ISO 15189:2012 Document matrix

Reference ISO
Document / Format No. Documented Information Title 15189:2012
Clause #
4.0 Management requirements 4.0
4.1 Organisation and Management Responsibility 4.1
Procedure for receipt, handling, storage and disposal of samples in
QP/01 4.1
line with the legal requirements
.===. Disposal records of samples 4.1
4.2 Quality Management System 4.2
QM/01 General structure of management system 4.2
4.3 Document Control 4.3
QP/02 Procedure for control of documents 4.3
F/SYS/01 Master list and distribution list of documents 4.3
F/SYS/02 Change Note 4.3
E/SYS/01 Codification system 4.3
4.4 Service agreements 4.4
Procedure for establishment and review of agreements for providing
QP/03 4.4
medical laboratory services to its customers / patients
F/CSD/01/01 Request for examination – Serum / fluoride plasma 4.4
F/CSD/01/02 Request for examination – Urine 4.4
F/CSD/01/03 Request for examination – Serum 4.4
F/CSD/01/04 Request for examination – Whole blood / serum 4.4
F/CSD/01/05 Request for examination – Whole blood with EDTA 4.4
4.5 Examination by referral laboratories 4.5
Procedure for selecting and evaluating referral laboratories and
QP/04 4.5
consultants
F/PUR/07 Evaluation for referral laboratory 4.5
4.6 External Services and Supplies 4.6
QP/05 Procedure for purchasing 4.6
F/PUR/01 Purchase Order 4.6
F/PUR/02 Indent 4.6
F/PUR/03 Approved Supplier List 4.6
F/PUR/04 Suppliers Registration form 4.6
F/PUR/05 Open Purchase Order 4.6
F/PUR/06 Supplier Evaluation report 4.6
F/PUR/07 Inspection report 4.6
4.7 Advisory Services 4.7
QM/01 Types of advisory services 4.7
4.8 Resolution of Complaints 4.8
Procedure for management of complaints or other feedback
QP/06 4.8
received from clinicians, patients, laboratory staff or other parties
F/CSD/03 Complain register 4.8
F/CSD/04 Complain report 4.8
4.9 Identification and controls of Non–conformities 4.9
QP/07 Procedure for identification and control of non–conformities 4.9
F/OPN/04 Control of non–conformities report 4.9
4.10 Corrective Action 4.10
QP/08 Procedure for Corrective Action 4.10
F/SYS/03 Corrective action report 4.10
4.11 Preventive Action 4.11
QP/09 Procedure for Prevetnive Action 4.11
F/SYS/09 Preventive action report 4.11
4.12 Continual Improvement 4.12
QM/01 Methods followed for continual improvement 4.12
4.13 Control of records 4.13
 QP/10 Procedure for Control of records 4.13
F/SYS/04 Masterlist of records 4.13
4.14 Evaluation and audits 4.14
QP/11 Procedure for internal audit 4.14
F/SYS/06 Audit Plan 4.14
F/SYS/07 Internal Audit Non–Conformity Report 4.14
F/SYS/08 Clausewise Document Wise Audit Review Report 4.14
F/SYS/11 Audit observation report 4.14
4.15 Management Review 4.15
QP/12 Procedure for managment review 4.15
.===. Circular - MRM Agenda 4.15
.===. Minutes of management review meeting 4.15
5.0 Technical requirements 5.0
5.1 Personnel 5.1
QP/13 Procedure for personnel and training 5.1
F/TRG/01 Training Calendar 5.1
F/TRG/02 Training report 5.1
F/TRG/03 Induction Training Report 5.1
F/TRG/04 Job Description And Specification 5.1
F/TRG/05 Skill Matrix 5.1
F/TRG/06 Confidentiality agreement 5.1
F/TRG/07 Appointment letter 5.1
F/TRG/08 Employees competence report 5.1
F/TRG/09 ISO 15189 training effectiveness check report 5.1
5.2 Accommodation and Environmental Conditions 5.2
QP/14 Procedure for Facility maintenance and environment 5.2
F/QCD/07 Environment condition monitoring reports 5.2
5.3 Laboratory Equipment, Reagents and Consumables 5.3
QP/15 Procedure for Selection, purchasing and management of equipment 5.3
F/CBC/06 Equipment history card 5.3
F/CBC/07 Equipment maintenance log 5.3
Procedure for Safe handling, transport, storage and use of
QP/16 5.3
equipment to prevent its contamination or deterioration
F/STR/01 Gate pass 5.3
QP/17 Procedure for Calibration of equipment 5.3
F/SYS/10 Calibration Status of Equipment 5.3
F/QCD/07 pH meter calibration report 5.3
F/QCD/08 Inhouse calibration report for Analyzer 5.3
Procedure for reception, storage, acceptance testing and inventory
QP/18 5.3
management of reagents and consumables
F/STR/01 Goods inward register 5.3
F/STR/02 Stock register 5.3
5.4 Pre–examination Processes 5.4
QP/19 Procedure for pre–examination process 5.4
F/CSD/01/01 Request for examination – Serum / fluoride plasma 5.4
F/CSD/01/02 Request for examination – Urine 5.4
F/CSD/01/03 Request for examination – Serum 5.4
F/CSD/01/04 Request for examination – Whole blood / serum 5.4
F/CSD/01/05 Request for examination – Whole blood with EDTA 5.4
QP/20 Procedure for collection and handling of primary samples 5.4
F/CSD/01/01 Request for examination – Serum / fluoride plasma 5.4
F/CSD/01/02 Request for examination – Urine 5.4
F/CSD/01/03 Request for examination – Serum 5.4
F/CSD/01/04 Request for examination – Whole blood / serum 5.4
F/CSD/01/05 Request for examination – Whole blood with EDTA 5.4
QP/21 Procedure for transportations of samples 5.4
QP/22 Procedure for sample receipt 5.4
 F/CSD/05 Inward register 5.4
QP/23 Procedure for pre–examination handling, preparation and storage 5.4
5.5 Examination Processes 5.5
QP/24 Procedure for validation of examination procedures 5.5
F/QCD/16 Design / Planning of the method validation 5.5
F/QCD/17 Validation report 5.5
5.6 Ensuring Quality of examination results 5.6
QP/25 Procedure for ensuring the quality of examination results 5.6
F/QCD/01 Four Years Plan For Quality Control 5.6
F/QCD/02 Re–examination plan / execution report 5.6
F/QCD/03 Z Score value report 5.6
F/QCD/05 Re–examination Analysis Report 5.6
5.7 Post–examination Processes 5.7
QP/26 Procedure for review of examination results 5.7
Procedure for identification, collection, retention, indexing, access,
QP/27 5.7
storage, maintenance and safe disposal of clinical samples
5.8 Reporting of Results 5.8
QP/28 Procedure for reporting the results 5.8
.===. Examination report 5.8
5.9 Release of Results 5.9
QP/29 Procedure for release of examination results 5.9
.===. Examination report 5.9
5.10 Laboratory Information Management 5.10
QP/30 Procedure for confidentiality of patient’s information 5.10
F/TRG/06 Confidentiality agreement 5.10
Abbrevation - For
QM - Quality Manual, QP - Quality Procedures, E - Exhibit, F - Format, W - Work instruction and SOP - Standard
Operating procedures

Note:
1) In this documentation package many documents are given based on our rich experience of management system. The
user of the kit can remove the format, which is not applicable. All this docuemnts are prepared based on ISO 15189:2012
standard