Quality Policy Manual

Quality Policy Manual
Compiled by: Bedane Midekso Signature:
Approved by: Fikru Yadeta Signature:
Effective Date Sept. 20, 2021 GC Version: 01
Document Number: MH/LQPM Copy Number:
Date of discontinue: _____________________________-

Meki Hospital Laboratory Department
Document No: MHL/QPM
Title: Quality Policy Manual Version No: 01
Effective Date: Sep.2021

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REVISION AND AMENDMENT

A. Annual Review of Document
Reviewed by: Approved by:
Revision No. Review Date
Name Signature Name Signature
B. Version Change History/Description

Version. Effective Description of Version Change Name & Name &
No. Date Signature of Signature of
Reviewer approval
C. Amendment
Rev. Page Description of Amendment Amendment Effective Name &
No. No Date Date Signature of
approval
Authority of Issue: MHL "This is a controlled document for internal use only"

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I. Table of contents
Contents
REVISION AND AMENDMENT..............................................................................................................1
I. Table of contents..................................................................................................................................2
INTRODUCTION.......................................................................................................................................7
Quality Policy Manual.................................................................................................................................7
Purpose of the QPM.....................................................................................................................................7
Vision and Mission......................................................................................................................................8
Vision:..........................................................................................................................................................8
Mission:.......................................................................................................................................................8
Values & Beliefs..........................................................................................................................................8
Values:.........................................................................................................................................................8
Beliefs:.........................................................................................................................................................9
1. SCOPE................................................................................................................................................10
2. NORMATIVE REFERENCES..........................................................................................................11
3. ABBREVIATIONS, TERMS AND DEFINITIONS.........................................................................11
a.Abbreviations..........................................................................................................................................11
b. Terms and Definitions...........................................................................................................................11
4. MANAGEMENT REQUIREMENTS...................................................................................................15

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4.1 Organization and Management Responsibility....................................................................................15
4.1.1 Organization.....................................................................................................................................15
4.1.1.1. General..........................................................................................................................................15
4.1.1.2. Legal Entity..................................................................................................................................15
4.1.1.3 Ethical Conduct.............................................................................................................................15
4.1.1.4 Laboratory Head............................................................................................................................16
4.1.2 Management Responsibility.............................................................................................................17
4.1.2.1 Management commitment.............................................................................................................17
4.1.2.2Needs of users.........................................................................................................................18
4.1.2.3. Quality Policy...............................................................................................................................18
Quality Policy Statement:..........................................................................................................................18
4.1.2.4. Quality objectives and planning...................................................................................................19
4.1.2.5. Responsibility, authority and interrelationships...........................................................................20
4.1.2.6. Communication.............................................................................................................................20
4.1.2.7. Quality Officer..............................................................................................................................21
4.2 Quality management system...........................................................................................................22
4.2.1 General requirements........................................................................................................................22
4.2.2Documentation requirements.............................................................................................................24
4.2.2.1 General...................................................................................................................................24
4.2.2.2 Quality Manual.......................................................................................................................24
4.3 Document Control..........................................................................................................................25

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4.4 Service Agreements.............................................................................................................................26
4.4.1 Establishment of Service Agreements..............................................................................................26
4.4.2 Review of Service Agreements........................................................................................................27
4.5 Examination by Referral Laboratories.................................................................................................27
4.5.1 Selecting and evaluating referral laboratories and consultants.........................................................27
4.5.2. Provision of examination results.....................................................................................................28
4.6 External services and supplies.............................................................................................................28
4.7 Advisory Services................................................................................................................................29
4.8. Resolution of complaints....................................................................................................................30
4.9 Identification and control of non-conformities....................................................................................30
4.10. Corrective Action.............................................................................................................................31
4.11 Preventive Action..............................................................................................................................31
4.12 Continual Improvement.....................................................................................................................32
4.13 Control of records..............................................................................................................................33
4.14 Evaluation and Audits........................................................................................................................33
4.14.1 General............................................................................................................................................33
4.14.2 Periodic Review of Requests, and Suitability of Procedures and Sample Requirements..............34
4.14.3 Assessment of user feedback..........................................................................................................34
4.14.4 Staff suggestions.............................................................................................................................34
4.14.5 Internal audit...................................................................................................................................35
4.14.6 Risk Management...........................................................................................................................35

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4.14.7 Quality Indicators...........................................................................................................................35
4.14.8 Reviews by external organizations.................................................................................................36
4.15 Management Review.........................................................................................................................37
4.15.1 General............................................................................................................................................37
4.15.2 Review input...................................................................................................................................37
4.15.3 Review activities.............................................................................................................................38
4.15.4 Review output.................................................................................................................................38
5. TECHNICAL REQUIREMENTS.....................................................................................................39
5.1 Personnel..............................................................................................................................................39
5.1.1 General......................................................................................................................................39
5.1.2 Personnel qualifications............................................................................................................39
5.1.3 Job descriptions.........................................................................................................................39
5.1.4 Personnel introduction to the organizational environment........................................................39
5.2. Accommodation and environmental conditions.................................................................................42
5.2.1 General..............................................................................................................................................42
5.2.2. Laboratory and office facilities.......................................................................................................42
5.2.3. Storage facilities.............................................................................................................................42
5.2.4 Staff facilities............................................................................................................................43
5.2.5 Patient sample collection facilities............................................................................................43
5.2.6 Facility maintenance and environmental conditions.................................................................43
5.3 Laboratory equipment, reagents and consumables.........................................................................44

