STEPS TO QUALITY IN LAB PPT EXPLAINS ABOUT STEPWISE GUIDE FOR HAVING QC IN LAB

1. What is Quality?
“Quality is doing the right things and doing those things right”.
Quality is the ability of a product or service to satisfy the stated or implied needs of a
specific customer achieved by conforming to established requirements and standards.
Quality Hierarchy:
1. Quality Control: The operational techniques and activities used to fulfill requirements
for quality.
2. Quality Assurance: “all the planned and systematic activities implemented within the
quality system that can be demonstrated to provide confidence that a product or service
will fulfill requirements for quality.
3. Quality Management System (QMS): Incorporates the organizational structure,
resources, responsibilities, document hierarchy, and the interaction of processes and
procedures needed to implement quality management of the laboratory.

2. NABL (National Accreditation Board for Testing
and Calibration Laboratories)
 Laboratory accreditation activities are administered under the direction of the National Accreditation Board for Testing and Calibration Laboratories (NABL).
 NABL involves the assessment team and accreditation committee as recommending authorities.
 The requirements NABL on specific criteria are based on the International Standard, ISO 15189:2022
 ISO 15189 2022: This document specifies requirements for quality and competence in medical laboratories.
• This document is applicable to medical laboratories in developing their management systems and assessing their competence.
• The requirements given in this document (ISO 15189 2022) are applicable to all medical laboratories applying for NABL accreditation regardless of the level at
which they function (small/medium/large / very large / laboratory with multiple locations) or the place in which they are located (village/town/district/city) or
whether they are private / government / quasi-government attached to a hospital / stand-alone
 Classification of laboratories:
• Small-sized: A laboratory receiving samples of up to 100 subjects per day
• Medium-sized: A laboratory receiving samples of up to 101- 400 subjects per day
• Large sized: A laboratory receiving samples of more than 401-1000 subjects per day
• Very large sized: A laboratory receiving more than 1000 subjects per day
• Multiple locations: A laboratory with more than one location in the same district with the same legal identity

3. The sequence of activities as per NABL:
1. Formats as per NABL
S. NO. FORMAT NAME NO. OF FORMATS AS PER NABL
1 Collection (CCC) 3
2 Customer service
(CSD)
5
3 Operation (OPN) 7
4 Purchase (PUR) 8
5 Quality control
(QCD)
9
6 Store (STR) 3
7 System (SYS) As per the machine
8 Training (TRG) 11

