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Best ISO-13485 Compliance Tools, Checklists & Templates

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ISO 13485 is an international standard for quality management systems (QMS) specifically designed for the medical device industry. It outlines the requirements for organizations involved in the design, development, production, installation, and servicing of medical devices.

The purpose of ISO 13485 is to ensure that medical device manufacturers establish and maintain an effective quality management system to consistently meet customer and regulatory requirements. Compliance with this standard demonstrates a company’s commitment to producing safe and effective medical devices while maintaining a focus on quality and customer satisfaction.

In this article, we will discuss some great requirements management software organizations can use for ISO-13485 compliance, standard checklist, and essential templates.

Best ISO-13485 Compliance Tools

Visure Requirements ALM Platform

Visure Requirements is a widely recognized and trusted requirements management tool, particularly in the medical device industry. It offers comprehensive integration throughout the entire Application Lifecycle Management (ALM) process, encompassing essential areas such as risk management, issue and defect tracking, traceability management, change management, and more. The platform also extends its capabilities to quality analysis, requirements versioning, and robust reporting.

Renowned organizations in the medical device sector, including Glaxo Smith Kline (GSK), Solta Medical, and Health Net, have placed their trust in Visure as their requirements management solution. These esteemed clients bear testimony to Visure’s ability to meet their demanding needs and contribute to their success.

Visure Requirements excels in providing end-to-end support for risk management, enabling users to identify, evaluate, and mitigate risks associated with medical device development. It facilitates efficient issue and defect tracking, ensuring that problems are captured, managed, and resolved effectively. The platform’s traceability management capabilities allow for establishing and maintaining traceability links between requirements, design elements, tests, and other artifacts, ensuring compliance with regulatory standards.

Here are some key capabilities of Visure Requirements that are relevant to ISO 13485:

  1. Requirements Management: Visure Requirements enables you to capture, organize, and manage requirements in a structured manner. It allows you to define requirements, link them to applicable regulations and standards, and ensure traceability throughout development. You can track changes, perform impact analysis, and ensure that all requirements are adequately addressed.
  2. Risk Management: ISO 13485 places a strong emphasis on risk management. Visure Requirements offers built-in risk management features, allowing you to identify, assess, and mitigate risks associated with your medical device development. You can define risk criteria, perform risk assessments, and track risk mitigation activities, ensuring compliance with ISO 13485 requirements.
  3. Document Control: The platform provides robust document control capabilities, enabling you to manage documents and records related to your quality management system. You can create, review, and approve documents, ensuring version control and maintaining a centralized repository of controlled documents. This helps in meeting ISO 13485 requirements related to document control and record keeping.
  4. Traceability: Visure Requirements facilitates end-to-end traceability, allowing you to establish and maintain traceability links between requirements, design elements, tests, and other artifacts. This enables you to demonstrate traceability from user needs to design, verification, and validation, as required by ISO 13485.
  5. Change Management: With Visure Requirements, you can effectively manage changes to requirements, design, and other project artifacts. The platform supports change request tracking, impact analysis, and change control processes. This ensures that any changes made to the medical device development are properly evaluated, approved, and documented, aligning with ISO 13485 requirements.
  6. Reporting and Compliance: Visure Requirements offers reporting capabilities that allow you to generate custom reports and metrics to monitor project progress, traceability coverage, risk status, and compliance with ISO 13485. The platform provides pre-defined templates and dashboards, making it easier to track and demonstrate compliance during audits.
  7. Multi-tier Collaboration: Visure supports XML-based standards, like ReqIF and XRI, that help you in exchanging requirements between various different customers and suppliers. 
  8. Security: Visure ensures proper security of information and requirements. The tool does this through its rigorous access policy where only certain people can access the artifacts even at the elementary level. 
  9. Quality Analysis: Visure’s Quality Analyzer allows you to perform a semantic analysis of the requirements to identify the quality of the requirements. Therefore, if the requirement is low quality, the tool will automatically flag them with ambiguity or inconsistencies.

