Find Out More About A Computerized Quality Management System
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.Hence one should not be afraid to dispense with paper and implement and computerized quality management system.
The benefits of an computerized quality management system far outweigh any drawbacks . 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.There is no doubt with the benefits of e-mail that an computerized quality management system can be an effective communication tool.A computerized quality management system exponentially increases the capability of an organisation to distribute information.The provision of evidence that what was planned, has actually been done requires slightly more controls using an computerized quality management system but is still achievable.
One would expect greater efficiency from a computerized quality management system.The fact a quality management system is computerized will mean that there will need to be additional controls to meet the requirements of the ISO 9001:2008 standard.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. Information technology support in establishing computerized quality management system software, software licensing, and software updates will be required.
An organization will need to have information technology policies and procedures appropriate to the computerized quality management system.Competent personnel will be required to run the computerized quality management system software. The computerized quality management system will need to be secured. Contingency plans will be required if for any reason the computerized quality management system is not available. To ensure documents and records are being maintained procedures will be needed to check the backup systems. The document controls that apply to the quality management system in-general also need to be employed for computerized system documents including document identification and revision level through appropriate procedures.Control of computerized quality management system records will need to be address in the system procedures.Interaction with the physical process will need to be defined to ensure all recorded information is accurate.
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.
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