ISO 13485 education and training is essential for any business that develops medical devices. ISO 13485 is an international quality management standard for the development and production of medical devices. The ISO 13845 policy was first published in 2003 in an effort to unify ISO 13485 procedures. Prior to 2003, ISO 13845 information was scattered about the ISO industry and medical devices did not have a standard of measurement. Medical device manufacturers did not have a benchmark that was simple to follow and would guarantee adherence to FDA guidelines for medical device production.
ISO 13485 standards have become more visible as the health care industry as a whole is being overhauled. As such, ISO 13845 info is constantly examined by quality professionals to ensure consistency. ISO 13845 resources are also becoming more readily available to industry professionals and to the general public. Currently, the ISO 13845 procedure is customer-focused and maintains quality objectives. The purpose of training for ISO 13485 is to:
1. Learn ISO 13845 procedures
2. Get an understanding of what an ISO 13845 requirement is for all medical devices
3. Learn how to implement an industry ISO 13485 standard
Get ISO 13485 certification easilyISO 13485 certification is necessary for any company planning to produce medical devices and sell the devices in any region that requires ISO quality management. Even if a company is not in the medical device manufacturing sector, the certification is a good move as it ensures to the public that the organization is compliant with FDA and ISO guidelines.
Learn about 13485 training proceduresMaterials regarding training for ISO 13485 for establishing procedures are widely available via the Internet. Document style training manual procedures are not as widely available, but do exist.
Get ISO 13485 training using softwareDocument management, training, and management reviews are just some of the special features of ISO 13485 software. Customer complaint handling, audit controls, and supplier conformity are some of the other features of using ISO 13485 software. Software can simplify the ISO 13485 management process and can be cost-efficient.
- Multinational corporations should be cognizant of the ISO 13485 standards for each country as the standards may be specific. Although ISO 13485 is an international benchmark, companies should be aware of the rules and regulations of each country where medical devices are sold.