Once you decide that you want to get NATA accreditation, how do you go about it? The NATA website includes a complex maze of documents describing NATA’s accreditation criteria and a brief description of the accreditation process. But their overview leaves out the all-important first step that will make your journey to accreditation much easier – tuning in to your customer’s needs.
Here is a more balanced overview of the accreditation process, with some insights that come from Cathy’s time working at NATA:
Step 1 – Customer focus
Decide which tests (and methods) your laboratory will need to offer (‘scope of accreditation’). You need to check with your clients for this: what are they asking you for? How will they be using the test results you provide?
You may need to read up on the regulations that your clients are working to, to find out if particular methods or techniques are specified. Or, if you know of a competitor that has NATA accreditation, you can look at the scope of their accreditation on the NATA website and base your scope on that.
If you are clear about the scope you need before you begin, you’ll know exactly which of NATA’s technical requirements you have to meet. This can save significant time and money when it comes to the NATA assessment.
Then, contact NATA to tell them that you’re thinking about getting accredited. They will guide you to the accreditation requirements you need and you can ask them for a cost estimate too.
Once you have copies of all of the accreditation documents, you’re in for some serious study. Review the documents, consider how your laboratory meets the criteria and identify areas that need attention. A good approach for this is a gap analysis.
Step 2 – Develop your quality system
Develop any processes or procedures that are missing from your system. If you haven’t already, start conducting internal audits. You also need to hold a management review meeting to plan your next steps in the accreditation process.
Step 3- NATA Advisory
Contact NATA to ask them to conduct an Advisory Visit. This informal process enables NATA to give you feedback on your quality system and any obvious gaps in your technical operations. They will expect you to rectify these before they agree to start arranging an assessment. The advisory visit is a great chance for you to ask questions about the accreditation criteria and how to apply them in your laboratory.
It is only after a successful advisory visit (and close-out) that you will be given an application form so that you can apply for accreditation.
Step 4 – NATA Assessment
Once you have responded to any issues raised during the advisory visit, NATA will arrange a technical assessment. This will be far more technical in focus than the advisory visit, as a peer assessor from a similar industry to yours will review all of the technical aspects of your laboratory. Meanwhile the NATA auditor will be reviewing the quality system in detail.
Step 5 – Post Assessment
NATA will leave you with a detailed assessment report, including non-conformances. These ALL need to be addressed before NATA grants accreditation. Sometimes this stage can be extended unduly because of misunderstandings and intransigence.
Step 6 – Accreditation
Finally the big day has arrived! NATA has sent you a certificate of accreditation that you proudly display in the foyer. You can start issuing NATA-endorsed test reports and using the NATA logo in your marketing materials.
You don’t get to just sit back and relax after all that! NATA returns on a regular basis to re-assess your laboratory and quality system. The exact details of this process vary depending on whether you have ISO 17025 accreditation or ISO 15189 accreditation.