ISO 13485 2016 Medical Device Quality System Standards

ISO 13485: 2016 Medical Device Quality System Standards
ISO 13485 is an international standard intended to reassure organizations purchasing and utilizing
medical devices that the developers and suppliers of these devices have instituted and implemented a
QMS that meets certain minimum requirements, Suppliers and developers express their conformity and
assurance to this level of medical device quality by becoming ISO 13485 certified. If a company or entity
participates in or provides design and development, production, storage, distribution, installation,
servicing or other technical support, their related operations most likely fall under the QMS standard.
The ISO 13485 quality management production cannot be overstated. For that reason, the production
of medical devices is heavily regulated across the world, falling under the jurisdiction of various national
and international bodies, such as the U.S. Food and Drug Administration and the European Commission.
To help companies comply with this international patchwork of standards, the ISO (International
Organization for Standardization) has published the ISO 13485, a guideline specifically intended for
companies that manufacture medical devices.
The ISO 13485 is a certification measure that is like ISO 9001 but basically acts as a standard to measure
best management practices in the health sector. This Standard specify requirements for a quality
management system that can be use by an organization for the design and development, production,
installation and servicing of medical devices, and the design, development, and provision of related
services. This Standard requirement for a quality management system and Risk management principles
are applicable to all types of organizations inattentive of size or nature and applicable to all like Health
Care, Hospital and Medical Devices manufacturing company in India.
The benefits of ISO 13485:2016 management systems are seen in will be all departments of your
company. The following are some of the benefits that you should take into consideration:

1. ISO 13485:2016 allows your organization to meet the customer requirements in the
production of medical equipment.
2. Provides necessary ideas to standardize quality management in the medical equipment
fields.
3. Certification will reduce or eliminates FDA audits
4. Well built QMS for medical devices help avoid the need to recall medical devices
5. Well-built ISO 13485:2016 QMS shows the way to adhere to all statutory and regulatory
requirements associated with medical devices.
6. Certified ISO 13485:2016 companies produce good quality medical devices which help
extend human or animal life expectancy
7. Critical in providing a competitive edge for your organization
ISO 13485: 2016 certification specifically addresses the way companies implement management
strategy that focuses on products that are safe and effective. The new standard requires a higher level
of responsibility to be in the hands of management by laying out detailed guidelines to create a stronger
quality management system (QMS) and process based approach which define, implement, and improve
effectives of quality management system that they expected by customers and regulatory requirements.
URS India has been holding itself up to these standards for a long time prior its application for
certification. The practice of quality management and control is deeply ingrained in our company culture
and in the way we develop our medical devices. With a closed-circuit operation where we can oversee
and work closely at all levels of design and production, there are less unknown variables that might
compromise quality or safety.