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It is the stated quality policy of G&B Electronic Designs Ltd. to satisfy the requirements of our customers as a minimum, and seek to exceed them in every way that we can. This can only be achieved by operating a comprehensive, co-ordinated quality system which assures the quality of all services offered by the company. This system is designed to meet the requirements of ISO 9001:2015, ISO 13485:2016, EC Medical Device Directive 93/42/EEC and CGMP-QS Title 21 CFR Part 820 USA will be implemented across the whole company and embrace all the activities which impact upon our customers.
The Managing Director and senior managers of the company are committed to ensuring that the system is effective in achieving quality and satisfying customers both now and in the future. To this end, we will strive to continually improve upon our services, processes and our quality management system. As part of this philosophy we will set quality objectives across the whole organisation which will be measured against and reported upon.
To foster a culture of continual improvement the company will continue to recognise and reward effective teamwork and individual achievement and will review its products and processes regularly.
All employees and associates will be made aware of the importance of achieving this policy which will itself be reviewed periodically to ensure its continued suitability and applicability. When the policy is changed it will be re-implemented within the organisation and with associates as required.
G&B’s Quality Manual describes the management objectives of the company for procurement, manufacture, handling, despatch, after sales activities and regulatory conformity of electronic components and electronic equipment.
It includes equipment described as “medical devices” in:
G&B’s Quality Management System is based on the process approach to quality management and conforms to the requirements of;
G&B is committed to consistently provide for the maintenance and continual improvement of product quality and customer satisfaction.
Instructions and guidance are provided to employees, subcontractors and suppliers to ensure that they understand their particular responsibilities that may include quality requirements, the need for added value, continual improvement and the principles of objective measurement.
The overall responsibility for the Quality Management System is maintained by the Managing Director who may delegate this function, or parts of this function, to other managers. See organisation chart in paragraph
As per the requirements of paragraph 1.2 of EN 13485: 2016 it is declared that G&B makes these exclusions from the requirements of this standard.
By management review G&B plans and implements the monitoring, measurement, analysis and improvement of processes needed to assure conformity to product requirements, conformity of the Quality Management System, and to continually improve the effectiveness of the Quality Management System.
As one of the measurements of the performance of the Quality Management System, G&B monitors customer feedback information relating to customer perception as to whether they have met their customer’s requirements. This provides early warning of problems and provides input into the corrective and preventative action system.
G&B plans and maintains an internal audit program of it’s work instructions and procedures to verify that they are implemented, effective and that they conform to planned arrangements. Any actions determined from these audits shall be acted upon without delay to eliminate non-conformities and their route causes.
G&B monitors and measures the characteristics of the products they design and/or manufacture to verify that requirements are met. This is carried out using separate work instructions and records dependent on the product concerned. Product release or service shall not be made until it is demonstrated that planned arrangements and specifications are met and the route card is signed off.
ISO9001 2015 Certificate (pdf)
ISO13485 2016 Certificate (pdf)
IPC Advice on Selecting an EMS Provider (pdf)
T: 01420 474188