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Designed to benefit: Risks & Opportunities in ISO 17025

A good system recognises the strategic benefit of minimising risk and maximising opportunity.

The new ISO/EIC 17025: 2017 standard puts extra emphasis on this by promoting risk-based thinking, preventive action and process design. It is about optimising your organisation’s overall strategy by planning, taking, and recording actions that prevent risk and enhance opportunity.

There is no need for a formal risk assessment process (although these can be very useful and even fun to do). The implication is that your system will alert you to risks and opportunities because it will be based on a proactive, risk-based approach embedded into your operations.

It’s a balancing act

Risk and opportunity is not an either or thing  – you are weighing both all of the time as one usually corresponds with the other. If I avoid x I will attain y. If I attain y I will avoid x. Likewise, assessing risk in the context of a laboratory must be viewed with the organisation’s overall strategy in mind.

The concept in the new requirement (clause 8.5.1) about action on risks and opportunity comes from ISO 9001:2016, which has a strong customer focus. ISO 17025 and ISO 15189 are standards written by laboratory people experienced in what can go wrong. They are designed to ensure that testing-related risks are managed, including business risks such as reputational damage. By complying with these international standards and having accreditation, you are addressing all the areas of risk (and opportunity) for a testing service.

To give you an idea of some relevant risks and opportunities, below is an example of factors that would need to be assessed by senior management if you received a request to do on-site testing for the first time. As you will see, many of these are interrelated and require consideration of the bigger picture.

These are just some of the risks and opportunities that might typically be identified before embarking on a new area of testing. Once these have been identified, measures will be put in place to manage, revisit and continue to identify risks and opportunities going forward.

It is likely that your laboratory is already employing actions stipulated by the new standard. But how do you demonstrate to NATA that you have addressed the new requirement (clause 8.5.1) for action to be taken on risks and opportunities, and if your system needs updating to meet the requirement, how extensive an overhaul does it need and what are some approaches to take? Below, we’ve outlined three ways that we’ve seen laboratories address the “new” requirement in ISO 17025 and (not-so-new) in ISO 15189:

1. Explain how you already control risks

Include a section in the quality manual outlining the measures already in place to manage known risks and to identify new or unidentified risks. Bear in mind that any risks and opportunities identified through these processes must have corresponding records to show what decisions were made about actions to address these.

A laboratory within a larger organisation may find this is enough, as bigger picture risks will be handled by the company.

2. SWOT analysis

Many of our clients run their own SMEs and a SWOT analysis every couple of years and find them to be useful tools that ensure they have taken some time to think outside the square about risks and opportunities. They may then decide to put some of them on the agenda of their management review meetings. This way they do get followed up periodically, and perhaps incorporated into plans for business growth. The important thing to bear in mind with a SWOT analysis is that it is a creative task that works best when you do it quickly, preferably under some time pressure.

The SWOT analysis ties into the ISO 9001 theme of identifying external (as well as internal) factors when considering the context of the organisation. Other useful tools include PEST and PESTLE, which provide more prompts for where the opportunities or risks may lie.

3. Formal risk assessment

Some (usually larger) organisations who are introducing new tests all the time find doing a risk assessment for each new technique or test introduced is a reliable way to ensure they don’t head down a path that is only going to waste time and money. These risk assessments need to cover all conceivable risks, not just safety. If you have to produce a business case for the new tests, much of the information will overlap. Although this may sound like a huge task, once you’ve done one, the others will be much quicker, and if you are using established systems, many of the risks will already be controlled.

How to make sure you’ve got everything covered? Use the headings from the laboratory accreditation standard of course!

Take-home message

The key to all of this is to have records of what action you have decided to take on any risks and opportunities identified, and ultimately how well you did in controlling that risk. Does this sound a bit like a corrective action report (or your equivalent)? Do you have a form where you record staff suggestions too?

We know some labs that use these types of reports to cover off on any actions arising out of management reviews – that way they don’t have multiple systems to keep track of things and their NCA, CAR, OPPI, FROG, FART or MAD system gets a good work-out.

Review how you are currently running your business in terms of managing risks and opportunities and you might find you don’t need to implement anything new, or you might just need to tweak a current process here or there.

Reporting Compliance in ISO 17025

Do you report results as pass or fail on test reports? As normal, high or low? Within spec, outside spec, complying or not complying? Would your clients like you to report with a statement of conformity? Then you need to know about decision rules in the new ISO 17025.

