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Jan 20, 2025

ISO Audit: What It Is and How to Prepare (Comprehensive Checklist Included)

ISO Audit: What It Is and How to Prepare (Comprehensive Checklist Included)

The need for a governing body for international standards was highlighted in 1946 in London as a direct response to globalization and increasing interconnectedness between countries.

Post that, sixty-five delegates from 25 countries met to discuss how international standardization would function. And in 1947, the ISO, or the International Organization for Standardization, was formed, with 67 committees that specialized in and focused on certain subjects.

The ISO plays a central role in global trade and commerce by setting quality, safety, efficiency, health, and environmental standards. These guidelines help organizations maintain consistency across their operations, boost efficiency, and strengthen customer trust.

They also make international trade smoother by ensuring compliance with global regulations, reducing risks, and addressing critical areas like sustainability, health, and safety. Along with minimizing risk, complying with ISO standards gives you a more competitive edge in the market by highlighting your reliability.

Companies are often required to perform regular audits to ensure that global standards are met. These audits involve careful and thorough examinations of their records to verify that all regulations are being followed.

This article will explore ISO audits, how the audit process works, and how to prepare for them with a comprehensive ISO audit checklist.

What are ISO Audits?

The ISO audit full form evaluates your organization's adherence to one of the regulations established by the International Organization for Standardization (ISO). The ISO, based in Geneva, Switzerland, decides on international standards and frameworks that outline industry practices in almost any field, ranging from car manufacturing to information security.

ISO 19011 provides the guidelines for auditing management systems, including quality and environmental management. It outlines audit principles, manages audit programs, and offers a framework for effective practices.

A company can undertake an ISO audit to verify that its internal processes adhere to global quality, security, and safety standards. These audits also ensure that management systems are implemented effectively.

Typically, two parties are involved in the process: the auditor and the auditee. The auditor carries out the audit on the company or person (the auditee).

During the audit process, auditors verify the following:

  • The suitability of regulations and procedures in the organization
  • Consistency in the implementation process
  • Areas of improvement
  • Compliance with regulatory requirements
  • Fulfill market demands and customer requirements

What are the Different Types of ISO Audits?

There are three different kinds of audits. These include:

Types of Audits

1. First-Party Audits

Organizations also perform internal audits on their own management systems. They are self-assessments that allow you to monitor your own management, compliance, and management effectiveness. They let you identify gaps in your business processes, areas of improvement, and more. They are also valuable in preparing for external audits.

First-party audits require you to outline your audit process management in your procedures, mentioning the purpose and frequency at which the internal audit will be conducted. Outsourced auditing teams or internal departments and auditors can carry them out.

These audits can evaluate ISO 9001:2015, ISO 45001, ISO 14001:2015, and others. You can also use them to identify gaps in your organization in areas like risk management, document control, management, and more.

2. Second-Party Audits

Also referred to as supplier audits, these are conducted by customers/purchasers of the company from which they receive products or services. These audits are typically unavoidable for any organization that has a purchasing process.

These audits check on suppliers' processes and their effect on their operations. They are usually carried out by audit teams appointed by the customer or purchasing party. Like first-party audits, they must be predetermined, communicated with the supplier, and integrated into the company's audit schedule.

3. Third-Party Audit

Certification bodies carry out third-party audits. They are also referred to as certification audits and help your company achieve certifications relevant to your industry's standards. Accredited certification bodies, like the ISO, must carry out these audits.

To qualify for a certification audit, your organization must present evidence that it has successfully implemented an audit management system for a certain period (usually two to six months, depending on the auditor).

Third-party audits are typically carried out in two stages. The first stage is known as a 'desk audit,' which checks the completeness of documents against the requirements of the standard.

The second stage is called the 'compliance audit'. Here, ISO auditors examine the company's documented information, procedures, records, and more. If the body finds nothing of concern, it will recommend your organization for ISO certification. A certificate will be issued, valid for three years. Following this, re-certification will be required.

How Can You Prepare for an ISO Audit?

ISO audits are usually conducted once a year, depending on the standard being checked. They cover all activities undertaken by your organization, especially those related to the ISO standards you adhere to and your management systems.

Having an ISO audit checklist can make your task much simpler. It will ensure that everything is in place to complete a successful audit.

Here are some guidelines to consider when preparing for an ISO audit 9001:

  • Prepare an internal audit to assess the status of your processes that will be audited. In this stage, your organization must consider the results of previous audits and the scope, frequency, and criteria of your upcoming audits. It is essential to consider any recurring issues you may encounter and the complexity of your procedures.
  • Next, your company must select impartial and objective auditors. Internal audits should be conducted by third-party individuals not affiliated with your organization or the evaluated area.
  • Essential points for an internal audit include understanding relevant standards, laws, procedures, and the areas that must be audited, including any processes that are to be outsourced.
  • After your company has conducted the internal audit, it will be better prepared for the actual ISO audit conducted by an external certification body.

Wrapping Up

ISO accreditation can be highly beneficial to your organization, establishing trust and ensuring that your processes are uniform, consistent, and of the highest standards. Taking the steps to be audit-ready (such as the ones mentioned above) can greatly improve your chances of a successful audit. However, the software and management systems you use are of equal importance.

If you are looking for a management system that will keep you audit-ready, consider Effivity. Our quality management software includes audit management tools to ensure that your organization streamlines processes, centralizes documentation, and adheres to global ISO standards.

Our audit management tools also keep you ready for internal and external ISO audits 9001. It defines a master internal audit schedule for different departments, defines audit plans and defines the location, auditor, and auditee, automates alerts to inform everyone of scheduled audits, and creates audit reports.

To learn more, visit our Effivity website today!


Kaushal Sutaria

Managing Director at Effivity Technologies
Kaushal Sutaria is an expert in strategic business management and an entrepreneur behind three global companies. His latest venture, Effivity Technologies, simplifies ISO standard compliance with innovative automation. Kaushal's dedication to best practices and mentorship has earned him clients in over 50 countries.

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