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5.3.1 Equipment.........................................................................................................................................44
5.3.1.1 General...................................................................................................................................44
5.3.1.2 Equipment acceptance testing................................................................................................44
5.3.1.3 Equipment instructions for use...............................................................................................44
5.3.1.4 Equipment calibration and metrological traceability.............................................................45
5.3.1.5 Equipment maintenance and repair........................................................................................45
5.3.1.6 Equipment adverse incident reporting....................................................................................45
5.3.1.7 Equipment records..................................................................................................................45
5.3.2 Reagents and Consumables..............................................................................................................46
5.3.2.1 General...........................................................................................................................................46
5.2.3.2 Reception and storage....................................................................................................................46
5.2.3.3 Acceptance testing.........................................................................................................................46
5.3.2.4 Reagents and consumables — Inventory management.................................................................46
5.3.2.5 Instructions for use........................................................................................................................47
5.3.2.6 Adverse Incident reporting............................................................................................................47
5.3.2.7 Records..........................................................................................................................................47
5.4 Pre-examination processes...................................................................................................................48
5.4.1 General..............................................................................................................................................48
5.4.2 Information for patients and users....................................................................................................48
5.4.3 Request Form Information................................................................................................................48
5.4.4 Primary sample collection................................................................................................................49

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5.4.4.1 General...................................................................................................................................49
5.4.4.2 Instructions for pre-collection activities.................................................................................49
5.4.4.3 Instructions for collection activities.......................................................................................49
5.4.5 Sample Transportation..............................................................................................................49
5.4.7Pre-examination handling, preparation and storage...................................................................50
5.5 Examination processes.........................................................................................................................51
5.5.1 Selection, verification and validation of examination procedures....................................................51
5.5.1.1 General...........................................................................................................................................51
5.5.1.2 Verification of examination procedures........................................................................................51
5.5.1.3 Validation of examination procedures...........................................................................................51
5.5.1.4 Measurement of uncertainty of measured quantity values............................................................52
5.5.2 Biological reference intervals or clinical decision values................................................................52
5.5.3 Documentation of examination procedures......................................................................................52
5.6 Ensuring quality of examination results..............................................................................................53
5.6.1 General..............................................................................................................................................53
5.6.2 Quality control...........................................................................................................................53
5.6.2.1 General...................................................................................................................................53
5.6.2.2Quality Control materials........................................................................................................53
5.6.2.3 Quality Control data...............................................................................................................54
5.6.3 Inter-laboratory comparison.............................................................................................................54
5.6.3.1 Participation............................................................................................................................54

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5.6.3.2 Alternative approaches...........................................................................................................54
5.6.3.3 Analysis of Inter laboratory comparison samples..................................................................54
5.6.3.4 Evaluation of laboratory performance....................................................................................55
5.6.4 Comparability of examination results...............................................................................................55
5.7 Post-examination processes.................................................................................................................56
5.7.1 Review of results..............................................................................................................................56
5.7.2 Storage, retention and disposal of clinical samples..........................................................................56
5.8 Reporting of results..............................................................................................................................56
5.8.1 General..............................................................................................................................................56
5.8.2 Report attributes................................................................................................................................57
5.8.3 Report content...................................................................................................................................57
5.9 Release of results.................................................................................................................................58
5.9.1 General..............................................................................................................................................58
5.9.2 Automated selection and reporting of results...................................................................................59
5.9.3 Revised reports.................................................................................................................................59
5.10 Laboratory Information Management................................................................................................59
5.10.1 General............................................................................................................................................59
5.10.2 Authorities and responsibilities......................................................................................................60
5.10.3 Information System Management...................................................................................................60
Annexes.....................................................................................................................................................62
Annex-II: Document Retention time.........................................................................................................63

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REFERENCE............................................................................................................................................65
INTRODUCTION
Quality Policy Manual
This Quality Policy Manual may be cited as the MHLQuality Policy Manual. The QPM provides the
framework and guidelines for the Quality Management System (QMS) of the MH Laboratory.
During the preparation of this manual, reference was made to the standard, ISO 15189: 2012-Medical
Laboratories – Requirements for quality and competence. The process approach has been adopted to
fulfill the requirements of the aforementioned standard. The Laboratory Quality Management System
incorporates the interrelationship of its processes with those of other departments of the Hospital.
Purpose of the QPM
This QPM communicates policies, processes, and practices of MH laboratory. This manual has been
established to provide guidance to the laboratory and other stakeholders on the laboratory’s endeavors to
attain consistently accurate results, meet customer needs and expectations, and efficiently and
effectively execute its functions, which include:
a) Performance of a range of tests as required by the various units of MHL as well as public health
needs in the region.
b) Participation in research programs.
c) Investigations of Epidemics.
d) Supporting the work of nearby District Hospital Laboratories within the province

