Great Resources On Implementing 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.A document is defined as quality management system information and it’s supporting medium, including electronic form, in ISO9000:2005 clause 3.7.2 .This means an electronic quality management system is perfectly acceptable.
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.There is no reason why a computerized quality management system cannot achieve these objectives. An computerized quality management system can provide almost instant communication using e-mail.Knowledge sharing can be made so much simpler using an computerized quality management system.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.A different element of control will need to be demonstrated for a computerized quality management system compared to a paper based system.The computerized quality management system will require information technology resources and infrastructure. The involvement of Information Technology personnel in the documentation, implementation and maintenance of the computerized quality management system should be defined within the system.Controls will need to be established for software, software licensing, and software updates for the computerized quality management system.
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.An organization will need to secure the information contained in the computerized quality management system. 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. 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.Interaction with the physical process will need to be defined to ensure all recorded information is accurate.
The computerized quality management system will need to have procedures for communication with customers, suppliers and other interested parties.
Policies and procedures for the authorisation of computerized quality management system documents and records will need to be applied.
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