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Introduction
Purpose & Scope
Quality Policy
Description of Laboratory
Terms & Definitions
Abbreviations
Management Requirements
Management Review
Staff Education & Training
Quality Assurance
Document Control
Records Maintenance & Archiving
Accommodation and Environment
Instruments
Reagents and Consumables Management
Selection and Validation of Examination Procedures
Safety
List of Examination Procedures
Pre-Examination
Validation of Results
Quality Control
Reporting of Results
Remedial Actions & Complaints
Communications
Audits
Laboratory Information Systems Management
Ethics
References
Appendixes
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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:
PLAN
ACT
RESOURCE MANAGEMENT
DO
USER
REQUIREMENTS
INPUTS
=
REQUEST
CHECK
EXAMINATION PROCESSES
16.0 SAFETY
17.0 LIST OF EXAMINATION PROCEDURES
18.0 PRE EXAMINATION PROCESSES
19.0 VALIDATION OF RESULTS
20.0 QUALITY CONTROL
21.0 REPORTING RESULTS
PROCESS
USER
SATISFACTION
OR
DISSATISFACTION
OUTPUTS
=
REPORT
1.0
1.1
Quality Manual:
This manual describes Particular requirements for quality and competence of United Laboratories.
It includes COMPANY XYZs 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 companys 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
2.2
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.
VISION:
To serve as a wide-reference company for Kuwait and Gulf region that provides laboratory testing
and consultation in the health care sector.
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. Its 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
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 organizations 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 organizations 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
4.23
quality objective
Something sought, or aimed for, related to quality
NOTE
Quality objectives are generally based on the organisations 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
8.0
9.0
QUALITY ASSURANCE
10.0
Level 1
Defines
Approach & Responsibilities
Quality Manual
Policies
Level 2
Answers
How
Level 3
Defines
Who, What & When
Departmental Procedures
Records
Level 4
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.
Supporting Procedure of this section:
Document and Record Control COMPANY XYZ/DOC001
11.0
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.
Supporting Procedure of this section:
Document and Record Control COMPANY XYZ/DOC001
12.0
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.
Supporting Procedure of this section:
Error Management COMPANY XYZ/EROR001
Document and Record Control COMPANY XYZ/DOC001
Internal Auditing COMPANY XYZ/ASS001
1 3 . 0 I NSTRUMENTS
COMPANY XYZ uses the state of art equipments to meet the users 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.
b.
c.
d.
e.
f.
g.
h.
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.
Supporting Procedure of this section:
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
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 manufacturers 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.
Supporting Procedure of this section:
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
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 XYZs 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.
Supporting Procedure of this section:
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.
Supporting Procedure of this section:
COMPANY XYZ Laboratory Bio-safety Manual COMPANY XYZ/SAF
17.0
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.
Supporting Procedure of this section:
Change Control Policy COMPANY XYZ/PCN001
Analytical Factors Important in Clinical laboratory COMPANY XYZ/MED012POL
Refer to Appendix E
18.0
PRE-EXAMINATION
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.
Supporting Procedure of this section:
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
20.0
QUALITY CONTROL
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.
Supporting Procedure of this section:
Report Contents COMPANY XYZ/MED006POL
Notification of Critical Values COMPANY XYZ/MED010POL
Corrected Reports Corrected Report COMPANY XYZ/MED041POL
Verbal Requests For Medical Testing COMPANY XYZ/MED042POL
22.0
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;
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
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, etcCommunication 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.
Supporting Procedure of this section:
Supplier Issues COMPANY XYZ/SUP001
Outsourcing Policy COMPANY XYZ/CC002
Report Contents COMPANY XYZ/MED006POL
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.
Supporting Procedure of this section:
Internal Auditing COMPANY XYZ/ASS001
25.0
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.
Supporting Procedure of this section:
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:
Administration staff shall also comply with supporting procedure of this section.
27.0
REFERENCES
NCCLS A Quality System Model for Health Care; Approved Guideline Vol. 19 No. 20
28.0
APPENDIXES