International standards are a way of maintaining consistency and quality across industries and countries. The International Organization for Standardization (ISO) is an independent, non-governmental, and not-for-profit international organization that develops standards to ensure the quality, safety, and efficiency of products, services, and systems. It has a membership of 165 national standards bodies.
Through its members, the ISO convenes experts in order to share knowledge that can inform the development of voluntary, consensus-based, market-relevant International Standards that support innovation and provide solutions to global challenges. The experts come from industry, government, consumer organizations, academia, and nongovernmental organizations.
International Standards are documents containing practical information and best practices, describing an agreed way of doing something There are 23,736 International Standards covering almost all aspects of technology and manufacturing, according to the ISO, and 793 technical committees and subcommittees tasked with developing standards.
ISO standards:
- Make products compatible, so they fit and work well with each other
- Identify safety issues of products and services
- Share good ideas and solutions, technological know-how, and best management practices
These ISO certifications are used in many areas of the industry to ensure consistency. Each certification has separate standards and criteria. Touchpoint Medical and iTD US, have ISO 13485 which means the company conforms to stringent international requirements for the design, manufacture, subcontract manufacture, and distribution of mobile and stationary equipment carts for medical applications.
Having the ISO certification means that our customers can be assured that quality standards have been met every step of the way. As ISO certification standards change and are updated, we also change to keep in adherence with these important standards.
What is ISO 13485?
The ISO 13485 standard governs quality management systems for medical devices and related services. It is published by the International Organization for Standardization. ISO 13485 addresses:
- Quality control
- Risk management
- Legal compliance
- Operational efficiency
- Ability to trace and recall products and devices
- Process and product improvement
ISO 13485 provides an advantage for organizations producing medical devices and related services, assuring a commitment to quality and increasing efficiencies within the organization. Certification to ISO 13485 demonstrates to regulators that TouchPoint Medical has met the requirements of the standard.
All ISO standards are reviewed every five years to establish if a revision is required in order to keep it current and relevant for the marketplace.