ISO 15189:2007 Quality Manual

QUALITY MANUAL
Author Name: Bilal Al-kadri Document Number: XXXXXX

Author Title: QA Consultant Issue Date: Feb/2009

Name, Title Signature Date
Approved
By

Name, Title Signature Date

SOP
Annual
Review

Version # Revision Date Description (notes)
Revision [0.0] [dd/mm/yy]
History

Name (or location) # of copies Name (or location) # of copies

Distributed
Copies to

UNCONTROLLED DOCUMENT IF PRINTED

TABLE OF CONTENTS

Section Topic Page

0.0 Introduction 3
1.0 Purpose & Scope 4
2.0 Quality Policy 5
3.0 Description of Laboratory 7
4.0 Terms & Definitions 8
5.0 Abbreviations 11
6.0 Management Requirements 12
7.0 Management Review 14
8.0 Staff Education & Training 15
9.0 Quality Assurance 15
10.0 Document Control 16
11.0 Records Maintenance & Archiving 17
12.0 Accommodation and Environment 17
13.0 Instruments 18
14.0 Reagents and Consumables Management 19
15.0 Selection and Validation of Examination Procedures 19
16.0 Safety 20
17.0 List of Examination Procedures 21
18.0 Pre-Examination 21
19.0 Validation of Results 23
20.0 Quality Control 23
21.0 Reporting of Results 24
22.0 Remedial Actions & Complaints 24
23.0 Communications 25
24.0 Audits 26
25.0 Laboratory Information Systems Management 26
26.0 Ethics 27
27.0 References 27
28.0 Appendixes 27


INTRODUCTION
This Quality Manual specifies requirements and policy for Company XYZ used to address
customer satisfaction, to meet customer and applicable regulatory requirements and to meet ISO
15189:2007 requirements.
COMPANY XYZ has adopted a business process map based on quality management system and
ISO 9001:2000. The new process map is represented in the diagram below:

ORGANISATION & MANAGEMENT RESPONSIBILITY
6.1 ORGANIZATION AND MANAGEMENT
6.2 RESPONSIBILITY & AUTHORITY
7.0 MANAGEMENT REVIEW
QUALITY MANAGEMENT SYSTEM
2.0 QUALITY POLICY
PLAN 8.0 STAFF EDUCATION & TRAINING ACT
10.0 DOCUMENT CONTROL
11.0 RECORDS MAINTAINING & ARCHIVING

RESOURCE MANAGEMENT
EVALUATION & CONTINUAL IMPROVEMENT
8.0 STAFF EDUCATION & TRAINING
12.0 ACCOMMODATION AND WORK ENVIRONMENTAL 9.0 QUALITY ASSURANCE
13.0 INSTRUMENTS 22.0 REMEDIAL ACTIONS & COMPLAINTS
14.0 REAGENTS AND CONSUMABLE MANAGEMENTS 23.0 COMMUNICATIONS
15.0 SELECTION & VALIDATION OF EXAMINATION PROCEDURES 24.0 AUDITS
25.0 LABORATORY INFORMATION SYSTEMS MANAGEMENT
26.0 ETHICS

CHECK
DO EXAMINATION PROCESSES

16.0 SAFETY
USER
17.0 LIST OF EXAMINATION PROCEDURES
USER 18.0 PRE EXAMINATION PROCESSES SATISFACTION
19.0 VALIDATION OF RESULTS
REQUIREMENTS 20.0 QUALITY CONTROL OR
21.0 REPORTING RESULTS
DISSATISFACTION

INPUTS OUTPUTS
= =
REQUEST PROCESS REPORT


1.0 PURPOSE & SCOPE
1.1 Quality Manual:

This manual describes Particular requirements for quality and competence of United Laboratories.
It includes COMPANY XYZ‘s quality policy and describes how it is implemented and sustained
throughout the organization.

It is written to meet the requirements of our customers as well as applicable International and
National Standards ISO 15189:2007. The key elements of acquiring these standards are
described with references to key organizational policies and procedures.

1.2 Purpose:

To ensure product and service quality continue to meet the highest standards demanded by the
organization and expected by its customers.

1.3 Scope:

Provide a reliable and high quality comprehensive diagnostic solutions and laboratory services in
the field of clinical and dental laboratories. Research and development services are not applicable
as supposed to the nature of services provided. This document applies to all COMPANY XYZ
sites including Quality System, Medical Laboratories (Central United Medical Laboratory (CUML)
and International Clinic Laboratory (ICL)), Al Seef Hospital, Dental Laboratory (Central United
Dental Laboratory (CUDL)) and any projected premises for COMPANY XYZ in the future.


