ISO 13485 Certification USA | SIS Certifications
Organizations involved in manufacturing and handling medical devices must comply with the standards set out in ISO 13485. ISO 13485 facilitates the implementation of the Quality Management System for Medical Devices (MD-QMS). It shows the competence of organizations to provide good quality and safe medical devices and relevant medical services which can meet the client and guarantee compliance with regulatory standards. ISO 13485 Certification in USA consists of establishing a quality management system for medical devices by identifying potential risks and documenting them efficiently.
ISO 13485 PRINCIPLES:
● Continual Improvement - Aimed at improving the interest of interested parties and the client. It will help support and sustain the customer, Increase customer base, ensure that needs and expectations are communicated by monitoring the company.
● Leadership- To meet quality objectives, leaders must establish a unity of goals by aligning their strategy, policies, procedures and resources.
● Engagement of People-To ensure effectiveness, it is possible to engage people at all levels by contacting employees about their needs within the company, sharing knowledge and experience.
● Process approach-When activities are understood and then implemented, the effectiveness of the outputs delivered will increase by understanding the capacity of organizations and identifying resource constraints before taking action.
● Improvement- Improvement is important for a company in order to maintain the current level of performance and even continue to develop. This can be done by giving appropriate training.
● Evidence-based decision making– Learning from mistakes is simply that decisions must be guided by the evaluation of data, which will make it possible to make more effective solutions by adding more. Intuitions must never be overlooked.
● Relationship management– Managing relations with other parties, one can achieve a well- managed supply chain that keeps a flow of resources stable.
