July 1, 2023

What is an ISO Audit?

Across the globe, organizations are held to different regional standards based on their own countries’ regulations. But global consumers – and global B2B buyers – need a common way to understand the organizations they support. We all require functional products, services, and systems; oftentimes, that translates to operational quality, safety, and reliability. This is where ISO, the International Organization for Standardization, comes into play. 

The pursuit of industry standardization and quality assurance has become increasingly vital for modern organizations. ISO helps to regulate and clarify certain operational standards to ensure consistency among organizations across the globe.

ISO sets the benchmark for global standardization of safety, efficiency, quality, and compatibility across products, services, and systems. For companies, achieving an ISO certification isn’t merely about showing an impressive label. It signifies a commitment to superior quality and trustworthiness. It provides stakeholders with the confidence that the business adheres to the most stringent guidelines. 

Because of this, in today’s competitive landscape, ISO audits are crucial. They confirm that a company’s operations and frameworks align with the rigorous ISO specifications.

Understanding ISO Audits

ISO audits are formalized assessments that enable organizations to evaluate their management systems per the standards set by the International Organization for Standardization (ISO). These audits are performed by external auditors from notified bodies certified by ISO, ensuring high objectivity.

The main goal of an ISO audit is to assess if a company’s operations and methodologies align with the requirements set out by the ISO standards. This includes examining the company’s recorded processes, watching how they’re carried out in real-time, and discussing with staff members to confirm they’re knowledgeable about and consistently adhere to these processes.

ISO audits hold significant value as they independently verify an organization’s commitment to quality, safety, and efficiency. This independent verification is crucial as it assures regulators, and stakeholders that the organization complies with internationally recognized standards.

The results of ISO audits are utilized across industries for different purposes. Regulators often rely on the results of ISO audits when making decisions about licensing and approvals.

Who Conducts an ISO Audit?

ISO audits are conducted by auditors from notified bodies, organizations recognized by national accreditation bodies to conduct ISO audits. These auditors have undergone rigorous training and certification processes to ensure they can effectively audit against ISO standards.

It’s important to distinguish ISO audits from inspections conducted by regulatory bodies. 

While both aim to ensure compliance with standards and regulations, the approach and focus differ. Regulatory bodies typically focus on enforcing compliance with laws and regulations, while ISO audits are more about ensuring continuous improvement and effectiveness of the management system.

The Role of ISO Audit Checklists

An ISO audit checklist is an essential tool used in the auditing process. It guides auditors through the elements that must be reviewed and evaluated during an audit. This ensures a systematic approach to the audit and enhances its effectiveness and efficiency.

The main goal of an ISO audit checklist is to comprehensively cover all pertinent areas, procedures, and facets of an organization’s management system during the evaluation. With the aid of this checklist, auditors are better equipped to address every essential aspect without missing key details, ensuring a comprehensive review.

When developing an ISO audit checklist, several considerations should be noted:

  • The checklist should be tailored to the specific ISO standard against which the audit is conducted. 
  • The checklist should reflect the unique operations, processes, and risks of the organization being audited. 
  • The checklist should facilitate the gathering of audit evidence and the documentation of audit findings.

Internal audit checklists are particularly useful for organizations conducting self-audits. These checklists help internal auditors maintain focus on the audit objectives, ensure all necessary areas are reviewed, and provide a record of the audit process and findings.

An ISO audit checklist typically covers various sections and processes depending on the specific ISO standard being audited. 

For instance, an ISO 9001 audit checklist might include sections on quality management system requirements, management responsibility, resource management, product realization, measurement, analysis, and improvement.

Exploring the Types of ISO Audits

ISO audits come in different forms, each with a unique purpose and focus. Here’s an overview of the various types of ISO audits:

First-Party Audit (Internal Audit)

First-party audits, commonly called internal audits, are carried out by the organization to determine its adherence to designated ISO standards. This entails setting up and organizing the audit, pinpointing the specific areas for review, and scrutinizing the organization’s methods, systems, and safeguards.

Areas typically checked during internal audits include quality management systems, operational processes, and risk management controls.

Second-Party Audit (Supplier Audit)

Second-party audits, often called supplier audits, require an organization to evaluate its suppliers against specific ISO standards. These audits are pivotal in mitigating supply chain vulnerabilities, guaranteeing product excellence, and upholding customer satisfaction. 

