What Are the Three Types of ISO Audits?

The International Organization for Standardization (ISO) has established a framework for three distinct types of audits: first-party, second-party, and third-party. Among these, the third-party audit holds the key to ISO certification, signifying ISO compliance with specific ISO standards.

Audits play a pivotal role in contemporary corporate governance and risk management, and ISO standards represent a renowned and comprehensive framework that aids organizations in managing risk effectively.

In this article, we delve into these three types of ISO audits, shedding light on which ones are most relevant for your organization and the circumstances under which they are applied to ensure ISO compliance with the various types of ISO standards.

What Is ISO Auditing?

ISO Auditing, such as an ISO 9001 audit, systematically examines an organization’s operations, systems, and processes to ensure they adhere to the ISO standards. This includes the evaluation of a Quality Management System (QMS).

Internal auditors may conduct ISO Audits as internal audits or by external ISO auditors during a certification audit performed by a certification body.

The audit process involves assessing the organization’s documented procedures and performance against ISO requirements and identifying nonconformities and areas for improvement. These non-conformities need to be addressed through corrective actions.

An audit checklist guides the audit, and the results are documented and presented during a management review. The primary goal is to verify compliance with ISO standards specific to the organization’s ISO certification.

Why Is an ISO Audit Important?

ISO Auditing is crucial for several reasons, especially for organizations that aim to become ISO-certified:

Quality Assurance: ISO standards, such as ISO 9001, focus on establishing a robust Quality Management System (QMS), ensuring high-quality products and services. An ISO audit helps organizations maintain and improve their quality policy and meet quality objectives.
Compliance: Many industries require ISO certification to meet regulatory and contractual obligations. An external auditor may perform a certification audit to confirm submission. Please comply to avoid legal issues or loss of business opportunities.
Risk Management: ISO Audits play a significant role in risk management by identifying potential risks and areas for improvement. Addressing these findings helps mitigate operational, financial, and reputational risks.
International Credibility: ISO certification signals stakeholders that an organization follows global best practices. This enhances trust and facilitates international trade.
Cost Savings: By optimizing business processes and reducing waste, ISO Audits can lead to cost savings over time. Improved efficiency and reduced errors result in financial benefits.

ISO Auditing is essential because it ensures organizations operate by international standards, leading to improved quality, compliance, risk management, enhanced credibility, and potential cost savings. It is a valuable tool for businesses aiming to continually improve and maintain a competitive edge in a global marketplace.

What are the three types of audits?

First-Party Audits

First-party audits are the internal audits we mentioned earlier. Typically, they are performed by a company’s staff to measure how well the company is (or isn’t) achieving business objectives. This ISO audit is a conformity assessment to check for compliance gaps and to prepare an organization for an external ISO certification audit (that is, a third-party audit).

Usually, first-party auditors will be enterprise employees, but they shouldn’t be vested in the audit results.

Second-Party Audits

A second-party or external audit is usually performed at a customer’s request (often by an audit firm contracted to act on the customer’s behalf) on a supplier of products or services.

The second-party audit assures that the supplier is doing what it has promised to do based on the contractual agreements. In this case, qualified staff members or employees of an outside consulting firm can perform a second-party audit.

A company will likely want to combine the results of a second-party audit with its first-party audits so the company will know when it’s ready for an ISO certification.

Third-Party Audits

The third-party audit is a certification audit. An organization typically undertakes a third-party audit to achieve an ISO certification. During the certification audit, a “certification body auditor” (an auditor formally certified to perform audits for the ISO standard in question) assesses whether an enterprise complies with the appropriate ISO standard. If so, the certification body auditor will award the certification.

As part of this audit process, the auditor may:

Assess the company’s adherence to the ISO standard’s requirements. These could include (but are not limited to) time, temperature, responsiveness, and component mixture.
Look closely at the resources, methods, and environment the company uses to transform inputs into outputs and the criteria used to determine performance.
Examine the process controls to ensure they are both efficient and effective. The auditor may also take a closer look at daily operations and training procedures to verify that the expectations for the standard have been met.

Since most ISO standards that are eligible for certification govern systems (for example, quality systems, information security management systems, food safety management systems, and environmental management systems), ISO certification audits are generally system audits.

There are more than 23,000 ISO standards – including the ISO 9000 family of standards, which govern quality management systems. ISO 9001 is the only standard in this group eligible for certification. ISO 14001 offers direction on how to develop an effective environmental management system. ISO 27001/27002 is an information security standard. These represent just a few examples of ISO standards organizations may pursue for certification, including the corresponding surveillance audits.

