ISO 9001:2015: The Ultimate Guide to Quality Management
ISO 9001 is the internationally recognized standard for Quality Management Systems (QMS), providing a framework for organizations to consistently meet customer and regulatory requirements. Implementing ISO 9001:2015, the latest version of the standard, enables companies to enhance customer satisfaction, improve process efficiency, and drive continuous improvement. This comprehensive guide will explore the key aspects of […]
ISO 13485 for Medical Devices: Everything You Need to Know
In the realm of medical device manufacturing, adherence to specific standards is not just beneficial; it’s imperative. The ISO 13485 standard represents a comprehensive quality management system framework designed for the regulatory requirements of medical device manufacturers. Its importance cannot be overstated, as it ensures devices are manufactured to the highest standards of quality and […]
Understanding CLAUSE 10 “IMPROVEMENT” ISO 9001:2015
ISO 9001:2015 Clause 10 emphasizes the importance of continual improvement, corrective actions, and addressing nonconformities within a quality management system. Key Takeaways Organizations are required to determine opportunities for improvement, implement necessary actions to meet customer requirements, and enhance customer satisfaction. Improvement actions should not only focus on current requirements but also on addressing future […]
Common Pitfalls in ISO 9001 Implementation
The benefits of ISO 9001 certification are clear. Certified companies have a more robust Quality Management System (QMS), higher employee engagement and customer satisfaction, and are more profitable. In fact, 69% of non-certified companies reported losing bids to ISO 9001-certified companies at least once. So, if you want to avoid this scenario, exploring common pitfalls […]
ISO 9001:2015 Requirements of the Standard Simply Explained
Introduction: What is ISO 9001? – Simply explained ISO 9001 is an internationally recognized standard for quality management systems (QMS). It specifies the requirements that a company must meet in order to establish and maintain an effective QMS. The main objective of ISO 9001 is to increase customer satisfaction through the consistent provision of products […]
New ISO 9001 amendment takes climate change into account!
The International Organization for Standardization updated its ISO 9001:2015 Quality Management System standard in 2024. The ISO 9001 Climate Action Amendment is in effect from February 23rd, 2024. But what does it all mean? Do certified organizations have to revamp their entire QMS? Are certificates issued before the amendment still valid? And how can organizations […]
Top 10 Reasons Why You Need ISO 9001 Certification
Are you an executive looking to improve your company’s performance? Do you want more profits? How about expanding to new markets? If you answered “yes”, you’re in the right place. Today, we look into quality management system certification and how it can improve all areas of your business. We will discuss the benefits and the […]
ISO 9001 Section 10 – Improvement clearly explained
“If you rest, you rust” – a well-known saying that applies not only to the human mind and body, but also to quality management systems. Such a system must never stand still, but must continually develop. ISO 9001:2015 emphasizes the need for continuous improvement in Section 10. Corrective measures and the elimination of non-conformities are […]
Understand ISO 9001 Chapter 7 Support
Summary Chapter 7 of ISO 9001:2015 emphasizes the importance of support from adequate resources to effectively establish, implement, maintain and continuously improve the quality management system (QMS). This support includes personnel, infrastructure, working environment and the monitoring and measurement of resources. Organizational knowledge also plays a decisive role in the success of the QMS. It […]
ISO 9001:2015 Clause 9 Performance Assessment
ISO 9001:2015 Clause 9 “Performance Assessment” establishes guidelines for monitoring, measuring, analyzing, and evaluating the QMS that enable organizations to make informed decisions based on objective data. By adhering to the goals of Chapter 9, companies can identify areas for improvement and increase customer satisfaction. The chapter focuses on evidence-based decision-making and continuous improvement. It […]