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e) In-Service training of laboratory personnel and hospital staff when necessary on relevant
programs and topics.
The QPM includes the history of the hospital and the scope of operations of the laboratory and the scope
of QMS. It also gives an overview of initiatives undertaken by MHL laboratory to meet the requirements
of the ISO 15189:2012 standard in a bid to consistently meet the requirements of its customers and
fulfill its stated mission and vision. The documented supporting procedures established for the QMS are
referenced in the QPM.
All laboratory personnel shall familiarize themselves with the documents, read, understand and apply
them.
Vision and Mission
Vision:
 “To be the premier and renowned laboratory in the country recognized international center of
excellence for its best patient-centered quality of laboratory service, teaching and health
research.”
Mission:
 “To protect and promote the health of the Community through addressing priority public
health problems and establishing and maintaining quality laboratory system”
Values & Beliefs
Values:
1. Respect the interest of client
2. Empower staffs
3. Appreciation, recognition and reward for best performers
4. Transparency and accountability
5. Efficient use of resources
6. Commitment to quality, equitable and proper health service
7. Partnership with all stakeholders

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8. Strong team sprit

9. Fast and immediate service
10. Confidentiality and patient privacy
11. Readiness for continuous change
12. Be gender sensitive
Beliefs:
1. Community first :
 We are here for nothing but to serve and satisfy our community.
 We treat them as we would like to be treated.
 We have three priorities: Community, Community, Community
2. Collaboration
 We work together in sprit of mutual support and understanding to achieve our collective
goals.
3. Commitments
 No matter what challenges we face and discomforts we feel, we stand firm, be patient and
exert our utmost and sustained effort to achieve our goals.
4. Change
 We innovate new ways of doing things and be open minded to reforms.
5. Trust
 Ensure maximum vulnerability and integrity to each other.
6. Continued Medical Education
 Capacitating all leaders at their respective levels
Operation Hours and Address
Operational Hours:
Working Time Working Days Weekends

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Day 2:01 Am to 11:00 Am local time 2:01 Am to 12:00 Am local time

Night 11:01 Am to 2:00 Am local time 12:01 Pm to 2:00 Am local time
Address: Meki Town Keble Oda
MHLaboratory
Meki- Oromia
Telephone: _______________________
Email___________________________
1. SCOPE
The scope of the Quality Management System described in this quality policy manual covers
processes of MHL Laboratory and its departments which are Hematology, Clinical Chemistry,
Bacteriology, Parasitology, Blood Bank, and Serology. The QMS is applicable to all
examinations carried out within the MHL laboratory. The documentation, implementation and
maintenance of the QMS in MHL laboratory are based on the framework (requirements)
provided by ISO 15189:2012 Standard.
The Laboratory is providing in-house and referral service for the following list of tests:
1. Hematology (both manual and automation)
 Automated CBC (complete blood count)

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 Manual (WBC, differential, blood morphology, ESR)

2. General Chemistry (LFT, RFT, Glucose, uric acid,)
3. Parasitology (Stool direct saline, blood film and Fecal Occult Blood test)
4. Urinalysis (chemical and sedimentation)
5. Serological tests (RPR, HCG, Widal & Weil flex, HBsAg, HCV, H.pylori, RF, ASO)
6. Bacteriology (Direct AFB Microscopy, MTB/RIF Assay (Gene X pert), TB Fluorescent
microscopy and Gram’s staining)
7. Immuno-hematology (Cross-match, Blood typing and CD4 enumeration)
8. Immunoassay(TFT, Cardiac Biomarker, Tumor Markers and Fertility test
9. Molecular Biology(Viral load & Early Infant Diagnosis DBS)
2. NORMATIVE REFERENCES
 ISO 15189:2012- Medical laboratories – Requirements for quality and competence.
 ISO/IEC 17000, Conformity assessment – Vocabulary and general principles.
 ISO/IEC 17025:2017, General requirements for the competence of testing and calibration
laboratories.
 ISO/IEC Guide 2, Standardization and related activities — General vocabulary
 ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and
associated terms (VIM).
 Clinical Laboratory Standard Institute (CLSI)
 WHO Laboratory Bio-safety Manual Third Edition 2004
 WHO Good Clinical Laboratory Practice (GCLP)
 ISO 19011: 2018(E) Guidelines for Auditing Management Systems
3. ABBREVIATIONS, TERMS AND DEFINITIONS
a. Abbreviations
• MHL: Meki Hospital Laboratory

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• SOPs: Standard Operating Procedures

