What Are ISO Standards For Medical Devices?
Do they differ from other standards? What does production according to ISO 13485 mean? How can I work with an EMS provider that meets ISO 13485 standards?. Keep reading to learn more about the differences between ISO 13485 and ISO 9001. In this article, we will discuss the differences between ISO 9001 and ISO 13485 and the similarities and differences between the two. When it comes to creating and selling medical devices, knowing which standards to follow is crucial
. Whether a medical device is a standalone item or part of a larger system, ISO standards are a good choice for manufacturers. These international standards represent the state-of-the-art in a technological field. Ultimately, they form the building blocks of harmonized regulatory processes that ensure quality and safety across the globe. Knowing which standards apply to a given product is critical for a successful marketing campaign.
Health and safety management systems:
ISO 45001:2018 is a set of health and safety management systems for medical device manufacturers. The goal of this standard is to reduce liability and occupational accidents. Other standards used in the medical device industry include ISO 15223-1:2016, which sets out symbols for medical device labeling and packaging. ISO 16142-2:2017 identifies essential principles of the safety and performance of medical devices, and defines standards and guides for conformity assessment. Finally, ISO 18113-1:2009 specifies the general principles for information provided by a medical device manufacturer.
EU product directives require manufacturers to meet certain standards. The Medical Device Directive, Active Implantable Medical Device Directive, and In Vitro Diagnostics Directive are all examples. These standards are harmonized to European legislation and are published in the Official Journal of the European Union. These standards are also published on the EU’s official website. The EU publishes these standards on its website for consumers to see. Further, notified bodies must adhere to these standards if they wish to be allowed to sell their products.
What is the ISO 13485 standard?
When a medical device manufacturer becomes certified to the ISO 13485 standard, they are avoiding the pitfalls of non-compliant companies. ISO 13485 covers a range of medical devices, including those used for diagnosis, prevention, and treatment of various diseases and conditions. In addition, it ensures that the device is safe for use and has the ability to withstand the required rigorous tests. To ensure this level of quality, medical device manufacturers must adhere to the requisite regulations in their local area.
ISO 9001 has undergone its most recent revision in March 2016. It incorporates many new requirements, including the focus on risk, clarification of management and training responsibilities, and improvements to facility requirements. ISO 13485 also outlines requirements for traceability procedures and enhances product cleanliness. To help companies better meet the requirements of the medical device industry, ISO 13485 certification has helped numerous companies improve their quality management systems (QMS).
ISO 13485 versus ISO 9001: similarities and differ
ISO 9001 is a global quality management standard that is adopted by organizations of all types and sizes. It emphasizes risk management, an efficient infrastructure, and trained staff. ISO 13485 emphasizes safety throughout the lifecycle of a medical device. These are two different standards, but share many similarities. Listed below are the similarities and differences between the two standards. Read on to learn more about how to decide which one is best for your organization.
Both standards require a manufacturer to demonstrate compliance with regulatory requirements, but ISO 13485:2016 is more specific about how the product is developed and controlled. The new standard also requires a manufacturer to demonstrate that they meet the requirements for post-market surveillance. This requires a comprehensive management system for medical devices. ISO 9001:2015 only mentions regulatory requirements 11 times. It begins by providing information specifically tailored to the medical device industry. Also, It defines and uses 14 new terms. It also explains the differences between medical device manufacturers, as well as post-market surveillance.
What does production according to ISO 13485 mean in practice?
What does production according to ISO 13485 for medical devices mean? This standard for the manufacture of medical devices is unique to the industry. It maintains the role of quality representative in top management, whereas ISO 9001 removed this role. The standard also includes more requirements for monitoring external providers and a focus on risk. This means more attention from the certifying organization. To ensure that your production processes are in line with ISO 13485 standards, look for manufacturers that have a proven quality management system.
To meet these requirements, a manufacturer must document a process for developing and manufacturing a medical device. This plan must detail the design process and journey of the product. It should also contain information about the final product. All these factors must be documented so that any defects can be detected and corrected in the production process. The entire process should planned, controlled, and monitored. This ensures that all parts are of a high quality, consistent with the rest of the process.
Working with an EMS provider in compliance with IS
For manufacturers of medical devices, the first step in the process is working with an EMS provider who is in compliance with ISO standards for medical devices. This means identifying a qualified manufacturing location. The OEM will likely have a location in mind. This location must meet strict criteria and be certified to ensure quality and safety. Once this is done, the OEM will then begin the certification process. To achieve this goal, the EMS provider must work with the OEM to determine what requirements the EMS company will have for its product.
Once the EMS provider has established the necessary standards, OEMs should ask them about all processes they use, from engineering change orders to documentation. They should also answer questions related to product risk analysis, adaptation, and forecast variability windows. The process should also address multilevel supply chain management and provide a forum to exchange information. Once a product is in production, the EMS provider should be in close communication with the OEM to ensure quality and cost control. Here you can find more information about Medical Electronics Manufacturing: https://asselems.com/en/medical-electronics-manufacturing