IBM DOORS

IBM Engineering Requirements Management DOORS can be effectively used to support compliance with ISO 13485 for medical device development. Here’s how IBM DOORS can assist in meeting the requirements of ISO 13485:

  1. Requirements Management: IBM DOORS provides a platform for capturing, organizing, and managing requirements. It enables users to define and document requirements in a structured manner, ensuring clarity and traceability. With DOORS, you can establish relationships between requirements, track changes, and maintain a comprehensive requirements repository.
  2. Traceability: ISO 13485 emphasizes the importance of traceability in the medical device development process. IBM DOORS allows you to establish and manage traceability links between various artifacts, including requirements, design elements, tests, and risk assessments. This enables you to demonstrate traceability from user needs to design, verification, and validation activities, as required by ISO 13485.
  3. Change Management: IBM DOORS offers robust change management capabilities, allowing you to effectively handle changes to requirements throughout the development lifecycle. It supports change request tracking, impact analysis, and change control processes. This ensures that any modifications made to requirements are properly evaluated, documented, and approved, aligning with ISO 13485 requirements.
  4. Risk Management: ISO 13485 places significant emphasis on risk management. IBM DOORS provides features to capture and assess risks associated with medical device development. You can document risk criteria, perform risk assessments, and link risks to corresponding requirements. This facilitates the identification, evaluation, and mitigation of risks, as mandated by ISO 13485.
  5. Compliance and Audit Support: IBM DOORS includes features to facilitate compliance and support audits. It allows for the creation of customizable reports, metrics, and documentation to demonstrate adherence to ISO 13485 requirements. DOORS’ reporting capabilities assist in monitoring project progress, traceability coverage, and compliance with industry standards.
  6. Integration and Collaboration: IBM DOORS supports integration with other tools and systems used in the development process. This enables seamless data exchange and collaboration between different teams and stakeholders involved in medical device development. Integration with tools such as testing software, configuration management systems, and project management platforms can enhance efficiency and streamline compliance efforts.

Siemens Polarion

Polarion Requirements is a comprehensive requirements management tool that can be effectively used to support compliance with ISO 13485 for medical device development. Here’s how Polarion Requirements can assist in meeting the requirements of ISO 13485:

  1. Requirements Management: Polarion Requirements offers a comprehensive platform for capturing, organizing, and managing requirements in a structured manner. It enables you to define and document requirements, ensuring clarity and traceability throughout development. Polarion Requirements allow for establishing relationships between requirements, facilitate change tracking, and maintain a centralized repository of requirements, aligning with ISO 13485 requirements for robust requirements management.
  2. Traceability: Polarion Requirements provides robust traceability capabilities, allowing you to establish and manage traceability links between requirements, design elements, tests, and risk assessments. This facilitates the demonstration of end-to-end traceability from user needs to design, verification, and validation activities, as mandated by ISO 13485. With Polarion Requirements, you can effectively track and document the relationships and dependencies between various artifacts, ensuring compliance with traceability requirements.
  3. Change Management: Polarion Requirements offers powerful change management features that facilitate the effective handling of requirement changes throughout the development lifecycle. It supports change request tracking, impact analysis, and change control processes, ensuring that modifications to requirements are properly evaluated, documented, and approved. These capabilities align with ISO 13485 requirements for robust change management, enabling organizations to manage changes effectively while maintaining compliance and ensuring the quality of medical device development.
  4. Risk Management: ISO 13485 places significant emphasis on risk management. Polarion Requirements provides features to capture and assess risks associated with medical device development. You can document risk criteria, perform risk assessments, and link risks to corresponding requirements. This facilitates the identification, evaluation, and mitigation of risks, as mandated by ISO 13485.
  5. Collaboration and Workflow: Polarion Requirements support collaboration and workflow management. It enables teams to work collaboratively on requirements, track changes, and manage approvals and reviews. This promotes effective communication and collaboration among stakeholders involved in medical device development, ensuring that all parties are aligned with ISO 13485 requirements.

