![Iso 13485 internal audit checklist](https://kumkoniak.com/100.jpg)
The checklist can include more than just questions it can also include statements from the procedures that the auditor wants to check.
![iso 13485 internal audit checklist iso 13485 internal audit checklist](http://imsxp.com/PrdResources/img/13ChkList-4-icon.gif)
For the example above, the audit checklist could include questions on supplier evaluation, and a review of the supplier audit reports that have been collected, to see if they are done when determined by the QMS.
#Iso 13485 internal audit checklist iso#
The checklist is created by reviewing the ISO 13485:2016 standard and any documented procedures or undocumented processes for the activity to determine what should happen. An audit checklist is basically a set of questions that the auditor wants to ask, or activities that the auditor wants to witness, in order to verify the planned arrangements as above. The company might also specify that this is done using an audit of the customers every three years, which would be the company-defined criteria for the process.įrom this, we can start to create the audit checklist. As can be seen above, there are two sets of planned arrangements to check: those required by ISO 13485:2016, and those that the company has put in place for their process to function.įor example, if you are auditing a purchasing process against the ISO 13485:2016 standard (section 7.4.1), you will want to confirm that external providers are evaluated, selected, monitored, and reevaluated based on their ability to provide processes, or products and services, according to the requirements, and that their lack of commitment would affect their risk associated with the purchased product.
![iso 13485 internal audit checklist iso 13485 internal audit checklist](http://www.grandavenue.com/site/images/AuditManagement001.png)
So, when you are creating an audit checklist, you want to include the information needed to make sure that you successfully check these two outcomes of the process.Īn internal audit is there to witness the outcome of a process through a review of records or witnessing the actions of the employees, and then to compare this to the planned arrangements for the process to see if what is being done is what was planned. to make sure that the process is implemented and maintained effectively.to make sure that the processes are meeting the planned arrangements and regulatory requirements that the company has identified for the process in the QMS, and any requirements that the ISO 13485:2016 standard has in place for that process.As per clause 8.2.4 of the standard, the internal audit is there to perform two functions: To better understand the why and how of internal audit checklists, it is helpful to understand what the ISO 13485:2016 requirements state about why we do internal audits. What does ISO 13485:2016 require the internal audit to do? Although audit checklists are not stated as a requirement in the ISO 13485:2016 standard, they are a widely used and important tool to make sure that when you perform an internal audit on a process, you do not miss any elements of that process. The ISO 13485:2016 requirements are very clear that this is a critical element of your QMS and, since you want to know how your processes are functioning, your internal audits become a key resource. One of the most important checking tools in a Quality Management System (QMS) for medical devices, or any management system, is the internal audit.
![Iso 13485 internal audit checklist](https://kumkoniak.com/100.jpg)