LPW Technology, a UK-based producer of metal additive manufacturing (AM) powders and powder software solutions, has achieved 'ISO 13485: 2016 Medical devices—Quality management systems—Requirements for regulatory purposes’ certification at its UK facility.
ISO 134851 is an internationally-devised standard for good management practices, policies and procedures, aiming to ensure that organizations consistently deliver products or services that meet customers’ quality requirements in the medical devices industry.
LPW Technology was previously accredited to ISO 13485: 2012 and has achieved the new ISO 13485: 2016 certification without any critical, major or minor non-conformances.
Commenting on the certification, Dr. Phil Carroll, founder and chief executive officer (CEO) of LPW Technology, said: ‘Achieving ISO 13485 demonstrates our commitment to delivering only the highest levels of quality assurance to the safety-critical sectors we serve. The providers of the life-changing bone and joint restoration products that we work with can have full confidence that our quality management systems ensure we operate to the most stringent of protocols.
‘Everything we do at LPW is founded on quality. From experienced engineer to apprentice, every one of the LPW team implements the quality processes that assure the integrity of the tightly controlled metal powder we develop and supply from our facilities.’
LPW Technology's UK facility has also attained: AS9100C—Quality management systems—Requirements for Aviation, Space and Defense Organizations; and AS9120A—Quality management systems—Requirements for Aviation, Space and Defense Distributors.
1 ISO 13485 specifies requirements for a QMS that can be used by an organization involved in one or more stages of a medical device's lifecycle—including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal—or the provision of associated activities such as technical support. The requirements can also be used by suppliers or other external parties providing products (e.g., raw materials, components, subassemblies, medical devices, sterilization services, calibration services, distribution services and maintenance services) to such organizations.