Helix ALM

Helix ALM is a versatile Application Lifecycle Management (ALM) tool that can be leveraged to support compliance with ISO 13485 for medical device development. Here are some additional features of Helix ALM that are relevant to ISO 13485:

  1. Test Case Management: Helix ALM provides robust test case management capabilities. It allows organizations to define and manage test cases, track their execution, and document the results. This enables comprehensive test coverage and verification of requirements, ensuring compliance with ISO 13485’s emphasis on validation and verification activities.
  2. Configuration Management: ISO 13485 requires effective configuration management to ensure the integrity and traceability of product designs and documentation. Helix ALM offers robust configuration management features, allowing organizations to control and manage versions of requirements, design documents, and other project artifacts. This ensures proper version control, facilitates auditing, and supports regulatory compliance.
  3. Quality Assurance and Defect Tracking: Helix ALM includes features for quality assurance and defect tracking. It enables the capture, tracking, and management of defects, non-conformances, and issues throughout the development process. This helps organizations identify and address quality issues, track corrective and preventive actions, and ensure continuous improvement in line with ISO 13485 requirements.
  4. Collaboration and Workflow: Helix ALM provides collaborative features that promote effective communication and collaboration among team members, stakeholders, and partners involved in medical device development. It supports configurable workflows, enabling organizations to define and manage their specific processes, approvals, and reviews. This facilitates compliance with ISO 13485’s requirements for collaboration, documentation, and effective communication within the quality management system.
  5. Integration Capabilities: Helix ALM offers integration capabilities with other development tools and systems. This allows seamless data exchange, synchronization, and traceability across various phases of the development lifecycle. Integration with requirements management tools, testing tools, and other systems used in medical device development enhances efficiency, improves data integrity, and streamlines compliance efforts.

Reqtify

Reqtify is a requirements management and traceability tool that can be effectively utilized to support compliance with ISO 13485 for medical device development. Here are some features of Reqtify that are relevant to ISO 13485:

  1. Requirements Traceability: Reqtify enables organizations to establish and manage traceability links between requirements, design elements, tests, and other project artifacts. It allows you to demonstrate traceability from user needs to design, verification, and validation activities, as required by ISO 13485. With Reqtify, you can efficiently track and document the relationships and dependencies between various artifacts, ensuring compliance with traceability requirements.
  2. Impact Analysis: ISO 13485 emphasizes the need for impact analysis when making changes to requirements or design. Reqtify provides capabilities for impact analysis, allowing organizations to assess the potential effects of changes on other related artifacts. This helps in evaluating the impact of changes on the quality management system and ensuring that appropriate actions are taken to maintain compliance with ISO 13485.
  3. Verification and Validation: Reqtify supports the management of verification and validation activities, which are crucial in medical device development. It allows organizations to define test cases, track their execution, and document the results. With Reqtify, you can ensure comprehensive test coverage and verification of requirements, meeting the ISO 13485 requirements for validation and verification activities.
  4. Change Management: Reqtify offers features to effectively manage changes to requirements and other project artifacts. It enables change request tracking, impact analysis, and change control processes, ensuring that modifications to requirements are properly evaluated, documented, and approved. These capabilities align with ISO 13485 requirements for robust change management, enabling organizations to manage changes effectively while maintaining compliance and ensuring the quality of medical device development.
  5. Reporting and Compliance: Reqtify provides reporting capabilities that allow organizations to generate customizable reports and metrics to monitor project progress, traceability coverage, and compliance with ISO 13485. The platform offers predefined templates and dashboards that facilitate the tracking and demonstration of compliance during audits.

ISO-13485 Checklist

The ISO 13485 standard outlines the requirements for a comprehensive quality management system specific to the medical device industry. While a complete checklist for ISO 13485 compliance is extensive and tailored to each organization’s particular needs, here is a general overview of key areas that should be addressed. This checklist provides a starting point to ensure essential elements are considered, including the establishment of a quality management system, management responsibility, resource management, product realization, measurement and analysis, and regulatory compliance.

