ISO 13485 and ISO 14971, sometimes referred to as ISO medical device standards, are the most widely recognized standards for producing medical devices. These standards are voluntary, but even countries (such as the United States) that enforce separate regulations encourage and expect medical device manufacturers to follow these standards as a matter of good manufacturing and business practice.
Due to the mutable nature of the industry, ISO medical device standards are often updated. ISO 13485:2003, the quality management system standard, was updated to ISO 13485:2016; ISO 14971:2007 is the current version of the risk management standard for medical devices.
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MasterControl quality and compliance software helps companies throughout the world in adhering to ISO medical device standards and in complying with FDA regulations, EU directives, and other regulatory requirements. It is an end-to-end solution that automates and connects all quality processes critical to regulatory and ISO compliance. Here is how MasterControl addresses ISO requirements:
Quality Management System: ISO medical device standards require the establishment of a quality management system, including quality procedures that are documented, controlled, implemented, and maintained. MasterControl Documentsâ„¢ provides a web-based electronic platform for a company's quality management system. It automates routing, review, and approval of documents, and provides a single location for all documents. It provides automatic revision control, so only the current version of SOPs and other documents are available in the system.
Training Control: Under these standards, personnel must have the right education and training for their jobs. The quality system must include a training process that defines acceptable levels of competence. MasterControl Trainingâ„¢ is designed to address training control requirements under ISO medical device standards and other regulations. It helps manage the training process more effectively by automating the assignment of training tasks, distribution of training materials, testing, and verification.
Nonconformance Management: A remedial process for correcting nonconformances is essential. Manufacturers must establish a procedure for handling nonconforming products, including documentation and correction. MasterControl CAPA is widely used by manufacturers to manage nonconformances, from initiation of a corrective and preventive action to investigation to closure. The CAPA process can be integrated with all quality processes so the system can track all quality issues that could potentially escalate to CAPA. MasterControl Nonconformanceâ„¢ is designed to automate the process for identifying, reviewing, and handling of nonconforming materials, parts, and finished products. Together, these solutions can be the foundation for a robust management of nonconformances.
Audit Management: ISO medical device standards consider internal audits critical to maintaining quality products. ISO 13485 requires medical device manufacturers to "plan and perform regular internal audits." Audit cannot be a one-time activity; it must be conducted regularly. MasterControl Auditâ„¢ streamlines the audit process by automating all recurring tasks, such as scheduling of audits, sending out assignments, and tracking them. It provides best-practice forms for gathering and tracking basic information (type of audit, lead auditor, objective and scope, etc.), as well as for tracking audit findings. The system also provides analytics and reporting capability to make the audit process more transparent.
ISO 13485 focuses on the establishment and implementation of a quality management system, while ISO 14971 provides risk management guidelines that apply specifically to medical devices. Together, these standards offer solid guidance on how manufacturers can produce safe products.
Risk Analysis: Manufacturers should establish a process for managing and controlling risks of their products. Risk analysis must be performed for every medical device, including documentation of the intended use of each product and characteristics that could affect safety.
Risk Control: Manufacturers should establish measures for controlling risks to an acceptable level. When risk-control measures are implemented, they must also be verified after implementation. Manufacturers should evaluate any residual risk based on their criteria of what is "acceptable risk."
MasterControl Risk™ provides a robust platform for compliance with risk management requirements found in ISO medical device standards. It provides a single location for all documentation and activities related to risk management, including electronic workflows, risk assessment forms, and analytics and reporting tools. When used with MasterControl Processâ„¢, all forms-based processes pertaining to risk assessment can be standardized and streamlined. Risk assessment processes can also be integrated with other quality processes that might impact risk.
MasterControl solutions are used by companies in regulated environments such as those under the jurisdiction of the FDA, EMA, MHRA, and MHLW, as well as by companies that adhere to ISO medical device standards. In addition to regulatory compliance, MasterControl helps organizations attain the following:
Increased Efficiency: Medical device manufacturers greatly increase overall efficiency and productivity by automating and streamlining quality and risk management processes.
Connectivity: With MasterControl, companies can connect all quality and risk assessment processes that are critical under ISO standards for an integrated approach.
Lower Compliance Costs: Investing in a robust electronic quality management system will help companies maintain constant inspection readiness and avoid (or at least minimize) costly CAPAs and reworks, if not adverse events, thereby reducing overall compliance costs.
To learn more about these standards or MasterControl's Quality and Audit software, please contact a MasterControl representative.