While you have utmost confidence in your laboratory’s test results, no test result is exact: there is always a band of uncertainty around it.  If the result is close to the limit do you really know if it passes or fails when you consider the band of uncertainty? Is this a decision or risk you are willing to take?

Uncertainty of Acceptance

The drawing shows

  • The tolerance limits: allowable results, normal range, standard specification, etc. Any result within this range is acceptable to the customer.
  • Four possible laboratory results  obtained, with the 95% confidence intervals shown.


We need a way of deciding if we will report the results as pass, fail, or even indeterminate.

The old approach

Using a standard decision rule that the results will be reported as pass or fail based on the numerical result, with 95% certainty:

A can be reported as a pass with a 95% confidence interval.

B can be reported as a fail, or above spec with a 95% confidence interval.

C can be reported as a pass, with a 95% confidence interval.

D can be reported as a fail, or below spec with a 95% confidence interval.

The new approach

The revised ISO/IEC 17025 uses the term “decision rule”and emphasises the need to communicate clearly with your clients about the strengths and limitations of the testing (clause 7.1.3) and to formally document decision rules (clause  7.8.6).

It might be more relevant to explain to your clients that:

A is a pass with a 95 or even 99% confidence interval.

B there is only 60% certainty that B is a fail, 20% of products that get this result could pass.

C There is a 2.5% chance that C is a fail.

D can be reported as a fail, or below spec with a 95 or 99% confidence interval.

Then you can discuss setting “grey zones” where results may be reported with additional comments to highlight that they fall close to the cut-off.

How you handle this depends on a range of factors, including the industry your clients are in, the uncertainty inherent in your method, the regulatory environment, the cost of false passes or fails to you and your clients and perceptions of risk.

Do we need a decision rule?

Before you get into the details, there is an easy and safe way out:  Don’t report pass or fail and let the client make the decision. You could report the tolerance and specification alongside the results to help the client make the decision, and reduce your risk in taking that final decision.


Developing a decision rule

Go to your client/s armed with some facts and thoughts on the following:

  • How big is the band of uncertainty? (i.e. what is the uncertainty of measurement). How does this compare to the tolerance?  Is that overlap in the band of uncertainty and tolerance likely to occur regularly?
  • Is it more important for the property to not exceed the limit or to fall below it? Or does it really need to hit the mark?
  • When you talk in terms of probability of a false positive/pass/accept versus probability of a false negative/fail/reject, how does you client see it?
  • Can they place a cost or risk assessment on the value of false passes or false fails?

You’ll get some other ideas by searching the internet with the following search phrases:

Accuracy Method

Consumer’s Risk

Shared Risk

Global Risk

Producer’s Risk

Guard Bands

Reporting compliance statements

If you are reporting compliance or non-compliance, make sure the reports are clear about exactly what you are passing or failing. The report also needs to clearly state:

  • Which results the statement of conformity applies to
  • Which specification/standard is met / not met
  • The decision rule applied (unless it is part of the specification/standard)

Examples of Decision Rules

The PME Services Decision Rule

The IKEA Test Laboratory Decision Rule

WADA Decision Rules

While these examples make interesting reading, you must get agreement from your customers for the decision rule/s you select. If you have significant customers, I would suggest conferring with them and getting their agreement before publishing a blanket rule on your website.

Useful Resources

An accessible and informative webinar put together by Fluke

NATA’s slide set on the new standard: look at slides 43-48.

EUROLAB’s Cook Book No.8 Determination of Conformance with Specifications

OIML Guide 19 on conformity assessment decisions in legal metrology

Addressing impartiality in the new ISO 17025

Get help with ISO 17025 transition

A guest post from Karen Moore, originally posted on LinkedIn August 2018

The ISO 17025:2017 has a bigger emphasis on impartiality and managing conflicts of interest. How do you plan to address these issues in a way that you can discuss with NATA? If you’re like most lab managers, this is a difficult subject to talk about, and just saying “they wouldn’t dare” may not cut it. Read on to find out some of the methods that labs use to manage these issues.

It’s also a reality that some of the practices in the construction industry aren’t ideal and it can be a difficult environment for testers. There’s pressure from clients, overbearing contractors or even internal management for the “right” test results. And similar pressures exist in many other sectors too.

