ISO 13485 Quality Management System for Medical Devices
Brief
The organizations that are involved in the manufacturing and handling of medical devices are required to adhere to the norms of ISO 13485 medical devices standard. ISO 13485 is a set of standards that helps in the implementation of the Quality Management System for Medical Devices (MD-QMS).
It demonstrates the competency of the organizations in delivering good quality and safe medical devices and relevant medical services that can fulfill the customer’s requirements as well as ensure compliance with the regulatory norms. The latest version of ISO 13485 Certification was published 2016 and hence, it is termed ISO 13485:2016.
ISO 13485 certification involves building a quality management system for medical devices by identifying the potential risks and documenting them effectively. The threats may arise from contamination of equipment or errors during handling. ISO 13485 provides for analyzing those threats and planning appropriate actions to prevent those risks.
ISO 13485 Certification Principles:
Customer focus – aiming to improve for the betterment of the interested parties and customer, this will help one sustain customer, increase customer base, makes sure to communicate their needs and expectation by monitoring throughout the organization
Leadership – to achieve quality objectives leaders need to establish unity of purpose which is by aligning its strategy, policies, procedure and resource this will lead to better coordination of the organization’s processes one needs to establish a culture of trust and integrity, provide people with the required resource, training, authority to act with accountability Engagement of people – for efficiency involve people of all levels, this can be done by communicating with the employees their needs in the organization, sharing knowledge, and experience, recognizing people’s contribution, learning, and improvement.
Process approach – when activities are understood and then executed then the efficiency of the delivered output will increase, by understanding organizations’ capabilities and determining resource constraints prior to action.
Improvement- improvement is important for an organization to maintain the current level of performance and to even keep on developing, this can be done by giving proper training and letting them understand that how does a work happens with that track, review and audit planning, implementation, recognize and acknowledgment, which will result into anticipation of internal and external risks and opportunity, improved process performance.
Evidence-based decision making – learn from mistakes, it is simply that decisions should be driven from evaluation of data, this will help one take better efficient solutions adding more, intuitions should never be neglected.
Relationship management – manage relations with relevant interested parties such as providers, one can achieve by keeping a well-managed supply chain that provides a stable flow of products and services, determining interested party’s relationship that needs to be managed.