Скачать с ютуб Understanding Quality Management Systems - ISO 13485 - Clause 7.4 - Purchasing в хорошем качестве

Understanding Quality Management Systems - ISO 13485 - Clause 7.4 - Purchasing

Welcome to our YouTube video on Clause 7.4: Purchasing of ISO 13485! In this video, we will explore this important clause in the ISO 13485 standard, which pertains to the purchasing process within a quality management system (QMS) for medical devices. If you're involved in the medical device industry or interested in quality management, this video is for you. ISO 13485 is an internationally recognized standard that sets out the requirements for a QMS specific to the medical device industry. Clause 7.4 focuses on the purchasing process and emphasizes the need for organizations to ensure that purchased products and services meet specified requirements. It outlines the essential steps and considerations involved in the purchasing process to maintain the quality and safety of medical devices. In this video, we will break down Clause 7.4 of ISO 13485 and discuss its key components. We will cover: Scope and applicability: We will provide an overview of Clause 7.3 and explain where it fits within the broader context of the ISO 13485 standard. Understanding the scope and applicability of this clause is crucial for organizations implementing ISO 13485. Purchasing process: We will dive into the various stages of the purchasing process outlined in Clause 7.4. This includes the identification of purchasing requirements, selection and evaluation of suppliers, establishment of purchasing information, and verification of purchased products. Supplier evaluation and selection: We will discuss the importance of evaluating and selecting suppliers who can consistently meet the organization's requirements. We will explore methods for assessing supplier capabilities, such as audits, performance evaluations, and quality agreements. Purchasing information: We will explain the essential elements that should be included in purchasing information to ensure clear communication with suppliers. This includes requirements for product or service specifications, purchase orders, and any relevant quality documentation. Verification of purchased products: We will highlight the need for organizations to verify that purchased products meet specified requirements. We will discuss methods for inspection, testing, and acceptance of purchased products to ensure their quality and conformity. Control of externally provided processes, products, and services: We will touch upon the requirements for managing processes, products, and services that are provided by external parties. This includes the establishment of controls, communication of requirements, and ongoing monitoring and evaluation. By following the requirements of this clause, you can enhance your organization's ability to consistently procure high-quality products and services for medical devices. Whether you are a quality professional, a medical device manufacturer, or simply interested in ISO 13485, this video will equip you with valuable knowledge and guidance on the purchasing process. Join us as we explore the intricacies of Clause 7.4 and its significance in maintaining a robust QMS for medical devices. Don't forget to subscribe to our channel and hit the notification bell to stay updated on future videos exploring other essential clauses of ISO 13485. Thank you for watching, and we look forward to helping you on your quality management journey! 🌐 *Connect With Us:* https://patientguard.com If you are looking for Quality Assurance Templates to help you with your Quality Management System then head over to: https://qmsregs.com