ISO 13485:2016 Medical Device Quality Management
ISO 13845:2016 is an international set of standard quality management systems that ensures the designing, production, servicing, manufacturing, and installation of products, services, or medical devices adhere to it. All the medical device manufacturers, service providers, or component providers to medical device companies, manufacturers, on a contractual basis, are meant to follow ISO 13845 in order to maintain that quality standard and provide the best to the patient or user.
It plays a major role in maintaining consistency and bringing efficiency at every step. Along with this, it reduces the cost in order to make it accessible to the customers. With this, it becomes possible to find the risk related to health issues and ensure compliance by maintaining the regulations and quality standards. To know more, keep reading further.
ISO 13485:2016 Overview
ISO 13485:2016 is an international standard of quality management system for all the industries and organizations that are involved in producing medical devices for the healthcare sector. It checks whether the producers are adhering to the international quality standard or not, and checks all the major things, such as designing, production, installation, and servicing. It is an updated version of ISO 13845:2013 standard quality norms that is looking for better changes ahead.
What Are The Requirements Of ISO 13845?
There are a number of reasons that make it a major requirement for all users out there. Let’s have a look at all those below:-
- It helps in maintaining and establishing a documented qms
- Support in controlling all the important documents and records.
- It also helps in ensuring that all outsourced processes are under control and compliant.
- It brings a quality policy.
- It helps in conducting management reviews
- It brings major focus on customer and regulatory requirements.
- It helps in implementing contamination control on the major necessities.
- It brings the customer’s requirements to the front
- It validates the production process.
Major Trends And Updates In ISO 13485
There are various kinds of trends and updates that you can pay attention to. Here are a few of them mentioned below:-
- A committee draft related to ISO 13485 was circulated in 2023 -2024
- There will be an alignment with the modern digital technologies, which are AI and connected medical devices
- In 2024, the U.S. FDA finalized the rule that it will replace 21 CFR part 820 with ISO 13485:2016.
- Companies are rapidly shifting towards ISO certification in order to enter the global market easily.
- There are various kinds of organizations that are integrating audit tracking, training management, automated CAPA, and documented control.
- A major focus has been placed on software as a medical device.
Benefits of Implementing ISO 13845:2016
There are various benefits of implementing ISO 13845. We have mentioned some of the benefits of it below that you can pay attention to and understand how important it is to have.
- It helps in accessing the global market in an easy and convenient way.
- By using ISO 13845:2016, risk defects and failures can be minimized.
- By this, it will become easy to maintain the consistency of the product cycle, such as development, designing, manufacturing, and servicing.
- It gives a boost to better traceability and documentation related to medical devices.
- It ensures the safety of the patient and enhances regulatory credibility.
- It builds relationships of OEMs, contract manufacturers, and suppliers with big companies.
- With the help of feedback systems, customer can share their experience and feel satisfied with the service.
Sum Up!
This was all about the ISO 13845:2016 that sets the international standard for Medical Devices Quality Management System. By this, it has become easy to maintain the quality of the medical devices for the patients and the maintenance of a fair process of production in the companies. This is vital for the upcoming times too, as it promotes well-being in every possible way and is better for the quality of life and growth of the patients.