• EQA: External Quality Assessment
• IQC: Internal Quality Control
• ISO : International Organization for Standardization
• QMS: Quality Management Systems
• LQMS: Laboratory Quality Management Systems
• TAT: Turnaround Time
• TFT: thyroid function test
• LFT: Liver function test
• RFT: Renal function test
b. Terms and Definitions
1. Accreditation: Procedure by which an authoritative body gives formal recognition that a body is
competent to carry out specific tasks.
2. Audit criteria: Set of policies, procedures or requirements.
3. Alert interval: Interval of examination results for an alert (critical) test that indicates an
immediate risk to the patient of injury or death.
4. Biological reference interval: Specified interval of the distribution of the values taken from a
biological reference population.
5. Calibration: The set of operations which establish, under specified conditions, the relationship
between values indicated by a measuring instrument or measuring system or values represented
by a material measure, and the corresponding known values of a reference standard.
6. Clinical decision value: A flag or warning, which indicates that it is time to take some action
(investigate, perform maintenance, etc.).
7. Competence: Demonstrated ability to apply knowledge and skill.
8. Continual Improvement: The measures taken to assess the effectiveness of the laboratory's
management system is improving by using the following activities: internal audits; management

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reviews; analysis of quality control data; corrective actions; preventive actions; the quality
policy; and the quality objectives.
9. Corrective action: Action taken to eliminate the root cause of an identified nonconformity or
other undesirable situation.
10. Customer: Clinicians and patients.
11. Equipment downtime: An interruption of testing services due to breakdown of equipment or
unavailability of reagents.
12. Examination Procedures: Activities and steps related to performing laboratory tests.
13. Inter-laboratory comparison: Organization, performance and evaluation of methods on the
same or similar items by two or more laboratories according to pre-determined conditions
14. External Quality Assessment: Participation of laboratories in a comparison program to assess
the quality of their performance by comparison of their results with other laboratories through
analyzing proficiency panels.
15. Laboratory Head: Person with responsibility for, and authority over a laboratory.
16. Lab Management: Person(s) who direct and manage the activities of a laboratory.
17. Non-Conformity: The non-fulfillment of a requirement.
18. Performance characteristics: These include consideration of: measurement trueness,
measurement accuracy, measurement precision including measurement repeatability and
measurement intermediate precision; measurement uncertainty, analytical specificity, including
interfering substances, analytical sensitivity, detection limit and quantization limit, measuring
interval, diagnostic specificity and diagnostic sensitivity.
19. Post-analytical phase: Processes that follow the examination, including: review of results,
retention and storage of clinical material, sample (and waste) disposal, formatting, releasing,
reporting and retention of examination result.
20. Pre-analytical phase: Processes that start, in chronological order, from the clinician’s request
and include: the examination request, preparation and identification of the patient, collection of

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the primary sample(s), transportation to and within the laboratory, and end when the analytical
examination begins.
21. Preventive action: Steps taken to eliminate the cause of a potential nonconformity or other
potentially undesirable situation to prevent occurrence.
22. Primary specimen: Discrete portion of a body fluid, breath, hair or tissue taken for examination,
study or analysis of one or more quantities or properties assumed to apply for the whole.
23. Process: A set of interrelated or interacting activities which transform input into outputs.
24. Quality: A degree to which a set of inherent characteristics fulfils requirements.
25. Quality Assurance: Part of quality management focused on providing confidence that quality
requirements will be fulfilled.
26. Quality Audit: A systematic, independent and documented process for obtaining objective
evidence and evaluating it to determine the extent to which the audit criteria are fulfilled.
27. Quality Control: The operational techniques and activities that are used to fulfil requirements
for quality.
28. Quality Indicator: Measure of the degree to which a set of inherent characteristics fulfils the
requirement.
29. Quality Management System: Management system to direct and control an organization with
regard to quality.
30. Quality Objective: Something sought or aimed for, related to quality.
31. Quality Officer: An individual with appropriate qualifications and experience approved by top
management and has overall responsibility of the Laboratory Quality Management System.
32. Quality Policy: Overall intentions and direction of an organization related to quality as formally
expressed and authorized by top management.
33. Record: Any information that produces evidence (e.g. requests, examination results and reports,
instrument printouts, laboratory workbooks and worksheets, accession records, calibration

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records, quality control records, audit records, complaints and action taken, external quality
assessment records and instrument maintenance).
34. Referral laboratory: external laboratory to which specimens are sent for examination.
35. Specification: Document that states the requirements to which the product, service, or test
method has to conform.
36. Standard Operating Procedures: Step by step description of the implementation of a policy
including responsibility, according to set requirements.
37. Support staff: Appropriately qualified or trained and experienced personnel responsible for non-
technical activities in the Laboratory.
38. Technical personnel: Appropriately qualified or trained and experienced technical personnel
responsible for the technical/testing activities in the laboratory.
39. Traceability: Ability to trace the history, application or location of an item, activity or result by
means of documented records.
40. Turn Around Time: The interval between specimen receipt by the laboratory personnel and
releasing of results.
41. Validation: The act of confirming that a product, service, or test method meets the requirements
for which it was intended.
42. Verification: Confirmation, though provision of objective evidence, that the requirements have
been fulfilled.

