This article briefly explains the internal audit checklist that organisations use to get the ISO 9001 certification. It also explains why an internal audit is a must-have practice for businesses to successfully implement their QMS and get certified.

The ISO 9001 certification is nowadays considered a benchmark achievement of organisations that proves their compliance with the highest quality regulations. However, this also means that the certification is not easy to achieve overnight. It needs planning and a lot of expertise by the organisation’s management and employees to understand the specific ISO 9001 requirements and meet all of them. The requirements of the standard are nothing but practical and best guidelines that organisations should follow to become compliant and get certified. While many businesses become confused while meeting the vast requirements underlined by the standard in 10 clauses, an internal audit checklist is a useful tool that helps them to comply with each. For understanding the internal audit checklist, you need to understand what an internal audit is and what its purpose is in the ISO 9001 certification.

Internal Audit: What is It?

The ISO 9001 certification needs organisations to develop and implement a suitable and comprehensive Quality Management System (QMS). Now, when they have developed their QMS, they need to assure that it is compliant with all requirements of the ISO 9001 standard and stays so in the long term. Internal audit is a systematic procedure to thoroughly check and objectively review the QMS after it is implemented to identify its conformity level with the ISO 9001 requirements. It helps in knowing which requirements the QMS has met, partly met, or not met at all. Therefore, based on the observations of the internal audit, you can determine what corrections or modifications are required in the QMS.

With this being the primary reason for conducting an internal audit, you should be conducting it at regular intervals to ensure that QMS is consistently compliant with ISO 9001 and also to discover new opportunities for improving the QMS.

What is an Internal Audit Checklist?

To successfully conduct the internal audit and achieve its purpose completely, a checklist is necessary. It is a key tool for planning and carrying out the internal audit. The checklist comprises an important set of questions that are framed based on the QMS requirements of the ISO 9001. It includes questions for confirming both the processes as well as documentation of the QMS. The checklist must be created by the chief auditor who would lead the auditing process, appoint other trained auditors and coordinate with the employees in the quality management team.

Preparing the Internal Audit Checklist

While the internal audit checklist is necessary to use for assuring your certification compliance, it should be prepared carefully. The checklist must be prepared by considering the specific processes of your organisation, the ISO 9001 standard’s requirements, documentation and records needed to operate the QMS, and personnel involved in its operations.

The main purpose of the audit checklist is to put forth all questions ticking off which while assessing the QMS processes would ensure it is meeting the ISO compliance requirements.

Benefit of Using the Internal Audit Checklist

Internal audit is considered the steppingstone for successful certification and so following the checklist is necessary to make compliance easily achievable. With the checklist, the auditors would look for evidence to confirm that your QMS processes meet the defined requirements of the ISO 9001 standard. The checklist would include everything, including reviewing supplier processes, reviewing inputs, evaluation of production processes, evaluation of outputs, customer support services, and so on.

Reviewing the practical execution of all these processes along with the documents describing them is included in the checklist. Therefore, by following the checklist you are reviewing the QMS processes against the ISO 9001 obligations as well as confirming that the processes are working according to what is documented. Thus, if any nonconformance with the ISO 9001 or any discrepancy with documentation is noticed, the process owner can be immediately notified. Corrective measures or improvements are made to the process to make sure it conforms to the standard or is in line with the documentation.

In a nutshell, the main importance of using an internal audit checklist is to add value to your audit procedure and make it a driving force behind your certification success. While it is undeniably challenging to comprehend and meet all the complex ISO 9001 requirements all by yourself, an external agency can help you. They would provide you with the checklist and guide you on the internal audit procedure or can do it themselves with an experienced team of auditors. In any way, the checklist is crucial!

Author's Bio: 

Damon Anderson is the owner and lead consultant of a leading ISO certification consultancy in Australia that assists organisations in various industry verticals to get certified. He is a specialised consultant for ISO 9001 and has gathered enough experience in the ISO 9001 requirements, internal audit, documentation and compliance success which he likes to share through his write-ups.