Situations of undue influence, conflicts of interest can lead to test results being either intentionally or unintentionally incorrect! If this is discovered after the results have been issued, it could not only be devastating to your business but potentially have criminal implications.

So, what can be done to protect the reputation and integrity of your business?

Identify what situations could arise in your organisation and write them down.  Think broadly and while many situations may seem unlikely it is still useful to get them out there.

Risks to impartiality

1.      Testing for compliance on an in-house product – what if the test result shows non-compliance, especially if the tester also has production responsibilities?

2.      Getting on site and being given a limited available area for testing, or an overbearing site manager who just insists testing is done at a specific location.

3.      Being pressured onsite to give a pass result, repeat the test, probably with instruction for a slightly different location.

4.      Conflicts of interest due to shareholdings, family relationships, etc.

5.      Under-pricing jobs, putting time pressures on staff while allowing full processes to be completed.

6.      Details in contracts or requests for testing that present a risk to your laboratory: site selection; financial penalties for delays in construction; methods specified not not match the materials

Now that these have been identified, read on to find out what can be done to reduce or eliminate these risks or find out how we can help.

6 ways to reduce risk of impartiality effecting reliability of test results

1.      Technology

  • Direct capture of test data in the lab – for example newer balances and load cells can be hooked up to a computer and directly record readings, also eliminating the risk of transcription errors.
  • Directly logging data in the field into a tablet.
  • Is automation an option? – Explore any possibilities, as they will likely improve you process efficiencies at the same time

These steps don’t necessarily need one of the off the shelf expensive software packages.  An in-house system that captures the on-site or lab data and stores this in a secure way so there is no question on the integrity of the data can also be an option.

Are there other technical advances in equipment that would allow for further automation that the industry could look at? Can your lab be a leader in introducing this? What an opportunity!

2.      Training and education

Make sure your staff know the implications of the test results. What happens if a structure fails and it is found that testing was not accurate? What if your product gets on site and is found to be non-compliant? The implications of finding failure at this point are massive! If a failure is identified and dealt with immediately, any short-term pain dealing with someone who doesn’t want the true result is negligible by comparison.

Let your staff know what to do if they experience pressure to change results, or less obvious pressure such as to test at a specific location. Who should they report this to? When should they stop testing and leave the site? Look at formally incorporating these policies into your training program.

3.      Organisational structure and reporting lines

Review the structure and reporting lines: look for potential conflicts of interest (such as results being used internally). This is common for production related organisations but also those involved in design engineering. Where possible, removing direct reporting lines such as the laboratory technician or manager reporting directly to the Production Manager or Design Engineer. It may be an option to look at alternate reporting lines for different aspects of a position for smaller organisations.

4.      Checking the data

An independent review of results introduces a level of impartiality as well as the benefits of a fresh set of eyes for errors. If work is being done remotely on a site lab, perhaps introducing back to base reporting will reduce any undue pressure on the technicians on-site as well?

5.      Contract review

Technical review of contracts is important. Many clients want to minimise testing costs for what is seen as an overhead. Checking the technical, as well as financial details of the contract will help make sure you are not left out of pocket or pressured to complete inadequate testing (see point 6 above for a couple of examples).

6.      Quality Culture

This comes from Top Management and installing a culture of openness, honesty and integrity goes a long way. Make sure employees know that they can speak up if they don’t feel something is right without the worry of some form of repercussion. No specific system can cover this, it is something that needs to be lived and breathed through the organisation at all levels.

Having a quality system that is integrated with the day to day work is an important part of this: encouraging non-conformances to be raised or renaming them to reflect a positive change approach can help; highlighting the benefits of processes such as internal audits are just some examples of how you can help instil a culture of quality within your organisation.

Getting help

We have been giving guidance on dealing with impartiality and other changes to ISO 17025. Get more details here or contact us via our contact page.

The 4 Big Benefits of NATA Accreditation


As business-owners, we must always think long-term and resist the tendency to be forever caught up in day-to-day demands. “A stitch in time saves nine” goes the old saying. This could not be more true than it is for laboratories offering quality-assured services, and vying for client trust in competitive markets.

benefits of NATA accreditation

There is no better way to ensure you are getting the most out of your lab and not wasting time and money in the long-term than to invest in the benefits of NATA accreditation.

