Everything You Need to Know About ISO Audit

Who is this article for?

• Manufacturing companies
• Technology and software companies
• Healthcare organizations
• Food and beverage companies
• Quality managers
• Operations managers
• Compliance officers
• Business owners and executives

These companies and roles are most likely to be involved in preparing for and undergoing ISO audits to ensure their products, services, and processes meet international standards for quality, security, sustainability and more. Achieving ISO certification provides a competitive advantage and is often required by customers.

What is an ISO audit and why is it important for your business?

An ISO audit is an objective evaluation to determine if your company’s quality management system (QMS) meets the requirements of a specific ISO standard, such as ISO 9001 for quality or ISO 27001 for information security. The audit is conducted by an independent, accredited certification body.

Undergoing an ISO audit and achieving certification is important for several reasons:

1. Ensures compliance: An ISO audit verifies that your QMS conforms to the standard, helping you maintain compliance. Studies have found that ISO audits unveil areas of non-conformity so you can take corrective action (Saizarbitoria et al., 2013).
2. Improves processes: Preparing for an audit gives you the opportunity to critically examine and optimize your processes. Research shows ISO audits lead to improved process performance and greater efficiencies (Pivka, 2004).
3. Enhances reputation: ISO certification demonstrates to customers, partners and other stakeholders that your products and services meet internationally recognized standards. This improves credibility and provides a competitive advantage.
4. Required by customers: In many industries, such as automotive and healthcare, customers contractually require their suppliers to be ISO certified. Meeting this requirement enables you to compete for and win more business.

What are the different types of ISO audits?

There are three main types of ISO audits:

1. Internal audits (first-party): Conducted by your own trained employees or a consultant to self-assess conformity to the ISO standard. This is a good first step to prepare for certification.
2. Supplier audits (second-party): When you audit your suppliers to ensure they also meet the requirements of the ISO standard. This is important since their performance impacts your own compliance and quality.
3. Certification audits (third-party): Performed by an independent, accredited certification body to achieve formal ISO certification. After initial certification, surveillance audits are conducted annually to maintain the certificate.

How do you prepare for an ISO audit?

Thorough preparation is key to a successful ISO audit. Here are the steps you should take:

1. Understand the ISO standard: Carefully review the requirements of the ISO standard you are pursuing certification for. Identify any gaps between the requirements and your current practices.
2. Implement a QMS: Establish a quality management system that meets all the mandatory requirements of the ISO standard. Document your processes and ensure they are being followed.
3. Conduct internal audits: Have your internal audit team review your QMS against the ISO standard requirements. Identify and correct any non-conformities.
4. Implement corrective actions: Address any areas of non-compliance found during your internal audits. Verify the effectiveness of the corrective actions.
5. Schedule the certification audit: Once you are confident your QMS fully conforms to the standard, contact an accredited certification body to schedule your audit.

What happens during an ISO certification audit?

During a certification audit, the auditor from the certification body will:

• Review your quality management system documentation to verify it meets all the requirements of the ISO standard
• Observe your processes in action to ensure they are being carried out as documented
• Interview employees to assess their understanding of the QMS and their specific responsibilities
• Examine records to confirm the effective implementation of the QMS over time
• Identify any non-conformities that must be corrected before certification can be granted

The length of the audit will depend on the size and complexity of your organization. After the audit, you will receive a report detailing the auditor’s findings, including any non-conformities that require corrective action.

How can Tallyfy help you prepare for an ISO audit?

Tallyfy is a powerful workflow management and process automation platform that can streamline your ISO audit preparation:

• Explain it once – AI-driven documentation: Easily document your processes to meet ISO requirements using AI-based guidance and templates.
• Real time tracking: Monitor the status of your ISO implementation and audit preparation tasks in real-time to stay on track.
• If this then that: Set up conditional rules to automatically route tasks and documents for review and approval, ensuring compliance.

Risks and challenges to watch out for with ISO audits

• Failing to fully implement the QMS requirements in daily practice, leading to non-conformities during the audit
• Inadequate training of employees on their roles and responsibilities within the QMS
• Lack of top management commitment and support for the ongoing maintenance of the QMS
• Treating ISO certification as a one-time event rather than an ongoing process of continuous improvement
• Choosing a certification body that lacks sufficient industry expertise to conduct a thorough audit

In conclusion, while ISO audits require significant effort and resources, the benefits of achieving certification are well worth it. By optimizing your processes, reducing waste, and demonstrating your commitment to quality and security, ISO certification helps you operate more efficiently, compete more effectively, and build greater trust with your customers.

