ISO 15189 Documentation Kit

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-lab-
qms-15189-certification-documents.htm
To get more information about ISO 15189:2012 Documentation kit Click Here
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The Total Editable Document kit has 6 main directories as below.
ISO 15189:2012 Editable Document kit for medical laboratories
Sr.
No.
List of Directory Document of Details
1. Quality Manual 01 files in MS Word
2. Procedures 30 Procedures in MS Word
3.
Standard operating procedure
40 Standard operating
procedure in MS Word
Collection (CCC) 08 Standard operating procedure in MS Word
Operation (OPN) 16 Standard operating procedure in MS Word
Testing (EXM) 16 Standard operating procedure in MS Word
4. Exhibits 06 exhibits in MS Word
5.
Formats 94 formats in MS Word / Excel
Clinical Biochemistry (CBC) 20 formats in MS Word / Excel
Collection (CCC) 07 formats in MS Word / Excel
Customer service (CSD) 09 formats in MS Word
Front Office & Patient Registration (FPR) 04 formats in MS Word
HR and Training (TRG) 11 formats in MS Word
Operation (OPN) 04 formats in MS Word
Purchase (PUR) 09 formats in MS Word
Quality control (QCD) 17 formats in MS Word / Excel
System Formats (SYS) 11 formats in MS Word
Stores (STR) 02 formats in MS Word
6. Audit checklist More than 350 questions
Total 170 files quick download in editable form by e delivery
Chapter-1.0 CONTENTS OF ISO 15189:2012 DOCUMENT KIT
(More than 170 document files)

B. Documentation:-
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 tier 1 of ISO 15189:2012 documents.
ISO 15189:2012 Manual Index
Table Of Contents
Chapter
No.
Subject
Amend
ment
No.
Page No.
ISO 15189
Clause Ref.
1
Cover page, Table of contents, amendment record
sheet and glossary of terms (abbreviation)
00 1 – 6 ==========
2 Authorization statement and laboratory profile 00 7 – 15 ==========
3 Control and distribution 00 16 – 17 ==========
Section – 2
4
Management Requirements
4.0
4.1 to
4.15
Management Requirements 00 18 – 51
5
Technical Requirements
5.1 to 5.10
5.1 to
5.10
Technical Requirements
00 79 – 80
Annexure
ANX–1 List of quality procedures 00 81 – 82 ==========
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 (30 Procedures):
It covers sample copy of mandatory procedures covering all the details of ISO
15189:2012 standard.
List of procedure
1.
Receipt, handling, storage and disposal of samples in line with the legal
requirements
2. Control of documents
3.
Establishment and review of agreements for providing medical laboratory services
to its customers / patients
4. Selecting and evaluating referral laboratories and consultants
5. Purchasing
6.
Management of complaints or other feedback received from clinicians, patients,
laboratory staff or other parties
7. Identification and control of non–conformities
8. Corrective action
9. Preventive action
10. Control of records
11. Internal audit
12. Management review
13. Personnel and training
14. Facility maintenance and environment
15. Selection, purchasing and management of equipment
16.
Safe handling, transport, storage and use of equipment to prevent its
contamination or deterioration
17. Calibration of equipment
18.
Reception, storage, acceptance testing and inventory management of reagents
and consumables
19. Pre–examination process
20. Collection and handling of primary samples
21. Transportations of samples
22. Sample receipt
23. Pre–examination handling, preparation and storage
24. Validation of examination procedures

25. Ensuring the quality of examination results
26. Review of examination results
27.
Identification, collection, retention, indexing, access, storage, maintenance and
safe disposal of clinical samples
28. Reporting the results
29. Release of examination results
30. Confidentiality of patient’s information
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 Transferase Cobas 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 – Room
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.

Global manager group is a progressive company and promoted by a group of qualified
engineers and management graduates having rich experience of 25 years in ISO
consultancy and management areas. The company serves the global customers through
on-site and off-site modes of service delivery systems. We offer a full range of consulting
services geared towards helping all types of industries and laboratories to achieve
competitiveness, certifications and compliance to international standards and regulations.
So far we had more than 1800 clients in more than 45 countries. Our readymade
training and editable document kit helps the client in making their documents easy
and make them complying to related ISO standard faster.
1. Our promoters and engineers have experience of more than 1800 companies globally
for management training, ISO series consultancy. We had clients in more than 45
countries.
2. Highly qualified 50 team members (M.B.A., Degree engineers) and owner is having rich
professional experience (since 1991).
3. We have 100% success rate for ISO series certification of our clients from reputed
certifying body and branded image and leading name in the market.
4. Suggest continual improvement and cost reduction measures as well as highly
informative training presentations and other products gives payback within 2 months
against our cost.
5. So far more than 50000 employees are trained by us in ISO series certification.
6. We had spent more than 60000 man-days (170 man years) in preparing ISO
documents and training slides.
Global Manager Group is committed for:
1. Personal involvement & commitment from first day
2. Optimum charges
3. Professional approach
4. Hard work and update the knowledge of team members
5. Strengthening clients by system establishment and providing best training materials in
any areas of management to make their house in proper manner
6. To establish strong internal control with the help of system and use of the latest
management techniques.
Chapter-2.0 ABOUT COMPANY

3.1 Hardware and Software Requirements
A. Hardware:-
 Our document kit can be better performed with the help of P3 and above computers
with a minimum 10 GB hard disk space.
 For better visual impact of the power point Document you may keep the setting of
colour image at high colour.
B. Software used in Document kit
 Documents written in Ms Office 2003 and window XP programs. You are therefore
required to have office 2003 or above with window XP
3.2 Features of Document kit:-
 Contains all necessary documents as listed above and comply with the requirements
of ISO 15189:2012 Standards.
 Written in Plain English
 It will save much time in typing and preparation of documents alone.
 User-friendly and easy to learn.
 Developed under the guidance of experienced experts.
 Provides model of a Management system that is simple and free from excessive
paperwork.
Chapter-3.0 USER FUNCTION

1. By using these documents, you can save a lot of your precious time while preparing the
ISO 15189:2012 documents.
2. Take care for all the section and sub sections of ISO 15189:2012 standard helps you in
establishing better system.
3. Document kit enables you to change the contents and print as many copies as you
need. The user can modify the documents as per their industry and create own ISO
15189:2012 documents for their medical laboratories.
4. Save much time and cost in document preparation.
5. You will get better control in your system due to our proven formats.
6. You will get better control in your system due to our proven documents and templates
developed under the guidance of our experts and globally proven consultants having
rich experience of more than 25 years in ISO consultancy.
7. Our products are highly sold globally and used by many multinational companies and
had provided total customer satisfaction as well as value for money.
8. In preparation of document kits; it is been verified and evaluated at various levels of our
team and more than 1000 hours are spent in preparation of this product kit.
9. Prepared by globally proven team of leading consultant
For purchase Click Here Contact Us
Chapter-4.0 BENEFITS OF USING OUR DOCUMENT KIT

ISO 15189 Documentation Kit

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