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, right? Nonetheless, you don’t understand… read more »
ISO 17025 Accreditation.
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 »
How to write great SOPs and declutter systems
The art of tidying up your SOPs When was the last time you thoroughly sorted through and updated your laboratory’s standard operating procedures? Perhaps you have some great procedures buried in long-winded prose that should be converted into a flowchart or diagram and proudly displayed around the workplace? Likewise, perhaps it’s time you finally culled… 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 »
From busy to business-mastery
Why all lab managers should fully embrace the process approach outlined in ISO17025, ISO9001 and ISO15189 No email-free holiday in years? Scared to take a day off? Alarm bells should be ringing. It may be the last thing you want to hear, but if you are overworked, always too busy or want bigger things for… read more »
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… read more »