Carmelton Co Ltd

Hong Kong
Office Address:

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Contact Person:
Mr. Sammy Leung
Position:
Sales & Marketing Executive

All Certifications
Name:
ISO 9001:2008
Reference:
ISO 9001:2008 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact ISO 9001:2008 is implemented by over one million companies and organizations in over 170 countries.
Name:
ISO 13485
Reference:
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
Name:
Global Manufacturer Certificate (GMC)
Reference:
GMC, Global Manufacturer Certificate, is a standard distinguishing quality Chinese manufacturers. The existing 8 GMC Benchmarks include manufacturing facilities, product quality control, company size, dedicated export team, research and development capability, social and environment responsibility, trust worthiness and reputation, as well as OEM/ODM experience.
Name:
FDA (U.S.)
Reference:
Under the FDA's Inspection Program by Accredited Persons (AP), manufacturers that meet specific criteria can elect to have their choice of accredited third party inspect their facilities for compliance with U.S. medical device regulations in lieu of an FDA official.

This voluntary program enables companies to combine FDA inspections with foreign certification audits, giving them more scheduling flexibility, limiting the administrative impact and streamlining the inspection process.

The FDA regulates most products with a set of published standards enforced by a modest number of facility inspections.

Name:
CE Mark
Reference:
The CE marking indicates the compliance with EU legislation of a product, wherever in the world manufactured, and enables its free movement within the European market. By affixing the CE marking on a product, a manufacturer is declaring, at its sole responsibility, conformity with all of the legal requirements to achieve CE marking which allows free movement and sale of the product throughout the European Economic Area. CE marking is intended for national market surveillance and enforcement authorities.
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