Mastering ISO Audits: Your Complete Guide to Success

Meeting compliance standards for the International Organization for Standardization (ISO) is crucial for many organizations. ISO audits are crucial for maintaining compliance and enhancing your organization’s quality management processes.

Numerous benefits of ISO audits can help transform your business and allow you to meet high-quality standards no matter what. This blog provides the ultimate guide to successful ISO audits to understand the importance of maintaining ISO compliance and quality. Read more to find out everything you need to know!

Understanding ISO Audits

A comprehensive ISO audit definition is crucial to understanding these audits and their role in quality assurance. Audit significance lies in its ability to evaluate and verify the quality and safety of products and services to guarantee compliance and quality. ISO audits test your company’s compliance with standards outlined by the ISO. These audits evaluate and confirm that your products and services are safe and secure, guaranteeing the quality of your offerings and proper service management.

ISO audits have five core objectives:

1. Determine the suitability of your company’s various regulations, standards, conditions, and implementation procedures.
2. Ensure consistency during implementations.
3. Seeking areas of improvement to develop processes and working conditions in your company
4. Complying with regulatory and statutory requirements
5. Fulfilling customer and market requirements

ISO standard 19011:2018 provides guidelines for correctly conducting an ISO audit for management systems.

The auditing process involves the auditor, the individual responsible for the audit, and the auditee, the individual being audited. Audits are measured against different ISO standards, such as the following:

• ISO 9001: Standards for Quality Management Systems
• ISO 14001: Standards for Environmental Management Systems
• ISO 45001: Standards for Occupational Health and Safety Management Systems
• ISO 50001: Standards for Energy Management Systems
• ISO 22000: Standards for Food Safety Management
• ISO 13485: Standards for Medical Devices
• ISO/IEC 27001: Standards for Information Security Management Systems

Types of ISO Audits

There are three core types of ISO audits: first-party audits (internal), second-party audits (supplier), and third-party audits (external). Below is a breakdown of these compliance audits:

First-Party Audits

First-party or internal audits are conducted by your company’s staff to determine how effectively you achieve your company goals. This audit determines relevant compliance gaps and is conducted to prepare for a third-party audit. This quality management audit checks issues like your organization’s risk management processes, resources, operation processes, quality objectives and policies, and other factors that might be considered in a third-party audit.

Second-Party Audits

Also known as external or supplier audits, a second-party audit is requested by the customer or purchaser on a supplier’s products or services. This auditing process guarantees that your company, as the supplier, meets quality standards and fulfills its contractual promises.

Second-party audits are often performed by consulting firm employees or qualified staff members. This audit can also be conducted by an audit team chosen by the customer. If your organization outsources its processes, the audit would involve you performing checks on your suppliers to evaluate their processes.

Third-Party Audits

Third-party audits, also known as certification audits, are typically conducted when your business wants to receive an ISO certification. This audit is carried out by a certification body auditor, an individual who is certified to perform audits for ISO standards.

In this audit, the auditor assesses your company’s compliance with the relevant ISO standard being audited. If your organization complies with this standard, you will receive ISO certification. This audit typically occurs over two stages. The first stage, the “desk audit,” determines the completeness of all documents against ISO standards. The second stage is the “compliance audit” portion and involves the auditor examining evidence of your compliance or noncompliance with ISO regulations.

ISO Audit Process: Step-by-Step

So, what does the ISO audit process look like in action? Taking the correct audit steps is crucial to ensuring that the process goes smoothly and you receive certification from the ISO. Below is what the typical ISO audit process looks like:

1. Schedule the audit and prepare for the process.
2. Choose verified auditors to conduct the audit.
3. Conduct an internal audit before the certification stage and collect reports from your internal auditing for compliance verification.
4. Take corrective actions to address any problems before the third-party audit.
5. Auditors will discuss the results after the scheduled third-party audit and provide certification if you meet all compliance standards.

Preparing for an ISO Audit

Preparing for ISO audit tests is stressful, especially if you aren’t sure where to begin. Testing your audit readiness is crucial to ensure you get the ISO certification you seek.

Compliance preparation should always begin with a gap analysis to determine if gaps exist between your current processes and ISO 13485:2016 requirements. Internal audits are also required and mandated by ISO, so conduct these audits frequently throughout the work year.

Along with frequent first-party audits, preparing for an ISO audit requires regular performance management reviews. These reviews ensure that core organizational processes adhere to your quality management standards.

If you notice any issues during your gap analysis, internal audits, and performance management reviews, take corrective and preventive actions (CAPAs) to address the problems before your certification audit.

Common Mistakes to Avoid in ISO Audits

People make several ISO audit mistakes during the auditing process, preventing them from receiving ISO certification. Avoiding errors during audits is possible if you understand the common mistakes that can occur throughout the process. Some standard audit pitfalls include the following:

• No proof of employee training according to training requirements outlined in ISO 9001 7.2
• No evidence of internal audits performed within your organization
• Not having enough evidence of previous CAPAs your organization has implemented or having an ineffective CAPA process
• Poor document control processes according to ISO 9001
• A lack of effective organizational management resources or processes

Best Practices for a Successful ISO Audit

Ensuring a successful audit and achieving compliance excellence is possible when you follow ISO audit best practices. Here are a few audit success tips to get you started on the right track:

• Prioritize thorough preparation
• Conduct internal audits on a scheduled basis
• Maintain a cohesive document control system
• Take corrective action when issues arise in your organizational processes
• Conduct gap analyses and mock audits
• Maintain transparency in your communication with ISO auditors and address their questions promptly
• Emphasize the importance of continuous improvement and show evidence of your company’s growth over time
• Train and engage with employees during the audit process
• Keep a continuous feedback loop between yourself, employees, and auditors

Conclusion

Mastering ISO audits is possible when you have a thorough audit summary and advanced quality assurance insights. Our ISO audit conclusion outlines three primary types of audits: first, second, and third-person audits. Thorough preparation for a third-party ISO audit is crucial to achieving ISO certification and maintaining compliance with ISO regulations. However, many companies encounter issues during auditing that can be avoided if you take proper steps.

i.e. Smart Systems has the resources you need to understand your ISO auditing requirements and prepare for future audits. Learn more about i.e. Smart Systems today!

i.e.Smart Systems is a Houston, TX based technology integration partner that specializes in design and installation of audio/visual technology and structured cabling. For more than three decades, our team of in-house experts has partnered with business owners, architectural firms, general contractors, construction managers, real estate developers, and designers in the Houston market, to deliver reliable, scalable solutions that align with their unique goals.