Medical devices have a significant impact on human lives. Therefore patient safety should be top priority when manufacturing these products and components. A solution partner as contract manufacturer that is registered with ISO can guarantee high quality, safety and efficiency.
International standards make things work
ISO is an international standard-setting body composed of representatives from various national standards organisations. The international standards give world-class specifications for products, services and systems, to ensure quality, safety and efficiency. They are instrumental in facilitating international trade and impact everyone, everywhere.
The international standards cover almost every industry, from technology, to food safety, to agriculture and healthcare. For medical devices there are a few essential ISO standards that a preferred contract manufacturer should comply with:
- ISO 9001 for quality management system
- ISO 13485 for quality management system and regulatory purposes
- ISO 14001 for environmental management system
- ISO 17025 for testing and calibration laboratories
ISO 9001 for quality management system
The ISO 9000 family addresses various aspects of quality management and contains some of ISO’s best known standards. The standards provide guidance and tools for companies that want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved. Certification is performed by an independent registrar, not by ISO.
ISO 9000 includes definitions and terminology that clarify concepts in the ISO 9001 requirements process standards used for certification. ISO 9001 is reviewed every five years and an updated version is expected in 2015.
ISO 13485 for quality management system and regulatory purpose
This standard specifies the requirements for companies providing medical devices and related services. This quality management system ensures they meet customer requirements and the regulatory requirements.
The primary purpose of ISO 13485 is to facilitate harmonised medical device regulatory requirements for quality management systems. It generally corresponds to the ISO 9001 guidelines, but it is not equivalent. ISO 13485 adds extra medical device-related requirements that are not included in ISO 9001, and removes others that are not applicable to their development.
ISO 14001 for environmental management system
This standard outlines how to put an effective environmental management system in place. It applies to those environmental aspects that a company identifies, can control and influence. ISO 14001 is designed to help companies remain commercially successful without overlooking environmental responsibilities. The standard provides the framework to allow companies to meet increasingly higher customer expectations of corporate responsibility as well as legal or regulatory requirements.
ISO 17025 for testing and calibration laboratories
This standard specifies the general requirements for the competence to carry out tests or calibrations, including sampling and documentation. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods. The standard is applicable to all companies performing tests or calibrations.
We are registered with the FDA and operate in accordance with QSR
Companies that develop medical device in the US must follow the Food and Drug Administration (FDA) Quality Systems Regulations (QSR). They are required by law to establish consistency with quality systems worldwide. Naturally, at Elos Medtech we are registered with the FDA and operate in accordance with QSR and also Good Manufacturing Practice (GMP).
We can meet all of our customers’ management and quality needs
We apply the same quality standards to all our medical device products and processes. This means that we maintain the same high quality regardless of application, market or classification. We can meet all of our customers’ management and quality needs and easily adapt to their processes. The medical technology products and components we manufacture are always safe to use, clean and sterile, consistent in quality and regularly controlled.
For more information about our registration numbers at FDA, certificates, CE-marking as well as classifications for cleanrooms and test-labs, check out our Regulatory Requirements.
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