The ISO 13485 standard is developed to meet the vast requirements for a Quality management system. It provides a foundation for manufacturers to address the requirements pertaining to the EU Directives, regulations, responsibilities as well as the commitment to the safety and quality of related to medical devices.
Certification to ISO 13485 is not only a requirement of the standard; organizations can reap many benefits from implementing the standard while going through the certification process. The certification process not only opens the doors of EU market for the Organization but it also gives product a quality symbol in the local business. All ISO standards are reviewed and revised regularly in order to keep it current and relevant for the marketplace. ISO 13485:2016 is latest quality management system standard which is designed to respond to latest technology and regulatory requirements.
Apart from taking up the certification of ISO 13485 for an organization, it is also necessary that each and every employee of the organization understands and follows the Particular standard the importance the basic requirements as stated by the ISO 13485.
That means that the employees of the organization should be given at least the foundation training of the standards so that once the certification is taken it can be maintained within the organization at each and every level. We have developed an in- house course specially aimed at imparting the foundation training of the standard.
During this training, you will be provided an introduction to the standard, including an overview of the purpose and requirements of ISO 13485:2016. Candidates will be helped to understand the intentions behind the revised management system standards. They will also be trained to apply the principles of quality management to an organization.
The course is being delivered by qualified experts and is aimed at anyone who is involved with medical devices and who has responsibility for developing and maintaining a quality management system (QMS).