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4. MANAGEMENT REQUIREMENTS
4.1 Organization and Management Responsibility
4.1.1 Organization
4.1.1.1. General
MHL Management strives to implement the Laboratory Quality Management System in
accordance to the requirements of ISO 15189:2012 in all operations and services at MHL.
4.1.1.2. Legal Entity
 MHL laboratory is part of the hospital which is legally identifiable under the Federal Ministry of
Health (FMOH) and registered in Ethiopian Food, Medicine, and Health Care Administration and
Control Authority (FMHACA) of Ethiopia (Registration Number:----).
4.1.1.3 Ethical Conduct
 MHL laboratory is committed to the principles of openness, integrity, confidentiality and
accountability in its dealings with all its customers.
 MHL laboratory staff and its associates (i.e. technical assessors, contracted and subcontracted
specialists,) are required to observe the highest ethical standards when carrying out duties related
to MHL services.
 The laboratory is guided by its policies on impartiality and confidentiality as described in the
Confidentiality procedure. In addition to those policies, the laboratory has work ethics agreement
which pave way for the smooth and professional execution of work.
 All laboratory personnel are oriented on the ethical requirements as per the New Employee
Orientation Checklist.
 All staff sign work ethics declaration form MHL which is placed in personnel file
 MHL use specimen management manual and specimen management procedure to ensure that
staff treats human samples, tissues or remains according legal requirements.
4.1.1.4Laboratory Head
 The Laboratory Head is responsible for the following:

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a) Providing effective leadership of the medical laboratory service, including budget planning and
financial management, in accordance with institutional assignment of such responsibilities.
b) To relate and function effectively with applicable accrediting and regulatory agencies, appropriate
administrative officials, the healthcare community, and the patient population served, and
providers of formal agreements, when required.
c) Ensuring that there are appropriate numbers of staff with the required education, training and
competence to provide medical laboratory services that meet the needs and requirements of the
users.
d) Ensuring the implementation of the quality policy.
e) Implementing a safe laboratory environment in compliance with good practice and applicable
requirements.
f) Serving as a contributing member of the medical staff for those facilities served, if applicable and
appropriate.
g) Ensuring the provision of clinical advice with respect to the choice of examinations, use of the
service and interpretation of examination results.
h) Selecting and monitoring of laboratory suppliers.
i) Selecting referral laboratories and monitoring the quality of their service
j) Providing professional development programs for laboratory staff and opportunities to participate
in scientific and other activities of professional laboratory organizations
k) Defining, implementing and monitoring standards of performance and quality improvement of the
medical laboratory service or services.
l) Monitoring all work performed in the laboratory to determine that clinically relevant information
is being generated;
m) Addressing any complaint, request or suggestion from staff and/or users of laboratory services

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n) Designing and implementing contingency plans, which are periodically tested to ensure that
essential services are available during emergency situations or other conditions when laboratory
services are limited or unavailable.
o) Planning and directing research and development, where appropriate.
4.1.2 Management Responsibility
4.1.2.1 Management commitment
MHL Management is committed to the development, implementation and continual

improvement of its quality management system (QMS) and to continually improve its
effectiveness through:
 Providing awareness training and ensuring that all personnel appreciate the importance of meeting
regulatory, accreditation and user’s needs and requirements as per the procedure for Establishment
and review of service agreements.
 Defining all the goals and implementation strategies of the organization’s QMS in a Laboratory
quality policy manual that is fully understood by all personnel.
 Establishing and defining measurable quality objectives and their implementation plans to ensure
that the laboratory meets the customer’s needs and regulatory requirements.
 Defining and assigning responsibilities, authorities and interrelationships for all personnel as per
Personnel Management Procedure.
 Establishment of internal and external communication processes based on the procedure for
Communication.
 Appointment and training of a Quality Officer to manage the implementation of the laboratory’s
QMS.
 Planning, scheduling and holding Management Reviews to discuss all aspects of the QMS
according to the Management Review Procedure and ensuring that action items raised are assigned
to relevant personnel and action to meet the requirements of the set standards.