2.0 QUALITY POLICY

Our company is dedicated to the Quality Policy that will ensure its products and services fully
meet and preferably exceed the requirements of its clients at all times. Our goal is to achieve the
highest level of client satisfaction. We achieve this goal by commitment to the implementation of
supporting managerial and business operational systems.

COMPANY XYZ believes in working together with clients and suppliers to achieve this policy, and
in continually striving for improvements in all areas of its business.

Our quality policy is based on four key principles:

1. Conformance with our clients‘ requirements at all times, ensuring that we fully identify and
conform to the needs of our clients
2. Looking at our business processes, identifying the potential for errors and taking the
necessary action to eliminate them
3. Ensuring that everyone in the organization understands how to do their job and does it right
first time
4. All personnel are having responsibility for quality

To ensure that the policy is successfully implemented:

1. Staff will be responsible for identifying customer requirements, and ensuring that the correct
procedures are followed to meet those requirements
2. Objectives, needed to ensure that the requirements of this policy are met and continual
improvement is maintained in line with the spirit of this policy, will be set, determined and
monitored at Management Review.
3. Our quality policy principles and objectives will be communicated and made available to
staff at all times.
4. Training will be an integral part of the strategy to achieve our objectives.
5. COMPANY XYZ will operate under the disciplines and control of Quality Management
System that conforms to international standards ISO 15189:2007 and College of American
Pathologists.
6. We will constantly review and improve our services to ensure tasks are completed in the
most cost-effective and timely manner for benefit of all our clients.
7. We will ensure that our personnel understand and fully implement our company‘s policies
and objectives and are able to perform their duties effectively through an ongoing training
and development programmers.


2.1 MISSION:
To offer reliable and high-quality laboratory services to all our customers while providing the best
working environment to our staff and assuring the highest return on investment for our
shareholders

 Aid in the diagnosis, treatment, and monitoring of the health status of our patients.
 Developing, sharing, and implementing disease management strategies to reduce
overall costs and improve patient care.
 Lowering unit costs by sharing, standardizing and integrating laboratory services.
 Increasing revenues through enhanced outreach services.
 Successfully competing for managed care contracts for laboratory services.

2.2 VISION:

To serve as a wide-reference company for Kuwait and Gulf region that provides laboratory testing
and consultation in the health care sector.

 Diagnostic services leadership in the Private health care of Kuwait.
 A single, influential, educational laboratory with an entrepreneurial approach
 High quality patient care through effective and efficient use of laboratory resources
 Maximal provision of specialized and reference clinical laboratory services for the country.
 Responsive to changing clinical, service, education, technological and fiscal needs
 Commercialized applied research and internationally recognized expertise
 Balance between generalists and specialists
 Serve as a Kuwait -wide reference company for laboratory testing and consultation


3.0 DESCRIPTION OF LABORATORY
Company XYZ (COMPANY XYZ) is a specialized company established in January 2004 to provide
comprehensive diagnostic solutions and laboratory services in the medical fields such as Clinical,
Dental, Animal, Environmental and food testing.

COMPANY XYZ is a subsidiary of ---------------------- which is one of the leading medical groups
providing multi-specialty healthcare services to the population of Kuwait through its specialized
medical group of companies.

COMPANY XYZ has established the largest private medical laboratory in the Gulf region capable
of performing comprehensive lab tests in the field of Hematology, Biochemistry, Microbiology,
Hispathology, Cytology, Molecular Biology and Immunology. It‘s a sister of a group of companies
under the umbrella of

COMPANY XYZ manages a number of clinical laboratories located geographically in different
areas in Kuwait. It also provides comprehensive and cost effective diagnostic services which
balance the needs of clinical programs with the resources of laboratory medicine.

As a result, COMPANY XYZ provides optimal patient care in the clinical and dental fields.

COMPANY XYZ became accredited by the College American of Pathologists (CAP) in 2007 (First
in Kuwait).
COMPANY XYZ became accredited under ISO 15189:2007 in 2009.


4.0 TERMS & DEFINITIONS
For the purposes of this document the following terms and definitions shall apply:

4.1 accreditation
Procedure by which an authoritative body gives formal recognition that a body or person
is competent to carry out specific tasks

4.2 audit
Systematic, independent and documented process for obtaining audit evidence and evaluating it
objectively to determine the extent to which audit criteria are fulfilled

4.3 corrective action
Action to eliminate the cause of a detected nonconformity or other undesirable situation
NOTE
Corrective action is taken to prevent reoccurrence whereas preventative action is taken
to prevent occurrence

4.4 efficiency
Relationship between the result achieved and the resources used

4.5 environment
Surroundings in which an organization operates, including air, water, land, natural resources, flora,
fauna, humans and their interrelation.
4.6 environmental aspect
Element of an organization‘s activities or products or services that can interact with the
environment.

