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Great Resources On Creating A Computerized Quality Management System
July 6, 2009 | | Leave a Comment
Quality Management System documents may come in any form or medium as defined in clause 4.2 of ISO 9001.Quality Management System documents can be in magnetic or electronic from as defined in ISO 9000:2005.This means an electronic quality management system is perfectly acceptable.
There can only be a positives from implementing an computerized quality management system. The main objectives of quality management system documentation are communication of information, evidence of conformity and knowledge sharing. An organisation is just as likely to meet these objectives using an computerized quality management system. Communication via e-mail is one of the great benefits of an computerized quality management system.Given the appropriate access to the computerized quality management system all personnel can benefit from greater knowledge sharing.An computerized quality management system can provide evidence of conformity in the same way as a paper based system.
A computerized quality management system should be more effective than a paper based system.A different element of control will need to be demonstrated for a computerized quality management system compared to a paper based system.Infrastructure and resource from the information technology department will be required for the computerized quality management system. The involvement of Information Technology personnel in the documentation, implementation and maintenance of the computerized quality management system should be defined within the system.The computerized quality management system software will need software, software licensing, and software updates.
The computerized quality management system software will need to be included in information technology policies and procedures. The computerized quality management system software will require competent information technology personnel. The computerized quality management system will need to be secured. Procedures will need to be in place to deal with a breakdown of the computerized quality management system. To ensure documents and records are being maintained procedures will be needed to check the backup systems. Computerized quality management system document controls procedures including document identification and revision level will need to be in place.Control of computerized quality management system records will need to be address in the system procedures.Details of how information from the physical processes is applied to the computerized system should be documented.
Methods of electronic communication with customers, suppliers and other interested parties should be described in the system procedures.
Policies and procedures for the authorisation of computerized quality management system documents and records will need to be applied.