ISO 13485

ISO 13485:2012 (ISO 13485:2016) – Medical devices. Quality management systems. Requirements for the purposes of normative acts.

ISO 13485

ISO 13485 is applicable to all organizations that carry out activities related to the design, development, production and marketing of medical devices, as well as to companies with the activity of designing, manufacturing, supplying, installing and maintaining medical devices.

The standard is applicable to a very wide range of products, such as implants, devices and equipment for screening and diagnostics, devices for use in invasive surgery, dressings, materials for laboratory and other tests, medical equipment and even for software performing diagnostics in medicine. The main focus of the standard is to achieve full compliance with regulatory requirements.

Although ISO 13485 is a stand-alone standard, it is based not only on the regulatory requirements of the ISO 9001 standard, but also includes some specific ones, such as:

• Risk analysis and management;
• Full traceability of production;
• Hygiene and sterility of production;

ISO 13485 is usually required by the authorities approving the production and marketing of the medical device at the stage of applying for this approval.

Main areas covered by the ISO 13009 standard:

• information services provided on beaches;
• services related to beach safety – signaling, flags, zoning, control measures;
• accessibility;
• cleaning and removal of waste;
• commercial services and entertainment – restaurants, sports, etc.;
• monitoring and risk assessment.

What are the benefits of implementing a quality management system for medical devices?

The implementation of the ISO 13485 standard brings a number of benefits and advantages:

• full compliance with regulatory requirements;
• high control of activity;
• reduction of claims;
• improvement of resource provision;
• predictable customer relationships;
• increasing the image;

The standard can also be applied independently, as well as integrated with other management systems, especially ISO 9001.