POWERbreathe receives certificate of approval for ‘Design & manufacture of medical devices for improvement of respiratory function’

The Quality Management System of POWERbreathe International Ltd has been approved by Lloyd’s Register Quality Assurance to the following Quality Management System Standards:

• ISO 13485:2003 - Certificate of Approval
• ISO 9001:2008 - Certificate of Approval

The Quality Management System is applicable to:

Design and manufacture of medical devices for improvement of respiratory function. 

BS EN ISO 13485:2003 Quality management systems 

Certification of approval for ISO 13485:2003 quality management system means that POWERbreathe International Limited has demonstrated the 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.

POWERbreathe International Limited holds a Certificate of Approval and operates a Quality Management System which complies with the requirements of ISO 9001:2008 and ISO 13485:2003 for the following scope:

Design and manufacture of medical devices for improvement of respiratory function.

ISO 9001 is the world’s most established quality framework

ISO 9001 helps POWERbreathe International Limited to effectively manage our business and meet our customers' requirements.

The ISO 9000 series of standards have been adopted by 951,000 organizations in 175 countries worldwide to date. ISO 9001 sets the standard not only for quality management systems, but management systems in general.

It helps all kinds of organizations to succeed through improved customer satisfaction, staff motivation and continual improvement.

POWERbreathe International Limited is committed to the overall aim of maximising customer satisfaction. We will provide impartial advice on what is appropriate for the customer and comply with such requirements that are necessary to supply high quality medical devices for improvement of respiratory function.