ISO/IEC 17025
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 »
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 »
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 »
No doubt you’ve read through the ISO/IEC 17025, ISO 15189, and ISO 17020 standards plenty of times and you’ve seen an increased emphasis on risk management. Some of these requirements have been in place for 5 years! These requirements mean you look at risks in a more formalised and strategic way. Having a risk …read more »
What happens when a management system to identify the causes of problems fails? Over Christmas, shoppers in Japan had an unexpected experience. Several hundred customers who ordered the “strawberry frill shortcake” later complained the cake had arrived damaged. In response to complaints, the Department Store issued the following statement: “We sincerely apologise …read more »
It’s been said that failing to plan is planning to fail. But sometimes we’re paralysed by the prospect of getting started and the time it takes to plan. Besides, there’s that other adage of “the best-laid plans of mice and men often go awry”. So you can only take these sayings with a grain …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 Himeji Castle I’ve been fortunate to visit several World Heritage sites over the past couple of weeks. Places like Hiroshima, Himeji Castle, the Palace of Versailles and Berlin’s Museum Island. I’ve also watched Oppenheimer in that same period. What’s the link between these things and why would I be writing about them …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 Method selection is one area that many labs take for granted. You often only have one choice…….or so you think. After all, when you have a hammer, everything is a nail, right? In this article we’ll explore some of the questions labs should be asking so that the right method is used …read more »
written by Maree Stuart We’ve all been disappointed by our suppliers from time to time, especially in times of supply chain constraints. Imagine being the CEO of the Commonwealth Games Federation a couple of days ago. You’re quietly minding your own business, basking in the last rays of glory that was Birmingham 2022 and looking forward …read more »
written by Maree Stuart I recently came across a process that went along like this: Team completes an activity Quality control by review of records and report by a supervisor Quality control by review of the records and report by a technical manager Quality control by review of the records and report by a committee of …read more »
written by Maree Stuart No doubt you’ve read through the ISO/IEC 17025, ISO 9001, or ISO 15189 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 …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 It’s the question that can excite you or make you groan, “Show me your method validation data”. It’s not like we are scammers trying to pull the wool over the eyes of the nearest gullible person. After all, we’re professionals! And the same response might apply when you’re asked about your method …read more »
written by Maree Stuart Oh Alan, I would give everything, not to be like him. Would you want to be Alan Joyce right now? He’s the butt of many jokes, including this one from The Shovel: With QANTAS seen to be the stand-out performer in poor customer service and failures to respond to …read more »
written by Maree Stuart Being in a lab isn’t always easy, especially when there are decisions to be made. According to prospect theory, if two equal options are put to a person but one option is described in relation to gains and the other is described according to losses, the person is more likely to …read more »
written by Maree Stuart Would you sell your soul for total control like Martha Davis in The Motels? Sadly, your documentation system isn’t just a ‘set and forget’. They require reviewing, updating and managing to ensure they’re accurate, up-to-date, and available. And that’s where a document control system comes in. A good system allows your documents …read more »
written by Maree Stuart I had a conversation with someone recently where we discussed what was meant by the concept “Quality”. The discussion quickly reached the subject of quality control and it was clear that there was a lack of understanding of what this term meant. We recently wrote about Quality Basics and included some …read more »
written by Maree Stuart It’s a thing you might hear from applicants for jobs in your workplace, “I am a natural-born leader”. And it’s a statement that is rarely questioned as you nod sagely. We can debate the accuracy of this statement along the lines of nature versus nurture. But that’s not what is actually important. …read more »
written by Maree Stuart Getting the basics right I’m sure if someone asked you what did “Quality” entail, you’d have a list of things that are done. Some of those things might be drawn from topics and requirements that appear in Standards like ISO 17025, ISO 15189, ISO 17020 and ISO 9001. Some of them might …read more »
