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Ensuring that your organization consistently delivers a high-quality product or service is one of the most critical activities any organization can engage in. Your customers expect that they’ll be getting what they were promised, each and every time, and your brand reputation depends on getting that right.
So, how can you be absolutely certain that your business is turning out consistent, reliable products and services? By leveraging proven standards and frameworks like those developed by the International Organization for Standardization (ISO) and regularly performing ISO audits to ensure you remain in compliance with them.
In this article, we’ll dig into what an ISO audit is, review some of the most widely-used ISO standards, and provide a framework for conducting your own ISO audits.
ISO audits assess whether your organization's processes, procedures, and management systems meet the standards set by the ISO. The ISO is an independent organization that develops internationally-agreed upon standards and best practices for managing a company’s technology, manufacturing, and management processes. Knowing whether your company meets those standards requires an ISO audit. Findings from ISO audits identify areas for improvement and help companies achieve operational excellence.
Conducting an ISO audit benefits companies in many ways:
ISO audits fall into three main categories: First-Party (Internal), Second-Party (Supplier), and Third-Party (Certification). Depending on your company's intent, size, budget, and resources, your company can choose the most suitable type of audit.
First-party internal audits are conducted within an organization to assess internal processes and procedures. These audits identify gaps in compliance, operational inefficiencies, and areas for improvement. Internal audits provide valuable insights to enhance the organization's performance and ensure adherence to ISO standards.
Typically, this is done as a first step to identify problems or issues that may need to be addressed before undergoing a third-party ISO audit to obtain certification. They’re also the type of audit you’ll be performing on an ongoing basis to ensure you’re maintaining ISO compliance at all times.
No matter how strictly your organization adheres to ISO standards within its own walls, it won’t mean anything if the third-party suppliers and vendors you contract with aren’t doing the same. Every bit of noncompliance in your supply chain trickles up to your organization and can affect the quality of your product or mean the difference between obtaining an ISO certification or not.
Second-party ISO audits assess how well your suppliers or vendors comply with the specific ISO standards you’ve chosen to implement in your own organization. These types of audits ensure that suppliers can deliver products or services that align with your organization's quality expectations.
Third-party audits are conducted by an independent certification body. These types of audits are designed to assess and certify whether an organization meets the requirements of a specific ISO standard.
Obtaining a third-party certification through a third-party ISO audit will make it a lot easier to demonstrate to customers, partners, and stakeholders that your organization has implemented and maintained the necessary quality management systems. That builds market trust and can generate a competitive advantage.
ISO standards detail guidelines and requirements for organizations to follow in specific areas of operation — and there are a lot of them. 24,850, to be exact. These standards advise the best way to manufacture a product, manage a process, deliver a service, or supply materials. Some standards are universal and apply to companies of any size or industry, while others apply only to certain businesses or industries. Here are some of the most commonly adopted ISO standards.
ISO 9001: This standard focuses on quality management systems, emphasizing customer satisfaction, continuous improvement, and effective processes.
ISO 13485: Specifically designed for medical device manufacturers, this standard sets requirements for quality management systems in the healthcare industry by demonstrating the company’s ability to provide medical devices and related services that consistently meet regulatory requirements.
ISO 14001: This standard addresses environmental management, helping organizations minimize their environmental impact and promote sustainability.
ISO 45001: This standard provides guidelines for occupational health and safety management systems to improve employee safety, reduce workplace risks, and create better, safer working conditions.
ISO 27001: One of the most well-known standards for information security, compliance with ISO 27001 safeguards organizations against data breaches and security threats. It provides guidance on establishing, implementing, maintaining and continually improving an information security management system.
ISO 22301: This standard focuses on operational resiliency and details requirements for a business continuity management system to protect against and improve recovery and response to business disruptions.
ISO 22000: This standard covers food safety management systems, ensuring the safety and quality of food products throughout the global supply chain.
ISO 50001: It provides a framework for energy management systems, helping organizations optimize energy use and reduce their environmental footprint.
