ISO 13485
Quality Management Systems For Medical Devices
The Quality Management System (QMS) for medical devices is the process and procedures by which an organisation directs and controls its quality-related business activities to achieve the organization's objectives. It encompasses the organisational structure, as well as the planning, processes, resources, and documented information, that an organisation uses to consistently meet customer and applicable regulatory requirements.
Some of the reasons why an Organization decides on the adoption
and implementation of a Quality Management Systems For Medical Devices are the following:
What is ISO 13485
The Quality Management System (QMS) for medical devices is the process and procedures by which an organisation directs and controls its quality-related business activities to achieve the organization's objectives. It encompasses the organisational structure, as well as the planning, processes, resources, and documented information, that an organisation uses to consistently meet customer and applicable regulatory requirements.
Benefits
Several factors contribute to an organization's decision to adopt and implement a quality management system according to ISO 13485, including the following:
- Increased emphasis on meeting customer requirements and expectations
- Customer satisfaction enhancement.
- Enhancement of medical devices / services offered in terms of quality
- Possibilities for expansion into new markets
- Where necessary, the establishment of opportunities for competition in tenders / orders
- Internal "quality" and communication within the business are improved.
- Enhancement of the organization's image and name / differentiation from competitors
- Acquiring a significant marketing tool
- A tool for identifying essential needs for staff training/skill development.
- Increased employee involvement in process improvements.
- It enables the organization's culture to change
- Meeting regulatory requirements
Interested Organizations
Organisations that may be involved in one or more stages of a medical device's life-cycle, such as design and development, production, storage and distribution, installation, or servicing, as well as design and development or provision of associated activities. (e.g. technical support). ISO 13485 can also be utilised by suppliers or external parties that provide products or services related to quality management systems to such organisations.
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