ISO Audit: What is it & How to Prepare a Checklist

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.

What is an ISO Audit?

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.

Why Are ISO Audits Important?

ISO audits are essential for ensuring that an organization complies with internationally recognized standards for quality, security, and efficiency. These audits provide a systematic assessment of processes, identifying potential weaknesses and areas for improvement. By undergoing regular ISO audits, organizations can enhance operational effectiveness, strengthen cybersecurity measures, and demonstrate their commitment to best practices. Additionally, compliance with ISO standards boosts credibility with stakeholders, clients, and regulatory bodies, fostering trust and competitive advantage in the market. Ultimately, ISO audits help organizations maintain continuous improvement, mitigate risks, and align with industry expectations.

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.

ISO Audit Checklist

1. Documentation Review

☐ Verify that all policies, procedures, and manuals are documented and up to date.
☐ Ensure compliance with ISO-specific documentation requirements.
☐ Confirm document control processes are in place (version control, approvals, access).

2. Management Commitment & Leadership

☐ Assess top management’s involvement in ISO compliance and continuous improvement.
☐ Review the organization’s quality objectives and alignment with ISO standards.
☐ Verify the existence of an internal communication strategy for ISO-related matters.

3. Risk Management & Assessment

☐ Identify potential risks and mitigation strategies.
☐ Evaluate the organization’s risk assessment and management processes.
☐ Confirm that corrective and preventive actions are documented and implemented.

4. Employee Training & Awareness

☐ Ensure employees are aware of ISO requirements and their role in compliance.
☐ Check records of training sessions and certifications related to ISO standards.
☐ Verify the effectiveness of training programs through employee feedback and assessments.

5. Internal Audits & Compliance Monitoring

☐ Review internal audit schedules and past audit reports.
☐ Confirm corrective actions from previous audits have been implemented.
☐ Assess the effectiveness of internal auditing procedures.

6. Operational Controls & Processes

☐ Verify that operational processes align with ISO requirements.
☐ Assess workflow efficiency and consistency in meeting quality/safety/security standards.
☐ Ensure the use of key performance indicators (KPIs) for continuous improvement.

7. Incident Management & Corrective Actions

☐ Review incident reports and how they were handled.
☐ Verify that corrective actions are documented and resolved effectively.
☐ Check if lessons learned from past incidents have been integrated into processes.

8. Supplier & Vendor Compliance

☐ Assess the organization’s process for evaluating and monitoring suppliers.
☐ Verify that suppliers adhere to required ISO standards.
☐ Review supplier contracts and performance records.

9. Customer Satisfaction & Feedback

☐ Check for processes to collect, analyze, and act on customer feedback.
☐ Verify complaint resolution procedures and response times.
☐ Ensure customer satisfaction metrics are being monitored.

10. Continual Improvement & Performance Evaluation

☐ Assess whether continual improvement initiatives are in place.
☐ Review data analysis methods for measuring performance.
☐ Verify that improvement plans are being implemented and tracked.

What are the Three Main 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:

Internal Audits (First-Party)

Internal 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.

Supplier Audits (Second-Party)

Supplier 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.

Certification Audits (Third-Party)

Certification 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 Audit Types by Standard

ISO 9001 (Quality Management System) 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.

ISO 14001 (Environmental Management System) Audit

Objective: To ensure that an organization’s environmental management system (EMS) complies with ISO 14001 standards and effectively minimizes its environmental impact.

Key Audit Areas:
☐ Compliance with environmental regulations and legal requirements.
☐ Identification and assessment of environmental risks and impacts.
☐ Implementation of policies for waste management, energy conservation, and pollution control.
☐ Effectiveness of environmental objectives and performance monitoring.
☐ Employee awareness and training on environmental responsibilities.
☐ Documentation and record-keeping of environmental management activities.
☐ Preparedness for environmental emergencies and response plans.

ISO 45001 (Occupational Health and Safety Management System) Audit

Objective: To verify that an organization’s occupational health and safety management system (OHSMS) ensures a safe working environment and reduces workplace risks.

