Good lab documentation isn’t just about ticking compliance boxes—it’s essential for reliable operations, successful audits, and consistent quality. Whether you’re striving for ISO/IEC 17025 or ISO 15189 accreditation, or are already in the accreditation world, clear, actionable documentation sets your laboratory apart. However writing clear, concise policies and procedures can be challenging. Labs often produce …read more »
When faced with a complex problem, do you find yourself feeling frustrated or stuck? What about recurring issues that never seem to resolve? Or those dreaded negative findings in an external audit, such as a NATA report? These challenges can feel overwhelming, but a powerful tool is at your disposal: root cause analysis. What Is …read more »
If someone were to ask whether your business had a Quality focus, how would you answer? Would it be an enthusiastic, “Well of course! Quality is at the core of everything we do!” Or would it be more like, “Sure. We’ve got that document thingy we follow. We put it in a glass cabinet, so …read more »
Many organisations have a quality (or environment, or safety) management system. That’s a great thing- it’s like the hidden helper and decision-maker to make our work lives easier. But I bet you’ve sometimes felt like the system rules your life, rather than you ruling the system. How did it get to be this way? More …read more »
NATA deficiencies (aka conditions for accreditation) give you a clue on how you measure up. The question is, how common are those deficiencies? You never really know how you compare with your peers, and it can be difficult to know what to focus on. Sure, there are those performance reviews, but are you being told …read more »
Much time is spent on NATA assessments discussing traceability – metrological traceability. But what about the other forms of traceability? They are just as important! In this article we highlight the requirements for the other forms of traceability, covering traceability of records and samples. But before we get too far into things, we have a …read more »
Climbing your Traceability Tree Most NATA accredited labs will butt up against the requirements for metrological traceability. Those requirements seem to have become more difficult to meet, with even the tiniest and what would seem an insignificant piece of equipment or reference material being the subject of a condition for accreditation. Many labs have …read more »
written by Maree Stuart When it comes to NATA accreditation, we’ve seen it all! Including what not to do! You might have just started down the path of NATA accreditation and are stuck. Or maybe you already have accreditation and feel like you’re in a maze and there’s no way out. Maybe it’s simply that …read more »
When you get a wicked problem, do you just throw your hands in the air and give up? What about those problems that simply won’t go away? Or the dreaded negative findings in an external audit report, like a NATA report? Let me help you understand this better with a classic example of a problem …read more »
written by Maree Stuart It’s now been 6 months since NATA commenced assessments against the new edition of ISO 15189. Time flies when you’re having fun! 🙂 In this article, we’ll explore some of the areas Medical Labs get stuck. 1. Management review for ISO 15189 labs We’ve written previously about management reviews so it’s worth revisiting this …read more »
Most NATA-accredited labs will butt up against the requirements for metrological traceability. Those requirements seem to have become more difficult to meet, with even the tiniest and what would seem an insignificant piece of equipment or reference material being the subject of a condition for accreditation. Many labs have told us of the relentless demands …read more »
Here at MAS, we’ve noticed a troubling trend with navigating the accreditation process. There is some dissatisfaction with the NATA accreditation process and the time taken to get answers to applications and other submissions to NATA, as well as “creeping criteria”. We’re not naming and shaming individuals. The problem seems to be more systematic. …read more »
How many times have you laboured away at doing Measurement Uncertainty, wondering what’s the point, besides ticking the NATA box? Do you even know what you’re doing in the first place? Well, the good news is that there is a point beyond simply complying with accreditation requirements, There are so many more things to MU …read more »
You always have a choice when it comes to who you partner with for training Listen up, because I’m about to lay down some truth. When it comes to education and professional training, you’ve got a choice. You can settle for the run-of-the-mill, cookie-cutter programs that promise the moon but deliver a flickering star, …read more »
written by Maree Stuart A while back, there was quite a stir about the Federal Government’s program for funding of commuter carparks. Under the Urban Congestion Fund (UCF), established in the 2018–19 Budget, the Commonwealth sought to ‘support projects to remediate pinch points, improve traffic safety and increase network efficiency for commuter and freight movements in …read more »
