Let’s break down ISO 13485. It has eight parts. The first three parts provide essential information such as references and word meanings used in the standard here. 

Then, from part 4 to 8, it explains how to start and keep up an ISO 13485 quality management system. Part 4 lists out the basic and documentation needs for the quality management system, like a need for a quality manual, medical devices file, document control, and record control. 

Part 5 talks about what the top management of a company using ISO 13485 Quality Management System needs to do, it stresses the management’s dedication to the system and a focus on the customer. It emphasizes a quality policy and planning for a quality management system. 

Also, it mentions who holds responsibility and power for the system, represents the top management, and communicates quality management system details internally. 

The final segment of Part 5 talks about its management review. It explains what input and output are required for the management review. 

Part 6 centers around resource management. It presents the needs for resource provision, human resources, infrastructure, workspace, and contamination control. 

Part 7 is all about turning the plan into a product. It involves planning, customer-based processes, design and development, purchasing, production, service provision, and finally, how to keep track of monitoring and measuring equipment. 

Lastly, Part 8 is totally about measurement, analysis and enhancement. It outlines the need for feedback, managing complaints, reporting to authorities, internal audits, watching and measuring processes, overseeing and measuring product, controlling non-compliant product, data analysis and improvement from corrective and preventative action.

medical devices. It takes into account all the needs of those who manufacture, supply, distribute, or have a role in the medical device field.

Why ISO 13485 is essential for medical device manufacturing project?

Getting ISO 13485 certified means meeting higher standards than just ISO 9000, specifically for the medical field. It comes with six notable upgrades if you’re working with an ISO 9000 provider. 

Better risk management ensures all risks in the process are identified. Management roles are clearly set so all involved know their duties. Staff get regular skill upgrades and help others learn too, under the enhanced training.

Keeping the facility clean and organized is important, and so is labeling and separating products. The way designs are created is improved, with clear and efficient methods for specific product types.

 Suppliers are held accountable at each step in the journey, ensuring traceability. An ISO 13485 manufacturer guarantees clear leadership, hygiene, efficient methods, and responsibility. 

For instance, a CT scanner for inspecting 3D printed metal parts. You need specialized machines used only for a particular material, not for other clients. Hence, the quality system highly values the isolation of all production risks. A be­tter explanation of management duties is necessary. This means every stakeholder has well-outlined roles and responsibilities. 

There’s improved training too. It implies that all quality-related staff continuously improve their skills and guide others.