ISO/IEC 13485 made practical
ISO 13485:2016 is the international benchmark for quality management systems in the medical device industry, defining strict requirements to ensure product safety, regulatory compliance, and full traceability across the product life cycle. As global regulations increasingly align with ISO 13485, organizations must implement structured, risk based, and audit ready processes that go beyond documentation and enable effective operational compliance.
Our ISO 13485 standard to feature mapping guide shows how BPAMedical365, directly supports each clause through integrated document control, CAPA, supplier management, traceability, and automated workflows.
Download the guidebook to explore the detailed clause by clause mapping and learn how BPA enables efficient, secure, and scalable ISO 13485 compliance.
Clause 4
GENERAL REQUIREMENTS
Establish and maintain a compliant QMS, including a controlled Quality Manual defining scope and processes. Define and assign roles and responsibilities to ensure accountability and traceability. Maintain Medical Device Files with complete design, specification, and manufacturing documentation. Control documents with approval workflows, version control, and revision tracking. Manage document and record lifecycle, ensuring secure storage, traceability and proper disposal.
How BPA eQMS helps
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Import master data in the eQMS prebuilt modules through the grid mode: organization chart, plants and departments with responsible persons; processes, owners, approvers, visual process map; collaborators, jobs and job description; ISO 13485 clauses and chapters; context
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Create/import documents in Compliance Documents, update/create document/form templates and publish them.
Concerned BPA modules
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La gestion des processus
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Contrôle des documents
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Technical files
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Forms management
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Q-Pilot
Clause 5
MANAGEMENT RESPONSIBILITY
Ensure top management commitment to QMS effectiveness and regulatory compliance. Establish a quality policy and measurable quality objectives aligned with organizational goals. Define roles, responsibilities, and ensure effective internal communication. Conduct regular management reviews to monitor performance and drive improvement.
How BPA eQMS helps
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Publish organization structure, roles, and responsibilities within the eQMS.
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Publish quality policy and manage quality objectives with automated KPI tracking.
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Collect and centralize customer feedback using integrated MS Forms surveys.
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Collaborate through built in discussion flows and manage actions with integrated task management.
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Plan, execute, and document management reviews with automated notifications and Power BI performance reporting.
Concerned BPA modules
- Gestion des documents
- La gestion des processus
- Stakeholder management
- Indicator management
Clause 6
RESOURCE MANAGEMENT
Provide and maintain adequate resources to ensure QMS effectiveness and product conformity. Ensure personnel are competent through appropriate training and maintain training records. Maintain required infrastructure and a controlled work environment to safeguard product quality and prevent contamination.
How BPA eQMS helps
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Manage personnel, roles, and competencies with automated competency assessment.
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Track equipment and assets, including verification schedules and corrective actions.
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Create, approve, train, and publish operational procedures using automated workflows.
Concerned BPA modules
- Contrôle des documents
- Gestion de la formation
- Equipment/asset management
Clause 7
PRODUCT REALIZATION
Plan and control product realization processes, including risk management and quality objectives. Define, review, and communicate customer and regulatory requirements. Control design and development with documented planning, verification, validation, and change management. Evaluate and monitor suppliers, and verify purchased products. Control production processes, including validation of special processes, identification, traceability, and product preservation. Ensure equipment is calibrated and maintained to guarantee accurate measurements
How BPA eQMS helps
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Manage risks and opportunities using prebuilt workflows based on FMEA, PHA, and ISO 14971, including initial, residual, and periodic assessments.
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Import or create compliance procedures for customer, regulatory, and product requirements, collect approvals and training, and publish them.
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Collect and centralize customer feedback and complaints via MS Forms with automated data capture in the eQMS.
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Control product and service design with document management, versioning, approvals, and creation of design or device history files.
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Manage suppliers through evaluation, approval, audits, and nonconformity tracking with prebuilt supplier modules.
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Track training, document approvals, and asset verification using preconfigured automation for efficient compliance management.
Concerned BPA modules
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Gestion des risques
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Health and safety
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Contrôle des documents
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Technical Files
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Gestion du changement
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Nonconformities management
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Gestion des audits
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CAPA
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Gestion des équipements
Clause 8
MEASUREMENT, ANALYSIS AND IMPROVEMENT
Establish processes to monitor, measure, analyze, and improve product quality and QMS performance. Collect and assess feedback, maintain procedures for complaints, production monitoring, audits, and regulatory reporting. Identify and control nonconforming products and apply CAPA. Review data such as feedback, nonconformities, audits, and supplier performance to evaluate QMS effectiveness. Drive continuous improvement through quality objectives, audits, post‑market data, performance analysis, CAPA, and management reviews.
How BPA eQMS helps
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BPA provides preconfigured modules for document creation, approval, training, and publication.
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It also includes modules for managing clients, customer feedback, complaints, internal audits, nonconformities, corrective actions, risks, and objectives.
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BPA offers preconfigured Power BI reports across key modules, such as actions, audits, nonconformities, document training, and risks, which can be combined into a comprehensive eQMS performance report for management reviews.
Concerned BPA modules
- Contrôle des documents
- Gestion des audits
- Nonconformities management
- CAPA
- Gestion des risques
Accéder à des ressources supplémentaires pour cette solution
Download our practical guidebook to explore a detailed feature-to-standard mapping
and discover how ISO 13485 compliance can be embedded into daily operations, supporting certification, long-term compliance, and a stronger information security posture.