Category Archives: iso 9001 audit checklist

ISO 9001:2015 Audit Checklist: How to Create It for an Internal Audit for QMS

One of the most important checking tools in a Quality Management System (QMS), is the internal audit. The requirements of ISO 9001:2015 are very clear that this is a critical element of your QMS; and, as you want to know how your processes work, your internal audits become a key resource. ISO 9001:2015 Audit Checklist are a widely used and important tool to insure that when performing an internal audit.

What is the ISO 9001: 2015 standard required by the internal audit?

ISO 9001:2015 Audit ChecklistTo better understand the why and how of internal audit checklists, it is helpful to understand what the ISO 9001:2015 requirements state about why we do internal audits. The ISO 9001:2015 internal audit is there to perform two functions:

  • to make sure that the processes are meeting the planned arrangements that the company has identified for the process in the QMS and any requirements that the IOS 9001:2015 standard has in place for that process
  • to make sure that the process is effectively implemented and maintained

So, when creating ISO 9001:2015 audit checklists, you want to include the information needed to verify these two process results correctly.

How to create an ISO 9001:2015 Audit Checklists to check conformance?

An internal audit is there to witness the outcome of a process through a review of records or witnessing the actions of the employees, and to then 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 9001:2015 and those that the company has put in place for their process to work.

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 checklist is created by reviewing the ISO 9001:2015 standard and any documented procedures or undocumented processes for the activity to determine what should happen. The ISO 9001:2015 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.

The checklist can include more than just questions; it can also include statements from the procedures that the auditor wants to check. The checklist is a tool for the auditor, and it is not something that the controlled entity should complete, so any format or questions and statements will be useful for the auditor to ensure that all the important parts of the process are checked will work.



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How to prepare ISO 9001 2015 Audit Checklist for QMS?

What is Audit Checklist?

Audit Checklist commonly known as “preparing the working papers”. The only purpose of creating audit checklist is to verify that the process is performing is according to plan or not. Audit Checklist is verification lists of all the information and questions that auditor wants to know during organizational implemented quality management system audit.

ISO 9001 2015 Audit Checklist

FotoFlexer_PhotoISO 9001 2015 Audit Checklist is a set of questionnaire required for quality management system certification that helps them in monitoring of the quality management system. It is one of the prior requirements for any organization that implementing QMS 9001 system for the first time or converting current system for upgraded version of ISO 9001 standard for re-certification. The QMS 9001 Internal Audit Checklist is useful for internal audit for fast quality management system certification. ISO 9001 2015 Checklist includes audit questions based on ISO 9001 standard for Quality Management System requirements of each organization. It is also helpful to understand the system and control for controlling the system.

Key points which should be keep in mind while preparing the QMS 9001: 2015 Audit Checklist

  • ISO 9001 Requirement: As per primary need of any Certification audit checklist, QMS 9001 2015 Audit Checklist also has critical part of internal audit for ensuring that ISO 9001 requirements are in this process or not. As such, including questions that will verify that the process is conforming to the requirements of the ISO 9001 standard is imperative. This is especially important if the process does not have a documented procedure associated with it.
  • Process Overview: This approach allows looking at the elements of the process even if there is no documented procedure. The focus is to ensure that each part is understood, consistent, and supports the effectiveness of the process, as well as the other processes before and after the process. When the process approach was introduced to the ISO 9001:2015 standard, many auditors implemented a process overview style of audit.
  • Process Objectives and Key Performance:  All processes have some sort of indicator of the acceptable results. Verifying the process performance against these expected results can help you, as an auditor, to understand whether the overall process is performing as expected. It can also help you to understand how well the resources are applied and implemented if the indication shows that improvement is needed.

Have a look and download sample ISO 9001:2015 Audit Checklist at


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