Lasertec Ireland has since 1994 focused on delivering engineering solutions for Contract Electronics Manufacturers and OEM’s in the Automotive, Medical Device and Telecommunications industries with
• Expert Design engineers, technicians and toolmakers.
• Development and Implementation of Integrated Process test and Automation solutions
• Design and Manufacture of Laser cut stencils, wave soldering pallets, Precision Fixtures & Tooling.
• Provision of Consumables and services.
In support of our drive to continually improve the quality of our service we have established a quality management system compliant with requirements of ISO 9001:2008.
Our quality system aims to
• Ensure compliance with relevant legal requirements
• Provide flexible customer focused services.
• Develop a partnership with our supply chain to ensure required standards are delivered.
• Provide framework for Equipment Validation and GAMP 5 implementation
By monitoring and reviewing our performance we aim to continually improve the effectiveness of our quality management system, processes and facilities and in doing so meet our overall objective of providing excellent products & services and customer care.
Documentation
ISO
ISO 9001:2008 specifies requirements for a 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.
GAMP 5
GAMP-5 (Good Automated Manufacturing Practices) is practical industry guide to achieve compliant computerized systems fit for intended use in an efficient and effective manner. It lays out a set of principles and procedures that help ensure that automation equipment has the required quality. One of the core principles of GAMP is “quality by design”; that quality must be built into each stage of the
manufacturing process. As a result, GAMP covers all aspects of production from the raw materials, facility and equipment to the training and hygiene of staff.
