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Document Control on a Budget

ISO 9001 requires that you maintain Control of Documents (7.5). 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 property information should be maintained in a database due to the liability.

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Customer Review:

"I have just passed my ISO-9001 Audit with zero non-conformances for the second year in a row using your ISO products to write my entire QMS. Thank you for producing documents of this quality"

Bettye Patrick

United Plating, Inc