written by Maree Stuart Do you make new year’s resolutions each year? A survey found that in 2022, just 23% of survey participants intended to make new year’s resolutions. The most popular resolutions for 2022 were living healthier (23%), personal improvement and happiness (21%), and losing weight (20%). Anyway, who really cares? By the time we …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 sixth day of Christmas, our field staff were given a gift from a client It’s always nice when a client recognises the hard work of our staff. But sometimes, …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 As we head into the silly season, we’re delighted to present: The MAS Management Systems 12 Days of a Lab Christmas! On the third day of Christmas, our Quality Manager discovered the benefits of a thorough root cause analysis. In an ideal world, everything would run smoothly with only very small bumps …read more »
written by Maree Stuart The world can be a risky place! With claims by Mark Bouris who says Australia runs the risk of “going overboard” and pushing interest rates too high next year, and ongoing risks to our personal data and privacy through data breaches, we’re besieged by warnings about the present and the future. Those …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 »
If you’ve been doing internal audits just to tick the ‘yes we did that’ accreditation or certification box, you’re doing your business a huge disservice. Of course, internal audits are necessary for compliance and conformance. But they can also drive real change and add value for your business. As well as determining if the lab …read more »
We’ve been speaking to lab managers and leaders about their roles and their challenges. These conversations have been collated into a series of articles that will probably resonate not only with lab leaders, but those across other businesses as well. While their pathways may have been somewhat different, all our respondents have clocked up well …read more »
We’ve been speaking to lab managers and leaders about their roles and challenges. These conversations have been collated into a series of articles that will probably resonate not only with lab leaders, but those across other businesses as well. While their pathways may have been somewhat different, all our respondents have clocked up well over …read more »
We’ve been speaking to lab managers and leaders about their roles and challenges. These conversations have been collated into a series of articles that will probably resonate not only with lab leaders, but those across other businesses as well. While their pathways may have been somewhat different, all our respondents have clocked up well over …read more »
We’ve been speaking to lab managers and leaders about their roles and challenges. These conversations have been collated into a series of articles that will probably resonate not only with lab leaders, but those across other businesses as well. While their pathways may have been somewhat different, all our respondents have clocked up well over …read more »
Every day we need to communicate. And whether it’s grunts from teenagers or the long, winding conversations we have with old friends, we also need to interpret what’s being said. Effective communication in the workplace is critical. Management is often judged by the quality of communications with the rest of the organisation. Teams judge their …read more »
Even the best labs can find themselves floundering a bit when external audit or assessment time rolls around. As consultants and mentors, we’ve visited a LOT of client’s labs over the years. And although each lab faces different challenges, we’ve found that there are a few issues that regularly crop up that can lead to …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 »
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 »
The ultimate guide to training in the lab – part one You know that having competent, well-trained staff ensures the stability and reputation of your business. A dedicated and skilled workforce allows for innovation and helps your business to stay ahead of the curve and to flourish. And that’s why you’ve put together a training …read more »
written by Maree Stuart You might remember the famous case where David Bowie and Queen took Vanilla Ice (or Robert Van Winkle as he is legally known) to court for copyright infringement of their song ‘Under Pressure’. Van Winkle had quite clearly sampled the classic bassline to Under Pressure. However, he famously insisted that the two …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 »
Breakups. Resignations. Bad health news. Job terminations. Performance reviews. We’ve all been there. We’ve all felt that stomach-clenching, head-pounding, clammy-palmed moment when we needed to have a difficult conversation with someone. Having to do this in a workplace, particularly if you’re in a supervisory role, can be even more stressful. That additional power dynamic adds …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 »
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 »
According to the American Society for Quality website a quality management system (QMS) is defined as: ‘…a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous …read more »
It’s been a few months since our last article about carrying out remote assessments. Although everyone has improved with experience, there are still new things we’re discovering. During a recent webinar with our friends at the RACI Pharmaceutical Science Group, we picked up these tips and wanted to share them with you. And if you …read more »