Whether you’ve been in your job for a while or if you’ve just started a new one (congratulations!) the ideal scenario is that you should always be learning. Not just the steep learning curve that comes with a new task or role but the knowledge that underpins what we do and helps us do it …read more »
The recent renewed focus on the quality of audits performed by the Big 4 accounting and audit firms has put a spotlight on audit outcomes and reporting. While the focus has been on pesky financial audits, there are plenty of subjects that are covered by audits. The topics can be wide-ranging and include audits of …read more »
written by Maree Stuart Welcome to our third and final part of our NATA Assessment Survival Guide. Last week in Lab Man vs Wild NATA, we looked at how reviewing and maintaining your staff competence and HR systems, equipment systems and methods go a long way in preparing for NATA Assessments. We also looked at …read more »
written by Maree Stuart Being a NATA-accredited lab can feel like you’re Bear Grylls, with a depleted level of resources but being pushed to achieve ever more thrilling feats to entertain the audience of NATA assessors. It’s hard to survive a NATA assessment. We get it- we’ve felt like that too! Being prepared not only will …read more »
written by Maree Stuart The things labs test and calibrate don’t magically appear out of nowhere. Somewhere along the line, there is a sample taken. Many labs aren’t in charge of sampling. That’s something left to clients, clinical staff and production line staff. Just because it’s somebody else’s responsibility does not mean laboratories can ignore it. …read more »
written by Maree Stuart Finally achieving the ‘holy grail’ of NATA accreditation might be your resolution for 2023. Problem is, you don’t know where to start. And we’re more than half-way through the year! You might have even started down the path of NATA accreditation and are stuck. And if you’re a medical lab, now …read more »
written by Maree Stuart Late last year, a new version of ISO 15189 was released. It wasn’t done under the cover of darkness – hopefully, those affected know it’s coming. The countdown is now on for implementation, and there’s less than a month to go until D-Day, 1 August. In this article, we’ll explore some of …read more »
written by Maree Stuart World Accreditation Day falls on 9th June each year. It was established by the International Accreditation Forum/ International Laboratory Accreditation Cooperation Joint General Assembly in 2007 to mark the importance of accreditation in conformity assessment. This year’s theme is Accreditation: Supporting the Future of Global Trade and focuses on how accreditation …read more »
written by Maree Stuart Last week, I attended the Future Labs Conference in Sydney. It was a fantastic opportunity to learn about developments in AI, machine learning, digitization, facility design, and systems. But there was a troublesome undercurrent in the discussions- dissatisfaction with NATA accreditation. Despite the enthusiasm to adopt new technologies in the lab, …read more »
written by Maree Stuart Late last year, a new ISO standard was released. It wasn’t done under the cover of darkness – hopefully those affected know it’s coming. In this article, we’ll explore some of the key changes and what that means to Medical Labs. We’ll also cover how you can prepare for assessments done to …read more »
written by Maree Stuart As we head into the silly season we are delighted to present: The MAS Management Systems 12 Days of a Lab Christmas! On the twelfth day of Christmas we had a NATA assessment For many lab folk, the prospect of a NATA assessment is the stuff of nightmares. If you’re a little …read more »
written by Maree Stuart As we head into the silly season we are delighted to present: The MAS Management Systems 12 Days of a Lab Christmas! On the eleventh day of Christmas a key supplier informed us of serious quality issues with their products This is probably one of the least expected things that could go …read more »
written by Maree Stuart As we head into the silly season, we’re delighted to present: The MAS Management Systems 12 Days of a Lab Christmas! On the fifth day of Christmas, we did our management review with our business planning session. Huh? You mean we can do a management review not just to tick the accreditation …read more »
written by Maree Stuart As we head into the silly season, we’re delighted to present: The MAS Management Systems 12 Days of a Lab Christmas! On the fourth day of Christmas, we did an internal audit of some new work we wanted to seek accreditation for. How many times have you requested a change to your …read more »
written by Maree Stuart It’s World Quality Week and this year’s theme is “Quality Conscience: Doing the right thing”. It’s a good opportunity to pause for thought. What does it mean to act with a “Quality Conscience”? Our conscience is our moral sense of right and wrong. We develop this from birth, with influence from our …read more »
written by Maree Stuart Being Budget Week, the talk has been all about the number. A billion here, several million there. It’s all a bit eye-watering. Luckily our numbers for measurement uncertainty (MU) are usually not as large as these kinds of figures. It does make me wonder, what does the MU look like for a …read more »
