Department of Laboratory Servicespage 1 of 2

Department of Laboratory ServicesPage: 1of 2

Title: Quality Policy / ID: LABM-QMS-QMS-A-001
Effective Date: <DATE HERE>
Revised Date: / Version: 1
Controlled document. Any documents appearing in paper form must be used for reference purposes only.
The on-line copy on the file server above must be considered the current documentation.
Draft

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Department of Laboratory ServicesPage 1 of 2

Manual

/ Quality Manual /

POLICY

Section / Quality Management System
Title: /

Quality Policy

Issuing Body: / Quality Management Team /

ID: LABM-QMS-QMS-A-001

Approved by: / Director of Laboratory Services
Effective Date
Revised Date / <DATE HERE> / Version: 1 / File Name:
LABM-QMS-QMS-A-001
Controlled document. Any documents appearing in paper form must be used for reference purposes only. The on-line copy on the file server above must be considered the current documentation.

Policy

The Department of Laboratory Services at <NAME OF ORGANIZATION> will develop, maintain, follow, review and continuously improve the Quality Management System documented in this manual.

Purpose

<NAME OF ORGANIZATION> is committed to excellence in providing health care for our patients by providing a comprehensive framework for the provision of laboratory services, which meet or exceed ISO 15189:2007 and OLA: 2007 recommendations.

Responsibility

Administration is responsible for ensuring corporate Policies and Processes are in keeping with the standards required to create, maintain and improve the Quality Management System.

The Quality Team is responsible for creating the Quality Manual and coordinating the Quality Discipline Task Teams.

Guiding Principles

• Decisions made through consensus
• All Policy, Processes and Procedures will be forwarded to the team before approval
• Processes, Policies and Procedures are to be the same at all operating sites
• Single format used by <NAME OF ORGANIZATION> for all documents
• Remain customer focused at all times

The Medical Director of Laboratory Services is responsiblefor reviewing & approving the Quality Management System.

The Administrative Director of Laboratory Services is responsible for creating, reviewing & approving the Quality Management System

The Quality Manager is responsible for creating, reviewing, approving, distributing and maintaining the documents and records of the Quality Management System.

The Manager, Charge Technologists, and Senior Technologistsare responsible for creating, reviewing, approving, distributing and educating staff of the Quality Management System.

Staff members are responsible for creating and maintaining knowledge of the Quality Management System.

Supporting Statements

Documents and Records

The laboratory has a documents and records management system to create, control, review and maintain all documents and records of the Quality Management System and Patient care.

Information Management

The Laboratory has systems in place to manage all laboratory information generated. The Laboratory collaborates with the other departments in order to receive requests for service and report patient results.

Occurrences

The Laboratory has a system to document, investigate, evaluate, implement and monitor corrective actions and communicate when necessary all incidences of non-conformance

Assessment

The Laboratory has quality indicators to monitor and evaluate the laboratories standards of performance, contribution to patient care, and quality improvement of services offered.

Quality Improvement

The Laboratory participates in quality improvement activities within the organization, and with user physician and will address any issues arising from these activities.

Service and Satisfaction

The Laboratory provides excellent customer service to both external and internal clients and determines the level of client satisfaction.

Referral Laboratories

The Laboratory has a system for selecting, monitoring and reviewing any referral laboratory or referral consultant whose services they use.

References

• NCCLS document HS1-A Vol.22, No.13- A Quality System Model for Health Care; Approved Guideline
• QMP-LS, SupportingReferencesforRequirements, Version 4, December 2007
• ISO 15189:2007

Supporting Documentation: Introduction to Quality Manual

Corporate Mission, Values, Vision

LABM-QMS-QMS-A-002 Statement of Purpose

LABM-QMS-QMS-B-001 Development of QMS Process

LABM-QMS-QMS-B-002 Education of QMS Process

LABM-QMS-QMS-B-003 Review of QMS Process