4.7 environmental impact
Any change to the environment, whether adverse or beneficial, wholly or partially
resulting from an organization‘s environmental aspects.

4.8 examination
Set of operations having the object of determining the value or characteristics of a property
NOTE
In some disciplines (e.g. microbiology) examination is the total activity of a number of tests,
observations or measurements

4.9 laboratory director
Competent person(s) with responsibility for, and authority over, a laboratory

4.10 laboratory management
Person who manage the activities of the laboratory headed by the laboratory director

4.11 multidisciplinary laboratory


Laboratory in which two or more pathology disciplines work in an integrated manner

4.12 nonconformity
Nonfulfilment of a requirement

4.13 organisation
Group of people and facilities with an arrangement of responsibilities, authorities and relationships
4.14 organisational structure
Arrangement of responsibilities, authorities and relationships between people
4.15 post examination process
Post analytical phase Processes following the examination including systematic review, formatting
and interpretation, authorization for release, reporting and transmission of results and storage of
samples of the examinations

4.16 pre examination process
Pre analytical phase steps starting in chronological order from the clinician‘s request, including
examination requisition, preparation of the patient, collection of the primary sample, transportation
to and within the laboratory and ending when the examination procedure starts

4.17 premises
Physical environment in which an organisation carries out particular functions

4.18 preventive actions
Action to eliminate cause of a potential nonconformity or other undesirable potential
situation
NOTE
Preventive action is taken to prevent occurrence whereas corrective action is taken to
prevent reoccurrence

4.19 procedure
Specified way to carry out an activity or process
NOTE
When the term ‗procedure‘ is used in this document a written procedure is required which is
subject to document control, regular review and revision.

4.20 quality improvement
Part of quality management focused on continually increasing effectiveness and efficiency
NOTE
The term ‗continual quality improvement‘ is used when quality improvement is progressive
and the organisation actively seeks and pursues improvement opportunities

4.21 quality management system
Management system to direct and control an organisation with regard to quality
4.22 quality manual
A document specifying the quality management system of an organization.


4.23 quality objective
Something sought, or aimed for, related to quality
NOTE
Quality objectives are generally based on the organisation‘s quality policy

4.24 quality planning
Part of quality management focused on setting quality objectives and specifying necessary
operational processes and related resources to fulfill quality objectives
4.25 quality policy
Overall intentions and direction of an organisation related to the fulfillment of quality
requirements as specified by laboratory management
NOTE
The quality policy should be consistent with the overall policy of the organisation and
should provide a framework for the setting of quality objectives
4.26 record
Document stating results achieved or providing evidence of activities performed
4.27 referral laboratory
External laboratory to which a sample is submitted for supplementary or confirmatory
examination procedure and report

4.28 requirement
Need or expectation that is stated, generally implied or obligatory

4.29 revision
Introduction of all necessary changes to the substance and presentation of a document to
ensure its continuing suitability, adequacy, effectiveness to achieve established objectives

4.30 review
Activity undertaken to ensure the suitability, adequacy, effectiveness and efficiency of the
subject matter to achieve established objectives

4.31 user
Patient, Medical doctor (Physician), clinic, or medical laboratory using the services of the
laboratory


5.0 ABBREVIATIONS
Users of this Quality Manual shall be familiar of abbreviations found in the contents of the
manual. Quality Assurance is responsible for maintaining those abbreviations.

CA: Corrective action

CAP: College of American Pathologists

CEO: Chief Executive Officer

DCC: Document Control Centre

EQA: External Quality Assessment

HR: Human resources

ISO: International Organization for Standardization

LIMS: Laboratory Information & Management System

MD: Medical Director

MR: Management Representative

MRM: Management Review Meeting

NCR: Non Conformance Report

PA: Preventive Action

PLM: Production Lab Manager (Dental)

PTP: Proficiency Testing Program

QA: Quality Assurance

QAD: Quality Assurance Department

QAM: Quality Assurance Manager

QC: Quality Control

QMS: Quality Management System

SOP: Standard Operating Procedure

COMPANY XYZ: Company XYZ


6.0 MANAGEMENT REQUIREMENTS
6.1 Organization and Management

Laboratory Director or CEO has the responsibility and authority to ensure that all medical
services offered in COMPANY XYZ shall meet the needs of patients and all lab staff
responsible for patient care.
Laboratory Director or CEO and top management has the responsibility to ensure that the
lab is designed to meet ISO 15189:2007 standards and the College of American
Pathologists CAP requirements during testing and other routinely activities.
CEO is responsible for ensuring that the Quality Policy is appropriate for the goals of the
corporation, that it promotes the continuing improvement of the effectiveness of the quality
management system and that it is reviewed for continuing suitability.