written by Maree Stuart There’s a saying often used by many a marriage partner, “Happy wife, happy life”. The same can be said for our business relationships, both inside and outside our organisations. The question is how do you get to that point? Well, like any partnership you have to work at it. But the investment …read more »
written by Maree Stuart Compliance is big news! The woes of Optus following its data breach keep on coming. And we can look forward to investigations by the Office of the Australian Information Commissioner and ACMA to help understand why this breach of data security requirements occurred. Hopefully, we’ll also get some insights into how these …read more »
written by Maree Stuart Have you heard that in New Zealand, they’re legislating for laws to ensure that bureaucrats use plain language? You’re probably thinking, that would be nice, but how does it relate to me? Have you read an ISO standard or NATA accreditation document recently??? Apart from those ISO and NATA documents, we see …read more »
written by Maree Stuart Since accredited or certified labs have solid systems in place, you could be forgiven for thinking there’s nothing much else that needs to be done. After all, your existing business processes are tried and true and mean that you can navigate those accreditation or certification visits relatively unscathed. But (there’s always a …read more »
A new financial year is approaching with alarming speed. Although it may not be a thrilling time for everyone, any end of year event comes with a certain amount of navel gazing. And 1 July is the perfect time to examine just what has and hasn’t worked in your business. For business owners, unless you’re …read more »
Imagine having all the documents you deal with in a week piled on your desk. If you were to include print outs of your work and personal emails the pile would probably be too high to see over! Clearly, you’re not going to do this (no time, waste of trees) but thinking about that pile …read more »
Every week there’s a special day to celebrate or cause to acknowledge. These range from important causes such as Breast and Prostate Cancer Awareness to those a little more left of field like National Sea Monkey Day (it was 15 May if you’re wondering). These days are useful for raising the profile or drawing attention …read more »
In our last article we looked at why you need a training plan and what you should consider when developing one. This week, we’re looking at the best ways to deliver that knowledge. Training isn’t a one-off event. It’s a continuous process that requires monitoring and upgrading as your business environment changes. Professional development isn’t a …read more »
written by Maree Stuart In the Hitchhiker’s Guide to the Galaxy, Marvin the Paranoid Android is a robot and has a ‘brain the size of a planet’, but he is seldom asked to use this capability. Instead, people ask him to perform simple tasks, like opening doors and picking up pieces of paper. Back in the …read more »
Those gurus that promise your lab will obtain accreditation (or re-accreditation) in seven days or less are like those recipes that tell you caramelised onions will only take five minutes. It just isn’t going to happen. We’ve certainly assisted clients to obtain accreditation quickly. This meant that with a lot of work, focus and effort, …read more »
During March, we took part in the Future Labs Conference. As well as the excitement (and strangeness!) of being back in a face-to-face conference setting, we heard insights from speakers on how their labs are preparing for the future. One such speaker was Dr Shabnam Tarahi Tabrizi, Lab Manager at Nanosonics. She was instrumental in …read more »
What if we told you that you’ll never have to do Measurement Uncertainty again? Would there be cheering? Balloons and streamers? Morris dancing in the halls? While we’d like to witness such unbridled joy (although perhaps not the Morris dancing…) unfortunately it’s not going to happen. And that’s because Measurement Uncertainty (MU) is a vital …read more »
We believe in seeking out information and ideas that will support your business to be better and smarter. Different perspectives on quality and business practices may provoke conversations in your workplace. This could lead to new and better ways of doing things. Paul Davies, Principal of Think Sustainability shares his thoughts on how sustainability, testing …read more »
If someone were to ask whether your business had a Quality focus, how would you answer? Would it be an enthusiastic, “Well of course! Quality is at the core of everything we do!” Or would it be more like, “Sure. We’ve got that document thingy we follow. We put it in a glass cabinet, so …read more »
written by Maree Stuart It happens to everyone eventually. That’s right, the ‘R’ word … Retirement. If you’re lucky enough to be the owner of your lab the possibility of lazing somewhere unencumbered by the worries of cash flows, BAS, HR management and the like is a great dream. But if you’re looking to sell your …read more »
