D135: DEMO OF ISO 15189:2012 DOCUMENT KIT Price 450 USD Complete editable ISO 15189:2012 document kit (Manual, procedures, SOPs, exhibits, formats, audit checklist etc.)
Website: http://www.certificationconsultancy.com/medical-labqms-15189-certification-documents.htm 5. Blank Formats (94 Formats): It covers sample copy of blank forms required to maintain records as well as establish control and make system in the medical laboratories. The samples given are as a guide and not compulsory to follow and medical laboratories is free to change the same to suit own requirements. List of Formats 1. 3. 5. 7. 9. 11. 13. 15. 17. 19. 21. 23. 25. 27.
Accident / Incident Record Calibration Register - Clinical Chemistry Critical Alert Results Register Equipment Maintenance Log Kit in Use Log Form LJ chart Template for Product Insert Mean Record Label Sample integrity register Sample storage and discadal register Monitoring TAT Bleeding Time & Clotting Time Register Non Conformance Register Sample rejection Register
29. 31. 33. 35. 37. 39. 41. 43. 45. 47. 49. 51. 53.
Request for examination – urine Request for examination – whole blood / serum Customer feedback form Complaint report Test Instruction Slips HIV Consent Form Training Calendar Induction training report Skill Matrix Appointment Letter ISO 15189 effectiveness check report Immunization report
55. 57. 59. 61. 63. 65. 67. 69. 71. 73. 75.
Disposal of non–conformities Indent (purchase requisition) Supplier registration form Material specification sheet Stock register Four Year Plan for Quality Control Z score report Re - Test Analysis Environment condition monitoring report Inspection report Intermediate check report – weighing balance
Temperature Log Form – Room
Preventive maintenance schedule
2. 4. 6. 8. 10. 12. 14. 16. 18. 20. 22. 24. 26. 28. 30. 32. 34. 36. 38. 40. 42. 44. 46. 48. 50. 52. 54. 56. 58. 60. 62. 64. 66. 68. 70. 72. 74. 76.
Equipment Maintenance Breakdown Record PT / EQAS / ILC / corrective action report Equipment History Record Housekeeping Record LJ chart Template for Lab Mean Non Conformance Register Repeat Test Result Register Sample Rejection Register Monitoring STAT Temperature Log Form - Room Housekeeping Register Sample Collection Register Sample Rework Register Request for examination – serum / fluoride plasma Request for examination – Serum Request for examination – whole blood with EDTA Complaint register Inward register Final Test Report Test Amendments Form Training Report Job Description and Specification Confidentiality Agreement Employees Competence Report Employee history card Equipment history card Equipment wise preventive maintenance checkpoints Purchase order Approved vendor list cum open purchase order Open purchase order Evaluation for Referral Lab Supplier evaluation form Re–test plan / execution report Uncertainty of Measurement Critical consumables pH Meter Calibration Report Normality record sheet Intermediate check report – oven
To get more information about ISO 15189:2012 Documentation kit Click Here www.certificationconsultancy.com Email sales@certificationconsultancy.com +91-79-2979 5322
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