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Document Control on a Budget

ISO 9001 requires that you maintain Control of Documents (4.2.3)

Here are some key items you should track, and some basic storage/control tips:

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About Document Control Software

You can use a tabbed binder or MS Word/Excel for these basic functions:

  • Management Reviews A file or tab for each review will aid in quick retrieval of information.
    Design Reviews should record each of the ISO requirements including timeline, specs, validation and verification as appropriate for your organization.
  • Internal Audits do not need to be maintained on a daily basis.
  • Personnel Training Records can be maintained in a notebook but an Excel spreadsheet is probably more practical to create a matrix of training and personnel.
  • Maintenance and calibration records are best in a database to ease report generation.
  • Revision and Documentation Control information should be maintained in a database. The 9000 Store Master Document List (Excel) is an easy way to track revisions. If you put it on a server (read only) then people can access it anywhere in your organization.
  • Bids/Orders/Changes are best in a database for easy access over time.
  • Non-Conforming Material, Traceability issues and customer propertyinformation should be maintained in a database due to the liability.

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