Whether you’re a NATA accredited lab in an assessment or going through a certification audit, it’s highly likely that there will be a discussion about metrological traceability. In fact, most labs will understand that there is a need to compare results over time or between different batches or laboratories. Metrological traceability enables tracking back to …read more »
written by Maree Stuart It’s a new school term and that means it won’t be long before students receive their next report card. If your lab were to receive a report card, how do you think you’d do? Hopefully it won’t look like this! When it comes to labs, you already know it’s important to stay …read more »
written by Maree Stuart When we think of risk and risk management, we often first ponder how we get rid of it. Indeed, in the COVID-19 Pandemic, many Australians, and governments, have shown themselves to be a very risk-averse lot! In contrast, some have shown themselves to be really tolerant of health risks in comparison with …read more »
As a lab manager or owner, you have your finger on the pulse of what’s happening in your laboratory. You have your eye on the big picture and introduce improvements to enable your staff to do their jobs and do them well. But what about those nitty-gritty, everyday issues that arise? Would your staff come …read more »
Have you ever sent a steak back in a restaurant because instead of being rare, it was extremely well done? Or returned a clothing item to a store because the large size was big enough to accommodate you and a friend? Your memory of how a company handles your complaint will colour your impression of …read more »
Remember back in 2017 when the latest version of ISO/IEC 17025 was released? You might remember a feeling of anxiety about the changes and how they should be implemented. This was particularly the case for NATA accredited labs whose first assessment visits after the standard was implemented were sometimes nerve wracking! Four years down the track, …read more »
While no longer the ‘new’ version of the Standard, when the 2017 version of ISO/IEC 17025 was released there was quite a bit of anxiety about the changes and how they should be implemented. This was particularly the case for NATA accredited labs whose first assessment visits after the standard was implemented were sometimes nerve …read more »
We all know that lab owners and managers have plenty to do and lots to think about. Juggling the daily needs of the business can be enough to fill your day. Setting aside time to make long term plans feels like a luxury you can’t afford. So perhaps you’ve been thinking that if you didn’t …read more »
No doubt you’ve read through the ISO/IEC 17025 standards plenty of times and you’ve seen an increased emphasis on risk-based thinking. We’ve written articles previously about risk management and discussed how the requirements need you to look at risks in a more formalised and strategic way. Since it’s not prescribed HOW this should happen, some …read more »
It’s Friday morning and as you walk out of your front door, you look up and think what a beautiful day it is. The overnight rain has left the air crisp and fresh. Stepping out onto the path, your foot slips on wet leaves and you feel yourself falling. You put your hand out to …read more »
Once you’ve completed your assessment visit, you may feel like you can take a deep breath and rest on your laurels for a while. And this is absolutely true. You certainly can do this. For at least a couple of hours. Because once you’ve waved goodbye to your NATA assessment team and closed the door, …read more »
We’ve written previously about your quality system. We’ve addressed training and internal auditing and how to be sure your QMS is up to scratch. But we also know that sometimes things can start to go wrong in a lab. And these are things that could lead to a lot of issues in your next assessment …read more »
Evidence of auditing has been discovered dating from the fourth millennium BC. Scribes in Mesopotamia kept records on clay tablets, some of which showed tiny marks beside the figures. These dots, ticks and circles indicate that checking of the records had been done. While we still use tablets today, generally they’re the electronic kind (if …read more »
At MAS, we’ve been part of and carried out hundreds of NATA assessments. It doesn’t take long before you start to see a pattern. You begin to see the same issues emerging and learn just where a lab is going to come unstuck. Labs know that preparing for their assessment is critical. But labs are …read more »
You may have excellent systems in place. You and your staff work as safely as possible. But despite your precautions, there’s always a possibility that something may go horribly wrong. That’s why having a disaster plan in place is so important. While it may not be a specific requirement of ISO standards it will add …read more »
There so much ‘stuff’ that goes on in a lab. People are busy, they’ve got important jobs to do. And all these questions and requirements about compliance and needing information and good practice! Honestly, what’s the point? That’s why you need information from someone who has presence. Someone with authority and The Force to back …read more »
