Quality Improvement in the Laboratory

Flashcards about Quality Improvement in the Laboratory

Rob Wardrop

Principal Scientist QEII CBPT 2025

Quality in pathology

Service driving a process

The Quality Standards

ISO 9001, ISO 17025, and ISO 15189

Quality as a Concept

Quality Cycles, Quality Improvement Systems, Process Review, Holistic Quality

ISO 9001

Quality management systems - requirements

ISO 17025

General requirements for the competence of testing and calibration laboratories

ISO 15189

Medical laboratories — requirements for quality and competence

ISO 9001:2015

An internationally recognized standard for creating, implementing, and maintaining a Quality Management System

ISO 9001 is the basis for any company to create a system to…

Ensure customer satisfaction and improvement

ACT in the Quality Cycle

Review the findings of the quality management system

PLAN in the Quality Cycle

Identify your goals and baseline

CHECK in the Quality Cycle

Control, measure, and monitor your outputs

DO in the Quality Cycle

Train employees on new processes

Testing laboratories

Determine the characteristics of an item of interest for conformity assessment

Calibration laboratories

Compare a measurement instrument of unknown accuracy to one of known accuracy

ISO 17025:2017

Sets out the general requirements for the competent, impartial, and consistent operation of testing and calibration laboratories

ISO 9001 certification

Recognition that an effective management system is in place

ISO 17025 certification

Includes recognition of the technical competence of laboratories

Medical laboratory services

Essential to patient care

ISO 15189:2023

Specifies requirements for competence and quality that are particular to medical laboratories

NATA

Accrediting Body

Laboratory Accreditation

Apply ISO 17025 and ISO 15189 principles

Assessing ISO Compliance

Fully ISO 9001 Compliant

17025:2017 Changes

Impartiality, Confidentiality, Risk, Evidential Documentation, Organisational Context

15189:2023 Changes

Governance, Resources, Risk, Process, POCT (Replaces ISO 22870:2016)

Standards and Requirements give a Medical Laboratory…

A Quality System Framework, The Legislative Framework, An Assessment Framework, A Governance Framework, A Process Framework

Definition of Quality in Healthcare

The degree to which health care services increase the likelihood of desired health outcomes (Institute of Medicine US)

Service quality

A customer’s comparison of service expectations as it relates to a company’s performance

Laboratory quality

The accuracy, reliability, and timeliness of the reported test results. (WHO)

Quality in laboratory medicine

Guarantee that each and every step in the total testing process (TTP) is correctly performed (AACC)