4. 5. Structural and governance requirements ( Legal entity, lab directory, lab activities, structure & authority, objectives & polic
risk management.
6. Resources requirements (General, facility and environment. Equipment)
7. Process requirement
8. Management requirement
Quality Procedures Sample copies of mandatory quality procedures as per ISO
15189:2022, which cover all the details like purpose, scope,
responsibility, how the procedure is followed as well as the list
of exhibits, reference documents, and formats.
34 1. Procedure for maintaining impartiality 2. Procedure for verification of examination method 3. Procedure for the confidentialit
patient information 4. Procedure for validation of examination method 5. Procedure for personnel and training 6. Procedure for
evaluation of measurement uncertainty (MU) 7. Procedure for equipment 8. Procedure for monitoring the validity of results 9.
Procedure for equipment acceptance procedure 10. Procedure for reporting the results 11. Procedure for responding to any
manufacturer's recall 12. Procedure for automated selection, review, release, and reporting of results 13. Procedure for equipm
calibration 14. Procedures for the issue of amended or revised results 15. Procedure for reception, storage, acceptance testing,
inventory management of reagents and consumables 16. Procedures for identification, access, storage, preservation, and safe
disposal of clinical samples 17. Procedure to establish and periodically review agreements for providing laboratory activities 18.
Procedures for identification and control of non– conformities 19. Procedure for externally provided products and services 20.
Procedures for the management of complaints or other feedback received from clinicians, patients, laboratory staff, or other pa
21. Selecting and evaluating referral laboratories and consultants 22. Procedure for continuity and emergency preparedness
planning 23. Procedure for all pre-examination activities and make them accessible to relevant personnel 24. Procedure for cont
of documents 25. Procedure for managing oral requests for examinations 26. Procedure for control of records 27. Procedures fo
the collection and handling of primary samples 28. Procedure for risk assessment 29. Transportations of samples 30. Corrective
action 31. Procedure for sample receipt 32. Procedure for internal audit 33. Procedure and appropriate facilities for securing pa
samples, ensuring sample integrity, and preventing loss or damage during, handling, preparation, and storage 34. Procedure for
management review
Exhibits It covers Skill requirements, Codification system, Calibration
periodicity, Secrecy rules, Recommended conditions for sample
collection, transport and storage for conventional cytogenetic
analysis, Minimum retention period for identified records,
Impartiality policy, Patient’s rights, etc. as per ISO 15189:2022.
8 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. The minimum retention period for identified records
7. Impartiality policy
8. Patient’s right
Standard Operating
Procedures
Standard operating procedures covering all the specific practice
areas and providing details for the operation of the training
organization.
7 1. SOP for Collection and transportation of sample
2. SOP for Specimen acceptance & rejection criteria
3. SOP for Treatment and disposal of biomedical waste
4. SOP for Housekeeping
5. SOP for Use of PPE and personal safety
6. SOP for Examination by lateral flow method
7. SOP for Examination of COVID–19 by CT Value.
Blank sample
formats for all the
departments
It covers sample copies of blank forms required to maintain
records as well as establish control and make a system in the
organization as per requirement and functioning.
62 1. Sample collection register 2. Method verification report 3. Sample disposal register 4. Goods inward register 5. PPE kit and
consumable disposal register 6. Stock register 7. Request for examination 8. Gate pass 9. Customer feedback form 10. The mast
list and Distribution list of documents 11. Complaint registers 12. Change Note 13. Complaint report 14. Corrective action repor
Inward register 16. Master List of Records 17. Equipment history card 18. Quality objectives (key performance indicator) 19.
Preventive maintenance schedule 20. Audit Plan / Schedule 21. Equipment-wise preventive maintenance checkpoints 22. Intern

5. Quality Manual
It describes how all requirements of ISO 15189:2022 standard requirements. It covers a list of procedures as well as an
overview of the organization and covers guidelines of ISO 15189:2022 documents.
1. Cover page, Table of contents, amendment record sheet and glossary of terms.
2. Authorization statement and laboratory profile
3. Control and distribution
4. General requirements ( Impartiality, confidentiality, requirements regarding patients)
5. Structural and governance requirements ( Legal entity, lab directory, lab activities, structure & authority, objectives &
policies, risk management.
6. Resources requirements (General, facility and environment. Equipment)
7. Process requirement
8. Management requirement

6. Quality Procedures:
1. Procedure for maintaining impartiality 17. Procedure to establish and periodically review agreements for
providing laboratory activities
2. Procedure for verification of examination method 18. Procedures for identification and control of non– conformities
3. Procedure for the confidentiality of patient information 19. Procedure for externally provided products and services
4. Procedure for validation of examination method 20. Procedures for the management of complaints or other feedback
received from clinicians, patients, laboratory staff, or other parties
5. Procedure for personnel and training 21. Selecting and evaluating referral laboratories and consultants
6. Procedure for evaluation of measurement uncertainty (MU) 22. Procedure for continuity and emergency preparedness planning
7. Procedure for equipment 23. Procedure for all pre-examination activities and make them accessible
to relevant personnel
8. Procedure for monitoring the validity of results 24. Procedure for control of documents 25. Procedure for managing oral
requests for examinations
9. Procedure for the equipment acceptance procedure 26. Procedure for control of records
10. Procedure for reporting the results 27. Procedures for the collection and handling of primary samples
11. Procedure for responding to any manufacturer's recall 28. Procedure for risk assessment
12. Procedure for automated selection, review, release, and reporting of
results
29. Transportations of samples
13. Procedure for equipment calibration 30. Corrective action
14. Procedures for the issue of amended or revised results 31. Procedure for sample receipt