Types of ISO audits

There are several types of ISO audits, each serving a specific purpose within the framework of ISO standards and management systems. Here are some of the most common types of ISO audits:

ISO 9001 (Quality Management System) Audit: This audit assesses an organization’s Quality Management System (QMS) to ensure compliance with ISO 9001 requirements, focusing on continuous improvement and providing quality products and services.
ISO 14001 (Environmental Management System) Audit: The ISO 14001 audit evaluates the Environmental Management System (EMS) to ensure compliance with ISO 14001 requirements and applicable environmental regulations, aiming to verify effective implementation and maintenance.
ISO 45001 (Occupational Health and Safety Management System) Audit: This audit ensures that the Occupational Health and Safety (OH&S) management system aligns with ISO 45001 requirements and relevant OH&S regulations, focusing on preventing work accidents and health impacts.
ISO 27001 (Information Security Management System) Audit: ISO 27001 audits focus on an organization’s Information Security Management System (ISMS), verifying compliance with ISO 27001 standards and regulatory requirements, emphasizing information confidentiality, integrity, and availability.
ISO 13485 (Medical Device Quality Management System) Audit: The ISO 13485 audit ensures compliance with ISO 13485 and various medical device regulations, particularly assessing an organization’s ability to maintain the safety, quality, and performance of medical devices.
Other ISO Management System Audits: Other ISO standards, such as ISO 22301 and ISO 22000, can be audited based on an organization’s specific products, services, business processes, and management systems. Depending on the organization’s goals and needs, these audits may encompass internal, supplier, and certification audits.

What Are the Benefits of a Third-Party Audit?

Investing in a third-party audit can demonstrate to potential customers that your information systems and business procedures follow strict security, availability, integrity, privacy, and confidentiality standards. Would-be customers can feel more comfortable working with you, knowing that your operations meet the rigorous ISO standards for performance.

This becomes even more true when considering cybersecurity and data privacy. Hackers are now a constant threat, and customers want to know before handing over valuable information to a business (such as yours) that it has taken serious steps for data protection. Achieving ISO certification gives them that assurance.

Is a Third-Party Audit External?

Yes. Independent auditors conduct third-party audits for a separate party’s benefit. An audit firm not connected to the supplier-customer relationship conducts a third-party audit without potential conflicts of interest.

What Happens During an ISO Audit?

An ISO audit involves a systematic assessment of an organization’s compliance with ISO standards and the efficiency of its management system. The process begins with meticulous planning, outlining the audit’s objectives and the specific ISO standards to be reviewed. An opening meeting sets the stage, where the audit team collaborates with the auditee, discussing the audit’s scope and agenda.

Auditors delve into a document review, scrutinizing the organization’s procedures, records, and policies to gauge their alignment with ISO standards. For on-site audits, auditors physically visit the organization’s premises, observing processes and conducting interviews with employees to gather firsthand information. During the audit, discussions are crucial to understanding the organization’s operations and identifying nonconformities—deviations from ISO standards requiring corrective actions.

Upon completion, auditors compile their findings, both positive observations and identified nonconformities, into an audit report. A closing meeting with the auditee provides a platform to discuss the results and any necessary corrective actions.

How to Prepare for Your ISO Audit

Preparing for an ISO audit is crucial in ensuring a successful audit process and demonstrating compliance with ISO standards. Here’s a step-by-step guide to help you prepare for an ISO audit:

Understand the audit scope, focusing on the ISO standard or management system to be audited.
Plan an internal audit program considering complexity, recurring issues, and process importance.
Select impartial auditors with a good understanding of audit standards.
Develop a detailed audit plan, including objectives, scope, schedule, and resources.
Gather necessary information and obtain the auditee’s cooperation for access.
Prepare an internal audit checklist to cover all necessary areas and evidence.
Review processes thoroughly for compliance with ISO standards.
Document findings, both positive and nonconformities, with evidence.
Collaborate on corrective actions for nonconformities and document them.
Use findings for continuous improvement and organizational enhancements.
Communicate results and provide necessary training.
Conduct follow-up audits if needed to verify corrective action effectiveness.

By following these steps and conducting internal audits regularly, your organization can better prepare for external ISO audits conducted by certification bodies. The internal audit process helps identify areas for improvement, ensure compliance with ISO standards, and demonstrate a commitment to maintaining a robust management system.

What Happens if Your Company Fails an ISO Audit?

If an organization fails an ISO audit, it must take corrective action to fix the problems. There are specific steps a company can take to remedy its problems and achieve ISO certification, including:

Analyze the situation. The auditor’s non-conformance report will describe whether there was a “minor non-conformance” or a “major non-conformance.”
- A minor non-conformance means the auditor has found gaps in the enterprise’s ISO compliance, but only a few. For example, the company didn’t follow one ISO requirement, or an individual didn’t have the necessary documentation to demonstrate compliance.
- A significant non-conformance indicates that the management system has a fatal flaw and needs to include something essential to achieve organizational goals or protect customers. For example, the company didn’t implement a primary procedure or requirement, or the organization needs to take the required preventive or corrective action to assure compliance.
Take corrective action. A minor non-conformance will ensure an organization achieves an ISO certification if the company immediately tries to rectify the problems outlined in the report. A significant non-conformance, on the other hand, denies certification. To achieve certification, the enterprise will have to schedule another audit.

Manage ISO Audits With ZenGRC

The ZenGRC compliance workflow management system is an easy, user-friendly tool for identifying high-risk areas before they become problems.

ZenComply’s workflow management tools simplify compliance paperwork via a real-time dashboard showing your control efficacy. By supporting your replies to auditor questions, you can create an audit trail while implementing corrective actions necessary to pass the audit.

ZenGRC’s single source of information platform reduces the need for follow-up requests from external auditors by supplying the required paperwork and facilitating stakeholder relationships with internal and external parties.

Schedule a demo to learn more about how ZenGRC helps businesses manage compliance.