The COLA Quality Management Systems Program. 2 Introduction COLA Quality Management Systems Program An ISO 15189:2003 Accreditation Program.

Slides:

Advertisements

Similar presentations

1 Documentation Legal Framework Air Navigation Orders Guidelines ATS Manual Airport Manual Safety Management Manual ICAO Annexes Licenses / Certificates.

Advertisements

Session No. 4 Implementing the State’s Safety Programme Implementing Service Providers SMS

Introduction- Laboratory Quality Management System

HIV Drug Resistance Training

PRESENTATION TO CEN/TC 319 VENICE - APRIL 13, 2005

Customer Service.

1 Process Control: Introduction to Quality Control.

ISO in Histopathology Louise O’Callaghan MSc FAMLS

1 Assessment: Norms and Accreditation. Assessment: Norms and Accreditation-Module 11 2 Learning Objectives At the end of this module, participants will.

ORGANIZATION. 2 Problem scenario  Develop an organizational chart for your laboratory showing lines of authority from the head of the organization to.

ORGANIZATION. 2 Purchasing & Inventory Assessment Occurrence Management Information Management Process Improvement Customer Service Facilities & Safety.

ISO 9001 : 2000.

A Quality Management System Viki Massey Quality Coordinator A Joint Venture of London Health Sciences Centre and St. Joseph’s Health Care London.

Laboratory Personnel Dr/Ehsan Moahmen Rizk.

Introduction 3.03 Understand support services Introduction.

1 Assessment: Audits. Assessment: Audits - Module 9 2 Learning Objectives At the end of this activity, you will be able to: Develop a process to prepare.

Quality Management.

Documents and Records-Writing a Quality Manual-Module 16 1 Quality Manual Structure and Contents Quality Manual Structure and Contents - optional.

Developing a Quality Management System Viki Massey Quality Coordinator A Joint Venture of London Health Sciences Centre and St. Joseph’s Health Care London.

Module BASICS OF THE QUALITY SYSTEM CONCEPT

Laboratory Management - 1

ISO 9000:2000 Quality system standards adopted in 1987 by International Organization for Standardization; revised in 1994 and 2000 Technical specifications.

Implementing a Quality Management System

Standardization. Introduction A standard is a document. It is a set of rules that control how people should develop and manage materials, products, services,

VHA - OCCC VHA ISO 9001 Implementation Initiative and Synergy with Baldrige Criteria Washington, DC October 2010 Christopher LoGrasso MCPM, PMP, CMQOE,

Ireland Army Community Hospital CLSI Quality Series.

The Molecular Diagnostics Research Laboratory University of Malaya Development and Implementation of a Quality System The Molecular Diagnostics Research.

4. Quality Management System (QMS)

QUALITY ASSURANCE Shree Baboolal 12 th February, 2005.

Welcome ISO9001:2000 Foundation Workshop.

Personnel. 2 Purchasing & Inventory Assessment Occurrence Management Information Management Process Improvement Customer Service Facilities & Safety The.

Creating Lasting Change for Your Business ISO 9001:2000 Management System Overview.

ISO 9001 Quality Management System

Quality Management Systems P.Suriya Prakash Final Mech Vcet

SMS Operation.  Internal safety (SMS) audits are used to ensure that the structure of an SMS is sound.  It is also a formal process to ensure continuous.

Module 4 Assuring the Quality of Testing: A Systems Approach to Quality (ISO 15189:2012) Assuring the Quality of Laboratory Testing: A Systems Approach.

Module 5: Assuring the Quality of HIV Rapid Testing

Introduction to ISO 9001:2000.

NEW ADVANCES IN QUALITY ASSURANCE INCLUDING MOLECULAR PATHOLOGY Kenneth D. McClatchey, MD Professor & Chairman of Pathology Helen M. & Raymond M. Galvin.

Module 4 Activity: Compare Quality Essentials to ISO 15189:2012 Checklist Sections.

4.3 Document control 4.4 Review of requests, tenders and contracts

Dispensary and Administration Site Information Presentation.

Preparing for Accreditation Viki Massey, Quality Coordinator A Joint Venture of London Health Sciences Centre and St. Joseph’s Health Care London.

Biochemistry Clinical practice CLS 432 Dr. Samah Kotb Lecturer of Biochemistry 2015 Introduction to Quality Control.

