SafetyCulture Summit 2020

ISO 9001 Audit Checklists

Evaluate effectiveness of your organization's Quality Management System (QMS) through digital audits

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Published September 3rd, 2020

What is an ISO Audit?

An ISO Audit is an official assessment sanctioned by the International Organization for Standardization (ISO) to determine if a company fulfills a set criteria, usually for developing a product, or rendering a service. An ISO certification gives merit to companies, and protects consumers by ensuring that international safety, reliability, and quality standards are met.

In this article we will answer the following questions: 

What is an ISO 9001 Audit?

An ISO 9001 audit is done to ensure that the existing Quality Management System (QMS) complies with ISO 900 standards. The audit helps organizations identify and address issues, and discover potential improvements they can make with their QMS to ensure that best practice processes are in place. An ISO 9001 audit is conducted in two methods:

Internal Audits

This type of audit is by an assigned member of the organization to compare existing QMS with ISO 9001 standards. Performing internal ISO 9001 audits help organizations prepare for the external audit by identifying signs of non-conformance, and see opportunities for improvement to ensure that QMS processes meet requirements for certification.

External Audits

this type of audit is performed prior to obtaining ISO certification. It is conducted with the help of an external auditor. The auditor will verify and ensure that the organization’s documentation meets the requirements of the ISO 9001 standard. At the end of the audit, the auditor will recommend whether you’ll be granted a certification or require corrective actions before you can be accredited.

ISO 9001:2015 vs ISO 9001:2008 Checklists

ISO 9001:2015 was intended to focus on the PDCA (Plan, Do, Check, Act) management method. Therefore these checklists are structured in that format. The purpose of this was to mitigate against complacency but giving momentum to continuous improvements in quality management systems.

Furthermore, ISO 9001:2015 focuses on risk-based thinking rather than preventative measures. Therefore the checklists reflect this by focusing on analyzing situations that are specific to your organization and deciding individual actions based on that risk analysis. This ensures that potential risks can be identified and acted on accordingly, long before preventative measures become apparent.

What is an ISO 9001 Audit Checklist?

ISO 9001 Internal Audit Checklists can help assess the effectiveness of an organization’s Quality Management System (QMS) and the achievement of ISO 9001 certification requirements. Internal audit checklists are great tools to help implement a QMS and prepare for a third party ISO 9001:2015 certification audit. Learn more about ISO 9001 and QMS in our beginner’s guide.

Get started with this ISO 9001:2015 Gap Analysis and Internal Audit Checklist built using iAuditor – the world’s number #1 inspection software platform. Use iAuditor to assess your organization’s QMS and take note of gaps and areas of improvement, and assign actions to appropriate departments.


Erick Brent Francisco

SafetyCulture staff writer

As a staff writer for SafetyCulture, Erick is interested in learning and sharing how technology can improve work processes and workplace safety. Prior to SafetyCulture, Erick worked in logistics, banking and financial services, and retail.