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Example checklist – document control audit - DOC

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					                                         Training for internal audit (September 2004)




                                 Central Manchester and Manchester
                                      Children’s University Hospitals
                                                                                                NHS Trust
                                                                            National Genetics Reference Laboratory (Manchester)
                                                                                                   Department of Medical Genetics
                                                                                                               St. Mary’s Hospital
                                                                                                                Hathersage Road
Head of laboratory: Dr. R.G. Elles                                                                           Manchester M13 0JH
       Accredited                                                                                        Tel: 0161 276 6122/6605
                                                                                                              Fax: 0161 276 6606




                   Example checklist – document control audit

1.   Is there an up to date SOP for document control?
2.   Is the document current and within review date?

3.   Is there evidence that document has been prepared, checked and approved by a suitably qualified

     member of staff?

4.   Does the document has the necessary information such as version number, unique identification, title,

     review dates, etc.?

5.   Is there evidence of cross referencing to other documents?
6.   Is there evidence that documents are accessible and secure?

7.   Is there evidence of appropriate document distribution?
8.   Is there evidence that this is working?

9.   Is there evidence of a process for document change?

10. Is there evidence of a backup procedure for the document control system?

11. Is there evidence that previous versions of documents have been archived?
12. Is there evidence that this archiving is correct?

13. Is there evidence that staff adhere to the document control procedure?

14. Is there evidence that out of date documents are being withdrawn from circulation?
15. Do they conform to the system as given?

16. Is this in line with the required standards?

17. Are they in date, appropriately formatted etc?
18. Is there evidence of regular review?

19. When was the last review?
20. Are staff trained in document control?

21. Do they have documented evidence of this?
22. Are out of date documents reviewed?
23. Is their adequate back-up?



                Organised by the National Genetics Reference Laboratory (Manchester), St Mary’s Hospital, Manchester

26/02/2010                                                                                                   Page 1 of 2
                                         Training for internal audit (September 2004)




                                 Central Manchester and Manchester
                                      Children’s University Hospitals
                                                                                                NHS Trust
                                                                            National Genetics Reference Laboratory (Manchester)
                                                                                                   Department of Medical Genetics
                                                                                                               St. Mary’s Hospital
                                                                                                                Hathersage Road
Head of laboratory: Dr. R.G. Elles                                                                           Manchester M13 0JH
       Accredited                                                                                        Tel: 0161 276 6122/6605
                                                                                                              Fax: 0161 276 6606

24. Are staff informed when documents are updated and available?

25. Are previous versions of documents available for retrieval?




                Organised by the National Genetics Reference Laboratory (Manchester), St Mary’s Hospital, Manchester

26/02/2010                                                                                                   Page 2 of 2

				
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