  1. Quality Management System (QMS):
  • Establish and maintain a documented QMS.
  • Define the scope of the QMS.
  • Identify and document the processes needed for the QMS.
  • Implement procedures for document control, record management, and change control.
  • Establish a framework for managing and addressing non-conformities.
  1. Management Responsibility:
  • Demonstrate top management commitment to the QMS.
  • Establish a quality policy and objectives.
  • Identify roles, responsibilities, and authorities within the organization.
  • Conduct management reviews to assess the effectiveness of the QMS.
  1. Resource Management:
  • Ensure the availability of necessary resources for the QMS.
  • Provide appropriate training and competency evaluation for personnel.
  • Establish procedures for managing infrastructure, including facilities and equipment.
  • Implement a process for managing and maintaining the work environment.
  1. Product Realization:
  • Establish processes for identifying customer requirements and ensuring their satisfaction.
  • Develop procedures for design and development activities, including risk management.
  • Implement controls for the purchasing of materials, components, and services.
  • Establish processes for product verification, validation, and release.
  1. Measurement, Analysis, and Improvement:
  • Implement procedures for monitoring and measuring product performance.
  • Establish processes for conducting internal audits of the QMS.
  • Implement procedures for managing and controlling non-conforming products.
  • Establish a process for analyzing data and implementing corrective and preventive actions.
  1. Regulatory Compliance:
  • Ensure compliance with relevant regulatory requirements and applicable standards.
  • Establish processes for managing documentation related to regulatory compliance.
  • Conduct regular assessments to verify compliance with regulatory requirements.

It’s important to note that the above checklist is a high-level overview, and each organization’s specific requirements may vary. It is recommended to refer to the complete ISO 13485 standard document and work with a qualified consultant to develop a detailed checklist tailored to your organization’s needs and objectives.

Essential ISO-13485 Templates

ISO 13485 compliance requires the implementation of various templates and documentation to establish and maintain a comprehensive quality management system (QMS) in the medical device industry. Here are some essential templates that can assist in achieving ISO 13485 compliance:

Quality Manual: 

The quality manual serves as a top-level document that outlines the organization’s quality policies, objectives, and commitment to ISO 13485 compliance. It provides an overview of the QMS structure, key processes, and responsibilities within the organization.

Procedures and Work Instructions: 

Procedures and work instructions provide detailed step-by-step guidance on how specific processes and activities should be performed. These documents cover areas such as document control, record management, risk management, design and development, purchasing, and control of non-conforming products. The content and format of these documents should be tailored to the organization’s specific needs and processes.

Forms and Checklists: 

Forms and checklists are used to record data, capture information, and facilitate compliance with ISO 13485 requirements. These templates can include forms for documenting customer complaints, non-conformities, corrective and preventive actions, internal audit findings, and management reviews. They ensure consistent data capture, facilitate traceability and support ongoing monitoring and improvement of the QMS.

Risk Management Templates: 

ISO 13485 places significant emphasis on risk management in medical device development. Risk management templates help organizations identify, assess, and mitigate risks associated with their products and processes. These templates can include risk assessment matrices, risk management plans, hazard analysis forms, and risk mitigation strategies.

Document Control Templates: 

Document control is crucial for maintaining an organized and controlled QMS. Document control templates include templates for document identification, version control, change requests, and approvals. They provide a structured approach for managing the creation, review, approval, distribution, and archiving of documents within the organization.

Training Records: 

Training records templates help track employee training and competency assessments related to ISO 13485 requirements. These templates capture information such as training objectives, topics covered, training dates, and personnel signatures. They demonstrate the organization’s commitment to ensuring a competent workforce and compliance with training requirements.

Internal Audit Templates: 

Internal audits are essential for evaluating the effectiveness and compliance of the QMS. Internal audit templates provide a framework for planning, conducting, and documenting internal audits. They include audit checklists, audit reports, and corrective action request forms, facilitating the identification of areas for improvement and compliance gaps.

Supplier Evaluation and Control Templates: 

ISO 13485 requires organizations to assess and control their suppliers’ activities. Supplier evaluation and control templates include supplier assessment questionnaires, performance monitoring forms, and supplier corrective action request templates. These templates support the systematic evaluation and management of suppliers to ensure compliance and the delivery of high-quality materials and services.

Conclusion

To conclude, ISO-13485 is an essential certification for all medical device manufacturers, and with the right know-how and tools, it doesn’t have to be daunting. Throughout this article, we have looked at what is ISO-13985, and the best ISO-13485 compliance to fulfill its requirements such as the ISO-13485 checklist and templates, providing you with a complete package of resources to achieve full certification. With all of these options at your disposal – coupled with a free 30-day trial from Visure Requirements ALM Platform – you have excellent resources to get you up and running. If implemented correctly, your organization can benefit greatly from achieving this certification. Investing time in making sure that your products meet and exceed these international standards for quality assurance demonstrates your commitment to safety and excellence in the industry.

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