Low Cost Record Keeping Options
A majority of the burden of an ISO 9000 quality system is the additional record keeping requirements that most companies would not do if they were not being periodically audited. These records can be managed in either paper (notebooks and files) or electronic (database) versions. Here are my recommendations the simplest and most cost effective ways to maintain records.
This information should be maintained as a notebook with a tab for each time the group meets.
This information should be maintained as a notebook with tabs for the each ISO requirements (original quality plan including timeline and spec, reviews, validation (signature showing conformance), verification (test against the spec))
This information should be maintained in a notebook with tabs for each audit. These records are not time critical and not needed on a daily basis.
Personnel Training Records
This information can be maintained in a notebook or database. The notebook is very simple to implement but labor intensive to maintain. A database is more costly to setup but simpler to maintain. The quickest option is to create one page for every employee and keep it in a notebook.
Maintenance and calibration records
This information could be maintained in a notebook or database. A database will allow automated generation of reports that can be used to notify appropriate personnel of the need for action. The database that could be as simple as an excel spreadsheet and should calculate when item will be due for calibration (plus the lead time for calibration).
Revision and Documentation Control
This information should be maintained in a database. The revision level is always changing at a "continuous improving" company. Everyone needs immediate access to the current requirements. There for the best system must allow all employees to log on and check the current revision level without having to go to a central physical location.
This information is maintained in a database at 95% of all companies. ERP and MRP systems are great for use in the ISO 9001 environment.
Engineering Change Request and Orders (Preventive and Corrective Actions)
This information should be maintained in a database. There is an extraordinary amount of critical information on the engineering change request and change order., This information is more useful when it is on-line and searchable. After the system has been in place for several years, the ability to summarize and search changes is priceless.
This information should be maintained in a database or spreadsheet. Analysis of the data is important for process control. A database allows instant access to summary data of potential quality problems. This help maintain conformance with both the continuous improvement and process control portions of the ISO 9001 standard.
These recommendations are based on small to medium manufacturers that are the bulk of the ISO 9001 certified companies. Larger companies will usually have large and complex system for the areas listed since they need to integrate a larger number of people and they have larger budgets to accomplish each task.