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 »
ISO 15189 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 »
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 »
Bullet-proof your laboratory accreditation
Keeping your laboratory accreditation (& business) safe Good laboratory quality systems do more than just cover the things that NATA expects to see. They also support the laboratory management to make the right decisions. Whether you have laboratory accreditation, GLP or ISO 9001 certification, consider these key practices, which well-run organisations use to protect… read more »
How Safe is Your NATA Accreditation?
Danger ahead: warning signs for NATA Accredited Labs When a lab has their NATA accreditation suspended, it usually comes as a huge shock. But there are warning signs for poor assessment outcomes. You can determine whether there are issues that you should address before NATA arrives. These are some of the red flags noticable in… read more »
The easiest internal audit program ever
I recently discovered there’s a way to do internal audits that takes (almost) no time at all. I got an invitation to a webinar Freshening Up Your Internal Audit Program featuring a dude who has been around the ISO 9001 certification scene for many decades. (Aha! I thought. I’m finally going to learn the secret… read more »