Here’s why you should get your systems sorted:

1. Feedback

Knowledge is Power

You need to know what is working and what is not in order to have confidence in your processes. But often we are too enmeshed in our own organisation and work to be objective, and no matter how professional we think we are, we all need that ‘second pair of eyes’. NATA’s independent peer review provides your lab with detailed feedback according to the most up-to-date checks on the competence and reliability of your testing, calibration, or inspection services.

A nudge in the right direction

By going through the accreditation process, you can be certain of how your lab’s quality assurance systems perform against others. Then, if change is needed, you can direct time, resources and money into necessary improvements. At the same time, you will avoid wasting time on unnecessary reviews in areas that NATA confirms comply with its standards. NATA’s feedback not only ensures you comply with standards but can lead to fundamental improvements in how you run your laboratory and business. Especially, in many cases, when you get support dealing with NATA.

2. Expert Advice

The money and time you spend going through NATA’s accreditation process is a win-win. Whether or not your lab complies with NATA standards, NATA’s technical advisors will advise you as to where to make changes in order to pass the final assessment. Even if you were to fail, which does happen in some cases but is less likely if you get support, you have gained expert guidance on what steps to take next. This is gold for the systems & processes in your organisation. NATA takes a constructive approach and is clear with applicants. But if you need help putting their advice into place and communicating points of disagreement, O’Dwyer Accreditation can help ensure you pass the final assessment.

3. Business boost

As well as giving you and your staff a feeling of pride that your lab is providing services of the highest standard, a successful NATA assessment also gives you a marketing edge. You can enhance your credibility by advertising that you are NATA-accredited and using the logo on your website. Even if accreditation is not a regulatory requirement in your industry, NATA’s stamp of approval may enable you to raise your prices or gain access to international markets (NATA accreditation is recognised and accepted globally).

Public and private sector organisations increasingly require accreditation credentials, with so many benefits to the public across the supply chain, from fishing to forestry, transport to technology, construction to communications. Ensure your business is accredited before the market or industry demands it. NATA offers accreditation in a wide variety of areas – not all of them are traditional testing. If you need help making sure your business is reaping the financial benefits of NATA accreditation, contact us today.

4. Foundation for growth

Setting up the right management system for your business lays the foundations for continued success into the future. It means that when your business grows you have the frameworks in place to manage that growth in a way that maintains the highest quality standards. Recently a client in this situation said to me; “I wouldn’t have a business now if it wasn’t for NATA accreditation. The NATA assessment process taught us the importance of having systems: defined ways of doing our work. This meant that, as our business grew it was easier to train new staff, delegate tasks and to be confident that everything was running efficiently.”

For further information on how to leverage the benefits of accreditation into the future visit our ongoing support page.











Five steps to implement new accreditation requirements


Wondering when you will get time to deal with all those new accreditation requirements?

You’ve been notified of new standards, guidelines, or regulations that need to be implemented. It’s time to get busy writing new procedures, right?  Jumping in without enough thought and preparation leads to woolly procedures, written solely to meet requirements, that clutter up your document system.  And they are not much fun to audit against or keep up-to-date either!

Approach new requirements documents with caution and your own quality system with curiosity. Just because a requirement is new doesn’t mean your lab is not already meeting it.

Follow these simple steps to keep your system on track without creating unnecessary procedures.

  1. Identify the new requirements – depending on who has issued them, this may be simple or very tedious.
  2. Do a GAP analysis of your current systems against the new requirements. Look for evidence of compliance. This where the curiosity comes in.
  3. Be analytical: Identify any gaps in processes and document them without deciding how to address them. Talk to NATA if necessary to find out the intent of any clauses that are confusing.
  4. Consult: Get together with your management team to agree if the gaps are really there and discuss conservative ways to address them.
  5. Plan: Make a plan and tackle it one step at a time.

When you review your own quality system, you can tend to see holes everywhere, and go too far writing new procedures to meet new requirements. O’Dwyer Accreditation can help you implement new accreditation requirements without getting tangled in unnecessary red tape.
Contact us now for a quote.

Behind the scenes: how our clients make the world a safer place

With World Accreditation Day highlighting the theme of safety this year, we want to celebrate the incredible work our clients are doing behind the scenes. From ensuring the reliability of rail infrastructure to safeguarding food production, these businesses remind us what accreditation is all about.

As an accreditation specialist, it’s no surprise that I have developed a portfolio of specialists as my clients. I am often struck by the fact that these specialists are keeping us safe in ways that most of us are not even aware of.

