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Procedures 31 Procedures in MS Word
Totally editable documentation package for quick process improvement to implement the system Completely editable document toolkit (Quality Manual, procedures, exhibits, standard operating procedure, blank forms, audit checklists, etc.) Buy at: www.globalmanagergroup.com
B. Documentation:-
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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. QualityManual:
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
Chapter No. Subject
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 Amend ment No. Page No. ISO 15189 Clause Ref.
00 1 – 6 ==========
00 7 – 15 ========== 00 16 – 17 ==========
4
Management Requirements
4.1 to 4.15 Management Requirements 00 18 – 51 4.0
5
Technical Requirements
5.1 to 5.10 Technical Requirements 00 79 – 80 5.1 to 5.10
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 (31 Procedures):
It covers sample copy of mandatory procedures covering all the details of ISO 15189:2012standard.
List of procedure
1. Procedure for requirements Receipt, handling, storage and disposal of samples in line with the legal 2. Procedure for Control of documents
To get more information about ISO 15189:2012 Documentation kit Click Here
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Totally editable documentation package for quick process improvement to implement the system Completely editable document toolkit (Quality Manual, procedures, exhibits, standard operating procedure, blank forms, audit checklists, etc.) Buy at: www.globalmanagergroup.com
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 consumables Reception, storage, acceptance testing and inventory management of reagents and 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.
To get more information about ISO 15189:2012 Documentation kit Click Here
www.globalmanagergroup.com E mail sales@globalmanagergroup.com Tele: +91-79-2979 5322 Page 3 of 9
