Iso 13485 Requirements For Improvement Of Medical Device Management System

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ISO 13485 Certified means an organization has implemented an ISO 13485 Quality Management System and has successfully encountered all of the requirements in ISO 13485. ISO 13485 assesses whether Quality Management System is proper and effective while emphasizing the safety and efficacy of medical devices.
These days, many organizations associated with manufacturing of Medical devices decide to implement ISO 13485 system and get registration because it assures customers that the company has a good Quality Management System (QMS). An organization with an effective QMS, as per ISO 13485 requirements will characteristically meet customer expectations and it will be always better than an organization that does not have one. This is because the Goals and Purposes of the QMS take the customer needs into account. As goals focus on the customer, the organization spends less time concentrating on individual goals of departments and more time working together to meet customer needs.
ISO 13485:2016 provides the requirements for measurement, analysis and improvements of these processes including:
• General.
• Monitoring ...
... and Measurement.
• Control of nonconforming product.
• Analysis of data.
• Improvement.
General:
All organizations are essential to create a plan and then apply to the monitoring, measurement, analysis and improvement processes required in order to meet the conformity needs of the product, to ensure the conformity of the QMS, and maintain the efficiency of the QMS. Today experienced consultancy group sell a readymade ISO 13485 documents on the website that can help such organization in preparing and maintaining the records and documents.
Monitoring and Measurement:
As part of the requirements each organization is essential to monitor and measure a variety of information in order to improve their process and meet customer requirements this includes:
• Customer Feedback.
• Complaint Handling.
• Reporting to Regulatory Authorities.
• Internal Audit.
• Monitor and Measure processes and products.
Control of nonconforming product:
Organizations are essential to react to any product that is not in compliance to product requirements. Organizations want to identify and control these products to confirm that they are not used and distributed further. This process wants to be documented and maintained. Corrective and Preventive Action (CAPA) processes is an important part of the ISO 13485:2016 Quality Management System, it helps to precise non-conformances requires doing something different than the action that caused them.
Analysis of data:
The organization needs to collect and analyze proper data to determine the efficiency of the QMS. The procedures to determine this essential to include data collection and analysis, including statistics to help understand the extent of the QMS productivity. The analysis wants to include at a minimum: feedback; conformity to product requirements, characteristics and trends of processes and products, suppliers, audits, service reports.
Improvement:
Improvements are a critical part of the quality management system. ISO 13485:2016 needs all organizations to focus on continually improving. Overall, the organization wants to identify and implement any changes essential to maintain the effectiveness of the QMS, and the medical device safety and performance. Organizations essential to do this by quality policy, quality objectives, audit results, post-market surveillance, analysis of data, corrective actions, preventive actions, and management review.