On the road

Did you know that there are sensors that detect light levels and adjust the light at tunnel entrances so that you don’t slow down as you approach and cause traffic problems?  Or that traffic lights are tested to make sure that when the sun shines on them they don’t appear to be on when they’re actually not?  There are some very special people at Steve Jenkins & Associates who do this and a whole array of other tests involving photometric measurements. Having accreditation means that we can all be sure that SJ&A don’t just get to have fun using their physics knowledge at work, but produce results that are reliable, meaningful and can be used by other scientists and engineers to ensure our safety.

Oil & gas, food and chemical processing

Whether it’s medical and industrial gases, steam, milk, petroleum or grain being processed, valves are used to control the flow and provide pressure release in the case of dangerous pressure build-up. In every application the valve design, trim and construction must suit the fluid in the pipelines, both chemically and physically. The valve must also be able to withstand certain pressures, and release at the correct pressure if a safety valve. Valve Services have been repairing, refurbishing and testing valves for 20 years and have become the authority on valves for many manufacturers as their own technical workforce is diminished. With accreditation of their valve testing service in the mix, we know that as well as being gurus on process automation, safety and stop valves, their results are reliable and traceable to international standards.

Transport upgrades

In Victoria right now, there are infrastructure projects at every turn: level crossing removal projects, metro tunnel, freeway upgrades for the Monash, Ring Road and Tullamarine, and countless other road projects. We are getting used to seeing asphalt trucks, cranes and rollers on our daily commutes.  Have you ever wondered how all this work is happening at such pace and can still be safe for us to use?  Thankfully we have accredited organisations such as Pearce Geotech who are testing the materials and construction processes as they are completed to provide regulatory authorities and engineers reliable test results.  They test aggregate, soil and rock and conduct site investigations during the design phase to help engineers build the road correctly.  They even check to see if those rollers have compacted the road to the right degree. An important part of their role is knowing how to select samples that are representative of the whole batch (of aggregate, soil, asphalt). All these activities are accredited so both we can all be sure that their test results are meaningful and accepted by a range of regulatory authorities.

Food safety

There’s something special about agronomists. They’re proud of the work they do to ensure a reliable and safe food supply to our growing population and they’ve got their feet firmly on the ground. When you eat fresh fruit and vegetables, you expect that there’s nothing harmful on the food. The agronomists at Kalyx Australia run field trials to ensure that the food we eat doesn’t contain residues of the pesticides used during their cultivation. Kalyx has sites in farming districts all over Australia where they trial new pesticide applications to be registered with the Australian Pesticides & Veterinary Medicines Authority.  From locating suitable sites, praying for rain, to sowing the seed and harvesting the crop, they treat these trials like they are their babies.  They check in on them regularly, delight in seeing new growth and do all they can to promote healthy development. Their GLP accreditation means we know the trials have been run according to international standards and the results will be accepted in Australia and internationally.

While their highly-specialised work is largely hidden from the spotlight, these businesses make a crucial contribution in maintaining the highest standards of testing and safety. It is a pleasure to support them in attaining and keeping the stamp of world-recognised NATA accreditation.

AS/NZS ISO 17025:2018 is here!  Now what?

SAI Global has just released the 2018 version of AS/NZS ISO 17025 the updated laboratory accreditation standard, and NATA has explained how they will approach the implementation. So it’s time to start thinking about how you will approach the changes. (If you need extra help getting on top of the changes, we can help your organisation through our ISO 17025: 2017  Transition With Confidence programs). 

AS/NZS ISO 17025
What you need to know about the new version of AS/NZS ISO 17025

What you need to know.

(No time? Jump straight to our five steps to compliance).

The changes made to ISO 17025 are designed to:

  • promote increased confidence in the results your laboratory is producing,
  • to facilitate improved cooperation across international borders, and between laboratories and other related bodies.
  • to make the standard more flexible and easier to work with (which means less paperwork in some cases!)

The new standard reflects the latest approach in quality systems, which presumes that risk-based thinking must inform our decision-making.

ISO says:
“The main changes compared to the previous edition are as follows:

  • the risk-based thinking applied in this edition has enabled some reduction in prescriptive requirements and their replacement by performance-based requirements;
  • there is greater flexibility than in the previous edition in the requirements for processes, procedures, documented information and organizational responsibilities;
  • a definition of “laboratory” has been added”.

