Great Resources On Creating 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.ISO 9000:2005 clause 3.7.2 defines a document as information and it’s supporting medium and can be in magnetic, electronic, or optical computer disc form.This means an electronic quality management system is perfectly acceptable.
An electronic quality management system can only add value to your organisation. 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.Given the appropriate access to the computerized quality management system all personnel can benefit from greater knowledge sharing.Evidence of conformity can still be provided using an computerized quality management system but controls discussed later need to be implemented.
The facts are a computerized quality management system should be more efficient.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.Appropriate information technology resources to ensure that the computerized quality management system operates effectively will be required. 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.
Information technology policies and procedures for the computerized quality management system will need to be in place. The computerized quality management system software will require competent information technology personnel. 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. Quality management system general procedures for document control including document identification and revision level will need to equally apply to the computerized system. A system will be required to control computerized quality management system records. A clear definition of how the system relates information from the physical process will be required.
Procedures for communication with customers, suppliers and other interested parties will need to be addressed within the computerized quality management system.
Policies and procedures for the authorisation of computerized quality management system documents and records will need to be applied.
The annual complaints analyzer calculates your complaints per million units for the month by product and category and has a colour coded alert level which you can preset. The system will automatically update your annual report so you can monitor complaints in a year to date format again with colour coded alerts.
This entry was posted on Friday, June 19th, 2009 at 7:47 am and is filed under Marketing and Advertising. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.
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