Easy Way to Create a Checklist for ISO 13485 Internal Audits

One of the vital checking tools in a Quality Management System or QMS designed for medical device is the internal audit. The latest version of ISO 13485 Standard, ISO 13485:2016, has clearly stated that an internal audit is a significant element of QMS; it helps you learn how your QMS is functioning.

Pay attention to many essential tools when you will perform ISO 13485 internal audits. You should not miss any element of this process.

A successful internal audit program depends on how you are executing it. Developing a proper checklist and following it is very important, and we will discuss an easy way to build this checklist. Before delving into the details, let’s try to explore what the ISO 13485 Standard requires internal audits to do.

For having a clear understanding of “why” and “how” of internal audit checklists, let’s focus on what the ISO 13485:2016 requirements have stated about internal audits. As per clause 8.2.4 of the standard, the internal audit has two functions-

1. It ensures that the quality management processes are performing according to the planned arrangement and relevant regulations that the organization has identified,

2. It makes sure that the QMS is implemented and maintained in the right way.

Therefore, if you want to create an audit checklist, you should include information which establishes that you have reviewed these two outcomes of the process.

How do you create a checklist?

An internal audit program is to determine the outcomes (stated above) of a QMS through a method of recording the actions of the employees. Once the actions have been recorded, you need to compare them to the planned arrangements of the QMS. This comparison will help you determine what is being done and what is expected to be done.

While performing internal audits, no matter whether it is, ISO 13485 or AS9100 internal audits, you should review two sets of planned arrangement:

• Requirements set out by the ISO standard (ISO 13485 in this context),
• Requirements set out by the organization.

For instance, if you are measuring a purchasing process with the ISO 13485:2016 Standard (section 7.4.1 in particular), you should confirm that external suppliers are evaluated, selected, monitored, and once again reevaluated on the basis of their ability to provide the processes or products as per the requirements. If loopholes are identified, it may create risks associated with the sold products. This is one of the vital ISO 13485:2016 requirements. From this you can start building your checklist for ISO 13485 internal audits.

A Final Takeaway

An audit checklist is nothing but a series of questions that the auditors would want to ask, or the activities that the auditor would want to review. For instance, an audit checklist could contain questions on supplier evaluation, statements from the processes that the auditors would want to verify, etc. In this context, it is important to remember that a checklist is a tool for the auditors. It is not something that auditees should fill out.