ISO 13485

Medical Devices Management

ISO is a widely recognised mark of quality within the medical sector and is vital to winning new business. Many businesses who are ISO certified themselves will seek out suppliers with ISO 13485 certification.

What is ISO 13485?

ISO is the international standard for quality management systems, demonstrating that procedures are in place to ensure the highest operational standards are met. Its aim is to prove that an organisation meets its own internal standards for quality and that these in turn meet international standards. ISO 13485 is based on delivering safe and effective medical devices that consistently meet the needs of your customers.

ISO 13485 can be applied to any size or type of business. It covers all aspects of an organisation’s activities and will apply to almost any business following repetitive processes to produce a consistent standard of product or service.

Many such businesses have well established internal systems for maintaining standards but ISO 13485 proves to stakeholders and customers that quality systems are meeting international best practice.

Having your quality management system independently certified by 360 Certification Ltd will demonstrate your commitment to quality, best practice and continual improvement of your procedures. It will also provide assurance that your quality management system is operating efficiently and effectively, continually demonstrating cost savings and efficiencies year after year.

The benefits of ISO 13485 certification:


Improved customer satisfaction, through better quality and a more consistent service


A well understood, common system with consistent processes and less duplication of effort


Staff will understand their responsibilities, know what to do and how to do it as well as how their work affects quality


Fewer quality problems and quicker identification of those that do occur


Better management control and reporting


Access to new markets and increased competitiveness


Confidence your process can deliver safe and effective medical devices


Better customer and supplier relationships

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