Article Context:

1. ISO 13485:2016
2. Difference between QMS & ISO
3. ISO 13485 Software
4. ISO 13485 Risk Based Thinking
5. ISO 13485 Regulatory Requirements

ISO 13485:2016

As per  ISO 13485:2016, it has been specified that organizations should maintain a quality management system to assess and record their ability to provide medical devices and other related services that meet customer and applicable regulatory requirements.  

Effective Quality Management System (QMS) is not merely adhering to ISO 13485 regulations; it is beyond that. It is about the organization’s overall effort that has a comprehensive approach with perfect planning to execution. 

 A medical gadget can be as simple as a thermometer or as complex as a scanning machine that remotely monitors the functionality of vital organs in individuals. All medical devices, however, have to be of the highest quality standards that are internationally recognized. Therefore, it is expected that businesses adhere to the ISO 13485 medical device quality management standard right from the initial stages of making medical equipment.  

 A quality management system (QMS) that complies with ISO 13485 regulations does not merely happen if your company is involved in the creation of a medical device. Instead, it requires a focused organizational effort, careful planning, and a comprehensive work approach. 

Regular checks and immediate corrections, feedback from customers, and monitoring of the medical equipment are recommended in  ISO 13485 regulations

A quality management System requires diligent planning and should be incorporated by leveraging the resources to achieve the company’s objectives. Therefore, measurable goals have to be part of the quality policy. 

It is imperative to take utmost care to maintain quality whenever the company introduces new products, new markets are added, processes change, or products change—all reasons to embrace the idea of QMS planning with defined quality objectives. 

Difference between QMS and ISO 

 ISO 14001 is a global standard for environmental management systems that many organizations in different industries are implementing. QMS is a more specific environmental management system standard designed for the chemical, pharmaceutical, and other manufacturing industries. 

Is ISO 13485 applicable to software too? 

ISO 13485, also known as the ISO/IEC 13485:2003 Standard, is a widely accepted international standard for the quality management of software. It was developed in response to the growing demand for internationally recognized quality assurance standards for software. You must understand that ISO 13485 is intended to provide a framework for the management of software quality. It covers a wide range of topics, including : 

1. Requirements gathering
2. Software development
3. Testing
4. Documentation
5. Release management.  

ISO 13485 is not limited to software development. It can be applied to all type of software systems. Thus we can conclude that ISO 13485 is not a certification standard. It does not provide any kind of certification

ISO 13485 connected to Risk-Based Thinking

ISO 13485 is a globally recognized standard for the management of risks in the health and safety of people. It provides a framework for assessing risk, setting priorities, and implementing risk management plans. 

 Risk-based thinking is an essential component of risk management. It involves systematically and critically analyzing the potential risks to an organization and developing strategies to manage them. Risk-based thinking is a process, not a tool. It is not a one-time event but a continuous process that needs to be applied throughout the organization.

ISO 13485 a regulatory requirement? 

 ISO 13485 is a regulatory requirement for the quality management system of pharmaceuticals. It was initially developed in the United Kingdom and is now used worldwide. ISO 13485 sets out requirements for quality management systems for Pharma/biosciences industry and defines the necessary elements for a quality management system. It provides a framework for managing a pharmaceutical company’s quality assurance and quality control processes. 

 ISO 13485 has been adopted as a global standard for the quality management system of pharmaceuticals. It provides a framework for managing a pharmaceutical company’s Quality assurance and Quality control processes.

The risk-based approach in medical devices

Risk-based approaches to medical devices are becoming more popular as manufacturers and regulators strive to ensure the safety of products. A risk-based approach considers the potential hazards of a product and allocates risk accordingly. As a result, devices with more significant risk may be subjected to more stringent safety standards. 

 A risk-based approach can be used to evaluate the safety of a product from a variety of perspectives, including: 

-The potential for harm 

-The likelihood of harm 

-The severity of harm 

 When assessing the potential for harm, manufacturers may consider factors such as the type of device, the dosage, the route of administration, and the patient population. In addition, a number of factors can affect the risk of a medical device causing a harmful event. These factors can include the design of the device, the way it is used, the environment in which it is used, and the people who are using it. 

 Device design is one of the most critical factors in reducing the risk of a medical device causing a harmful event. The design of a medical device should include features that will help prevent it from causing a harmful event. These features can include features that prevent the device from being easily tampered with, features that prevent it from being accidentally activated, and features that prevent it from being damaged.

ISO 13485 Requirements

ISO 13485 is a set of requirements for quality management systems for healthcare organizations. It was developed in the 1990s and has been updated several times. The latest version, ISO 13485:2015, was published in 2015. 

 ISO 13485 is based on the concept of Quality Management and the ISO 9001 family of standards. It requires that healthcare organizations establish and maintain a quality management system (QMS) to ensure the quality of their products and services. 

 The QMS must include procedures for: 

 ISO 13485 is not a regulatory requirement but a requirement of many healthcare organizations. Many healthcare organizations have already implemented ISO 13485. 

ISO 13485:2016 is designed to respond to the latest quality management system practices, including technological changes, regulatory requirements, and expectations. It also emphasizes risk management and risk-based decision-making, as well as changes related to the increased regulatory requirements for organizations in the supply chain.