ISO 13485

ISO 13485 – Everything You Need to Know

The International Organisation for Standardisation (ISO) sets global standards for specific industries. For a business to achieve an ISO accreditation, like ISO 13485:2016, it must demonstrate quality, safe and efficient processes. There are many benefits for a business to have an ISO certification. Find out more about why you need a trusted, certified medical device manufacturer like Europlaz, below.

View our ISO certificate here.

ISO standards target different business areas and industries, for example, ISO 45001 focuses on occupational health and safety whereas ISO 13485 concentrates on the application of a risk-based approach in establishing and maintaining a Quality Management System (QMS) for medical devices.

An ISO13485:2016 accreditation is an internationally recognised gold standard for quality in the medical device industry. It provides a framework for an organisation’s quality management system to ensure that it meets customer and regulatory requirements for medical device manufacture and provision of services.
Organisations with this accreditation can be involved in one or more stages of the life cycle of a medical device, such as design and development, production or storage and distribution.

Why is ISO 13485 important?

In the medical device industry, risk management, safety and quality are of the utmost priority. ISO13485 ensures that manufacturers, such as Europlaz can actively demonstrate their quality management processes.
The organisation that holds the certification should be able to demonstrate best practices in everything they do. As it is an international standard, it provides assurance that ISO medical device manufacturers across the world have effective quality management systems in place.

Advantages of ISO 13485 to organisations

● Providing a set standard for the medical device industry internationally
● Giving organisations instructions on how to adopt risk-based decision-making processes
● Showing that an organisation produces its products with patient safety in mind
● Meeting customer expectations and satisfying regulatory requirements

Why should you use an ISO certified manufacturer?

In addition to the above benefits, an ISO 13485 certified manufacturer can provide a customer with peace of mind. Customers can trust that a certified manufacturer has in-depth knowledge of the medical device manufacturing process.

It will provide reassurance that the manufacturer you use has a quality management system that concentrates on applying best practice. You will also be assured that your medical devices are designed, developed, produced, installed and disposed of safely.

Due to the use of efficient processes developed within a quality management system, an experienced ISO 13485 certified manufacturer can:

● Provide faster turnaround times
● Reduce waste
● Guarantee consistency
● Keep quality high and costs low

Quality Management System

At Europlaz, our ISO 13485  certificate demonstrates our commitment to providing quality products. It helps us to take a common-sense approach to the management of the organisation while continuously improving our working practices.

The Europlaz Quality System means consistently providing a product that meets or exceeds customer and business requirements and continually improving the effectiveness of its business processes/quality management system.

If you have any questions or would like to find out more, please do not hesitate to contact us.

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