Key Audit Areas:
☐ Compliance with health and safety laws and regulations.
☐ Hazard identification, risk assessment, and control measures.
☐ Employee involvement in safety programs and consultation mechanisms.
☐ Implementation of safety training and awareness programs.
☐ Monitoring of workplace incidents, reporting, and corrective actions.
☐ Emergency preparedness and response procedures.
☐ Continuous improvement initiatives for workplace safety.

ISO 27001 (Information Security Management System) Audit

Objective: To assess the effectiveness of an organization’s information security management system (ISMS) in protecting data confidentiality, integrity, and availability.

Key Audit Areas:
☐ Risk assessment and management of information security threats.
☐ Implementation of security policies, procedures, and controls.
☐ Access control measures and data encryption practices.
☐ Incident management and response strategies for data breaches.
☐ Employee training on cybersecurity awareness and compliance.
☐ Physical and technical security controls, including network security.
☐ Compliance with legal and regulatory requirements related to data protection.

ISO 13485 (Medical Device Quality Management System) Audit

Objective: To confirm that an organization’s quality management system (QMS) for medical devices meets ISO 13485 standards and regulatory requirements.

Key Audit Areas:
☐ Compliance with medical device regulations and industry standards.
☐ Risk management processes for product safety and performance.
☐ Design and development controls to ensure product quality.
☐ Supplier evaluation and control for component and material sourcing.
☐ Manufacturing process validation and product testing procedures.
☐ Documentation of quality records, including corrective and preventive actions (CAPA).
☐ Post-market surveillance, customer feedback, and regulatory reporting.

These audits ensure organizations maintain compliance with industry-specific ISO standards, improve operational efficiency, and enhance customer trust while mitigating risks.

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.

ISO Audit Process

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.

What ISO Standards Apply to Information Security?

Information security is a critical concern for organizations across industries, and several ISO standards provide guidelines for safeguarding data and managing risks. The most relevant standard is ISO 27001, which establishes the framework for an Information Security Management System (ISMS). It outlines best practices for risk assessment, access controls, encryption, and incident response.

Other ISO standards that complement ISO 27001 include:

• ISO 27002 – Provides a detailed code of practice for implementing security controls.
• ISO 27701 – Focuses on privacy information management, helping organizations comply with data protection regulations like GDPR.
• ISO 27017 & ISO 27018 – Address cloud security and privacy controls for cloud-based services.

By implementing these standards, organizations can strengthen their cybersecurity posture, ensure regulatory compliance, and protect sensitive information from cyber threats.

ISO Certification

ISO certification is a process in which an independent certification body verifies that an organization meets the requirements of a specific ISO standard. This certification demonstrates a company’s commitment to quality, security, or compliance in areas such as information security (ISO 27001), environmental management (ISO 14001), and occupational health and safety (ISO 45001).

The certification process generally involves:

1. Gap Analysis – Identifying areas that need improvement to meet ISO standards.
2. Implementation – Developing and enforcing policies, controls, and procedures.
3. Internal Audit – Conducting self-assessments to ensure compliance.
4. Certification Audit – An external audit performed by an accredited body to verify compliance.
5. Ongoing Compliance – Regular audits and reviews to maintain certification.

Achieving ISO certification can enhance business credibility, improve operational efficiency, and build trust with customers and stakeholders.

How Long Does It Take to Become ISO Certified?

The timeline for ISO certification varies depending on factors such as organization size, existing processes, and the specific ISO standard being pursued. However, a general estimate for certification includes:

• Small Businesses (1-50 employees): 3-6 months
• Medium-Sized Organizations (50-500 employees): 6-12 months
• Large Enterprises (500+ employees): 12-18 months

The certification process involves documentation, employee training, risk assessments, internal audits, and external certification audits. Organizations that already have structured management systems may achieve certification more quickly, while those starting from scratch may require more time.

To streamline the process, companies can work with ISO consultants or certification bodies to ensure efficient implementation and compliance.

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.