Tallyfy’s customizable workflow templates and real-time process tracking make it easier to implement and maintain a robust QMS that will impress any auditor. Sign up for a free trial to see how Tallyfy can help you breeze through your next ISO audit.

What is an ISO Audit and Why is it Important?

An ISO audit is a process of evaluating an organization’s quality management system (QMS) against the requirements of the relevant ISO standard, such as ISO 9001 for quality management or ISO 14001 for environmental management. The purpose of an ISO audit is to determine whether the organization’s QMS conforms to the standard and is being effectively implemented and maintained.

ISO audits are important because they provide an independent and objective assessment of an organization’s QMS. This helps to ensure that the organization is meeting the requirements of the standard and is continuously improving its processes and performance. ISO certification can also provide a competitive advantage, as it demonstrates to customers and stakeholders that the organization is committed to quality and excellence.

According to a study by Saizarbitoria et al. (2013), the ISO 14001 certification audit process can be somewhat subjective and ambiguous, with auditors focusing more on procedural aspects rather than substantive improvements in environmental performance. This highlights the importance of ensuring that ISO audits are rigorous, independent, and focused on driving real improvements in organizational performance.

How Can Organizations Prepare for an ISO Audit?

Preparing for an ISO audit requires a systematic and proactive approach. Some key steps organizations can take include:

• Conducting internal audits to identify and address any nonconformities or areas for improvement
• Ensuring that all required documentation, such as procedures and records, are up-to-date and readily available
• Providing training to employees on the requirements of the relevant ISO standard and their roles and responsibilities in the QMS
• Engaging top management to demonstrate leadership and commitment to the QMS
• Communicating the importance and benefits of the ISO audit to all levels of the organization

According to Pivka (2004), conducting “value-added audits” that go beyond just checking compliance and also provide insights for improvement can help organizations derive long-term economic benefits from their ISO certification. This requires auditors to take a more holistic and strategic view of the organization’s QMS.

What are the Future Trends in ISO Auditing?

As ISO standards continue to evolve, so too must the auditing process to ensure it remains relevant and effective. Some emerging trends and technologies that may shape the future of ISO auditing include:

• Greater use of data analytics and artificial intelligence to analyze large volumes of audit data and identify patterns and trends
• Increased focus on risk-based auditing, where audit resources are targeted at areas of highest risk or importance to the organization
• More integrated audits that cover multiple ISO standards (e.g. ISO 9001 and ISO 27001) to create efficiencies and a more holistic view of the organization’s management systems (Hoy & Foley, 2014)
• Greater emphasis on auditor competence and soft skills, such as communication and relationship building, to foster a more collaborative and value-adding audit process
• Use of remote auditing techniques, such as video conferencing and drones, to conduct audits in a more flexible and cost-effective manner

By embracing these trends and technologies, organizations can ensure their ISO audits continue to drive real improvements in performance and deliver value in an increasingly complex and dynamic business environment. Having a robust and effective ISO audit program can help organizations streamline their processes, reduce costs, enhance customer satisfaction, and ultimately gain a competitive edge in their industry.

Related Questions

Who is responsible for ISO audit?

In most organizations, the quality management team is responsible for coordinating and managing ISO audits. This typically involves a quality manager or a designated ISO management representative who ensures that the company is prepared for the audit and that all necessary documentation and processes are in place. However, the actual audit is conducted by an independent, third-party auditor who is certified to assess compliance with the relevant ISO standards.

What is the ISO 9001 audit checklist?

An ISO 9001 audit checklist is a tool used by auditors to evaluate an organization’s quality management system against the requirements of the ISO 9001 standard. The checklist covers various aspects such as document control, management responsibility, resource management, product realization, and measurement, analysis, and improvement. It helps auditors ensure that all relevant areas are assessed and that the audit is conducted in a systematic and consistent manner.

Who audits ISO 9001?

