Quality Management System for Medical Devices & ISO 13485

ISO 13485 is an international standard that defines quality management system requirements for manufacturers of medical devices.
The primary objective of the standard is to facilitate harmonised quality management system requirements for regulatory purposes within the medical device sector. It is based on ISO 9001.
In particular, the requirements for customer satisfaction and continual improvement have been modified to make them more appropriate for regulatory purposes.


 An ISO 13485 certificate proves your commitment to the quality of medical devices. It enables you to demonstrate that your quality management system has been assessed and found compliant in order to meet regulatory requirements and customer needs.
Medical devices and is an increasingly important health care area in relation to their impact on health and health care expenditure.
ISO 13485:2003 – “Medical devices – Quality management systems – Requirements for regulatory purposes” is the internationally recognized standard for quality management system in the medical device industry. It specifies requirements for a quality management system where an organization need to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and applicable regulatory requirements. It is designed and intended for use by organizations for the design and development, production, installation and servicing of medical devices.
As this is a highly regulated sector across the world, the primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems. ISO 13485 is a standalone standard. It is largely based on the structure of ISO 9001, but includes some particular requirements for medical devices such as risk analysis, sterile production and traceability and excludes some of the requirements of ISO 9001 that are not necessary as regulatory requirements. Because of these exclusions, organizations being certified to ISO 13485 can not claim conformity to ISO 9001 unless they also conform to all requirements of ISO 9001.
ISO 13485 is the most accepted standard worldwide for manufacturers of medical devices (e.g. USA, Japan, Canada, EU). This standard is based on ISO 9001, but includes additional requirements specific to this business sector. In addition important terms have been defined, such as medical device, active medical device, active implanted medical device, sterile medical device, and many more.
ISO 13485 supports the reduction of unexpected risks with regard to the devices and enhances their management. This applies not only to companies that construct, produce and service medical devices, but also to organizations distributing and using them. The standard aims to increase the organization’s reputation in the eyes of customers and authorities.
ISO/TR 14969:2004  is a standard that provides guidance for the application of the requirements for quality management systems contained in ISO 13485:2003. This guidance can be used to better understand the requirements of ISO 13485 as it helps illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 13485:2003.
ISO 14971:2007 is a standard that specifies a procedure by which a manufacturer can identify the hazards associated with medical devices and their accessories. It also specifies a procedure to estimate and evaluate the identified risks, control these risks and monitor the effectiveness of the control.
The requirements of ISO 14971:2007 are applicable to all stages of the lifecycle of a medical device, but do not apply to clinical judgments relating to the use of a medical device and it does not specify acceptable risk levels.
If you are a producer, distributor, or supplier of medical devices, in-vitro diagnostic devices, or active implants, we will certify your quality management system in line with ISO 13485. This standard combines all regulatory requirements relating to medical devices.
ISO 13485 is more than just a pure quality management system. In order to meet the high requirements in the field of medical devices, it also integrates a risk management system. This enables you to identify hazards relating to the medical device or the associated procedures at an early stage. You can then take swift, targeted action.