Quality control & Statistics. Definition: it is the science of gathering, analyzing, interpreting and representing data. Example: introduction a new test.

National Incident Management System (NIMS)

It was found in 1946 in Geneva, Switzerland. its main purpose is to promote the development of international standards to facilitate the exchange of goods.

Revision N° 11ICAO Safety Management Systems (SMS) Course01/01/08 Module N° 9 – SMS operation.

QUALITY MANAGEMENT SYSTEMS STANDARDS IN HEALTH LABORATORIES

Workshop on Accreditation of Bodies Certifying Medical Devices Kiev, November 2014.

Quality Management Systems are All About Client Service and Satisfaction Customer Requirements Customer Satisfaction Input  Output PRODUCT Answer to Question.

Submitted By: Tanveer Khan M.Tech(CSE) IVth sem.  The ISO 9000 standards are a collection of formal International Standards, Technical Specifications,

TAIEX Workshop on the Accreditation of Medical and Clinical Laboratories (55902) “ROLE AND VALUE OF THE MEDICAL LABORATORIES ACCREDITATION” Aliki Stathopoulou.

Hospital Accreditation Documentation Process & Standard Requirements

“Quality Improvement – Who Cares?”

Steve Barfoot, President Advantage International Registrar, Inc.

QUALITY MANAGEMENT Suzanne Kamel-Mohamed PhD, MBA, MT (ASCP) Associate

Overview of Quality Assurance

3.03 Understand support services Introduction

Achieving ISO Compliance

3.03 Understand support services Introduction

Integrated Management System

3.03 Understand support services Introduction

Introduction- Laboratory Quality Management System.

3.03 Understand support services Introduction

3.03 Understand support services Introduction

3.03 Understand support services Introduction

3.03 Understand support services Introduction

Escape the Trap Climbing Over the Professional Service Need Assessment College of Medical Laboratory Science, Sri Lanka December 30, Teaching Hospital,

Presentation transcript:

The COLA Quality Management Systems Program

2 Introduction COLA Quality Management Systems Program An ISO 15189:2003 Accreditation Program

3 Global community standards We are all part of a global economy Standards and management of quality apply world-wide International & domestic operations to achieve and maintain accepted levels of quality Uniform standards across borders with a minimum of confusion and concern over quality

4 ISO: International Organization for Standardization A world-wide federation of national standards bodies using ISO technical committees Define standards for quality management systems ISO 9000 series = fundamentals and vocabulary ISO 9000:2000 = requirements for QMS Origins in manufacturing organizations with manufacturing terminology

5 ISO: Growth from manufacturing to medical Medicine realized the advantages of applying quality management system practices to laboratory operations

6 ISO technical committee sought to 1.Standardize & interpret the ISO 9000 into language more familiar to healthcare organizations 2.Retain the core essence of the ISO 9000 quality principles ISO 15189:2003: Particular Requirements for Quality and Competence in Medical Laboratories ISO: Growth from manufacturing to medical

7 Quality System Essentials Foundation of the COLA QMS accreditation program is the concept of Quality System Essentials (QSE) Essential components of quality Defines all aspects of the laboratory operation Basis of compliance with regulations

8 Quality System Essentials QSEs are the Infrastructure for Quality Managements Procedure Manual Management sets policies and designs processes for each QSE Both management and staff follow procedures in the QSEs QSEs are everyones responsibilities

9 The 12 Quality System Essentials Organization Process Control Personnel Assessments Equipment Documents & Records Facilities and Safety Purchasing & Inventory Occurrence Management Information Management Customer Satisfaction & Service Process Improvement

10 Workflow Analysis: Path of Workflow Operational aspect defines how a particular service or product is provided Sequence of activities from the initiation of a request through the provision of laboratory products or services

11 Preanalytic Analytic Postanalytic Testing Results Review and Follow-Up Interpretation Result Reporting and Archiving Specimen Management CLSI GP26 Test Ordering Specimen Collection Transport Receipt/Processing

12 Quality Management System: Laboratory Model

13 The COLA QMS Accreditation Program: Epilogue Goals of QMS Accreditation Program Built-in standards of quality Continuous systems for quality assessment, improvement, and feedback Maintenance of Quality Standards Resulting in Enhances patient care Integrated Incident Management Optimized operational efficiency