Laboratory management is responsible for maintaining the effectiveness, adequacy and
improvement of the QMS. This shall include the following:

a. management support of all laboratory personnel by providing them with the
appropriate authority and resources to carry out their duties;
b. arrangements to ensure that management and personnel are free from any undue
internal and external commercial, financial or other pressures and influences that
may adversely affect the quality of their work;
c. policies and procedures for ensuring the protection of confidential information (see
Appendix A);
d. policies and procedures for avoiding involvement in any activities that would
diminish confidence in its competence, impartiality, judgment or operational
integrity;
e. the organizational and management structure of the laboratory and its relationship
to any other organization with which it may be associated;
f. specified responsibilities, authority and interrelationships of all personnel;
g. adequate training of all staff and supervision appropriate to their experience and
level of responsibility by competent persons conversant with the purpose,
procedures and assessment of results of the relevant examination procedures;
h. technical management which has overall responsibility for the technical operations
and the provision of resources needed to ensure the required quality of laboratory
procedures;
i. appointment of a quality manager (however named) with delegated responsibility
and authority to oversee compliance with the requirements of the quality
management system, who shall report directly to the level of laboratory
management at which decisions are made on laboratory policy and resources;
j. appoint deputies for key managerial personnel (could be impractical in smaller
labs)


6.2 Responsibility & Authority

The CEO is appointed as the Laboratory Director.

Medical Director and Technical Director each reports to the Laboratory Director.

Lab Supervisor reports to both Medical & Technical Directors as necessary.

The CEO has appointed the Quality Manager as the management representative who,
irrespective of other responsibilities, has the responsibility and authority for:
a. ensuring that processes of the quality management system are established,
implemented and maintained;
b. reporting to top management on the performance of the quality management
system, including needs for improvement;
c. acting as liaison with external customers on matters relating to the quality
management system and CAP requirements.
The responsibilities of personnel in the laboratory with an involvement or influence on the
examination of primary samples shall be defined in order to identify conflicts of interest.
UCL had developed detailed responsibilities of all employees in the form of job
descriptions, which are maintained by the Human Resources Department and the
Document Control Center.

Supporting Procedure of this section:

COMPANY XYZ Organization Chart OG01
Employee Job Descriptions Manual


7.0 MANAGEMENT REVIEW
The CEO, Laboratory Management and Quality Manager review the lab‘s QMS and all its
medical services by conducting management reviews meetings (MRMs) periodically in
order to ensure the effectiveness and adequacy of the QMS in support of patient care and
for continual improvement.

Management review meetings shall take account of, but not be limited to:
a. follow-up of previous management reviews;
b. status of corrective actions taken and required preventive action;
c. reports from managerial and supervisory personnel;
d. the outcome of recent internal audits;
e. assessment by external bodies;
f. the outcome of external quality assessment and other forms of inter-laboratory
comparison;
g. any changes in the volume and type of work undertaken;
h. feedback, including complaints and other relevant factors, from clinicians, patients
and other parties;
i. quality indicators for monitoring the laboratory‘s contribution to patient care;
j. nonconformities;
k. monitoring of turnaround time;
l. results of continuous improvement processes;
m. evaluation of suppliers.

Findings from MRMs and the actions that arise from them shall be recorded. The Quality
management shall ensure that those actions are carried out within an appropriate and
agreed timescale.


Management Review COMPANY XYZ/ORG001


8.0 STAFF EDUCATION AND TRAINING
To provide excellence in medical, dental and administration services, COMPANY XYZ
have established ―United Training and Continuing Education Center‖ whose objective is
primarily promoting continuing education and new technologies to COMPANY XYZ staff
and other medical and dental technologists in Kuwait and the Gulf region.
It is the responsibility of the Head of the United Training and Continuing Education Center
to ensure that training plan is always in place for future development and growth at
COMPANY XYZ. Moreover department managers should:

 identify competency needs for personnel performing testing activities
 assign specific tasks and duties to personnel‘s experience, education, training
and/or demonstrated skills and ability.
 provide training or taking other actions (e.g., coaching, communication, reading) to
satisfy these needs when training is required;
 ensure that staff are aware of the relevance and importance of their activities and
how they contribute to the achievement of the quality objectives;
 assess the effectiveness of training and take actions accordingly;
 maintain appropriate records of education, training, skills and experience.


Training and Competency Program
Training and Development COMPANY XYZ/HR-21

9.0 QUALITY ASSURANCE
QA represents all those planned and systematic activities implemented to provide
adequate confidence that an entity will fulfill requirements for quality (ISO definition). QA
has been a key component of the QMS implemented at COMPANY XYZ‘s. The QA
program has been established through documentation (quality manual, procedures,
policies, records, etc …), training of staff, corrective actions, internal audits, control of
records and process control. QA is defined as a program that guarantees quality patient
care by tracking outcomes through scheduled reviews. The QA process at COMPANY
XYZ can be divided into three phases; Pre-analytical (Pre-examination Procedures),
analytical (examination Procedures) and post-analytical (Post-examination Procedures).