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 Performing competence assessments on all technical personnel to ensure competence in their

assigned activities as per Competency Assessment Procedure.
 Ensuring availability of all resources to enable personnel to provide uninterrupted service in all
three phases of the QMS namely pre-examination, examination and post-examination phases.
4.1.2.2Needs of users
 MHL Management regularly reviews the requirements of their customers through management
reviews, customer satisfaction surveys, review of customer and staff feedback and review of the
service agreements to ensure that all human and material resources are available to meet the
customers’ needs.
 All reviews are done as per procedures for management review, customer service, resolution of
complaints and feedback and establishment and review of service agreements.
4.1.2.3. Quality Policy
AUARTHL management is committed to the implementation and the maintenance of the
Laboratory Quality Management System objectives according to the requirements of ISO
15189:2012, national and international regulations, documented quality policies and procedures
that ensure the laboratory to be a center of excellence in laboratory testing service provision.
Quality Policy Statement:
 MHL’s main business is to provide medical laboratory examination services that are of high
international standards in line with principles of good professional laboratory practice. Laboratory
Management strives to produce accurate, reliable and timely results that are always generated in
accordance with stated procedures and customer requirements while complying with ISO
15189:2012 requirements. The Hospital Senior Management and Governing Board is committed
to the provision of adequate resources and monitoring the effectiveness of the QMS and ensures
all laboratory personnel are aware and dedicated to the provision of a quality service to all
customers.

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 In order to continue providing good leadership and full commitment to the improvement of the
LQMS, Laboratory Management is responsible for establishing & reviewing the quality policy
and objectives and conducting management reviews on annual basis as a minimum.
4.1.2.4. Quality objectives and planning
 MHL Management has developed measurable quality objectives that are reviewed against
performance goals during the scheduled management review meetings (Management Review
Procedure,) and are communicated to all personnel.
 The management has established the quality objectives to assure the customers of their
commitment to maintaining their QMS and its continual improvement. The objectives and
planning to achieve them are detailed on objectives and planning form Meki Hospital
 MHL Management is committed to ensure that the QMS quality plans for the achievement of
these objectives meet the customer requirements and ISO 15189:2012 guidelines. The change
processes are implemented in a manner that will not compromise these requirements and
guidelines.
4.1.2.5. Responsibility, authority and interrelationships

 MHL management has defined all personnel responsibilities, authorities and interrelationships
in an organ gram that includes deputies of key personnel.
 The Laboratory Head authorizes all personnel to perform relevant duties according to
documented in duty roasters and key tasks as defined in the Personnel Management Procedure.
 All duties are communicated to personnel in writing to ensure they are understood and
implemented according to the QMS requirements.
 Laboratory Management has also developed job descriptions for all personnel and the latter
attest to understanding their roles and responsibilities. The Laboratory Head’s responsibilities
are outlined in section 4.1.1.4 and the Quality Officer is stated in section 4.1.2.7 of this QPM.

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All other job descriptions are filed in the personnel folders and maintained by MHL
Management.
4.1.2.6. Communication
 MHL Management has established procedures for internal and external communication
procedures between laboratory personnel and their customers and other stakeholders
concerning quality issues such as customer complaints and feedback, staff concerns and
feedback and QMS improvement issues. The communication procedures include but it is not
limited to: verbal, electronic, memoranda, log books, meetings, training sessions, letters, and e-
mails and outlined in the Communication Procedure.
 Management has established the continuous reviews of the effectiveness of the communication
channels within the laboratory. To ensure that the laboratory personnel implement and
maintain an effective management system that exhibits staff ownership and the management is
committed to involving the staff as widely as possible in all development and maintenance
phases of the QMS.
4.1.2.7. Quality Officer
 The Quality Officer is appointed by the Medical Director and has access to the highest executive
level, heads the QMS activity, and has the following responsibilities:
a) Ensuring that processes and procedures needed for the QMS are established
according ISO 15189:2012 and are effectively implemented and maintained.
b) Reporting to the laboratory Head on the performance of the laboratory
quality management system and any need for improvement.
c) Maintenance of all QMS documentation.
d) Training of personnel on QMS including awareness training of non-
laboratory personnel.
Supporting Documents:

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S.No Document Title

.
1 SOP for Communication
2 SOP for Conducting Staff Meeting
3 SOP for Avoiding and Managing Conflict of Interest
4 SOP for Specimen Management
5 SOP for Ensuring Confidentiality of Information
6 Code of conduct form
4.2 Quality management system

4.2.1 General requirements
 MHL maintains a QMS whose policies and procedures are based on the ISO 15189:2012
guidelines and it integrates all processes required to fulfill MHL quality objectives and includes a
plan for continuous improvement to ensure customer satisfaction.
 MHL Management defines and implements the following:
a. Processes required for the implementation of the QMS at MHL.
b. The sequence and interaction of all the processes involved in the application of the QMS
through process mapping.
c. Documentation of standard operation procedures (SOPs) to ensure effective implementation
of all the processes approved by the Federal Ministry of Health (FMOH) for examination of
samples. Quality Control plans and procedures are also in place to assure the quality of
results generated and corrective and preventive action plans are used to mitigate non-
conformities.
d. The availability of resources required to support the laboratory’s operations and the quantities
that will prevent service interruptions.

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e. Internal and external audit schedules, plans and implementation to monitor and evaluate the
QMS process
f. Identification of non-conformities from audits and stakeholder feedback, troubleshooting and
corrective actions and implementation of continual improvement projects.
The management processes constitute some of the monitoring and evaluation processes needed to ensure
continual improvement of the quality management system while the support processes indicate the
resources needed to support the quality management system.

