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 »
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 »
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 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 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 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 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 »