How to create a checklist for ISO 13485 Internal Audit for Quality Management Sy

Posted by Charles Wilson on March 16th, 2022

An unsuccessful audit can mean severe significances; resulting in process failure, patient disappointment and controlling noncompliance. Enhance auditing skills with the internationally recognized ISO I3485:2016 and boost internal audit abilities. Increase confidence in planning and performing an effective audit, as well as reporting and taking corrective action where needed. This is intended for medical device quality professionals wishing to build on their current knowledge of ISO 13485 and assess the effectiveness of QMS. It shows the principles and practices of actual audits in accordance with ISO 13485:2016 and ISO 19011:2018.

One of the most significant checking tools in a Quality Management System (QMS) for medical devices, or any management system, is the internal audit. The ISO 13485:2016 requirements are very clear that this is a critical element of QMS and, since want to know how processes are operative, internal audits become a key resource. Although audit checklists are not specified as a requirement in the ISO 13485 standard, they are an extensively used and important tool to make sure that when perform an internal audit on a process, do not miss any elements of that process.

What does ISO 13485:2016 require the internal audit to do?

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 do internal audits. As per clause 8.2.4 of the standard, the internal audit is there to perform two functions:

  • To assure that the processes are meeting the planned arrangements and regulatory requirements that the company has known for the process in the QMS, and any requirements that the ISO 13485 standard has in place for that process.
  • To ensure that the process is executed and maintained effectively.

So, when creating an audit checklist, contain the information required to assure that successfully check these two outcomes of the process.

How to create a checklist to check conformance?

An internal audit is there to observer the outcome of a process through a review of records or observing 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. As can be seen above, there are two sets of planned arrangements to check: those required by ISO 13485, and those that the company has put in place for their process to function.

Auditing a purchasing process against the ISO 13485:2016 standard, want to confirm that external providers are estimated, selected, supervised, 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. This is the ISO 13485 requirement. The company might also require that is done using an audit of the customers every three years, which would be the company-defined criteria for the process.

ISO 13485 internal auditor training provide that essential to know about the Quality management system and fulfill all the requirements as an ISO 13485 QMS auditor. ISO 13485 auditor training will guide management as well as employees of organization in the field of manufacturing, supply of a medical device or its components for Quality management system based on ISO 13485:2016 standard. An audit checklist is essentially a set of questions that the auditor wants to ask, or activities that the auditor wants to observer, in order to verify the planned arrangements as above. The checklist is created by reviewing the ISO 13485 standard and any documented procedures or undocumented processes for the activity to determine what should happen. The checklist can include more than just questions; it can also include statements from the measures that the auditor wants to check. Remember that the checklist is a tool for the auditor, and not something to give the auditee to fill out, so whatever format or questions and statements will be useful for the auditor to ensure that all important parts of the process are checked will work.

Why should use checklist in Internal Audit?

While the ISO 13485 standard does not contain requirements that state an internal audit checklist must be used, it is a beneficial and effective way to document the questions need to ask to ensure that process outputs meet the planned arrangements for process. When reviewing process plans, write down what need to check, and in this way, assure that nothing important is forgotten. When finished an internal audit, do not want to find that neglected to collect the proper information and need to reschedule audit to complete it.

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Charles Wilson

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Charles Wilson
Joined: September 3rd, 2019
Articles Posted: 104

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