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Figure1. Quality management system process mapping

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4.2.2 Documentation requirements

4.2.2.1 General
 MHL QMS documentation comprises the following:
a) A Laboratory Vision, Mission Statement and Quality Objectives stated in sections4.1.2.3 and
4.1.2.4 of this QPM.
b) This Laboratory Quality Policy Manual which is the main quality document described in
section 4.2.2.2 below.
c) Standard Operating Procedures (SOPs) and records which are compliant with the
ISO15189:2012 standard.
d) Controlled documents and records that are developed by MHL management to ensure the
effective planning, operation and control of the laboratory’s QMS.
e) Reference to all regulations, standards and other normative references that are related to the
Laboratory QMS.
4.2.2.2 Quality Manual
 MHL Management developed and maintained a Laboratory Quality Policy Manual (QPM) that
outlines the following:
a) The laboratory’s Quality Policy Statements (section 4.1.2.3).
b) The MHL scope for the QMS.
c) The MHL organizational chart and management structure including the relationship between
the Hospital, which is the parent organization and the laboratory (Organizational Structure).
d) Job descriptions for key positions that ensure compliance to the QMS and ISO 15189:2012
Standard.
e) The structure and description of the documents that are used to fulfill the QMS, regulatory,
ISO 15189:2012 and other requirements. These documents are structured as shown in the
pyramid Figure 1below:

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Figure 1: Hierarchy of QMS Documentation

Note: - External documents of external origin adopted into the system to support polices
 The quality manager distributes copies of quality manual and supporting documents to
each section so that staff can have easy access. All staffs are trained on the use of quality
manual and supporting documents.
S.No. Document Title Document No.

1 SOP for Process Control/Mapping MHL/SOP

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4.3 Document Control

 In order for the processes and activities of the laboratory to be executed with consistency
regardless of who is performing work, MHL laboratory has a Document Control Procedure
(for both internal and external documents) that provides guidelines on how the laboratory
controls the development, review, approval, distribution, revision amendment and disposal of
the documents that make up its quality management system to ensure that the right sets of
documents are used by the staff members at the right times.
 All QMS documents are reviewed at least once every two years.

1 SOP for Document Control MHL/SOP
4.4 Service Agreements
4.4.1 Establishment of Service Agreements
 MHL has developed and implements a procedure for the Establishment and Review of Service
Agreements which outlines how the laboratory handles service agreements with their customers
which in this context is the laboratory request and service agreement form.
 MHL considers individual request as agreements, in this context the laboratory request form is
used to review the agreement.
 MHL also considers group requests e.g. from insurance companies, food handlers etc. as
agreements. In this context memorandum of understanding is entered into with the
representative of group clients.
 In order to meet the customer needs, the laboratory meets the following terms and conditions
when entering into a service agreement:

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a) The customers are provided with a Laboratory Handbook which defines all the examinations
and services provided by MHL to ensure that they meet the customer needs.
b) MHL Management ensures that they have the necessary resources to meet the customer’s
requirements and they have documented the management of resources in the Inventory
Management Procedure.
c) MHL employs qualified and competent personnel with relevant skills and expertise required
for requested examinations. Personnel are trained and assessed for competence as per
documented procedures (Competence Assessment Procedure).
d) The menu of examinations provided by MHL was selected and is reviewed to ensure that it
meets the need of the customers and guidelines are provided to the customers on the
biological references to ensure the correct intervention is made to the patient.
e) MHL Management informs their customers and staff in writing through memoranda when
deviations from the SOP occur that may impact the clinical diagnosis of the patient.
f) If MHL cannot perform a requested test, customer will be informed before the sample is sent
to a referral laboratory.
g) For program based laboratory services included in the national referral network, the national
referral linkage document can be considered as a service agreement.
4.4.2 Review of Service Agreements
 MHL Management reviews the service agreements to ensure they remain relevant to the
customer’s needs as per the Establishment and Review of Service Agreements.
 All changes to the agreement are communicated to the customer in writing including changes
made after the examinations have begun as per Communication Procedure.
S.No Document Title Document No.
.
1 SOP for Establishing and Reviewing of Service Agreement MHL/ SOP

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4.5 Examination by Referral Laboratories

4.5.1 Selecting and evaluating referral laboratories and consultants
 MHL is a government laboratory which uses a tier based referral system stated by the FMOH.
Therefore, MHL refers viral load samples to the regional laboratory.
 When there is temporary interruption for Chemistry, Hematology, CD4, and Genexpert MHL
refers samples to laboratories within the region.
 MHL send samples to regional laboratory and EPHI for further confirmation.
 MHL has a documented procedure for selection and evaluation of referral laboratories and
consultants, which gives detail on criteria for selection and monitoring performance of referral
laboratory.
 MHL maintains a list of approved referral laboratories and ensures their performances are
monitored every year.
4.5.2.Provision of examination results
 When samples are referred to another laboratory, the results report is issued out on the referral
laboratory’s report, the referral laboratories are responsible for reporting of patient’s results. If
MHL adds comments, this will be clearly shown to indicate that the results were generated
from another laboratory and reviewed.
 MHL ensures results are received with agreed TAT and forwarded to clients. A copy of results
is retained in MHL.
 If there is any problem with the result in terms of interpretation or cost, MHL resolves the
issues with referral laboratories without impacting patients cares.

