ISO 15189:2012 documents kit contains more than 170 editable MS-Word files. These editable documents address all the elements of medical laboratory accreditation.

  • A Manual
  • Required Procedures
  • Formats
  • Sample Filled Forms

Original price was: $650.00.Current price is: $550.00.



Procedures and formats provided in the documentation kit, can help in fine-tuning the processes and establish better control for system establishment for reference material producers.

Content of Documentation Kit for ISO 15189:2012 Accreditation

The ISO 15189 Documentation kit has a total of 170 editable files for requirements for the medical laboratory quality management system. This kit includes the following ready-to-use templates, which can accelerate the documentation process for ISO 15189 accreditation.

  1. Sample ISO 15189 Manual – 01 editable file to define how ISO 15189:2012 system is implemented.
  2. Mandatory Procedures – Total 30 procedures in word format for various departments.
  3. Standard Operating Procedures – Total 40 SOPs for collection, operation and testing process and used as reference documents.
  4. Exhibits – Total 06 editable exhibits in word format to follow while implementing an effective system.
  5. Readymade Formats – Total 94 editable forms and templates for various departments of medical laboratories to fill up records and learn system requirements.
  6. ISO 15189 Audit Checklist – More than 350 audit questions to verify the implemented quality management system and add effectiveness in the medical laboratory accreditation.
The standard ISO 15189:2012 is developed for use by medical laboratories in developing their quality management systems and assessing their own competence. ISO 15189 certification can be also used for confirming or recognizing the competence of medical laboratories by laboratory customers (patients / corporate customers/ hospitals etc.), regulating authorities and accreditation bodies.


Our document kit is having sample documents required for ISO 15189:2012 certification as listed below. You need to study it do necessary changes as per your company need and within 4 days your entire editable documents with all necessary details are ready and many medical laboratories are accredited globally in 1st trial with the help of our documents from any kind of stringent accreditation assessment.
Under this directory further files are made in word Document as per the details listed below. All the documents are related to any kind of medical laboratories.

1. Quality Manual:

It covers sample copy of quality manual for medical laboratory. It describes how all requirement of ISO 15189:2012. It covers list of procedures as well as overview of medical laboratories and
covers tier1 of ISO 15189:2012 documents.
(A) Table of Contents
1. Cover page, Table of contents, amendment record sheet and glossary of terms (abbreviation)
2 Authorization statement and laboratory profile
3 Control and distribution
Section – 2
4. Management Requirements
4.1 to 4.15 Management Requirements
5. Technical Requirements
5.1 to 5.10 Technical Requirements
ANX–1 List of quality procedures
Note The amendment number given above is at the time of issue of this manual. If any page is amended then latest amendment number of such pages is recorded in amendment record sheet and on the table of content given above.

2. Procedures (31 Procedures):

It covers sample copy of mandatory procedures covering all the details of ISO 15189:2012standard.
List of procedure
  1. Procedure for Receipt, handling, storage and disposal of samples in line with the legal requirements
  2. Procedure for Control of documents
  3. Procedure for Establishment and review of agreements for providing medical laboratory services to its customers / patients
  4. Procedure for Selecting and evaluating referral laboratories and consultants
  5. Procedure for Purchasing
  6. Procedure for Management of complaints or other feedback received from clinicians, patients, laboratory staff or other parties
  7. Procedure for Identification and control of non–conformities
  8. Procedure for Corrective action
  9. Procedure for Preventive action
  10. Procedure for Control of records
  11. Procedure for Internal audit
  12. Procedure for Management review
  13. Procedure for Personnel and training
  14. Procedure for Facility maintenance and environment
  15. Procedure for Selection, purchasing and management of equipment
  16. Procedure for Safe handling, transport, storage and use of equipment to prevent its contamination or deterioration
  17. Procedure for Calibration of equipment
  18. Procedure for Reception, storage, acceptance testing and inventory management of reagents and consumables
  19. Procedure for Pre–examination process
  20. Procedure for Collection and handling of primary samples
  21. Procedure for Transportations of samples
  22. Procedure for Sample receipt
  23. Procedure for Pre–examination handling, preparation and storage
  24. Procedure for Validation of examination procedures
  25. Procedure for Ensuring the quality of examination results
  26. Procedure for Review of examination results
  27. Procedure for Identification, collection, retention, indexing, access, storage, maintenance and safe disposal of clinical samples
  28. Procedure for reporting the results
  29. Procedure for Release of examination results
  30. Procedure for Confidentiality of patient’s information
  31. Procedure for Risk analysis

3. Standard operating procedure (40 SOPs):

It covers sample copy of standard operating procedures covering all the details of ISO 15189:2012 standard.
List of standard operating procedure (SOPs)
  1. Collection & Transport of Specimens for Biochemistry Examinations
  2. Patient Preparation Instructions
  3. Needle Stick Injury – Care & Precaution
  4. Specimen Acceptance & Rejection Criteria
  5. Treatment and Disposal of Biomedical Waste
  6. House Keeping Procedure
  7. Personnel Safety Procedure
  8. Sample Preparation and Storage
  9. Sample collection
  10. Sample rejection
  11. General departmental procedure
  12. Quality control procedure
  13. Equipment maintenance & operating procedure
  14. Measurement of Uncertainty
  15. Monitoring Turn-Around-Time
  16. Critical Alert Level Values / Panic Values
  17. Repeat Test
  18. Data backup plan
  19. Generation of test results
  20. Housekeeping
  21. Personal protection and safety
  22. Treatment and Disposal of Biomedical Waste
  23. Data backup plan, Linearity and range of testing, Accuracy& Precision
  24. Equipment calibration plan procedure
  25. Test procedure – Serum – Alanine Amino TransferaseCobas c501
  26. Test procedure – Serum – Albumin – Cobas c501
  27. Test procedure – Serum – Bicarbonate – Cobas c311
  28. Test procedure – Serum – Bilirubin Total – Cobas c501
  29. Test procedure – Serum – Calcium – Cobas c501
  30. Test procedure – Serum – Creatinine – Cobas c501
  31. Test procedure – Serum – GGT – Cobas c501
  32. Test procedure – Serum – Glucose – Cobas c501
  33. Test procedure – Serum – HDL Cholesterol – Cobas c311
  34. Test procedure – Serum – Phosphours – Cobas c501
  35. Test procedure – Serum – Aspartate Amino Transferase – Cobas c501
  36. Test procedure – Serum – TGL – Cobas c501
  37. Test procedure – Serum – Total Cholesterol – Cobas c501
  38. Test procedure – Serum – Total Protein – Cobas c501
  39. Test procedure – Serum – Urea – Cobas c501
  40. Test procedure – Serum – Uric Acid – Cobas c501

