Information

  • Document No.

  • Audit Title

  • Client / Site

  • Conducted on

  • Prepared by

  • Location
  • Personnel

4.1. General Requirements

  • Has the processes needed for the BMS been identified and documented? If Yes How?

  • Has the interaction of those processes been identified?

  • Determine the criteria and methods required to ensure the effective operations and control of these processes?

  • Ensure the availability of information necessary to support the operation and control of these processes?

  • Are the relevant processes identified monitored, measured and where applicable analyzed

4.2 Documentation requirements

  • Does the QMS include a documented quality policy and documented objectives

  • Does the QMS contain a documented quality manual

  • Does the QMS contain documented procedures and records

  • Does the QMS contain records determined necessary to ensure the effectiveness planning, operation, and control of its processess

  • Does the quality manual include the scope of the QMS and any relevant exclusions?

  • Documented procedures or reference to them

  • A description of the interaction between the processes of the QMS

  • Is there a documented procedure for document control

  • Does the procedure address the following issues:<br>-approve documents for adequacy prior to use<br>-review, update as necessary and re-approved documents <br>-ensure that the current revision status is identified on the document <br>-ensure that relevant versions of documents are available at point of use<br>-are documents legible and readily identified <br>-are obsolete documents removed from source and controlled<br>

  • Is there a procedure to control records?

  • Has the retention period for documents been specified ?

  • Has documents been identified for retention as quality records?

  • Has areas been identified for storage?

  • Has the procedure for disposition of records been identified

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