It took just over two years, but on 10 August 2021, Temperature oControls were thrilled to finally be granted NATA accreditation! Considering the restrictions placed on businesses during The Time of Covid, this achievement is even more noteworthy. The beginnings Temperature oControls began in 1988, originally focussing on producing temperature and level sensors for industrial …read more »
Eccentric business owners. Cantankerous managers. Agitated lab staff. Confused clients. As consultants, we’ve seen it all (well most of it anyway…). However, by far the most consistent issue we’ve come across is confusion about measurement uncertainty (MU). Often, a business will approach us after an accreditation body (AB) such as NATA has rejected their MU …read more »
written by Maree Stuart If you’ve been keeping up with the news, you’ll have noticed quite a stir about the Federal Government’s program for funding of commuter carparks. Under the Urban Congestion Fund (UCF), established in the 2018–19 Budget, the Commonwealth sought to ‘support projects to remediate pinch points, improve traffic safety and increase network efficiency …read more »
We know you’re busy. For business owners or managers, there’s always plenty of juggling to be done. And with Covid restrictions thrown into the mix, you’d be forgiven for thinking that keeping an Accreditation Body happy is the last thing on your mind! However, we also know that keeping your business processes and procedures up …read more »
You’ve received the notification. Your assessment is coming up in two weeks and the team will be arriving at 8:30am on the day. Deep cleansing breaths. With a bit of preparation, assessment day may not be a breeze, but you’ll definitely feel in control. Being prepared shows your assessment team that your organisation is professional …read more »
We’ve all heard the expression knowledge is power. In the hands of cybercriminals, knowledge is also big business. In a lab setting, it’s understood that keeping information safe and secure is in the best interests of clients and your business. If you hold accreditation or certification, it’s also a requirement of the standard. ISO standards …read more »
It’s entirely possible that metrological traceability won’t come up at your next social gathering. However, if you’re looking for a conversation starter in a lab, this is a sure-fire winner! Anyone working in science and technology understands that there is often a need to compare results over time or between different batches or laboratories. Measurement …read more »
Many organisations have a quality (or environment, or safety) management system. If you’re in one of these organisations, then I bet you’ve sometimes felt like the ‘system’ rules your life, rather than you ruling the system. How did it get to be this way? More importantly, how can you change this? It probably got to …read more »
How many times have you heard the expression ‘two heads are better than one’? Or heard someone bemoan the fact that they could do with an extra pair of hands. By using a business consultant, you can add an extra brain and another pair of hands without getting bogged down in the process of a …read more »
Ah, the start of a new year. Our resolutions are still fresh and crispy (like the salads we’ve committed to eat more of this year…). We have new calendars and wall planners, just waiting for the imprints of our fabulous new year. But before you leap into the year ahead, there’s a couple of things …read more »
As any accredited lab will know, understanding ISO/IEC 17025 is a critical part of how your lab operates. From developing your quality manual to sending out reports to your customers, the process is clearly defined, simple to follow and easy to implement. Right? Well…judging by the number of ‘help with ISO/IEC 17025 courses’ available, maybe …read more »
Measurement Uncertainty. OK, we understand that this isn’t the sexiest of topics. In fact, it probably isn’t something that makes it through your front door, let alone into the bedroom! However, if you’re running a lab, Measurement Uncertainty (MU) is something you should know about in all its shades of grey. Let’s take a look …read more »
No business has ever regretted implementing standards for improvement. A quality management system is put in place because you want to deliver on the expectations of your customers. Get this right, deliver your goods or services according to expectations while remaining compliant with regulations, and you have a recipe for business success. A quality management …read more »
We all know the feeling when an external assessment is coming up. The scurrying search for documents, the interminable hours of scanning, the crossing of eyes and slurping of teas… But what about internal audits? Your colleagues do these. They’re all on your side so you’re bound to get a free pass on some of …read more »
We know that businesses often walk a tightrope between what must be done and what’s possible with the tools and resources they have available. This includes implementing risk management processes. Labs face a particular set of challenges with compliance and maintaining NATA accreditation while still remaining competitive and viable. We’ve put together this list of …read more »
