ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
In order to ensure the safety and efficacy of medical devices, manufacturers must comply with the requirements of ISO 13485:2016. This international standard provides guidance on quality management systems specifically for the medical device industry. In this article, we’ll take a closer look at what ISO 13485:2016 requires and how it can benefit manufacturers.
What is ISO 13485:2016 ?
ISO 13485:2016 is an international standard that specifies requirements for a quality management system (QMS) for the design and manufacture of medical devices.
The standard is designed to help organizations ensure that their medical devices are safe and effective. It can be used by any organization that designs, manufactures, or distributes medical devices.
ISO 13485:2016 is based on the ISO 9001:2015 quality management system standard and draws from other international standards, such as ISO 14971:2007 ( Risk Management for Medical Devices).
The standard was first published in 2003 and was updated in 2016 to reflect the latest changes in the medical device industry.
Organizations that are certified to ISO 13485:2016 can use the certification to demonstrate to customers and regulators that they have a QMS in place that meets the requirements of the standard.
What are the requirements of ISO 13485:2016 ?
The requirements of ISO 13485:2016 are designed to help organizations develop and implement quality management systems for medical devices. The standard covers all aspects of medical device development, production, and distribution.
ISO 13485:2016 is based on the quality management principles of the ISO 9000 family of standards. It can be used by any organization that manufactures, distributes, or provides services for medical devices.
The standard includes requirements for risk management, product development, production control, post-market surveillance, and product recall. Organizations that implement ISO 13485:2016 can use it to demonstrate their commitment to quality and safety in the medical device industry.
Audit checklist for ISO 13485
- Does the organization have a quality management system in place that meets the requirements of ISO 13485?
- Is the quality management system appropriate for the organization’s size, structure, and activities?
- Are the processes and procedures in the quality management system followed by all employees?
- Is the quality management system regularly reviewed and updated as needed?
- Are audits of the quality management system conducted on a regular basis?
- Are corrective and preventive actions taken when problems are identified during audits or at other times?
- Is there evidence that the quality management system is effective in improving the organization’s performance?
What are the benefits of ISO 13485:2016 ?
There are many benefits of ISO 13485:2016, but some of the most notable ones include:
- Improved patient safety – One of the main goals of this standard is to improve patient safety by ensuring that medical devices are designed and manufactured in a way that minimizes risks.
- Greater market access – Many countries require certification to ISO 13485:2016 as a prerequisite for selling medical devices within their borders. This means that companies who are certified to the standard will have greater access to global markets.
- Enhanced reputation – Certification to ISO 13485:2016 can help to improve a company’s reputation by demonstrating their commitment to quality and patient safety.
- Increased efficiency – The standard can help companies to streamline their processes and procedures, leading to increased efficiency and productivity.
- Cost savings – Implementing ISO 13485:2016 can help companies to save money by reducing waste and rework, and improving the overall efficiency of their operations.
If you need more support with ISO 13485:2016, please contact us at +91-8595603096 or firstname.lastname@example.org