No matter which ISO standards you intend to achieve certification for, you’ll need to carefully plan your audits to ensure that they’re successful.
Before undertaking an ISO audit, define the end goal of the audit and what you aim to achieve through the process. Is this a first-party audit, intended to gauge current compliance with the standard within your immediate organization? Or is it intended to evaluate your supply chain or achieve third-party certification? Each of these scenarios has a very different scope.
Start by identifying the ISO standard or standards that apply to your organization and define the audit scope. The scope should outline the areas, processes, and departments to be assessed during the audit. Setting clear goals and scope will provide direction to the audit team and ensure a thorough audit.
Whether your organization is seeking its first ISO certification or undergoing a recertification audit, create a detailed plan including timeline, milestones, and the necessary steps to fulfill the requirements of the ISO standard. Allocate the appropriate resources and budget, and identify key stakeholders to support the certification process. A well-structured plan will help your organization stay on track and avoid unnecessary delays or complications during the audit.
Appointing the right individuals to the audit team is crucial to a successful ISO audit. Ensure the assigned individuals possess the necessary skills and knowledge to carry the process out. The team should understand the ISO standard being audited at a deep level and have clear roles and responsibilities, with a lead auditor overseeing the entire process.
Investing in necessary training and education for your audit team members is vital to preparing for an ISO audit. Train audit team members to enhance their understanding of ISO standards, audit procedures, and industry-specific requirements. Training can be provided through internal workshops, external courses, or by hiring experienced consultants. Well-trained auditors will conduct more effective and insightful assessments, leading to a higher chance of a successful audit.
Use checklists to streamline the ISO audit process. Create detailed checklists for each stage of the audit, based on specific requirements and criteria outlined in the ISO standard, as part of your planning process. These checklists will guide the auditors during their assessments, ensuring that nothing is overlooked. Additionally, checklists make it easier to track progress and keep the audit team organized.
Efficient document control is crucial in any ISO audit. Put in place document management systems to organize and control audit documentation. Ensure that all relevant documents, records, and policies are accessible, up-to-date, and organized. A centralized audit and document management system, like LogicGate Risk Cloud, helps auditors quickly retrieve the necessary information and simplifies the ISO audit process.
Nothing grinds an ISO audit to a halt quite like having to wait days, or even weeks, for stakeholders in other departments to produce the evidence you need to conduct your audit. Identify ways to streamline this process to reduce the time to audit. Modern GRC platforms that support automated evidence collection can help you remove friction from this part of the process by having evidence automatically fed into your central repository from other business systems as work naturally progresses across the organization.
Conducting an ISO audit is not a one-time deal. Continuously monitoring and reviewing your organizational processes can identify areas for improvement and helps maintain compliance amid changing ISO standards and industry best practices. Implement a cadence for regularly reviewing and updating your ISO audits to maintain compliance with ISO standards. Conduct internal audits periodically to identify any deviations or areas needing improvement. Address non-conformities promptly and implement corrective actions.
ISO audits play a vital role in driving continuous improvement and enhancing organizational performance and growth. Here are some of the ways you can put the results of your ISO audits to use:
ISO audits often identify non-conformities and areas of improvement. Correcting these issues can ensure compliance and prevent recurring problems.
ISO audits provide insights into inefficiencies and areas for enhancement. By implementing the suggested improvements, your company can optimize processes, increase efficiency, and enhance overall performance.
Regular ISO audits identify outdated or ineffective policies and procedures. Updating and aligning with ISO standards helps your company maintain best practices.
ISO audits often uncover training gaps or areas where employees lack sufficient knowledge. By providing targeted training and education, your company can enhance employee skills and improve overall competence.
Conducting ISO audits manually or in sprawling spreadsheets is laborious, time-consuming, and prone to human error. Having the right GRC technology in place can drastically increase the likelihood that your ISO audits will be successful.
LogicGate Risk Cloud offers all of the functionality you need to streamline, automate, and scale the ISO audit process. Schedule a demo today to discover how Risk Cloud can help you shorten audit time, automate controls testing and evidence collection, and catch problems before the external auditors do.
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