So far so good, and no need for any urgent action.

In their December 2017 Update, NATA gave us their take on the main changes to the standard.  Their list of 11 points included the following four that might require action:

  • greater emphasis on impartiality, risks and opportunities
  • requirements covering information technology and the validation of such systems have been included
  • the term ‘decision rules’ has been introduced in relation to pass/fail results for statements of conformity
    –   how MU is to be considered when making such statements
  • two management system options
    –   Option A = comply with the management system requirements as covered
    –   Option B = adoption of an ISO 9001 system”

The significant changes.

  1. Impartiality: The extra detail in the 2018 version means that some labs may need to explain more clearly how they manage this risk and what they do to monitor it on a regular basis (clause 4.1).
  2. Pass/fail testing: It’s clearer how to handle MU when testing to determine conformity with a specification (clause 7.8.6). This will save some arguments at assessments.
  3. LIMS: the standard now outlines what you need to do to manage risk with respect to IT systems (clause 7.11).
  4. Risks and opportunities: You need to show how you are considering risks & opportunities in your quality management system. This may require a tweak to your management review process and/or corrective action process (clause 8.5).
  5. ISO 9001: If you have certification to the quality system standard, you can opt for NATA to accept that your quality system is in place and concentrate on the technical part of the assessment (clause 8.1, Options A & B).
  6. Procedures: Many of the clauses look very similar to the previous version, but there are fewer mentions of procedures.  If your processes are working, or the clause is not relevant to your laboratory, you might be able to reduce the number of written procedures that you have.

What about NATA’s Transition Policy?

NATA have sent out a 17-page document that you must complete and return to them.  Reading through it, you might get the impression that you have to do something to address each point in the table provided. This is wrong. You need to examine your current policies, procedures and practices to see if you need to change anything to meet these new or re-worded requirements.

I would expect that many labs will need to do something to address points 1-4 above.  Most Australian laboratories will already meet the remaining changes that NATA has identified or will do so with small changes to the quality system.

NATA’s roll-out plan for AS/NZS ISO 17025

NATA will assess each laboratory to the new standard as their assessments come up. This includes surveillance visits.  Unless you have some pressing reason to gain accreditation to the new standard, you have some time to work on adapting your quality system.

What you need to do: 

Five steps to compliance with AS/NZS ISO 17025:2018

  1. Buy a copy of the new standard here.
  2. Have a look through NATA’s ISO/IEC 17025:2017 Transition Policy and use the final column of the transition worksheet to record the policies, procedures and practices you currently have in place that may meet the intent of the clause.
  3. Decide whether you need to change what you are doing now. Be conservative about making too many changes – you will already have processes in place to meet many of the new requirements (see Risk & Opportunities below).  Avoid putting something in place just to meet the new standard, unless you can see how it will benefit your business.
  4. Check the wording of AS/NZS ISO 17025 carefully to see if you need to write procedures to support your new process.
  5. Start making the changes and try to have them completed before your next NATA assessment / surveillance visit.  Keep a copy of the transition worksheet for your reference.

If you are ready for a major revamp of your quality system, take the next step: do a full gap analysis against the new standard and determine which procedures you can retire.

Ready for some guidance? O’Dwyer Accreditation can help you transition with confidence.

Risk & opportunities: Tweaks only

Looking at the new section in AS/NZS ISO 17025 titled, ‘actions to address risks and opportunities’ this might seem like a big change, requiring yet another new process. On a closer examination there is actually no need for a formal risk assessment process.

You are very likely already doing activities that could be used to demonstrate compliance. Such as:

  • a rolling internal audit schedule that focuses on areas that present greatest risk to your business
  • as part of accepting new work, you consider:
    –   is the information from your client clear enough?
    –   are there any conflicts of interest or other things that need to be considered to protect your integrity?
    –   Is there the potential for further opportunities to work with the client?
  • When reviewing any changes to the volume/type of work as part of your management review process, you look at:
    –   what risks there are to your business
    –   what resources you may need to look at to minimise any risks and maximise opportunities.

So, consider how you are currently running your business in terms of risk and you might find you don’t need to implement anything new. Or you might just need to tweak a current process here and there.

If you are ready for some help reviewing your quality management system against the new standard or need advice on how you can meaningfully fill any gaps in your systems contact us now.

