ISO 13485:2003
ISO 13485:2003 is a specific standard which ensures the integrity of medical equipment.
- It is the foundation for all related regulations, and is therefore essential for proving that Milesman operates with the highest possible products.
- It proves Milesman’s commitment to comply with the most rigorous standards and to observe legal requirements at any given moment, and also acts as a framework, allowing us to improve our management methods and key processes.
- It is granted by an independent entity holding international accreditation, which inspects and oversees that the company fulfills all required conditions.
MILESMAN has been granted ISO 13485:2003 certification.
A few important aspects overseen by ISO 13485:2003 certification
Quality control: Product traceability, supplier control, assembly control, component quality, etc.
Electrical safety: Laboratory trials approved by IEC 601-1, whereby an ILAC-approved laboratory (International Laboratory Accreditation Cooperation) ensure that the equipment respects all regulations in terms of electrical security for low tension equipment, and that the user incurs no risks in using the device.
Radiation emissions: Laboratory trial approved by IEC 601-1-2, certifying that the equipment emits no harmful radiation.
Laser security: Laboratory trial approved buy IEC 601-2-22, certifying that the equipment emits the parameters (wavelength, pulse length, energy density, etc.) put forth in the instruction manual. This ensures that the equipment works in accordance to its specifications. A guarantee is also given in terms of the device’s conformity with the laser security regulations.
Software validation: This proves that the software works perfectly, that it is subject to errors, and that there is no risk of it emitting an energy that is different to the one required.
ISO 13485:2003 and international regulations
EUROPE: ISO 13485: 2003 This standard harmonizes all three European directives. It means that in being in compliance with this standard, a device is automatically in compliance with the specific parts of European directives requiring a quality control system.
United-States: The revised regulatory quality system (21 CFR 820, 7 oct. 1996) now rests on ISO 9001 and ISO 13485 quality standards.
When manufacturers operate at a global market level, global or international standards such as ISO 13485:2003 do not only become a simple competitive advantage - obtaining them is required in some countries. For instance, Canada requires that manufacturers of medical equipment marketing their products in their country have an ISO 13485 certified quality system, accredited by the SCC.
ISO 13485:2003 = QUALITY, SAFETY AND CREDIBILITY
