The art of tidying up your SOPs Today, more than ever, having a set of standard operating procedures (SOPs) in your lab is crucial for any organisation. But when was the last time you sorted through and updated your laboratory’s standard operating procedures? Or maybe you’ve got great procedures hiding in long-winded documents that would… read more »
ISO 17025 Accreditation.
A minimum viable audit program
Do you feel overwhelmed by the lack of support when you plan ISO17025 or ISO15189 audits? Or have you planned too many audits and can’t finish them all (because they’re all a good idea, right)? Or – do I even need to ask this? – do you struggle to get internal auditors to do the… read more »
The six pillars of a successful NATA application
So you’ve decided to look into getting NATA accreditation, but it’s early days and the tests aren’t completely set up in your laboratory yet. If you’ve approached NATA, or attended one of their training courses, you wouldn’t be alone if you feel completely overwhelmed by how many things you need to do and how many… read more »
Save time and money on NATA requirements with 5 strategic steps.
The assessment is over, you have ushered the audit team out the door, and you already know how you’re going to fix most of those niggly things they brought up. The assessment team was very constructive. It’s going to feel great to get all of these NATA requirements ticked off! You don’t understand why some… read more »
Why you need a gap analysis
You’ve had your quality system documents in place for years now, and you made sure they met NATA’s requirements at the beginning. But NATA keeps suggesting or even requiring more changes to the system. So you start adding extra bits and pieces all over the place, or additional procedures, as you prepare to send a… read more »
Anatomy of a NATA non-conformance
Do you sometimes struggle with decoding the non-conformances in NATA assessment reports? Some labs come to us after they have replied to the assessment report, bewildered by the response they’ve got back from NATA. They thought they had already covered what NATA was asking them to fix and can’t see what to do differently. Not… read more »
Addressing Impartiality in ISO 17025
Risks to impartiality are alluded to in both ISO 17025 and ISO 15189, but neither standard is really clear about what the sources of risk might be. These risks have always been around – they’re just more evident in some types of lab than others. If you have identified possible risks to impartiality you will… read more »
Risks to impartiality in ISO 17025
Risks to impartiality and managing conflicts of interest are hot topics in lab accreditation since ISO 17025 was updated. These risks are also alluded to in ISO 15189, but neither standard is really clear about what the sources of risk might be. These risks have always been around – they’re just more evident in some… read more »
Creeping criteria: when auditors stray
Creeping criteria: this wonderful term was coined by my old boss at NATA (Helen Liddy) for those times we put a “condition” in an assessment report that was almost a requirement (but really an opinion on how to address a requirement), or when we had taken a criterion from one part of the accreditation documents… read more »
4 Steps to Reducing The Mental Load of Lab Managers
Following on from our previous post on the topic, here’s a step-by-step guide to show you how to implement the process approach. How to implement the process approach 1. Start at the top: Getting your team to embrace the process approach starts with YOU Do you like the sound of having more time to focus on… read more »