ISO 13485 Software

ISO 13485 Standard: Requirements for Medical Device Quality Management Systems

ISO 13485:2016 is the set of requirements for a Quality Management System (QMS) for medical device manufacturers and their suppliers. It provides a harmonized model for creating and maintaining a QMS, and has been updated to include suppliers and incorporate risk.

These standards apply to manufacturers and any external party involved in design and development, production, storage and distribution, instillation or servicing of the device or related activities.

The requirements are applicable to organizations of all sizes and types, extending equally to external parties involved in the manufacturing process—under the responsibility of the organization.

How EtQ Reliance Helps Device Makers Meet the Latest Requirements of ISO 13485

The EtQ Reliance quality management platform is an integrated, configurable and easy-to-use solution designed to facilitate adherence to standards like ISO 13485. Here’s how Reliance can meet requirements while increasing efficiency and reducing compliance costs:

  • eValidation: FDA regulated companies are required to validate their systems. EtQ has released the eValidator utility to automate key steps of this process, cutting validation time by as much as 400%.
  • Corrective Action: Reduce the time needed to resolve adverse events with the visibility to take immediate action. Take a systematic approach to responding to adverse events and a proactive approach to preventing similar issues in the future.
  • Audit Management: ISO 13485 is being recognized by many countries as a global standard for audits and inspections. Automate the audit process and link it to reporting and improvement initiatives to ensure that compliance remains a top priority.
  • And more! See the full list of modules.
ISO 13485 Clause How EtQ Reliance Helps Medical Device Makers Meet the Latest Requirements of ISO 13485
Clause 4: Establishment of a Quality Management System and identify all the support processes and how they are interlinked, as well as applying a risk based approach to your QMS. EtQ’s Quality Management System Software (QMS) is designed to provide a comprehensive platform for managing and tracking all processes. For Medical Device companies, EtQ’s robust Document Control system provides the workflow and escalation rules to ensure that all documentation is managed and tracked and revision controlled.
Risk Based Approach to Supplier and internal processes. EtQ’s Operational Risk Management capabilities help to provide a risk-based approach to Quality Management systems, with Quantitative and Qualitative tools to foster systematic, object decision making.

In addition, EtQ’s Supplier Management Solutions provide a centralized way to manage all supplier agreements, materials and scorecarding to ensure your suppliers are meeting your quality objectives. Furthermore, leveraging EtQ’s Reliance Cloud Portal, you can directly interact with your suppliers in a secure, cloud-based environment.
Clause 5: Defines the management commitment by establishing a quality policy, Document all processes, and conduct regular management Reviews. For Medical Device organizations, leveraging document control processes that are interlinked help to provide a single source for all management commitments to Quality, including a quality policy. Furthermore, leveraging processes such as Quality Records and Meeting Management provide a centralized repository for Medical Device management reviews, complete with Action items and enhanced scheduling features.
Clause 6: This section involves the ability of the organization to manage and train knowledgeable personnel, and track acceptable levels of competency. EtQ’s robust Employee Training management solution provides an integrated approach to ensuring knowledgeable employees. Linking with the Document Control process, employees can automatically be notified of pending training requirements, take tests, and demonstrate their ability to be trained on newly release procedures and documentation.
Clause 6 also asks you to provide the infrastructure and the work environment that you need in order to meet product safety and performance requirements, to identify your health, cleanliness, and clothing requirements, and to establish arrangements to control products that are or may be contaminated. EtQ provides a comprehensive Environmental Health and Safety EHS solution that helps to ensure that you are not only meeting QMS processes, but you are integrating the Health and Safety requirements for compliance. EtQ’s EHS can be integrated with the QMS, providing a seamless EHSQ solution.
Clause 7: Involves the process of Product Realization, and how you will set product quality objectives, Design and Development processes, and communication with Customers and regulators for compliance. EtQ’s Quality Management System Software (QMS) helps to provide the foundation for product realization by documenting all product specifications with Quality in mind, setting up management of change initiatives for gathering post-market feedback into new product introductions as well as product Registrations.

In addition, leveraing post-market processes like Complaint handling provide an environment to collect customer feedback, and feed this information into Corrective Action as well as regulatory submission, such as eMDR.
Clause 7 also asks to determine your monitoring and measuring requirements, to select suitable monitoring and measuring equipment, to establish monitoring and measurement procedures, to prepare calibration and verification plans, and to protect your monitoring and measurement equipment. EtQ provides solutions to help in the monitoring and maintenance of your equipment and overall processes. With processes such as Calibration and Maintenance, Monitoring and Inspection, and others, you can schedule maintenance, monitor results and ensure your processes align with acceptable levels of quality and compliance.
Clause 8: Involves the concept of establish feedback methods and procedures, and to investigate complaints, take action, and report results. EtQ’s Complaint Handling System provides you with a centralized method for tracking incoming customer feedback, leveraging risk-based tools to filter and determine severity of those complaints, and submit them for action, and regulatory submission.
Clause 8 also concerns the ability to conduct regular Audits within the QMS, and how to measure and take action on findings. EtQ’s Audit Management solution provides you with a scheduled and ad-hoc method of conducting process-based audits, both internally and externally for the purpose of streamlining the audit process. Use templated reports to conduct audits, leverage EtQ’s mobile platform to conduct mobile audits and integrate with EtQ’s CAPA process for taking action.
Clause 8 also looks at the process of taking corrective and preventive action and to make any changes that must be made in order to maintain QMS suitability and effectiveness and ensure product safety and performance. EtQ’s CAPA process provides you with a centralized hub of investigating, assessing risk and taking action on both corrective and preventive risks. It provides integration with other processes, such as Nonconformances, Audits, Complaint Handling and others, and provides outputs to Management of Change and product quality initiatives.
Clause 8 Finally looks at analyzing data about your organization’s QMS in order to evaluate its suitability and effectiveness. EtQ features a centralized reporting solution that not only collects data from all areas of the QMS and helps you to assess the effectiveness of your program, but it also provides you with risk-based KPIs, dashboards, and regulatory compliance reporting to ensure that you are getting the full picture within your medical device Quality Management System.

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