ISO 15189

Woman medical testing labISO 15189 is a quality management system standard particularly for medical laboratories. The standard also includes requirements for technical competence of those laboratories.

Laboratory accreditation bodies, such as NATA, use this standard to evaluate the technical competence and management systems of a medical laboratory.

In addition, for Australian laboratories, if you operate under the Medicare framework then you must be accredited by NATA.

Your laboratory will need to meet some additional requirements. These requirements are included in the NPAAC and NATA documents. A checklist of the specific accreditation requirements can be found on the NATA website.

It’s not a simple task to gain accreditation. For example, you may have to wade through many additional documents to meet accreditation criteria. And you may not have the resources to dedicate a staff member to take on this task while completing their own duties.

You may also feel anxious about facing an accreditation team. What will they be looking at? Will they be critical about your systems? And how will your staff react?

The good news is that the requirements are often things you are already doing, such as having trained and competent staff, calibrating equipment and undertaking quality control. But how do you demonstrate that competence in the accreditation context?

We have some articles on how to navigate the NATA maze and upgrading your systems on our Blog page.

But the best option is to contact us for an obligation-free discussion on how we can support your ISO 15189 lab accreditation journey.

We can answer your questions and help remove some of the anxiety you’re experiencing.

Need help with training? We also offer professional training courses and workshops.