Manual of Standards on Quality

Management System in the Clinical

Laboratory
Top management shall be responsible for setting the
direction of the clinical laboratory towards providing
quality services and continuous quality
improvement.

1. Management Commitment
- Management shall commit itself to the
development and implementation of a Quality
Management System in the Clinical Laboratory.
 Compliance with legal and regulatory
requirements

 Vision, Mission, and Quality Policy

 Quality Manual
2. Leadership
- Management shall appoint qualified health
professionals to manage and supervise the
clinical laboratory and its sections.

 Head of the Laboratory – is a duly licensed

physician certified by the Philippine Board of
Pathology
 Each section/division is supervised by a health
professional who has had post graduate
education, training or program of continuing
professional education (CPE) in the discipline for
w/c he/she has responsibility.
3. Organizational Structure and Functions
- The management shall design and implement
an organizational structure appropriate to the
size and complexity of the laboratory.

 A quality manager is appointed by the Head

with the responsibility and authority to oversee
compliance with the requirements of the quality
management system.
4. Quality and Strategic Planning
- Management shall draw up a plan to ensure
that a quality management system is in place and
that the strategies that the laboratory shall
undertake responds to the needs of the
customers they serve.
1. Human Resource Management
- The laboratory shall have a system for the
management of human resources to ensure
adequate, suitable, qualified and trained
personnel for specific tasks required.

 Staffing

 Work Schedule

 Staff training and education

 Personnel policies, discipline, resignation, and
termination

 Personnel records

 Staff meetings and communication

2. Management in Physical Facilities
- The laboratory shall provide physical facilities
with adequate space for the services rendered
and ensures the safety and security of the staff,
patients and visitors.

 Laboratory space and facilities

 Facilities for patients and personnel
 Facilities for storage
3. Equipment and Instruments
- The laboratory shall have an adequate number
of operational equipment and instruments
required for the provision of services

 There is a system of technical validation,

procurement and acquisition of equipment and
instruments used in the laboratory.

 The equipment is checked, calibrated and

undergo performance validation before it shall be
put in use.
 There are written procedures for proper care,
maintenance and cleaning of all laboratory
equipment performed by trained personnel

 Any equipment that is defective and non-

functional shall be taken out of service and shall
be clearly labeled as being out of service, until it
has been repaired and functional.
3. Reagents, Controls, Standards, Glassware and
Supplies

There are procedures for the procurement and

inventory control of glassware, reagents,
controls, standards, and supplies

There is sufficient quantity of reagents,

controls, standards, glassware and supplies
necessary for efficient operation in the
laboratory.
 New standards/reagents or new lots/batch
are tested and verified before use.

 There are procedures for proper storage,

handling, cleaning and disposal of glassware
used in the laboratory.

 Measuring devices and volumetric glasswares

are calibrated.
1. Customer Needs and Requirements
- Laboratory services shall be selected that will
meet the needs and requirements of patients,
doctors, and other users of service.
The laboratory has a document that describes:
• Range and scope of the services available
• STAT services available
• Type of sample and amount needed for each
type of test
• Containers and preservative to be used for
each test
• Special preparation of patient, if any
• Conditions of transport
 The laboratory shall have a system for
collecting, recording and analyzing data to
monitor quality of performance.

1. Internal Quality Control

- The laboratory shall establish an Internal

Quality Control Program to verify that, for every
batch of examinations, the intended quality of
results is achieved.
• When the results of the control samples are
outside the control range, the results of the batch
of examinations are held and an investigation is
done on the reagents, technique, calibration,
control, etc. to determine the cause/s of out of
control
2. Performance Indicators
- There shall be regular monitoring of
performance indicators such as Turn-around-Time.

3. Patient Satisfaction
- The laboratory shall conduct activities to
monitor information as to whether the laboratory
has met patient requirements.
4. Resolution of Complaints
- There shall be a system of handling
complaints of customers.

5. External Quality Assessment Surveys

- The laboratory applies and participated in
the External Quality Assessment Surveys (EQAS)
conducted by the National Reference Laboratories
(NRL) or the Philippine Council for Quality Assurance
in Clinical Laboratories (PCQACL)
• The laboratory performs appropriate
examinations on the EQAS samples received.

• The laboratory submits the results from EQAS

samples to the organization running the EQAS.

• The evaluation of the performance of the

laboratory is reviewed and corrective actions are
taken when needed.
• The laboratory performs appropriate
examinations on the EQAS samples received.

• The laboratory submits the results from EQAS

samples to the organization running the EQAS.

• The evaluation of the performance of the

laboratory is reviewed and corrective actions are
taken when needed.