November 2020 saw NATA accreditation transition to ISO/IEC 17025:2017. While the majority of labs have already made alterations to their processes, we did a review of the changes in the new version. Many organisations base their business decisions on information and results provided by laboratories. It is critical that the sampling, testing and calibration activities carried …read more »
We hear it from laboratories all the time (quite often accompanied by an eye-roll or a groan!). Measurement Uncertainty (MU) is something that laboratories do because they have to. Because ISO 17025 and ISO 15189 say so. And, of course, because NATA says so. Every measurement is subject to some uncertainty. That’s why the MU process …read more »
The move to carrying out lab assessments remotely has been sudden, with little time for transition. However, considering the cost and time savings, carrying out assessments this way could become the new normal. Maree Stuart, Principal of MAS Management Systems, recently went through this process with one of our clients and shares her experiences. “With …read more »
Will your laboratory business be staying alive during the Coronavirus crisis? The news is full of doom and gloom and there’s a lot of uncertainty about the future. People are clearly wanting control and going into survival mode, as the ‘toilet paper wars’ visibly demonstrate. If you fail to plan, you plan to fail and …read more »
Breaking news! The Guardian says “The only uncertainty is how long we’ll last”. Clearly they haven’t heard about the MAS MU for Testing Labs workshop! Calculating Measurement Uncertainty (MU) can be a daunting prospect for some people. Once they see that it involves numbers, their brain goes numb! That’s why our training course is different. …read more »
The laboratory shall, if relevant, to the extent necessary, maintain records of competence to read standards. Understood? Deciphering these kinds of phrases in standards is not easy. Learning to read and understand them is like learning a new language. But once you get the hang of it, a whole new world of interpretation opens up. …read more »
Finally achieving ‘holy grail’ of NATA accreditation might be your resolution for 2018. Problem is, you don’t know where to start. You might have even started down the path of NATA accreditation and are stuck. And now you’ve heard there’s a new version of ISO 17025 and are worried you’ll have to start over! Or …read more »
Are your laboratory’s problems prone to re-surface over and over again? Are you spending most of your valuable time and resources tackling a recurring problem in preparation for an audit? You may be convinced that your answers are ‘THE’ solutions to the problems identified in your lab. But perhaps it’s time you took a closer …read more »
So you’re facing a NATA audit and it’s being done to the new 17025. You’ve probably read various bits and pieces online that have given you an idea about the significant changes. An ISO 9001-friendly structure, new emphasis on impartiality, confidentiality and customer complaints, decision rules, and a lot of stuff about risk management. A …read more »
ISO 17025:2017. You can see it looming ahead of you. You vaguely know that there’s some change you have to grapple with. Or perhaps you might have already been through an assessment to the new standard. The question is, how do you conquer the NATA ISO 17025:2017 beast? You know, the Titanic hit the …read more »
When you’ve done hundreds of NATA audits, you get to know what the issues are that bring laboratories stuck. One question at a NATA audit will always be, what evidence do you have that your staff are competent? Here are some helpful tips on how to respond and show just how good your people are. …read more »
In my last article, I talked about how you can take steps to simplify your management system. But as a true systems expert, I like to deal with the root cause of a complex problem. The other cause of the creation of a management system is a failure to critically analyse feedback from auditors and …read more »
Many organisations have a quality (or environment, or safety) management system. If you’re in one of these organisations, then I bet you’ve sometimes felt like the system rules your life, rather than you ruling the system. How did it get to be this way? More importantly, how can you change it? It probably got to …read more »
It’s a nice, sunny Sunday afternoon and you’ve decided to take a drive. So you hop in your car and off you go. But I bet you’ve never given a thought to how metrology helps you do this. Let’s take the physical car itself Your car is made so that it can actually …read more »
Our social media feeds are filling up with the doom and gloom of celebrities and musicians we lost in 2016. The world has also experienced some tumultuous events through the likes of Brexit, Trump and the long-running war in Syria. But it’s been a great year for science, with some important discoveries and insights into …read more »
The NATA equipment tables might be on their way out! Who will tell me how often to check my gizmo? So, you’ve been minding your own business and just doing as NATA says to do for equipment calibrations for years. Now they tell you that you might have to work out your own calibration frequencies and ‘prove’ that …read more »