems.  It’s always a shock when it happens.

You will (hopefully) realise during the assessment that things aren’t going too well, then receive a rather long assessment report. The NATA lead auditor will probably tell you that the accreditation might be suspended.

Advice from an external body

NATA can act on information received from a range of external agencies such as RCPA, RMS, Victorian Government and many more, and put in place a process that leads to your laboratory accreditation being suspended.

Choosing suspension of accreditation

When you know that your laboratory cannot meet the accreditation criteria, and you are able to do without accreditation for a while, you can choose to have the accreditation suspended.  Make sure you get a written agreement from NATA first as to what steps you will need to take to regain accreditation.

Avoid suspension at all costs

If NATA forms the view that a laboratory’s accreditation should be suspended, they will send a notice to “show cause” why it should not be.  At this stage the horse has probably bolted.  Very few appeals to the suspension process succeed.

From experience with several laboratories, once you are subject to an involuntary suspension, correspondence with NATA can become quite bewildering and difficult to interpret.  It can seem impossible to come up with a corrective action that will satisfy them. Certainly, there is no fast way back.

Clearly the best avenue is to avoid getting into this situation in the first place. If you are keen to keep your systems on-track with auditors who think outside the square, contact O’Dwyer Accreditation, where practical experience with NATA accreditation is our game.