Stephanie Shea – Accreditation Program Manager (NEPDN)
The Communicator: Volume 6, Issue 2, February 2025 
"I should probably start working on my accreditation stuff, but where do I start?"
If you're thinking this or have thought this, you are not alone. You are actually in great company as many others are thinking this right now. Here is some information to help get you started.
Log into the NPDN portal and navigate to the Core Accreditation Webpage by clicking the Member Dashboard then clicking Core Accreditation (or clicking this link and logging in https://www.npdn.org/core_accreditation). This page is home to all things Accreditation. There are tons of resources available. To get started, I would suggest downloading the three key documents: Core Standard, Quality Manual Template, and Core Audit Checklist. Not sure what each of these items are? The webpage has a description of each so take a quick look there. Brief definitions are provided below.
The Core Standard was created by the Accreditation Committee and defines the requirements of the Accreditation Program. You can use the Quality Manual Template to begin making your own Quality Manual for your lab. Remember, the template is just an example of ways to satisfy each requirement of the Core Standard, but there is more than one way to do anything (referring to the requirements, but also a good plug for a life lesson!). The template does provide a helpful blueprint to get started (and already has the numbering and formatting that could be useful). The Core Audit Checklist essentially repeats exactly what is in the Core Standard, but then has additional columns that includes what we might be expecting you to have to provide evidence that you are accomplishing each specific subsection. It might even give you tips such as "for this section you can rewrite what is in the Core Standard." This document can be used as a guide as you complete your quality manual. Consider it the rubric we were given in class that outlined how we would be graded. We will use this document when reviewing your lab's quality management system.
What is the difference between a quality manual and quality management system? Good question. The Quality Manual is a single document that is the blueprint to your lab. It is the one document that outlines and references your processes and procedures in your lab. Your quality management system is your documents, processes, and procedures that ensure quality diagnostics in your lab and is tailored specifically to the requirements of the Core Accreditation Program. So, you are outlining your quality management system within your quality manual.
My suggestion? Read the Core Standard (either within the Core Standard itself or within the Core Audit Checklist) one subsection at a time and think about how your lab does what the Core Standard is telling you that you must do. Odds are, you already do it. So just write down what you do in your Quality Manual for that subsection. At times, you will have to create documents (or reference ones you already have) to fully satisfy the requirement. When you need to create a document, make a note or comment in your Quality Manual to come back to that section to make an external document, and continue until you have finished creating your Quality Manual. Then, go back through your Quality Manual notes or comments, and create your external documents one-by-one. As you do this, feel free to use the examples in the Document Repository on the Accreditation webpage. These examples serve as a great starting point but be sure to tailor them to your lab. Just because it is in an example or on the template, does not mean you need to do it that way. Remember there is more than one way to do anything. Then you will have created your system!
There are many other resources available on the webpage, take a moment to navigate through to see what is available to you! Don't see what you're looking for? Ask us! Email accreditation@npdn.org with any questions.
Next month's Accreditation Corner will explain the application process. See you then!