The primary areas of scrutiny include the supplier’s approach to quality management, their production techniques, and their practices concerning environmental management.

Third-Party Audit (Certification Audit)

Third-party audits, often referred to as certification audits, are carried out by unbiased external evaluators. Their primary role is to determine an organization’s alignment with particular ISO standards, aiming for certification. 

Typically, these audits are a two-step process – The initial Stage 1 audit gauges the organization’s preparedness for the full certification review, while the subsequent Stage 2 audit delves into the comprehensiveness and efficacy of the organization’s management framework.

ISO 9000 Quality Audit

The ISO 9000 Quality Audit examines objective evidence to determine an organization’s compliance with the ISO 9001 international quality management system standards. 

The audit focuses on leadership commitment, customer focus, the adequacy of resources, process approach, and continuous improvement.

ISO 9001 Quality Audit

The ISO 9001 Quality Audit involves a systematic examination to determine whether an organization’s quality management system suits and conforms to the ISO 9001 standard. 

This audit checks quality planning, quality control, quality assurance, and quality improvement.

How do I Prepare for an ISO Audit?

The first step in preparing for an ISO audit involves scheduling and planning the audit. The audit plan should outline what areas will be audited, who will be involved, and when the audit will occur. 

This planning phase is crucial as it sets the stage for a well-organized and effective audit. Audit complexity and frequency considerations should be considered during this stage. For instance, areas that present higher risks or have had issues in the past might require more frequent or detailed audits.

The selection and training of auditors is another critical aspect of audit preparation. The auditors should know the ISO standard being audited against and understand the organization’s processes and systems. 

They should also be trained in audit techniques to ensure they can effectively conduct the audit and document their findings. Preparing an audit checklist can help guide the auditors through the audit process and ensure all relevant areas are covered.

Conducting internal audits and performing a gap analysis against the ISO standards are proactive steps that organizations can take to prepare for ISO audits. Internal audits allow organizations to assess their compliance with the ISO standards and identify any areas of non-compliance. 

A gap analysis, on the other hand, involves comparing the organization’s current practices with the requirements of the ISO standards to identify any gaps that need to be addressed. By proactively conducting these activities, organizations can identify and address any issues before the external audit, thereby increasing their chances of a successful ISO audit.

What does an ISO Audit Entail?

The process of conducting an ISO audit involves several steps and requires careful planning, preparation, and execution. These steps include:

1. Communication with Auditees

Conducting an ISO audit begins with clear communication with the auditees. This involves informing them about the audit’s purpose, scope, and schedule. To encourage a cooperative environment, it’s essential to ensure that all parties involved understand what the audit entails.

2. Examination of Documented Evidence

The audit process then moves into the examination of documented evidence. This includes reviewing procedures, work instructions, records, and other documentation relevant to the audited areas. 

The aim is to evaluate whether the documented practices align with the actual operations and if they comply with the relevant ISO standards.

3. Evaluating Process Performance

The next stage in the audit process involves evaluating process performance against the ISO standards. This includes assessing how well processes are implemented, monitored and improved. A key part of this evaluation is assessing staff competency and the relevance of the audited areas.

4. Assessing Staff Competency

Auditors need to verify that staff members are adequately trained and competent and that their roles and responsibilities align with the organization’s objectives and the requirements of the ISO standard.

5. Addressing Identified Problems

Addressing identified problems and non-conformances is a critical part of the audit process. Any issues identified during the audit need to be documented, communicated to the relevant parties, and corrective actions initiated.

6. Role of Internal Audits and Management Reviews

Beyond the standard audits, it’s essential for organizations to undertake internal audits and managerial evaluations as integral components of their comprehensive quality management approach. 

Internal audits serve as pivotal mechanisms to oversee the performance of the quality management system (QMS). Simultaneously, management reviews grant senior leadership the chance to evaluate and refine the QMS’s alignment, completeness, and overall functionality, paving the way for significant improvements as needed.

Ensuring Compliance and Continuous Improvement

ISO audits are more than just a regulatory hoop to jump through – they’re an essential part of building trust, ensuring safety, and promoting continuous improvement in various industries worldwide. As the world becomes more interconnected, the role of ISO and its rigorous audits will only become more crucial.