How to create Internal Audit Checklist for ISO 9001 QMS
Internal Audit is one of the most vital assessing and analyzing tools during implementing ISO 9001 certification for Quality Management System (QMS), or any other ISO standard pertaining to the management system. An ISO 9001 QMS certification needs are pretty obvious, internal auditing has often become a crucial part of ISO certification for QMS and other standards. Since you are interested to know how the processes in your organization are functioning, your internal audits are an ultimate key resource. Though audit checklists don't seem to be declared as a requirement in the ISO 9001 QMS standard, they are being widely used and vital tools to ensure that when you perform an internal audit on a process you do not miss any parts of that process.
What are ISO 9001 QMS needs for a successful internal audit?
To comprehend in a better way the why's and how's of internal audit checklists, it is quite beneficial to know the ISO 9001 QMS certification requirements concerning why we need to devise periodic internal audits. As per clause 9.2.1 of ISO 9001 standard, the internal audit is mainly devised to perform two important functions in any organization:
To ensure that all existing and newly implemented processes are meeting the scheduled arrangements that an organization has devised for those processes in line with ISO 9001 QMS and any necessities that the ISO certification standard has in place for that process.
To ensure all processes are successfully implemented and strictly follows ISO 9001 QMS needs and requirements and those are maintained without any hurdles.
So, when you are drafting an internal audit checklist you should incorporate the data and information required to ensure that you successfully check these 2 outcomes of the process.
How does one draft an internal audit checklist to ascertain conformity of ISO 9001 QMS?
An internal audit is predominantly implemented to ascertain the efficiency and result of a process through a thorough review of records or witnessing the actions of your organization's workforce, which is then compared with the scheduled arrangements for your organization's process to check if what is being done is what was planned. As mentioned above, there are two sets of planned and scheduled arrangements to check: improvements needed by ISO 9001 QMS standard and improvements or modifications that an organization has put in place for their process to operate.
For example, if you're assessing buying process flow in accordance with ISO 9001 QMS standard (section 8.4.1), you will need to substantiate that external suppliers are selected, monitored, and evaluated on the basis of their ability to supply processes or products and services in line with ISO 9001 requirements. This is often ISO 9001:2015 demand that an organization or company may additionally specify that this can be done using an extensive audit of the customers every two or three years, which would be company-defined criteria for the process.
From this, any organization will be able to jot down or draft an internal audit checklist. An internal audit checklist is essentially a group of questions that the auditor desires to raise or activities that the auditor desires to witness, so as to verify the scheduled arrangements as are being implemented and followed strictly. The checklist is drafted by reviewing the ISO 9001 QMS standard and any documented procedures or unplanned processes for the activity to work out what ought to happen. For the instance above, the internal audit checklist may embody questions on supplier analysis and a review of the supplier audit reports that are collected to check if they are done when determined by the QMS.
An internal audit checklist can include more than just simple questions; it can even include statements concerning procedures that the auditor desires to examine. It will very helpful if you keep in mind that an internal audit checklist could be a tool for the auditor and not something to allow the auditee to fill out. Therefore whatever the format or queries and statements are going to be beneficial for the auditor to implement in order to ensure that all vital components of the process are strictly monitored.
How can you tell if the process is effective?
This is the main part to check the efficiency of the internal audit. This part of ISO 9001 QMS internal audit necessities could be trickier to evaluate. However, depending on the process, an implementation may also be quite straightforward. Several organizations use the idea of key performance indicators (KPI) for the processes when fulfilling ISO 9001 QMS requirements to assess and analyze performance. This idea is for the process owner to possess one or many main measures for his or her organization's process that may allow them to apprehend that the process is functioning impeccably.
Why should use internal audit checklists?
While the ISO 9001 QMS standard doesn't encompass the needs or requirements that state an internal audit checklist should be used. It's a helpful and effective way to document the queries you would like to raise to ensure that your process is functioning efficiently to meet the scheduled arrangements for your organization's process. When you are reviewing your process plans you will be able to narrow down what you wish to envision, and during this approach, you will be able to ensure that nothing vital is left out.