4. Exhibits (06 Exhibits):

It covers sample copy of exhibits covering all the details of ISO 15189:2012 standard.
List of Exhibits
  1. Skill Requirements
  2. Codification System
  3. Calibration Periodicity
  4. Secrecy Rules
  5. Recommended conditions for sample collection, transport and storage for conventional cytogenetic analysis
  6. Minimum retention period for identified records

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. Accident / Incident Record
  2. Equipment Maintenance Breakdown Record
  3. Calibration Register – Clinical Chemistry
  4. PT / EQAS / ILC / corrective action report
  5. Critical Alert Results Register
  6. Equipment History Record
  7. Equipment Maintenance Log
  8. Housekeeping Record
  9. Kit in Use Log Form
  10. LJ chart Template for Lab Mean
  11. LJ chart Template for Product Insert Mean
  12. Non Conformance Register
  13. Record Label
  14. Repeat Test Result Register
  15. Sample integrity register
  16. Sample Rejection Register
  17. Sample storage and discadal register
  18. Monitoring STAT
  19. Monitoring TAT
  20. Temperature Log Form – Room
  21. Bleeding Time & Clotting Time Register
  22. Housekeeping Register
  23. Non Conformance Register
  24. Sample Collection Register
  25. Sample rejection Register
  26. Sample Rework Register
  27. Temperature Log Form – Roomn
  28. Request for examination – serum / fluoride plasma
  29. Request for examination – urine
  30. Request for examination – Serum
  31. Request for examination – whole blood / serum
  32. Request for examination – whole blood with EDTA
  33. Customer feedback form
  34. Complaint register
  35. Complaint report
  36. Inward register
  37. Test Instruction Slips
  38. Final Test Report
  39. HIV Consent Form
  40. Test Amendments Form
  41. Training Calendar
  42. Training Report
  43. Induction training report
  44. Job Description and Specification
  45. Skill Matrix
  46. Confidentiality Agreement
  47. Appointment Letter
  48. Employees Competence Report
  49. ISO 15189 effectiveness check report
  50. Employee history card
  51. Immunization report
  52. Equipment history card
  53. Preventive maintenance schedule
  54. Equipment wise preventive maintenance checkpoints
  55. Disposal of non–conformities
  56. Purchase order
  57. Indent (purchase requisition)
  58. Approved vendor list cum open purchase order
  59. Supplier registration form
  60. Open purchase order
  61. Material specification sheet
  62. Evaluation for Referral Lab
  63. Stock register
  64. Supplier evaluation form
  65. Four Year Plan for Quality Control
  66. Re–test plan / execution report
  67. Z score report
  68. Uncertainty of Measurement
  69. Re – Test Analysis
  70. Critical consumables
  71. Environment condition monitoring report
  72. pH Meter Calibration Report
  73. Inspection report
  74. Normality record sheet
  75. Intermediate check report – weighing balance
  76. Intermediate check report – oven
  77. Housekeeping checklist
  78. Checklist for Medical Laboratory Collection Centre / Facility
  79. Quality control plan method
  80. Design / Planning of the method validation
  81. Validation report
  82. Master List Cum Distribution List of Documents
  83. Change Note
  84. Corrective action report
  85. Master List of Records
  86. Quality objectives (key performance indicator)
  87. Audit Plan / Schedule
  88. Internal audit non–conformity report
  89. Clause wise document wise audit review report
  90. Preventive Action Report
  91. Calibration status of equipment
  92. Audit Observation Report
  93. Goods inward register
  94. Stock register

6. Audit checklist (more than 350 questions)

It covers sample audit questions based on all the ISO 15189 requirements. It helps the auditor to make own audit checklist for quick and perfect auditing to ensure all the ISO 15189 requirements are fulfilled by the medical laboratories.

7. Sample risk template

The ready to use risk template in editable form is given to prepare the risk document for the organization. It is given in excel and can be use as ready to use template.

How useful?

  • The users/ iso 15189 consultant can modify readymade templates as per their working system and they can create their own documents for quick accreditation.
  • Procedures and formats provided in the documentation kit can help in fine-tuning the processes and establish better control over the management system.
  • It saves a lot of time and cost in document preparation. It gives value for money to customers and the number of payback is very low.
  • Ready to use templates in .doc format will reduce your time in the documentation process as well as useful in giving training to staff.
  • Takes care of all the sections and sub-sections to give better confidence to iso 17065 consultant as well as improve the system.
  • Audit checklist for iso 15189 accreditation is given with more than 350 internal audit questions, which is useful to train all the employees for an accreditation audit.


There are no reviews yet.

Only logged in customers who have purchased this product may leave a review.