Question 6.
Explain four features of management and technical requirements related to the ISO15189 Medical
laboratories-particular requirements of quality and competence.
Table 3. Four features of management requirements related to the ISO15189 Medical laboratories(10)
Features
1. Organization
management
responsibility
Description
and Medical laboratory services designed to meet the needs of the
patient and the employee's responsibilities for patient care,
the medical laboratory, and the organization must be legally
identified.
Laboratory management is accountable for the
implementation, improvement, and maintenance of the QMS,
including documented policies, procedures, programs, and
work instructions, and notify all relevant staff.
The QMS should include internal quality control and external
quality assurance comparison programs. The lab's scope, the
quality objectives, the commitment to good practice, and the
testing quality must be consistent with the quality policy.
2. Quality
management The quality manual should outline the document structure
system
used in the QMS.
The purposes and duties of technical and quality management
should be described in the manual.
Laboratory management should establish, implement, and
document preventive maintenance and calibration programs
for instruments, reagents, and analytical systems.
3. Document control
The laboratory should determine and maintain procedures for
controlling all documents and their retention duration.
Document assigned to laboratory staff must be reviewed and
approved by authorized personnel before release.
The laboratory should have a documented system to assure
that only currently authorized versions of relevant documents
are available for use, and obsolete documents are promptly
discarded from all points of use, and the material is periodically
reviewed and revised as needed and approved by authorized
persons.
Document related to QMS must be uniquely classified with
title, current version number, revision number, issuing
authority, etc.
4. Examination by referral Laboratories must have an efficient procedure for selecting
laboratories
and evaluating referral laboratories.
The laboratory must sustain a register of all referral
laboratories with which it has used.
The referring laboratory, not the referral laboratory, should be
accountable for assuring that test results are provided to the
requestor.
Table 4. Four features of technical requirements related to the ISO15189 Medical laboratories (10).
Features
1. Personnel
Description
Laboratory personnel are competent by determining whether
having appropriate education, training, skills, and experience.
Personnel must be provided with required training and are
evaluated for the effectiveness of the training to meet the
quality objectives of the organization.
Documentation of employee qualifications, membership of
professional associations, training and performance
evaluation records in the laboratory should be provided as part
of the NATA competency assessment process. Proof of
acceptance and recognition of overseas qualifications must be
available
2. Accommodation
and Laboratory and office facilities shall provide a proper working
environmental
environment for the tasks to be carried out to meet the
conditions
requirements of customer and the quality management
system. This includes storage facilities, supporting services,
patient sample collection equipment and supplies,
maintenance of facilities, and environmental circumstances.
The laboratory shall have procedures in place to control and
document environmental conditions that do not adversely
affect the performance of sampling equipment and
equipment. The sterility, dust, humidity, temperature
according to relevant technical activities need special
attention.
3. Laboratory equipment, The laboratory shall have all necessary equipment to provide
reagents,
and its services. Laboratories must also have a procedure that
consumables
describes how they select equipment. Equipment includes
documented procedures, proficiency testing, manuals,
measurement calibration and traceability, maintenance and
repair, adverse indentation reports and records.
Reagents and consumables include documented procedures
and instructions, reception and storage, standards and
materials reference, inventory management, adverse incident
reports and records.
4. Post-examination
Authorized personnel systematically review test results,
processes
authorized assess them against the patient's clinical
information before releasing the results.
Retention of primary and other laboratory samples is subject
to the approved policy.
Handling samples should be carried out according to local
regulations or recommendations for waste management and
in accordance with internal policy.