Management Review COMPANY XYZ/ORG001
Error Management COMPANY XYZ/EROR001
Internal Auditing COMPANY XYZ/ASS001


10.0 DOCUMENT & RECORDS CONTROL
The quality manual, organizational policies, subordinate procedures, work instructions,
and references are controlled documents. Changes to the quality manual require the
approval of CEO or designate. Printed copies of any documents are considered
uncontrolled and shall be destroyed once retrieved.
COMPANY XYZ/DOC001 had been established to illustrate how to:
a. approve documents for adequacy prior to issue;
b. review, update as necessary and re-approve documents;
c. ensure that the changes and the current revision status of documents are
identified;
d. ensure that relevant versions of applicable documents are available at points of
use;
e. ensure that documents remain legible and readily identifiable;
f. ensure that documents of external origin are identified and their distribution
controlled;
g. to prevent the unintended use of obsolete documents, and to apply suitable
identification to them if they are retained for any purpose;

The quality document pyramid at COMPANY XYZ is defined as follows:

Level 1
Defines
Approach & Responsibilities
Quality Manual
Level 2
Answers
Policies How
Level 3
Defines
Who, What & When
Departmental Procedures

Level 4
Records Evidence& Proof


Records reveal that all aspects of a documented quality system are in place and
adequately applied. Records are an integral part of the documented system and provide
evidence to demonstrate conformance to international standards and the effective
operation of the quality system.

Document and Record Control COMPANY XYZ/DOC001

11.0 RECORDS MAINTENANCE & ARCHIVING
QA department is responsible for the implementation, the follow-up and the upkeep of the
quality manual, quality procedures, working Instructions, and quality plans, etc…
Documents are reviewed periodically, revised as necessary and approved by the
management representative prior to distribution and use, have provisions for
review/approval signatures, and have a means for indicating the document revision level.
Documents are numbered and assigned to an individual or area of use, and current
versions are available at locations where related activities are performed.
A register is kept with DCC to indicate the document/copy number, locations of all
controlled documents, and the current revision status of the document.
The DCC alone has the authority to distribute a new version of the Quality Manual.
Manager(s) or designate(s) have the responsibility of supporting quality assurance
procedures in their respective services. Records are stored and maintained in a manner
that is readily accessible and minimizes deterioration, damage, or loss.



12.0 ACCOMMODATION AND WORK ENVIRONMENT
12.1 Infrastructure
The laboratory management determines, provides and maintains the infrastructure needed
to achieve the conformity of service/product to requirements, including, as applicable:
a. buildings, workspace and associated utilities;
b. testing equipment, (both hardware and software);
c. supporting services (such as transport and communication).
d. work environment

12.2 Work Environment
The Laboratory management determines and manages the work environment (e.g.,
facilities and supporting items/services) and conducts audits to achieve service/product


conformity to requirements. This audit includes: (a) infrastructure, (b) health & safety, (c)
housekeeping and recycling, (d) work ethics, and (e) ergonomics.



1 3 . 0 I NSTRUMENTS
COMPANY XYZ uses the state of art equipments to meet the user‘s requirements and for
patients and staffs safety during testing activities. ―Equipment Policy‖ COMPANY
XYZ/EQP001 has been established for the management and control of new and existing
equipments at COMPANY XYZ. This policy and other related policies cover the
followings:

a. selection and defining intended use
b. acceptance criteria, validation
c. Staff training
d. maintenance, service and repair
e. transfer and troubleshooting
f. record of instrument failure and subsequent corrective action
g. planned replacement and disposal
h. reporting major breakdown

Lab management assures that any equipment related records and forms shall be
maintained and available upon request.
Note: For the purpose of ISO15189:2007, instruments, reference materials, consumables,
reagents and analytical systems are included as laboratory equipment, as applicable.