ISO 9001 audits are typically conducted by independent, third-party certification bodies that are accredited by recognized accreditation bodies. These auditors are trained and qualified to assess an organization’s quality management system against the requirements of the ISO 9001 standard. They review documentation, observe processes, and interview employees to determine whether the system meets the necessary criteria for certification.

How to prepare for ISO 27001 audit?

Preparing for an ISO 27001 audit involves several key steps. First, ensure that your information security management system (ISMS) is well-documented and that all policies, procedures, and controls are in place. Conduct internal audits and management reviews to identify and address any nonconformities or improvement opportunities. Ensure that all employees are aware of their roles and responsibilities related to information security. Finally, gather all necessary documentation and evidence to demonstrate compliance with the ISO 27001 standard during the audit.

How to conduct ISO internal audit?

Conducting an ISO internal audit involves several stages. First, develop an audit plan that outlines the scope, objectives, and schedule of the audit. Then, select and train a team of internal auditors who are independent of the areas being audited. During the audit, review documentation, observe processes, and interview employees to gather evidence of compliance or nonconformity. Document all findings and communicate them to the relevant parties. Finally, follow up on any corrective actions and verify their effectiveness.

How to avoid common ISO 27001 internal audit mistakes?

To avoid common mistakes during ISO 27001 internal audits, ensure that your auditors are well-trained and familiar with the standard’s requirements. Plan the audit carefully and allocate sufficient time and resources. Focus on high-risk areas and processes, and use a risk-based approach to prioritize audit activities. Communicate clearly with auditees and maintain open lines of communication throughout the audit. Finally, document all findings and recommendations clearly and concisely, and follow up on corrective actions to ensure continuous improvement.

References and Editorial Perspectives

Ammenberg, J., Wik, G., & Hjelm, O. (2001). Auditing External Environmental Auditors—Investigating How ISO 14001 Is Interpreted and Applied in Reality. Eco-management and auditing, 8, 183 – 192. https://doi.org/10.1002/ema.165

Summary of this study

This study examines how external environmental auditors interpret and apply the ISO 14001 standard in practice. Through interviews with auditors from certification bodies in Sweden, the research reveals significant differences in how key requirements of the standard, such as determining significant environmental aspects and demonstrating continual improvement, are understood and assessed. The findings highlight the influential role auditors play in shaping the real-world implementation of ISO 14001.

Editor perspectives

As a workflow platform, Tallyfy is very interested in this study as it underscores the importance of clear, consistent interpretation and application of process standards. Variations in how auditors assess conformance to ISO 14001 could lead to disparities in the robustness of certified environmental management systems. This has implications for the credibility and value of the certification. Tallyfy aims to support organizations in adhering to standards and regulations in a systematic, auditable way.

Biazzo, S. (2005). The New ISO 9001 and the Problem of Ceremonial Conformity: How Have Audit Methods Evolved?. Total quality management and business excellence/Total quality management & business excellence, 16, 381 – 399. https://doi.org/10.1080/14783360500054145

Summary of this study

This paper examines the evolution of ISO 9001 auditing practices in light of changes to the standard and the problem of “ceremonial conformity” – superficial compliance without real quality improvement. Focusing on small and medium enterprises in Italy, the study develops behavioral indicators of performance-based auditing and finds traditional compliance-oriented approaches still prevalent. The authors argue national accreditation bodies must drive auditors to adopt methods that can unveil ceremonial conformity.

Editor perspectives

At Tallyfy, we recognize that the true value of standards like ISO 9001 lies in driving genuine performance improvement, not just achieving certification on paper. This research highlights the crucial role of the audit process in distinguishing between substantial and superficial conformance. As a workflow management tool, Tallyfy can provide the granular process visibility and consistency that enables organizations to move beyond box-ticking to meaningful adherence to quality standards.

Dogui, K., Boiral, O., & Saizarbitoria, I., H. (2013). Audit Fees and Auditor Independence: The Case of ISO 14001 Certification. International journal of auditing, 18, 14 – 26. https://doi.org/10.1111/ijau.12008

Summary of this study

This qualitative study explores how the fee structure for ISO 14001 certification audits, based on a “user-pays” model, may impact auditor independence. Through interviews with certification professionals, the authors find that while contractual obligations, ethical codes, and separating fee negotiation from the certification decision are seen as safeguarding independence, auditors do adapt their behavior to clients’ size and financial context. The paper discusses this as a potential conflict of interest, drawing parallels to financial auditing.

