ISO 13485:2003

ISO 13485:2003 is a specific, compulsory standard for quality systems in medical devices.

• Today it is the cornerstone of all legal regulations, and the most stringent one around.
• It encompasses control over the entire production process and product monitoring in the market.
• It is granted by an accredited certification body with international accreditation that audits and checks whether the company fulfils all the quality requirements.
• MILESMAN has earned ISO 13485:2003 certification

SOME of the most important ASPECTS AUDITED in ISO 13485:2003

Quality processes:The traceability of the product, control of suppliers, control of assembly, quality of the components, etc.

	Seguridad eléctrica: Test by an IEC 601-1-certified laboratory, where a laboratory certified by ILAC (International Laboratory Accreditation Cooperation) guarantees that the device meets all the electrical safety norms for low-tension devices and that users therefore run no risk when using it.
	Seguridad láser:Test by an IEC 601-2-22-certified laboratory which certifies that the device emits the parameters (wavelength, pulse length, energy density, etc.) stated in the instruction manual. This ensures that the device operates according to its specifications. It also guarantees that the device fulfils all the regulations in place for lasers.
	Software validation:This indicates that the software works smoothly and that it has no errors or risks of emitting energy other than what is required..

ISO 13485:2003 and international norms

EUROPE: ISO 13485: 2003 harmonises all three European directives. This means that if a device meets this standard, it automatically demonstrates compliance with the specific parts of the European directives that require a quality management system .

USA:The revised system of the Quality System Regulation (21 CFR 820, Oct. 7, 1996) is based on the ISO 9001 and ISO 13485 quality standards.