Equipment Policy COMPANY XYZ/EQP001
Equipment Validation Protocol COMPANY XYZ/EQP002
Equipment Trouble Shooting COMPANY XYZ/EQP003
Validation of New Storage Equipment COMPANY XYZ/EQP004
Equipment Transfer Policy COMPANY XYZ/EQP007
Change Control Policy UCL/PCN001


14.0 REAGENTS AND CONSUMABLES MANAGEMENT
Existing policy COMPANY XYZ/SUP002 illustrate how to manage reagents and other
consumables used during storing and testing activities. It is very crucial for lab
management to ensure the availability of reagents, calibration and quality control material
required to provide and carry on services. It is the primary responsibility of purchasing
department to ensure that received consumables are identified, checked and stored
according to manufacturer‘s requirements. COMPANY XYZ has a supplier management
process where assessment and selection of suppliers are based on in-house criteria and
evaluation of suppliers and services are conducted periodically and as necessary.
COMPANY XYZ/SAF explains how to dispose of consumables when required. All records
pertinent to supplies management are maintained and archived as per Document Control
COMPANY XYZ/DOC001. Consumables in use shall be correctly identified with the date
of receipt, lot numbers, first use and expiry.


Supplier Issues COMPANY XYZ/SUP001
Receipt, Inspection and Testing of Incoming Supplies COMPANY XYZ/SUP002
COMPANY XYZ Laboratory Bio-safety Manual COMPANY XYZ/SAF

15.0 SELECTION AND VALIDATION OF EXAMINATION PROCEDURES

The CEO and laboratory management select and choose a new examination procedure
which fulfill the needs and requirements for the user and the market. The selected method
(s) or procedure (s) shall be within COMPANY XYZ‘s scope and method of applications.
The new examination procedures shall be validated for its intended use and prior to
introduction. All pertinent records of method validation and other data as necessary (i.e.
training of staff, equipment, etc…) shall be maintained for any justification in the future. At
COMPANY XYZ, every existing examination procedure is validated and for every
examination there should be a relevant SOP and related forms. All current examination
procedures at COMPANY XYZ are maintained and available in English in relevant
sections of the laboratory.


Analytical Factors Important in Clinical laboratory COMPANY XYZ/MED012POL
Change Control Policy COMPANY XYZ/PCN001


16.0 SAFETY
The CEO and Management Representative at COMPANY XYZ have issued and approved
a safety policy to provide and maintain a safe work environment for patients, staff and/or
any personnel available on the premises of COMPANY XYZ. Safety Policy statement is
as follows:

Company XYZ COMPANY XYZ is committed to providing safe and healthy workplaces.
The WHO Guidelines and National Regulations define the essential standards for health
and safety performance for employers, employees and contractors; these standards may
be complemented by other legislation and may be exceeded by specific COMPANY XYZ
Safety Policies and departmental procedures for risk management and due diligence.

COMPANY XYZ is committed to preventing occupational injuries and expects managers
at all levels to be responsible and accountable for injury prevention. Management is
committed to solving health and safety problems in a co-operative approach with
employees, to performing workplace inspections, monitoring on the-job safety
performance, auditing for health and safety program success, and is committed to the
process of continuous improvement in health and safety performance.

COMPANY XYZ is committed to training and motivating employees for safety performance
and to sustaining and updating their safety knowledge. COMPANY XYZ strives to
integrate safety knowledge and/or safety performance expectations into its operations.
Personal safety and responsibility shall be promoted for employees both on and off-the-job
and for those who live, learn and pursue recreational activities at COMPANY XYZ.
COMPANY XYZ expects that all employees shall work safely and that they shall regard
safety as a priority in all employment-related activities. Employees are expected to be
familiar with prescribed safety requirements and institutional policies pertinent to their jobs,
to anticipate safety needs for every task, to report safety hazards or contravention of
prescribed requirements to their supervisors, and to constructively support employee and
management initiatives for improving workplace health and safety conditions.


COMPANY XYZ Laboratory Bio-safety Manual COMPANY XYZ/SAF


17.0 LIST OF EXAMINATION PROCEDURES

At COMPANY XYZ there are written and approved SOPs for the conduct of all
examinations that include and/or refer to, as applicable, the following:
 purpose of examination
 principle of procedure used for examinations
 specimen requirements and means of identification
 equipment and special supplies
 reagents, standards or calibrators and internal quality control materials
 relevant work instructions
 limitations of the examination
 recording and calculation of results
 reporting reference limits
 responsibilities of personnel in authorizing, reporting, and monitoring reports
 hazards and safety precautions
 uncertainty of measurement

Laboratory management is accountable and responsible for ensuring that the contents of
examination procedure are complete, current and have been thoroughly reviewed. All
SOPs are reviewed annually and verified by lab management.


Change Control Policy COMPANY XYZ/PCN001
Refer to Appendix E

18.0 PRE-EXAMINATION
18.1 Requisition form
The request form used at COMPANY XYZ contains enough information to identify the
patient and the requestor as well as pertinent clinical data. The request form shall allow
the inclusion of the following items but not limited to:
a. sufficient information to allow unique identity of the patient (ID, DOB, Sex, etc…)
b. identification(s) and the location of the requesting individual
c. date and time of specimen collection
d. type of specimen and, where appropriate, anatomical site of origin
e. date and time of receipt of samples by the laboratory
f. relevant clinical information
g. identification of priority status
h. laboratory accession number.


