Quick Guide to ISO 13485 Quality Management System
Discover QMS Requirements for Medical Device Development
The ISO 13485 standard details the quality management system (QMS) requirements for organizations involved in one or more stages of medical device development. It’s designed to ensure that devices consistently meet customer and regulatory requirements. If you’re wondering how the standard applies to your organization, our new summary will help. You will learn:
The purpose of ISO 13485 in medtech manufacturing.
The requirements for ISO 13485 compliance.
Key aspects of an effective quality management system (QMS).
How a digitized QMS facilitates ISO 13485 compliance.
Trusted By
Simplify ISO 13485 Compliance With MasterControl
With MasterControl quality management system (QMS) and manufacturing execution system (MES) software, you never have to sacrifice compliance to achieve efficiency. Our solutions are designed to ensure compliance with regulatory requirements, while also increasing operational efficiency. By natively connecting quality and manufacturing data in one powerful digital tool, MasterControl enhances data connectivity and provides real-time visibility into processes across the entire life cycle of your regulated products. Read on to learn how to add efficiencies, embed quality into manufacturing operations, and bring your life-changing products to market faster.
See what our users are saying
Understand the ISO 13485 standard
Gain valuable insight about ISO 13485 compliance in one helpful overview.
ISO 13485 Compliance FAQ
What are the key components of a Quality Management System (QMS) under ISO 13485?
A QMS is a variety of elements united to manage quality. It consists of a continuous improvement program, efficiency imperatives, methods to collect and analyze data for decision making, and documentation of all QMS processes.
How does ISO 13485 differ from FDA 21 CFR Part 820?
ISO 13485 requires manufacturers to have a quality manual that defines their QMS. The 21 CFR Part 820 regulation does not require a quality manual. Also, ISO 13485 is more risk management-focused than Part 820.
What are the benefits of ISO 13485 certification for medical device manufacturers?
When you’re ISO 13485 certified, your products stay on the market without issues, giving you stronger market competitiveness. Also, customers are more inclined to do business with companies that are ISO 13485 certified.
What is the role of risk management in ISO 13485 compliance?
The current version of ISO 13485 focuses heavily on active risk assessment and mitigation in quality processes. This includes documenting requirements and maintaining risk management records throughout the product’s life cycle.
Essential Components of ISO 13485 Requirements
ISO 13485 contains specific standards manufacturers must comply with. The following are key components of the standard.
-
Document Management
ISO 13485 has specific document management requirements for routing, approving, updating, reapproving documents, and removing out-of-date documents from circulation.
-
Risk Management
Manufacturers must apply risk management measures to product development, design change, manufacturing, corrective action/preventive action (CAPA), and post market surveillance. In addition, they need to create and maintain records of all risk management activities.
-
Equipment Maintenance
Medical device companies are obligated to ensure that all equipment used in the manufacturing process meets specified requirements for equipment maintenance, adjustment, cleaning, and use.
-
Design Control
ISO 13485 requires companies to ensure that products are always designed and assembled according to the specified user needs and engineering requirements. Manufacturers must continually check designs against requirements at each stage of product development.
Benefits of Digitizing your Quality Management System
Consistently Achieve ISO 13485 Compliance
-
Reliable Document Control
Simplify document control tasks by using an integrated, collaborative workspace in a secure architecture. You can automate document routing, revision control, storage, and archiving.
-
Effective Risk Management
Employ a digitally connected, data-driven approach to monitoring trends and identifying and mitigating risks before they result in costly delays, rework, or product recalls.
-
Proactive Equipment Maintenance
Prevent unplanned outages by automating processes such as monitoring and creating tasks before maintenance is due and creating reports of maintenance and calibration activities.
-
Error-Free Design Control
Integrate design control with your other enterprise systems, including enterprise resource planning (ERP), supervisory control and data acquisition (SCADA), laboratory information management system (LIMS), QMS, etc.
