ISO 13485 is an international standard that sets requirements for a quality management system specific to the medical device industry. This quality standard ensures that the consistent design, development, production, installation, and delivery of medical devices is safe for their intended purpose. Encompassing a robust system of different regulatory best practices, ISO 13485 provides the medical device industry with a common language and business management framework.
Why should a medical device manufacturer become accredited with ISO 13485?
The medical device industry recognizes the ISO 13485 standard as a best practice for manufactures and distributers of medical devices. Compliance to the standard is required throughout the supply chain to ensure that the products delivered to consumers are of the highest safety and quality. Accreditation to the ISO 13485 standard ensures that the medical device manufacturer establishes and maintains effective business processes within the organization as well as maintaining compliance with regulatory requirements. Third party accrediting bodies assess manufacturers to ensure devices manufactured protect patient health and safety. With this accreditation being internationally recognized, companies accredited will be recognized for the highest quality assurance and good manufacturing practices.
What are the benefits of using ISO 13485?
The ISO 13485 standard provides a framework for businesses in establishing quality management system practices that will yield consistent and compliant product design, development, and manufacturing results. Tools such as risk assessments, validation, and statistical techniques, allow manufacturers to engineer product design enhancements for better safety, quality, and efficacy of the device. Likewise using continual improvement techniques prescribed within the standard such as internal audits, corrective and preventative actions, and management review help to identify areas of non-conformity and correct the gaps. The ISO 13485 quality management system provides the framework to evaluate and implement business decisions and manage the product lifecycle. Manufacturers also must have a customer feedback process to ensure that customer needs and expectations are met. With the prescribed focus on sound engineering, quality, regulatory compliance, and customer satisfaction, medical device manufacturers will ensure the reliability and safety of the device when used for its intended purpose.
Is ISO 13485 required by any regulations or standards?
Due to the global nature of the medical device industry it is essential that common protocols be used in the manufacturing of devices to ensure quality and consistency across nations. Some countries including the European Union, require ISO 13485 as a regulatory or legal requirement to distribute the medical device within their borders. Though ISO 13485 is a voluntary standard in the United States, it is internationally recognized, and industry driven.
How can Labtopia help medical device manufacturers meet the ISO 13485 Standard?
Labtopia can evaluate your organization’s needs, products, and processes to implement the right sized quality management system. Working with Labtopia, all services are geared to the identity of your business while also ensuring ISO 13485 standard requirements are met. Labtopia offers turn-key quality management system implementations for companies seeking first time ISO 13485 accreditation. Additionally, Labtopia offers a-la-cart services for currently accredited companies. Services include:
- Define/Refine Business Processes
- Technical Writing
- Gap Assessments
- Risk Assessments
- Internal Audits
- Validation Protocol Design
- Product Quality Reviews
- Quality Management
- Supplier Quality Audits
- Third Party Audit Support