In the world of manufacturing, the term ISO is becoming increasingly common. Standards change, as do customer demands and legal regulations. This signals that quality is becoming a higher priority, which is certainly a good thing! However, to comply with ISO standards, you must first achieve ISO certification through an ISO audit. In this blog, you will learn everything about ISO, audits, and certifications.
What is an ISO audit?
ISO stands for the International Organization for Standardization. In manufacturing, ISO provides the key standards to ensure the safety, efficiency, and sustainability of products and processes. To verify whether an organization meets a specific ISO standard, audits are conducted: these are ISO audits. Each standard can have its own separate ISO audit. In manufacturing, the ISO 9001 and ISO 27001 audits are the most commonly applicable.
During an ISO audit, the effectiveness and functionality of the quality management system are assessed. This is why ISO audits are often conducted internally to better evaluate internal processes. On one hand, an ISO audit is required to obtain specific ISO certifications, but on the other, it provides valuable insights for continuous improvement. Since ISO standards are rigorously reviewed every five years, conducting ISO audits is not a one-time action. Quality systems must be regularly reviewed to maintain ISO certification.
What is ISO certification?
The goal of an ISO audit is ISO certification. This certification tells the company and its customers that the organization’s quality system complies with the strict standards and requirements set by ISO. At the same time, the certification demonstrates that the organization adheres to legal and regulatory requirements concerning quality and production.
Each type of ISO audit has its own certification. This requires time and other investments from the organization. Even a well-prepared company should expect it to take several months to achieve certification. However, achieving ISO certifications also offers significant benefits. These include increased efficiency, optimized business processes, and an improved company image. Certifications like ISO 27001 and ISO 9001 can only be issued by a qualified party authorized to conduct these audits.
Why is an ISO audit important?
For companies looking to objectively assess their systems and processes, an ISO audit is an essential tool. It provides an objective assessment, offering valuable input to improve business processes. Additionally, an ISO audit provides better insight into how well international standards related to quality, environment, and safety are being followed. ISO audits are also useful for identifying risks. By checking whether standards are consistently followed, mistakes can be identified, corrected, and prevented in the future.
This control can be done easily through the use of checklists and forms for both the execution of process steps and the audits themselves. On top of these benefits, ISO audits inspire confidence among customers, partners, and suppliers. They show that a company takes quality and sustainability seriously, potentially leading to a competitive advantage and improved reputation. It is also important to remember that ISO certification is mandatory for certain markets.
Internal ISO audit vs. external ISO audit
ISO audits come in two forms: internal ISO audits and external ISO audits. These audits are conducted by different parties with different purposes. An internal ISO audit can be performed by employees of the company or designated internal auditors, who are independent of the processes being assessed. The purpose of an internal ISO audit is to verify if the quality management system complies with ISO standards, including ISO 9001.
Internal audits often identify potential areas for improvement, which must be addressed to kickstart a continuous improvement process. These audits are typically conducted regularly, such as annually or quarterly. For an external ISO audit, an independent and external body must be hired that is authorized to issue ISO certifications. This party assesses whether the ISO standards are adequately followed and whether the company qualifies for certification. Even after certification, this external body must confirm whether the certification can be renewed. Hence, external ISO audits also affect the retention of certifications.
What should you do during an ISO audit?
An ISO audit starts with preparing documentation, such as policies, procedures, work instructions, and records, which must be up-to-date and accessible to the auditor. Next, it is important to inform employees about the ISO audit and provide training, so they understand the audit’s goals and their own role. This helps them recognize how their tasks contribute to the quality management system and prepares them for potential questions from the auditor.
In the case of an external ISO audit, it is also advisable to conduct an internal audit first to identify and resolve any potential issues before the external audit takes place. Open communication is essential to ensure the audit runs smoothly. Provide access to documents, guide the auditors, and answer all questions honestly. If the auditor identifies issues requiring corrective action, address them immediately to meet ISO standards. After the ISO audit, all results are presented to management for collective analysis.
How can you prepare well for an ISO audit?
Preparation is key for an ISO audit. It is important to follow an ISO audit checklist to ensure no crucial steps are missed and that actions are taken in a practical order. Avoid losing time and resources due to well-known mistakes during ISO audits. To help you, we provide an ISO audit checklist and a list of common mistakes during ISO audits.
ISO audit checklist
For conducting ISO audits in manufacturing environments, the following ISO audit checklist can be used:
- Documentation check: Are procedures, work instructions, records, and quality policies up-to-date? Are process and quality objectives clearly documented and communicated?
- Process management: Are production processes carried out according to standardized procedures? Are process controls and measurement methods effectively implemented?
- Materials and inventory management: Is there a system for managing inventories, and are all incoming materials properly checked and recorded to keep inventory up-to-date?
- Product quality control: How is a production batch checked for quality and conformity? Are there procedures in place for handling non-compliant products?
- Maintenance: Is equipment maintained regularly, and are these records up-to-date and complete?
- Safety and environment: To what extent are safety and environmental standards followed? Are there measures in place related to waste management and energy efficiency?
- Training and competence: Is the need for training regularly reviewed and followed up on? Are employees trained and qualified to perform their tasks?
Common mistakes during an ISO audit
Several common mistakes still occur during ISO audits, but you can avoid them. Insufficient preparation and poorly conducted internal ISO audits are two examples. Another frequent mistake is the lack of evidence to demonstrate compliance with standards. Avoid starting an ISO audit with a management team that is not well-informed about the quality management systems, or that is overly focused on just achieving certification at the expense of actual improvement. Lastly, incomplete or misleading communication and failure to implement corrective actions are also common pitfalls. Stay quick, honest, and open in communication.
Questions about ISO audits?
Want to learn more about preparing for and conducting ISO audits? Or are you looking to improve and speed up the audit process? EZ Factory can help. With our EZ-GO platform, you can quickly use practical checklists and forms to easily track both audits and daily tasks for employees. The real-time insights provided by the platform allow you to access crucial data during audits. Perfect for use in production environments!