Information

  • Conducted on

  • Auditor Name

  • Document No.

  • Audit Location / Department

  • Audit Scope / Focus

  • Related documentation, regulatory, or accreditation requirements?

Define who has responsibility, authority and/or ownership of this process? ISO9001:2008 5.5.1. (Capture roles or each process owner.)

  • Role of Director / Manager?

  • Role of Staff?

  • Role of Outsourced (contracted service / staff)?

  • Audit Notes

  • Compliant (no follow-up required)

Define -- Do you have a Documented Procedure? ISO9001:2008 4.2.1 (Consider policies, procedures, checklists, tools, forms to be completed.) How do you know that it is the latest version? ISO9001:2008 4.2.3

  • Documents Reviewed : Review / Revision Date

  • Approved

  • Changes / Current Revision Status Indentified

  • Available at point of use?

  • Current Version

  • Audit Notes

  • Compliant (no follow-up required)

What are the training requirements for this process? ISO9001:2008 6.2.2 (Consider training, educations, skills). Can you show me evidence of training or training records? ISO9001:2008 4.2.4

  • Education, Training = Competency?

  • Records of competency?

  • Audit Notes

  • Compliant (no follow-up required)

Define The Process

  • Walk me through the process...

  • Add media

  • Add drawing

  • Add media

  • Audit Notes

  • Compliant (no follow-up required)

Define the Objectives for this process? ISO9001:2008 5.4.1

  • Are objectives related to the strategic plan? Determine whether objectives are measurable and relevant to the department or functional-area. Why was this process selected?

  • Audit Notes

  • Compliant (no follow-up required)

Measure & Monitor ISO9001:2008 8.2.3 / 8.2.4

  • Show/explain to me how you measure the objectives? What activities occur to monitor this process?

  • Audit Notes

  • Compliant (no follow-up required)

Analysis ISO9001:2008 8.4

  • What do you do with the data you have collected? How do staff know how their unit/department is performing? Evaluate Results for Levels, Trends, Comparisons and Integration (Segmentation)

  • Audit Notes

  • Compliant (no follow-up required)

Improve and Control ISO9001:2008 8.5.1 / 8.5.2 / 8.5.3

  • Is there any opportunity for continual improvement, corrective action or preventive action? Please explain. What have you learned as a result of evaluating this process?

  • Audit Notes

  • Compliant (no follow-up required)

ADLI

  • Evaluate the PROCESS for ADLI <br>

LeTCI

  • Evaluate the RESULTS of the process for LeTCI

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