Editor perspectives

Tallyfy sees auditor independence as a cornerstone of the integrity and value of ISO certifications. This study raises important questions about how the economic relationship between auditors and their clients can subtly influence the certification process, even with policies in place to mitigate bias. As an impartial workflow tool, Tallyfy can help by standardizing and documenting processes in a way that supports thorough, consistent audits, regardless of client characteristics.

Hernández, H., H. (2010). Quality Audit as a Driver for Compliance to ISO 9001:2008 Standards. The TQM journal, 22, 454 – 466. https://doi.org/10.1108/17542731011053361

Summary of this study

This paper investigates how companies that began as R&D organizations and later moved into full operations can effectively implement and certify their quality management systems to ISO 9001:2008. Using a case study of an automotive industry supplier, the author argues that these types of companies require a unique approach, with quality audits serving as a key driver for achieving and maintaining compliance to the standard.

Editor perspectives

At Tallyfy, we’re fascinated by how different types of organizations navigate the journey to ISO 9001 certification. This study highlights that there’s no one-size-fits-all approach – companies with an R&D background may face distinct challenges in operationalizing quality management. The emphasis on auditing as a compliance tool resonates with Tallyfy’s focus on leveraging workflow management to embed quality processes into day-to-day operations, making adherence to standards a continuous, auditable practice.

Hoy, Z., & Foley, A. (2014). A Structured Approach to Integrating Audits to Create Organisational Efficiencies: ISO 9001 and ISO 27001 Audits. Total quality management and business excellence/Total quality management & business excellence, 26, 690 – 702. https://doi.org/10.1080/14783363.2013.876181

Summary of this study

This research proposes a framework for conducting integrated audits of ISO 9001 (quality management) and ISO 27001 (information security) systems. Through a literature review and testing in a commercial organization, the authors conclude that combining these audits can reduce the overall audit effort, number of audits, and resources required while still realizing benefits like process improvement. The paper provides a structured methodology for planning and executing integrated management system audits.

Editor perspectives

Tallyfy is excited about the potential of integrated auditing to streamline compliance efforts and drive organizational efficiency. As companies increasingly adopt multiple management system standards, tools like Tallyfy that provide a unified platform for process management and visibility can be a key enabler for audit integration. We believe the framework presented in this study offers valuable guidance for companies seeking to realize synergies across their ISO 9001 and ISO 27001 compliance programs.

Murmura, F., Liberatore, L., Bravi, L., & Casolani, N. (2018). Evaluation of Italian Companies’ Perception About ISO 14001 and Eco Management and Audit Scheme III: Motivations, Benefits and Barriers. Journal of cleaner production, 174, 691 – 700. https://doi.org/10.1016/j.jclepro.2017.10.337

Summary of this study

This study surveys Italian companies certified to ISO 14001 and/or EMAS (Eco-Management and Audit Scheme) to understand their motivations, perceived benefits, and barriers related to these environmental management system (EMS) standards. Key findings include a strong correlation between ISO 14001 and EMAS adoption, with larger, internationally-oriented firms more likely to pursue certification. Motivations and benefits were found to vary based on company size and certification duration. The research provides insights into effective EMS implementation.

Editor perspectives

At Tallyfy, we believe understanding the factors that drive and shape EMS adoption is crucial for supporting companies in their sustainability efforts. This study’s findings around the relationship between ISO 14001 and EMAS, and the influence of firm characteristics on certification outcomes, provide valuable context for tailoring workflow management to the needs of different organizations. Tallyfy’s customizable platform can help companies of all sizes operationalize and demonstrate conformance to environmental standards.

Pivka, M. (2004). ISO 9000 Value-Added Auditing. Total quality management and business excellence/Total quality management & business excellence, 15, 345 – 353. https://doi.org/10.1080/1478336042000183406

Summary of this study

This article argues that traditional compliance-oriented auditing of ISO 9001 quality management systems does not necessarily lead to improved competitiveness and business success. The author distinguishes between conformance auditing, focused on fulfilling standard requirements, and value-added auditing that incorporates a management perspective. Integrating these audit approaches is presented as key to realizing long-term benefits from ISO 9001, both for organizations in general and software companies specifically.