Bullet-proof your laboratory accreditation


Keeping your laboratory accreditation (& business) safe

Good laboratory quality systems do more than just cover the things that NATA expects to see. They also support the laboratory management to make the right decisions.  

Whether you have laboratory accreditation, GLP or ISO 9001 certification, consider these key practices, which well-run organisations use to protect their accreditation status and their business: 


Say no. Decline work when it is not right (too much, too little, wrong type, wrong client, wrong time)


Prepare staff. Train your team thoroughly before sending them out on their own


Fill gaps. Replace departing staff members promptly


Keep a full team. Back-fill for staff members on extended leave. 


Price check. Review prices regularly.


Ideal clients. Cultivate ideal clients through suitable marketing


NATA know-how. Know the accreditation requirements and how you are meeting them


Stick to a system. Have a system in place and follow it


Testing expertise. Understand the science and measurement trace-ability behind the tests you do


Take stock. Regularly review operations, make decisions and follow through


Manage change. Plan changes thoroughly, involving all stakeholders


Apply feedback. Use incidents and complaints and internal audits to improve systems


Organisations that stick to these practices have happy employees who know they are in a secure, supportive job.  Staff know they will be given the time to learn before they have to do a task, and that there is always someone there who knows more than they do.

Celebrating success in lab accreditationSo when NATA comes visiting, these staff members may be nervous but not afraid.  They will be looking forward to showing the laboratory operations to the NATA assessment team and hoping that all their hard work will be obvious.  The discussions with NATA will be engaging and open, and disagreements handled without animosity.

Keep these practices up so you can celebrate after your next laboratory accreditation assessment.


Laboratory quality systems can help

Most of these issues are alluded to in ISO 17025, especially under “Management Review”.  But many labs with long-term NATA accreditation are just going through the motions to tick off on management review rather than finding ways to use these criteria constructively.  Unfortunately, NATA is often not in a position to really push labs on the fundamentals that underlie good laboratory management, until it is too late.

O’Dwyer Accreditation can review your laboratory quality system and help you to identify the risks to be addressed. We provide practical, experience-based advice. Contact us today.



How Safe is Your NATA Accreditation?

Danger ahead: warning signs for NATA Accredited Labs

NATA accreditation safe or at risk?


When a lab has their NATA 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 arrives.

These are some of the red flags noticable 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.

The laboratory is chronically short-staffed . This may be due to illness or other unavoidable factors.

Business has expanded but staff-training and resources are lagging.  No time to train the front-line staff and update resources for quality management and internal audits.

Lots of phone calls from customers.

Technical problems that everyone is aware of remain in the lab.

Staff members are putting off internal audits due to busy schedules.

New NATA accreditation requirements, but keep delaying working out how they apply.

Quality-assurance systems spread too thinly: NATA accreditation covers many different labs, some of which managers have never seen. In some cases, they haven’t even met the staff members.

Nobody knows where to find a copy of the last NATA assessment/surveillance report.

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 spells doom for your accreditation. But if you are saying “yes” to two or more of them, this is a warning sign that you need to slow right down and take stock.

How to protect your NATA accreditation 

Take stock and review

Some labs are caught off guard by a sudden suspension of their accreditation. Others may have had a fair idea that things were rough around the edges and were just hoping for the best. There are things you can do to avoid both of these scenarios and protect your accreditation status.

If you think your laboratory may have a problem, take stock of your whole organisation (the accredited part at least).  The Management Review clauses in ISO17025, ISO15189, and most other “quality” standards is the best place to start.  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 just make up things to put under each category. Do try to include any relevant information that you can think of. And remember to record what is going well.

Decide which items you need to action and develop plans for each one.  Don’t aim too high – you need a good enough system, not a perfect one. Keep the bigger picture in mind. Being too narrow in your focus could waste valuable time. Start with the things that are clear technical problems, affecting the validity of your test results.

Implement changes

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 appease 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 kept 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” , 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 warn 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. It can then put in place a process that leads to the suspension of your laboratory accreditation.

Choosing suspension of accreditation

When you know that your laboratory cannot meet the accreditation criteria, and can manage 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 decides a laboratory is not meeting the criteria for accreditation, it will send a notice asking the organisation to demonstrate otherwise.

At this stage the horse has probably bolted.  Very few appeals to the suspension process succeed.

From our 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.

