Quality management systems rely heavily on process control, communication, self-audits, preventative and corrective actions. Extensive documentation and record keeping must be created, revised, controlled, secured and made available in order to implement, manage and validate the quality management system.
Companies can choose how to manage the documentation and record keeping. Volumes of paper documents can be difficult to revise and control. A system with outdated documents poses a hazard to operations and can jeopardize employee safety, as well. For large companies, controlling all copies of documents and records can be an impossible task. Quality assurance software and quality management software can simplify the requirements to update and secure ISO 9000 documentation.
There are many options available on the market, and companies should first determine their individual needs according to the size and complexity of their quality management system. Installing an entire SAP system may not be necessary for a small company, while Microsoft Office would not handle the complexity of a global engineering company with multiple products and locations. Regardless of the size of the company, quality assurance software must have certain capabilities:
- Documents should be accessible to people who do the work where they work
- Protect documents from unauthorized alterations
- Control access to the latest versions of documents
- Maintain a history of document revisions with approvals
- Allow tracking of the document approval process
- Simplify the corrective action and preventive action process
- Provide a secure recordkeeping system
- Keep a master list of all documentation and provide for easy updates
- Generate and easily disseminate reports
- Have the capacity to handle the volume of documentation and operations
Compatibility is another issue when selecting quality management software. If your company has a combination of Macs and PCs with a variety of operating systems, you may need to purchase new hardware and standardize your operating systems.
Look for a vendor with a track record of successful installations and system conversions. A local vendor, or one who sends a representative to manage installation onsite, can walk you through any problems or questions you may have. Systems must be tested using sample data to be sure everything is working as needed before taking the system “live.” Software should be easy to customize to your particular system and handle any changes. It should have built-in tutorials and an extensive help program for troubleshooting problems.
Once in place, an electronic quality management system takes the hassle out of document tracking, distribution and security. You can find the best software for your company’s particular needs with a little planning and due diligence.