ISO Quality Certifications

Quality Management and consistency is of key significance to providers, stake holders and of most importance you, the customer.  Andromedical is certified by the British Standards Institution (BSI) and acknowledged as complying with the ISO (International Organization for Standardization), being the only medical company in the sector with ISO 9001:2008 and ISO 13485:2003 accreditations.

Andromedical complies with and is certified in quality management standards in the ISO 9001:2008 and ISO 13485:2003:

ISO 9001:2008 - Is proposed for use in any institute which designs, manufactures, installs and services any product or provides any form of service. Some of the requirements in ISO 9001:2008 include:

• monitoring processes in the company to ensure they are effective

• maintaining adequate and appropriate records

• examining output and product for defects and ensuring appropriate and corrective action when required

• frequently reviewing respective processes and the quality system itself for efficiency and effectiveness

• being involved in and facilitating constant improvement and development within the company and products

ISO 13485:2003 - Details particular requirements for a quality management system and only includes those companies which demonstrate the ability to provide medical devices and related services that consistently meet customer expectations and regulatory requirements relevant to the medical devices and related services of the company.