The best avenue is to avoid getting into this situation in the first place. If you want to keep your systems on-track but need help from auditors with NATA-know-how, contact O’Dwyer Accreditation. Practical experience with NATA accreditation is our game.

Are you wasting time & money on NATA requirements?

The assessment is over, you have ushered the audit team out the door NATA Requirements ticked offand you already know how you’re going to fix most of those niggly things they brought up.  The assessment team were really helpful and you know it’s going to feel great to get all of these NATA requirements ticked off.

You’re not sure why these issues are important enough to be in the assessment report, but you need to get the response under control so the “Just Do It” approach wins.  You get the assessment report and hold a meeting to decide who will do what, including all the observations and recommendations.  Great work – you’ll have everything fixed and your reply to NATA post haste.

Can I just say whoa?!

When we behave like this we are focussing on one risk: the risk of NATA being annoyed with us for not having a response in time.  What about the other risks?  The real risk to your business presented by the issues the audit team identified?  The risk of wasting time and money on interventions for trivial problems?  The possibility of the same issue coming up in future assessments, which can threaten your accreditation and your reputation.

This is the time to slow down and take a quality improvement approach to each of the issues raised by the auditors. Here’s my step-by-step process to address these findings so that hopefully they never come back to haunt you again.

Understand the problem

Study the finding closely.  Make sure you have understood exactly what the auditors found that is wrong & why it is wrong.  Go and check what they were looking at if you haven’t seen it.  Look up the clause of the standard that they refer to in the report and check the wording of that.  Phone up the auditor if necessary, to ask for more context.

You should be able to say what the actual thing is that has gone wrong (or could go wrong).

For example, NATA finds a staff member working in section B who has not been signed off as competent in section B.  Is it that they are not signed off that’s the real problem? No!  It’s that a staff member could be working without all the skills and knowledge that they need to do the job and might stuff it up!

Whether you are accredited to ISO 9001, ISO 17025, ISO 15189 or GLP standards, what they are asking you to do is to make sure that you have trained, qualified and competent staff members doing the job.  The training or competency record is a tool for management and others in the organisation to be able to plan (training programs, rosters, recruitment drives, etc).

Investigate further

Check other staff, projects, samples, invoices to see how widespread that problem is.  Record this information, including dates and reference numbers.  If the problem turns out to be more serious than you thought it was, you will want to use this data as a benchmark.

Assess the risk

1.       Assess the risk from the issue to your business. Severity x frequency is the basic formula and there’s a whole Australian Standard on this if you want to formalise your process of risk assessment.  Usually an informal assessment of risk is good enough.

In this case the risk is the possibility that a person without adequate training works in section B and produces invalid results. How serious this issue is depends on the nature of the work, how much supervision is in place, how structured it is and how much impact it could have on your test results.  Frequency will be determined by discussing the training records with the relevant manager – how representative of the actual state of training are they?

2.       If it is a minor issue that has little or no impact on your business you can reply to the auditor at this stage, detailing your investigation and stating that you have corrected the issue they found.  However, do not neglect the risk of the issue coming up again at the next assessment.

Corrective action is for NATA requirements too

If the issue is serious and/or is happening on a regular basis, then you need to plan and implement corrective action.  Identify all the reasons why it is going wrong and prioritise these.  Use brainstorming to come up with ways to prevent it from happening.

Decide which actions are worth taking and implement following the change management practices in your organisation.  By this stage you will probably have sent a reply to your external auditor, but you must not drop the ball at this stage.

Once the changes have been in place for a while, assess how effective they are.  This is where the data from your original investigation will be useful: so you can demonstrate improvement.

NATA Requirements signed offIf the corrective action has been effective and is not costing too much (time, money) to implement, then this is the time to update your procedures and standardise the new steps in your process.  However, if it has not been effective you may need to go back and reconsider your corrective actions to find something more effective.  However, often we need to accept that our fixes will just be good enough and not perfect.


Can we change our minds about what action we take?

I’ve heard people say “but we told NATA we were going to do this, so we have to keep doing it”.  This is not an argument for keeping an ineffective or wasteful process in place.  Management of any organisation has the right to decide that something is no longer a problem, that they will bear the risk, or that they will investigate further when control measures have been ineffective.  So if you decide to adopt NATA recommendations, make sure you understand which risk they are trying to control so you can decide if it is working or not.

If you want assistance to respond to an assessment report, or to plan for your next reassessment contact us to discuss your requirements.