Lab staffs are instructed to encourage the requestor for proper completion of the request
form to facilitate for the benefits of the patient and satisfaction of requestor.

18.2 Specimen Collection and Handling
Lab management at COMPANY XYZ has established specific procedure for collecting a
specimen from the patient or from the requestor. Proper preparation of the patient,
specimen collection and handling are essential for the production of valid results by a
laboratory.
Prior to, during and after executing the medical testing of the specimen collected the lab
staff shall:
a. Check the completion of the request form and confirming the identity of the patient
b. Verify that the specimen container is labeled correctly
c. Ensure that the patient is appropriately prepared
d. Ensure that the specimen is collected correctly
e. Exercise precautions and awareness of risk of interchange of samples
f. Ensure that environmental and storage conditions are fulfilled
g. Ensure the safe disposal of all materials used in specimen collection
h. Ensure that all spillages and breakages are dealt with correctly

These procedures for specimen collection are available for the phlebotomist and all other
staff in the hematology departments. Other policies which focus on the transportation of
specimen with a minimum risk on the safety of courier and the receiver are available.
These policies cover the followings;
a) Ensuring the safety of the courier, the general public and receiving laboratory
b) packaging, labeling and dispatch
c) Protection of the specimens from deterioration
d) Reporting incidents during transportation that may affect the quality of the
specimen or the safety of personnel.

At the receiving area, laboratory staff shall accept and or refuse the collected specimen as
per in house procedure and criteria.

Note: Phlebotomist cannot label any specimen they did not personally collect.


Receiving Samples and Releasing Results Lab to Lab COMPANY
XYZ/MED001POL
Receiving Samples and Releasing Results COMPANY XYZ/MED003 POL
Specimen Labeling Requirement COMPANY XYZ/MED004 POL
Requisition Requirements COMPANY XYZ/MED005 POL


Phlebotomy Manual
Rejection of Specimens COMPANY XYZ/MED008POL
Transporting Specimens COMPANY XYZ/MED009POL

19.0 VALIDATION OF RESULTS
All healthcare equipments at COMPANY XYZ undergo a preventive maintenance program
to produce valid test results for safety and care of the patient. There are established and
approved policies which instruct lab personnel on how to report and deal with invalid test
results. In addition COMPANY XYZ All test report results shall be reviewed and
validated by Medical director at COMPANY XYZ. Laboratory staff shall first review the
results and ensure no discrepancies or deficiencies are observed. In addition a LIMS is
available at COMPANY XYZ to provide more sophisticated services, to reduce downtime
during testing activities and to provide valid test results.


Report Contents COMPANY XYZ/MED006POL
Invalidation Test Results COMPANY XYZ/PCN003

20.0 QUALITY CONTROL
QC is defined as a process where known samples are tested routinely, in a systematic
way, in order to confirm the reliability and precision of analytical procedures. QC can be
considered part of the operational control of processes, being extremely useful for
detecting and correcting real and potential deviations. Areas of phlebotomy subject to QC
are: Patient preparation procedures, Specimen collection procedures (Identification,
puncture device, evacuated tubes, Labeling and etc…). COMPANY XYZ currently
participates in inter-laboratory comparison ―proficiency testing program‖ provided by the
College of American Pathologists in order to monitor the validity of tests and tests results.
Laboratory management at COMPANY XYZ is responsible for monitoring the results of
EQA and implementing corrective actions when control criteria are not fulfilled.


Proficiency Testing Program COMPANY XYZ/PCN002
Response To Unsatisfactory Proficiency Testing Program COMPANY XYZ/PCN004
Review PT Evaluation COMPANY XYZ/PCN005
Investigating PT Failure COMPANY XYZ/PCN006


21.0 REPORTING OF RESULTS
The main method of communicating the results of examinations to the user of the
laboratory is through a report. The report is electronic and could be written.
COMPANY XYZ have developed a typical report format which comply with the needs of
users, clear and unambiguous and enables the user to interpret the results. The report
shall be as follows:
 the laboratory name
 the unique identity of the patient
 requester and/or address for delivery
 type of specimen, date and time of collection
 Clear identification of the examination.
 time and date of report
 results, including reasons if no examination is performed
 comments as appropriate
 status of report as appropriate, eg, copy, interim or corrected
 identification of the person authorizing the release of the report;
 signature or authorization of the person checking or releasing the report, where
possible.

Authorized lab staff may release the results by telephone or email as advised by the
medical director or designee. Communicating report results to the user are further
discussed in relevant medical policies.