Editor perspectives

Tallyfy strongly resonates with the concept of value-added auditing presented in this paper. As a workflow management platform, our goal is to help companies not just achieve ISO compliance, but leverage the standard as a framework for operational excellence and continuous improvement. By digitizing and automating processes, Tallyfy enables a more holistic, management-oriented view of quality systems that can be carried through to the audit process, driving real performance gains.

Poksińska, B., Dahlgaard, J., J., & Eklund, J. (2006). From Compliance to Value-Added Auditing – Experiences From Swedish ISO 9001:2000 Certified Organisations. Total quality management and business excellence/Total quality management & business excellence, 17, 879 – 892. https://doi.org/10.1080/14783360600595294

Summary of this study

This study examines the auditing practices and perceived value of ISO 9001:2000 certification among Swedish organizations. Survey results indicate that while audits help improve quality management systems and motivate quality work, companies want auditors to go beyond verifying compliance and provide improvement suggestions based on their experience. The research also finds variations in audit practices and certification requirements among different auditors and certification bodies, and notes improvements following the year 2000 ISO 9001 revision.

Editor perspectives

Tallyfy appreciates this study’s emphasis on the value-adding potential of ISO 9001 audits. We believe auditors can and should be partners in the continuous improvement journey, sharing cross-industry insights that help companies optimize their processes. At the same time, the findings around inconsistencies in audit practices underscore the importance of tools like Tallyfy in standardizing and documenting quality processes to ensure a robust, reliable foundation for certification.

Saizarbitoria, I., H., Dogui, K., & Boiral, O. (2013). Shedding Light on ISO 14001 Certification Audits. Journal of cleaner production, 51, 88 – 98. https://doi.org/10.1016/j.jclepro.2013.01.040

Summary of this study

This qualitative study of ISO 14001 certification in Canada questions the assumption that audits are necessarily objective, rigorous, and unambiguous. Through interviews with certification professionals, the authors find evidence of an “elastic” interpretation of the standard, with a focus on procedural rather than substantive aspects of environmental management systems. The research suggests a gap between the public perception and on-the-ground reality of ISO 14001 auditing, with implications for the credibility of the certification.

Editor perspectives

At Tallyfy, we believe in the power of standards like ISO 14001 to drive meaningful environmental performance improvement, but recognize that the audit process is critical to realizing this potential. This study’s findings of interpretive flexibility and procedural emphasis in audits are concerning from the perspective of certification integrity. As a workflow management platform, Tallyfy can help close the gap by making environmental processes more explicit, consistent, and measurable, enabling more substantive audit evaluations.

Sampaio, P., Saraiva, P., & Rodrigues, A., C. (2010). A Classification Model for Prediction of Certification Motivations From the Contents of ISO 9001 Audit Reports. Total quality management and business excellence/Total quality management & business excellence, 21, 1279 – 1298. https://doi.org/10.1080/14783363.2010.529367

Summary of this study

This research develops a model to predict whether an organization pursued ISO 9001 certification primarily for internal (e.g., quality improvement) or external (e.g., marketing) reasons based on the content of their audit reports. Analyzing reports from 100 companies, the authors find statistically significant differences between internally and externally motivated firms. The resulting classification model can infer a company’s main certification driver from audit report language, shedding light on the substance of their quality management system implementation.

Editor perspectives

Tallyfy finds this study fascinating for its innovative use of audit reports as a window into organizations’ ISO 9001 journeys. The fact that certification motivations can be reliably deduced from the auditor’s assessment speaks to the real impact of these drivers on the depth and seriousness of standard adoption. As a process management tool, Tallyfy aims to help companies pursue certification with a genuine continuous improvement mindset, using the audit as an opportunity for feedback and optimization.

Glossary of terms

Audit

A systematic, independent examination to determine whether an organization’s activities and results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve the organization’s policy and objectives. In the context of ISO standards, audits assess conformity to the requirements of the relevant standard.

Certification body

An independent, accredited organization that assesses and certifies an organization’s management system as conforming to the requirements of a standard, such as ISO 9001 for quality or ISO 14001 for environmental management. Certification bodies employ auditors to conduct the conformity assessment.

Continual improvement

A recurring activity to enhance performance. In ISO management system standards, continual improvement is a core principle,