How to Optimize a Quality Management System ISO 13485 that includes Regulatory-Critical Processes?
- Arlette Schilter
- Feb 18
- 2 min read
Updated: Apr 7
A quality management system (QMS) compliant with ISO 13485 is mandatory for manufacturers of medical devices and IVDs. Without ISO 13485 certification, products cannot be placed on the market.
5 Steps to Optimize a Quality Management System According to ISO 13485—Without Jeopardizing Regulatory Approval
Enabling faster development of innovative medical devices in compliance with ISO 13485.
Difference: NO MARKET APPROVAL = No sales
A Quality Management System (QMS) should not be a bottleneck for innovation—but in many organizations, it is. Here are five key business process optimization for healthcare themes that can transform your QMS from static documentation to a dynamic system.
1. Systematic Process Modeling (Business Process Optimization for Healthcare)
📌 Today: Processes are described in static documents, making updates and traceability difficult.
📌 Tomorrow: Processes exist within a system, allowing real-time updates, interdependencies, and better process management.
2. Process Steps & Dependencies
📌 Today: Process steps are recorded in documents, often lacking clear roles, responsibilities, and outputs. Circular dependencies between processes create inefficiencies.
📌 Tomorrow: Process steps exist as database elements with global roles and defined outputs, preventing redundant loops.
3. Roles & Responsibilities
📌 Today: Roles are defined outside the QMS, with no connection to resource planning, causing fragmentation.
📌 Tomorrow: Roles are structured inside a database, forming the foundation for efficient resource planning and traceability.
4. Compliance Process Requirements (10,000+ MedTech Process RQs)
📌 Today: Compliance requirements are assessed in separate systems by different teams, leading to inefficiencies.
📌 Tomorrow: Compliance is embedded into the process framework, ensuring alignment between business processes and regulatory requirements.
5. Technical Documentation Management
📌 Today: Documentation is scattered across multiple subprocesses, with template-driven redundancies.
📌 Tomorrow: A centralized system detects redundancies, provides a clear overview, and streamlines documentation workflows.
Outcome: Compliance, Cost Optimization & Innovation Enablement
These principles redefine Quality System Management and Business Process Management, ensuring that compliance supports—not hinders—innovation.
How is your organization optimizing QMS processes?
Let’s discuss!
ColabON includes Intelligence that supports quality management system ISO 13485 process optimization.
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