ISO certification in Qatar assist the organisation to have an established management system which can handle each and every department with respect to International standards. ISO 13485 standard mainly focuses on the quality management system of medical devices. Design and implementation of the manufacturing sectors in the organisation must consider implementation of this particular quality management system ISO 13485 standard in their administration. ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. ISO 13485 adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance. Thus, it is more prescriptive in nature and requires a more thoroughly documented quality management system. ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose. The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a quality management system (QMS). Adopting ISO 13485 provides a practical foundation for manufacturers to address the regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.
The medical device manufacturing sector is one of the most regulated sectors in which significant quality systems and product requirements must be satisfied. The regulatory requirements are intended to ensure that manufacturers consistently design, produce, and place onto the market, medical devices that are safe and fit for their intended purpose.
High performing organizations expect ISO 13485 auditing to be thorough, fair, competent, relevant and challenging of the manufacturers quality management systems, effective auditing drives significant benefits to the manufacturer. The beneficial outputs of an effective audit include: Meaningful feedback on the effectiveness of the quality management system, Confidence in compliance with regulations, Identification of areas requiring attention, Confirmation that best practise is achieved, Detection of areas of non-compliance and possible risk, Reporting and certification that is valuable and recognized.
A medical device manufacturer’s quality management system is the foundation for maintaining regulatory compliance, driving improvement, effectiveness and achieving stakeholder confidence in the manufacturer and their products. The requirements of ISO 13485 provide the model quality management system building blocks of success.
Benefits of ISO 13485 certification in Qatar:
ISO 13485 is important to designers, manufacturers, and distributors of medical devices. In addition, suppliers and service providers can enhance an organization's marketability as more and more manufacturers require certification in order to do business with a vendor. When it comes to medical device manufacturing, patient safety greatly depends on the quality and consistency of medical products, and ensuring effectiveness, control and maintenance of your quality management system is critical to customers, stakeholders, patients and users, and regulatory agencies. The value of ISO 13485 is not just in the implementation, but also in providing a tool for a thorough audit to test the effectiveness of the system. It provides the manufacturer a higher level of confidence in the ability to consistently achieve and maintain compliance with regulatory requirements. Also, it can help to minimize surprises and failures which might adversely affect patient safety and damage a manufacturer's reputation.
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