ISO 9001:2015 Complete Audit Checklist

An ISO 9001 audit checklist is an indispensable resource for internal auditors in conducting and recording their audit activities, while serving as a handy way of measuring compliance with ISO standards.

Gaining ISO certification can bring great financial returns as customers build trust with your brand. But, getting there won’t be easy!

Preparation
Quality management systems (QMSs) are an integral component of modern businesses, helping ensure products and services meet both customer and regulatory expectations. Regular internal audits help evaluate the effectiveness of QMSs by providing information on areas of noncompliance as well as feedback about how effective their implementation has been.

Acquiring ISO certification can be a complex, time-consuming and demanding process, demanding the complete dedication and support from an entire organisation. Businesses seeking ISO certification should create a plan outlining exactly what needs to be done in order to meet ISO standards – with full backing from leadership teams throughout this journey.

First step of an audit program should be defining its objectives. These may relate to your management system, supplier, product or customer. Once this step has been taken, a detailed audit checklist can be developed and administered.

Auditing
Auditing involves inspecting resources (equipment, materials and people) and environments used to transform inputs to outputs and assess whether they meet ISO standards. Furthermore, process controls established through procedures, work instructions or flowcharts may also be examined to evaluate effectiveness as well as training adequacy and product specifications.

Internal audit results are documented and used to identify areas for improvement and corrective actions, which will then be implemented to optimize processes and increase efficiency, providing higher-quality products, better customer experiences and increased competitive advantages.

Once an internal audit has been successfully completed, businesses can then prepare for an external ISO 9001 certification audit. By ensuring their QMS is established and properly documented, businesses can increase their confidence that they can pass an external audit successfully and be better prepared to address issues raised by an auditor as well as start planning for improvements long before an external audit becomes necessary.

Reporting
Your auditor will conduct an in-depth evaluation of how ISO 9001 is being applied within your processes, also known as gap analysis, to ascertain whether your current system satisfies with standard requirements.

As soon as your documentation is in order, a certification body will conduct an on-site audit to confirm that it complies with ISO 9001 standards. This audit often occurs prior to ISO certification being granted and forms part of its three-year renewal cycle.

Once your business obtains ISO certification, surveillance audits with its respective certification body must take place every year until a new certificate or transfer occurs. During these audits, planning activities and broad system requirements must be reviewed to ensure compliance. During these reviews, areas needing improvement may also be identified and implemented – giving your business an added competitive edge by showing clients and customers your commitment to quality management.

Follow-Up
Once ISO 9001-certified, it’s crucial that your business demonstrates its dedication to quality by upholding this certification. Doing so will lead to long-term success for your brand while creating trust among consumers worldwide – as well as opening up global opportunities! However, maintaining an effective quality management system requires constant refinement.

Internal audits are an ideal way to accomplish this. A gap analysis can be an invaluable way of comparing your current quality management system against ISO 9001’s requirements, while creating immediate corrective actions and keeping an account of their results.

This template simplifies and streamlines audit preparation and record-keeping. It features a checklist for both process and clause audits, covering all ISO 9001:2015 requirements. Internal auditors or third-party auditors may use it, as it’s highly customizable according to company needs.