Documents is managements communications to staff that quide the work to be performed.  It tells the staff what to do, its intention and implementation of activities in your quality management system which is prepared by management.

Records are evidence of the work performed and results achieved.  If you didn't record it, it was not done!  Records are prepared by staff.

Forms must bear the lab ID, address and license # if applicable.  Date and time, info and result and ID of tech doing the work.  Forms are blank documents, when they are completed they are records.

The quality manager should write all policies for the QSE.

Deficiencies most commonly cited by assessors are:   No documents, outdated documents, incomplete documents, incorrect documents or different versions in different places. 

Document control is managements way  of ensuring the staff have current, correct and complete consistent information about work processes and procedures.   Develop documents for staff, not inspectors.  Appoint one person for overall document control or one person per clinical section. 

Electronic document control can be purchased or database management systems are available on current office suite programs for PC's.  Do not confuse with electronic documents.