Why The Iso 13485 - Medical Devices Quality Management System Important?

By Author: Charles Wilson
Total Articles: 128
Comment this article

p style="text-align: justify;">The ISO 13485 Certification can help you improve your overall performance, eliminate uncertainty, and increase market opportunities Whether you want to work internationally or expand locally. To use the ISO 13485 framework demonstrates your commitment to helping your company ensure continuous improvement and better operating procedures and Acquiring the required knowledge and skills.
It also shows that you understand the importance of the safety and performance of medical devices and how the Medical Device Quality Management System can ensure that, as a result of what leads to customer satisfaction. Similarly, The Framework of ISO 13485 can bring you new opportunities, such as working for large companies that offer high quality products and services. Companies will value your knowledge and expertise at this level, while enabling you to increase your leadership potential.
While ISO 13485 is based on the concept model of the ISO 9001 Plan, Do, Check, Act, it is designed to comply with the rule. It is more restricted to the environment and requires a fully ...
... documented quality management system. To deliver secured medical devices, The ISO 13485 ensures consistent design, development, production, installation. ISO 13485 is to support Medical Device Manufacturers in developing quality management systems for ISO 13485 that establish and maintain the effectiveness of their own procedures.
However, ISO 13485 can also be used by certification bodies that can assist in certification programs. ISO 13485 serves as a tool for organizations to improve and maintain their processes effectively. Organizations striving for sustainable development will benefit from this level by being able to provide safe and accessible medical devices and gain customer trust.
Your organization can obtain ISO 13485 Certification and compliance with ISO 13485 through a variety of methods. You can try to manage quality processes or use a system that incorporates a variety of different systems for staff training, quality measurement and document management. Under ISO 13485: 2016, Staff dealing with quality processes and special tasks need to have the necessary skills and strength to perform their roles. Skills can be acquired through education, ISO 13485 Auditor Training, skills development, and experience. So here are the ISO 13485 Training Requirements that standard requires are following:

You should write down how you will see the skills, training, and experience needed for each person. The frequency of training and how the information should be done should also be recorded.
Records of all training programs, such as certificates of attendance, attendance sheets, or knowledge tests, should be kept.
The effectiveness of the training should be assessed, such as testing for information, or inconsistent tracking caused by errors after the test has been performed.
Each participant in a critical process needs to be fully aware of the importance and significance of his or her work and its impact on product quality and quality goals.
For some skills, it is recommended that you have periodic training to maintain the high level of skills required in the organization.

Source:13485certificationprocedures.wordpress.com