Notification of Critical Values COMPANY XYZ/MED010POL
Corrected Reports Corrected Report COMPANY XYZ/MED041POL
Verbal Requests For Medical Testing COMPANY XYZ/MED042POL

22.0 REMEDIAL ACTIONS & COMPLAINTS
Laboratory management and QAD are highly committed to resolve any complaint or a
problem whether the complaint is internal or external. Once a problem occurs, lab
management takes into consideration first to document the problem, and assign a
designate for problem solving. Problem solving will involve root cause analysis, corrective
actions and preventive actions.

COMPANY XYZ/EROR001 – Error Management policy defines requirements for:
 reviewing nonconformities (including customer complaints);
 evaluating the need for actions to ensure that nonconformities do not recur;


 determining and implementing the corrective & preventive action(s) needed;
 reviewing of corrective and preventive actions taken.
 evaluating the need for action to prevent occurrence of nonconformities;



23.0 COMMUNICATIONS

23.1 Staff

The CEO has identified communication processes (e.g., memos, e-mail, fixed and cell
phones, and employee meetings) to ensure communication is taking place regarding the
effectiveness of the quality management system. Weekly management/employee
communication meetings cover the QMS and customer operating issues as well as
improvement opportunities. Management review meeting conducted periodically as per
ISO requirements and in house policies.

23.2 Patients & Health Professionals

Lab staffs at COMPANY XYZ communicate to patients face to face (verbally), customer
feedback, test reports (electronic or written), by the phone, emails, etc….

23.3 Suppliers

COMPANY XYZ maintains a list of registered suppliers that supply our company with
reagents, washing solution, test tubes, dental supplies, etc…Communication with the
supplier is by phone, emails, self evaluation survey, supplier evaluation, etc…

23.4 Referral Laboratories

COMPANY XYZ maintains a list of approved referral lab (accredited), customer care
services at COMPANY XYZ communicate with referral labs through email, phone, fax, and
airway services.


Supplier Issues COMPANY XYZ/SUP001
Outsourcing Policy COMPANY XYZ/CC002


24.0 AUDITS

UCL conducts internal audits to determine whether the QMS conforms to the requirements
of ISO 15189:2007 and CAP and has been effectively implemented and maintained. QA
Manager develops the audit plan annually, taking into consideration the status and
importance of the activities and areas to be audited as well as the results of previous
audits. The audit plan is revised after each audit and updated if needed. The audit criteria,
scope, frequency and methods are defined.
Audits are conducted by personnel other than those who perform the activity being
audited. Internal Auditing Policy COMPANY XYZ/ASS001 identifies the responsibilities
and requirements for conducting audits, recording results and reporting to management.
Responsible managers take timely corrective action on deficiencies found during the audit.
Follow-up actions include the verification of the implementation of corrective action, and
the reporting of verification results.



25.0 LABORATORY INFORMATION SYSTEMS MANAGEMENT

Like other sophisticated medical labs, COMPANY XYZ currently uses a LIMS in all
applications in the laboratory. LIMS is very crucial to the lab where it serves as a tool for
tracking all tasks related to primary samples from receiving, collecting, testing, retesting,
and reporting test results. Hence COMPANY XYZ have developed a manual which
enables all lab staff to be familiar with and to ensure consistency in all tasks and validity of
test results in the lab.


Laboratory Information and Management Systems Manual COMPANY XYZ/LIS

26.0 ETHICS
Laboratory management at COMPANY XYZ has set principles and standards by which lab
staffs practice their duties and daily activities. Medical Lab and dental staff at COMPANY
XYZ shall:

 Maintain strict confidentiality of patient information and test results.
 Be accountable for the quality and integrity of the services and tests they provide.
 Exercise sound judgment in conducting, and evaluating laboratory testing.
 Maintain a reputation of honesty, integrity and reliability with respect to profession.


 Establish a sound respectful relationship with health professional and colleagues.
 Contribute to the general well being of the community.

Administration staff shall also comply with supporting procedure of this section.


Business Integrity and Ethics COMPANY XYZ/HR-24

27.0 REFERENCES
 College Of American Pathologists, Lab Accreditation manual, 2010 Edition
 Medical laboratories — Particular requirements for quality and competence
ISO 15189:2007(E)
 NCCLS A Quality System Model for Health Care; Approved Guideline Vol. 19 No. 20
 Quality Management Systems -- Requirements ISO 9001 Fourth edition
 General requirements for the competence of testing and calibration laboratories
ISO/IEC 17025:2005(E)

28.0 APPENDIXES

 Licensing from MOH, refer to A
 Certificates & Accreditations, refer to B
 COMPANY XYZ Business Process Interaction, refer to C
 Confidentiality Agreement. refer to D
 List of Examination Procedures, refer to E


ISO 15189:2007 Quality Manual

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