It is a presentation for understanding the quality and quality control in clinical laboratories.

1. What is Quality?
“Quality is doing the right things right, the first time and every time”.
 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.
 Laboratory quality can be defined as accuracy, reliability and timeliness of reported test results. The laboratory results must be as accurate as
possible, all aspects of the laboratory operations must be reliable, and reporting must be timely in order to be useful in a clinical or public health
setting.
Quality Hierarchy:
1. Quality Control: Process of monitoring and evaluating the performance of work by measuring that performance against established standards.
2. Quality Assurance: QA refers to all aspects of operation starting from preparation of the patient to sample collection, sample analysis, recording of
the result and its dispatch..
3. Quality Management System (QMS): It includes all activities of the overall management function that determine quality policy objectives, implement
them by means such as quality planning, quality control, quality assurance and quality improvement within the system.

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 in 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. It is also applicable for confirming or
recognizing the competence of medical laboratories by laboratory users, regulatory authorities, and accreditation bodies.
• 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. Need for legal entity:
 Legal entity is an association, corporation, partnership, proprietorship, trust, or an individual, that has legal standing in the eyes of law.
 Compliance requirements: Laboratory should comply with local / regional / national requirements, as applicable. A few statutory compliances have been
listed below:
 No objection certificate from the Competent Fire Authority
 Authorization under Bio-medical Waste Management Rules (2016).
 Clearance from State Pollution Control Board.
2. Quality Management System (QMS): “Coordinated activities to direct and control an organization with regard to quality”.
 The primary goal in a quality management system is continuous improvement of the laboratory processes, and this must be done in a systematic manner.
 In a quality management system, all aspects of the laboratory operation, including the organizational structure, processes and procedures, need to be
addressed to assure quality.
• QMS implementation includes identifying important processes in the laboratory’s management infrastructure (ie, the quality system essentials [QSE]) and
path of workflow and clearly communicating, educating, and training relevant personnel on their responsibilities.

4. QMS Essentials:
The QMS essentials are:
• Organization
• Customer Focus
• Facilities and Safety Management
• Personnel Management
• Supplier and Inventory Management
• Equipment Management
• Process Management
• Documents and Records Management
• Information Management
• Nonconforming Event Management
• Assessments
• Continual Improvement

5. Organization 1. The term organization is used to indicate the management and the supporting organizational structure of the laboratory.
2. Management committed to a quality management system.
Facilities and Safety Management 1. The laboratory work space and facilities must be such that its workload can be performed without compromising the quality of work
and the safety of the laboratory staff, other health care personnel, patients, and the community
2. When designing a laboratory or organizing workflow, ensure that patients and patient samples do not have common pathways
Personnel Management 1. Personnel are the most important laboratory resource.
2. Critical to the implementation of the quality management system are people who possess integrity and recognize the importance of
their work and participate in continuous improvement.
Supplier and Inventory Management 1. Efficient and cost-effective laboratory operations need the uninterrupted availability of reagents, supplies, and services. Inability to
test, even for a short time, is very disruptive to clinical care, prevention activities, and public health programs.
2. Quantification is a very important process that can help calculate how much is required of any particular item for a given period of
time, and it is an essential part of a successful inventory management program.
Customer Focus 1. Customer satisfaction is a major component of a quality management system, and a significant focus in the ISO standards.
2. A central figure in the client list is the physician or health care provider. The initial request for service originates with this person,
and the laboratory staff generally identify the ordering physician as the primary client.
Equipment Management 1. Proper management of the equipment in the laboratory is necessary to ensure accurate, reliable, and timely testing.
2. Equipment management responsibility may be specifically assigned to a technologist in the laboratory.
3. Everyone who uses the equipment should be trained in calibration and daily maintenance.
Process Management 1. Process improvement is a systematic and periodic approach to improving laboratory quality, and the inputs and outputs that glue
these processes together.
2. PDCA Cycle: Plan-Do-Check-Act.
3. This is the continual improvement process, and, in the laboratory, this process is applied to all procedures and processes that are a
part of the Path of Workflow.
Documents and Records Management 1. Documents & records are the collected information produced by the laboratory in the process of performing and reporting a
laboratory test.
2. Some examples of records include: completed forms, charts, sample logs, patient records, quality control information, and patient
reports.
Information Management 1. Information management is a system that incorporates all the processes needed for effectively managing data—both incoming and
outgoing patient information.
2. The information management system may be entirely paper-based, computer-based, or a combination of both.
Nonconforming Event Management 1. Dealing with laboratory errors, is important in assuring good service from the laboratory.
2. It is the process by which errors, or near errors (also called near misses) are identified and handled.
Assessments 1. Assessment is an important element of the 12 quality system essentials (QSE).
2. It is the means for determining the effectiveness of a laboratory’s quality management system through internal and external audits,

7. Documents Required For Quality:
 Quality Manual
 Quality Procedures (34 formats)
 Standard Operating Procedures -SOP’s (7 SOP)
 Blank Sample Formats For All Departments (62 formats)
 Job Description (6 key hierarchy members JD)
 ISO 15189 Audit Checklist (Pool of 500+ sample questions)
 Sample Risk Assessment Sheet
 Exhibits (8 formats)

8. THANK YOU