What is ISO 13485:2016 Medical Device Quality Management System?

ISO13485 is a quality management system standard, the most authoritative international quality system standard in medical device industry. Following this standard demonstrates that the relevant medical device manufacturer has established a quality assurance system to protect public safety. On the basis of ISO9000, ISO13485 adds special requirements of medical device industry and puts forward more stringent control requirements for identification, process control, and other aspects of products.

Benefits of Implementation:

― It can be used as evidence of compliance with laws, regulations, and contractual requirements

― Manage and minimize risks

― Emphasize competence

― Prevention of defects has priority over correction of defects

― Improve the quality of performance

― Win customer and employee satisfaction

― The internal process is transparent and clear

― Save time and costs

― Quality policy is met and corporate objectives are achieved

― Prevention of defects has priority over correction of defects

― Manage and minimize risks

Applicable Scope

The ISO 13485:2016 Medical Device Quality Management System shall apply to relevant industries engaged in the design and development, production, and installation of medical devices and services for medical devices, or the design, development, and provision of related services.

Medical devices as defined in this standard are instruments, equipment, appliances, machines, utensils, implants, in vitro reagents or calibrators, software, materials, or other similar or related articles, whether used alone or in combination, intended by manufacturers for human use for one or more of the following specified purposes:

―Diagnosis, prevention, monitoring, treatment, or alleviation of diseases;

― Diagnosis, monitoring, treatment, and mitigation of, or compensation for injuries;

―Study, substitution, or regulation of anatomical or physiological processes;

― Life support or maintenance;

― Control of pregnancy;

― Disinfection of medical devices;

— Providing medical information by means of in vitro examination of samples taken from the human body.

Its main design effect on the human body surface or in the body is not achieved by pharmacological, immunological, or metabolic means, which, however, may be involved and play an auxiliary role.