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ISO 9001 Audit Checklist

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We live in an increasingly regulatory environment, where companies are obliged to meet compliance, safety and also quality standards to operate in the marketplace. Consequently, it is important to keep up to date with all regulations particularly where goods or services are distributed internationally.

First introduced in 1987, ISO 9001 is an international standard for a quality management system (QMS). It is part of the ISO 9000 series but is the only standard in the series that offers certification to organisations. Indeed many organisations make it a requirement that suppliers are ISO 9001 certified before they will do business.

What should an Audit Checklist do?

An audit checklist, as it is commonly known, acts as a reference point so you don’t miss any necessary requirements during your ISO 9001 audit. It helps when building an audit checklist to think of it as similar to a product inspection. In this case, rather than a product, the management system your organisation uses will be inspected, but the basic principles remain the same.

The auditors will use a checklist created after reviewing the ISO 9001 requirements for the organisation, and the relevant process documentation. So while there are templates for ISO 9001 audit checklists, it is important that you adapt these to the processes used by your organisation.

How should an Audit Checklist be structured?

Simply put, your checklist should be a list of questions that might be asked during the audit and the information that the auditor will require in order to verify the performance of the process in question. So, what is the documented procedure, and what are the elements of the process? Is each part of the procedure understood, is it consistently applied, and does it support the overall effectiveness of the entire process? Does this then provide everything that is needed for the next process, if it feeds into another process?

What should Audit Checklist questions look like?

For example, part 1 of the ISO 9001 checklist looks at the Context of the organisation. To start with, the first question analyses strategic direction. Has the organisation identified issues, both internal and external, that will impact on the strategic direction of the company, and its ability to reach its intended goals? The finding will be supported with reference to documented information and suggestions for the OFI (opportunities for improvement).

As the audit progresses, the checklist will be worked through in a systemic way by the auditor, who will also check any findings with the organisation. It might be that missing documentation, for instance, such as a signed safety record which is in fact kept in a daily folder before being transferred to the timeline folder for that particular event. This is where an audit checklist helps not just the auditor, but also the auditee be prepared.

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