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 »
NATA 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 »
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 »
How to get NATA Accreditation – The Ultimate Guide
So you want to get NATA accreditation for your laboratory, but you’re stuck on where to get started? It seems like an arduous process and you want to know you are going about it in the right way, and not wasting time. Perhaps you’ve contacted NATA and they referred you to a bewildering array of… read more »
Succeeding in laboratory quality management
We see that many laboratory quality managers inadvertently waste time due to misinformation and misunderstandings about NATA requirements. They may do too much, creating unnecessary or inefficient processes in an effort to please the NATA assessor. Or they may do too little in the areas that really matter – the things that will actually affect… 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 »
Tools and Tips for NATA-Ready Cause Analysis
How to get root cause analysis right for NATA We all love that feeling when NATA accepts our first response to an assessment report! But since NATA introduced their new reporting format, we’re seeing NATA reject many responses from labs because they haven’t included an adequate root cause analysis. If you’re struggling to understand what… 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 »
Reporting Compliance in ISO 17025
Do you report results as pass or fail on test reports? As normal, high or low? Within spec, outside spec, complying or not complying? Would your clients like you to report with a statement of conformity? Then you need to know about decision rules in the new ISO 17025. While you have utmost confidence in… read more »