Quality Management

Camelot Biomedical Systems S.r.l. has implemented the following quality management standards as certified by Bureau Veritas Certification Body:

  • ISO 9001:2008 with the scope  "Design and Development of Software Products"

Download the ISO 9001:2008 Certificate 

  • ISO 13485:2012 with the scope  "Design and development of software products for medical devices and in-vitro diagnostic medical devices" 

Download the ISO 13485:2012 Certificate

 

ISO 9001

ISO 9001 specifies general requirements for quality management system where an organization

  • needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and
  • aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

All requirements of ISO 9001 are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

Source: International Organization For Standardization (ISO) website

ISO 13485

ISO 13485 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 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.

All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.

Source: International Organization For Standardization (ISO) website