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1 SOP for Selection, Evaluation and Monitoring Referral MHL/SOP
Laboratory and Consultants
4.6 External services and supplies

 MHL as part of the government laboratory is bound to using the established government supply
arrangements (EPSA).
 In case of out of stock at EPSA, private’s suppliers are also used. MHL defines specifications of
the required equipment/reagents and submit to Hospital management which advertises for
tender. The tender is awarded based on ability to meet required specifications with best price.
 MHL gives feedback to Hospital management on the quality of supplies received.
 MHL seeks calibration services for ancillary equipment from meteorological agencies that are
accredited or having systems fulfilling requirements of ISO 17025.
 The list of approved vendors (suppliers) is maintained and it contains the name of the supplier,
their contact details as well as the type of services they offer for future reference.
 A checklist to evaluate suppliers used to ensure compliance of the supplies received is in place.
S.No. Document Title
1 SOP for Selection and Purchasing of External Services and Equipment’s
2 SOP for Selection and Purchasing of Reagents and Consumable Supplies
3 SOP for Selection, Evaluation and Monitoring Suppliers
4.7 Advisory Services

 MHL authorized staff to provide advisory service according to qualifications and experiences
as shown in the matrix in table below:

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Type of
Technici
Technol
Cleaner
Lab aid
advice
clerk
ogist
MSc
Data
QM
LD
SO
SS
an
Choice of examination     X   X X X
Sample collection and        X X X
handling
Interpretation of result     X   X X X
Use of laboratory     X   X X X
Advise on individual     X   X X X
clinical cases
Advise on use of LIS        X  X
 MHL also distributes laboratory handbook to customers to provide advice on choice of

examination, use of services, type of samples required, sample collection and handling, repeat
frequency.
 The Laboratory staff participates in regular meetings with the clinical staff to provide an advice
in general or individual cases and also to discuss on the effectiveness of the services offered.

1 SOP for Advisory Service MHL/SOP-01
4.8. Resolution of complaints

 MHL has a procedure for the resolution of customer complaints (Customer Service, Management
of complaints and feedback) to ensure that all complaints are resolved satisfactorily and in a
timely manner.

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 All complaints, their investigations and customer feedback are recorded and reviewed for
effectiveness during Management Review Meetings (Management Review Procedure).
1 SOP for Management of Complaints MHL/SOP
4.9 Identification and control of non-conformities

 The MHL has procedure to identify and manage all nonconforming events in any aspect of the
quality management system.
 The laboratory uses management systems tools such as internal quality audits, laboratory
proficiency testing, management reviews, customer surveys, staff observations etc. to identify
non-conformities.
 It is the responsibility of all staff to identify the nonconformity and to take immediate action to
fixes the problem or mitigates the risk.
 Each episode of NC is documented on Non conformity and corrective action form, where
immediate action, root cause analysis and corrective actions are recorded.
 It is the responsibility of the QM to ensure all NC are resolved within agreed time frame.
 The QM makes use of the NC register to conduct trend analysis and identify the most
problematic areas which are then reported to Management review.
1 SOP for Management of Non-conformities MHL/SOP

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4.10. Corrective Action

 MHL laboratory is committed to:
a) Identifying and reviewing nonconformities
b) Going beyond addressing the symptoms of the problems by establishing the root cause in
order to ensure that such problems do not recur.
c) Employing appropriate analysis techniques for example fishbone, (5-Why’s) to investigate.
d) Using the appropriate root-cause analysis tool to identify potential corrective actions and
the most suitable solution to be implemented.
e) Recording of actions taken to maintain the implemented corrective action
f) Monitor to ensure effectiveness (Management of Non-conformities, preventive action and
continual improvement).
 All the above activities are recorded on non-conformity and corrective action form.
1 SOP for Management of Non-conformities MHL /SOP
2 SOP for Preventive Action MHL /SOP
4.11 Preventive Action

 MHL has a procedure for preventive action which guides staff to be proactive in identification
of potential non conformities.
 Preventive actions are identified through reviewing of laboratory data such as temperature
monitoring, QC, EQA, review of procedures etc.
 When a potential non conformity is identified the following will be done:
a) Determine root cause of potential non conformity

b) Evaluating the need of preventive action

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c) Implementing the preventive action

d) Reviewing the effectiveness of preventive action
 The above actions (a-d) are recorded on potential non conformity preventive action form
.
1 SOP for Preventive Action MHL/ALS/SOP
2 SOP for Risk Management MHL/SOP
4.12 Continual Improvement
 MHL laboratory continuously improves the effectiveness of its quality management system
through the use of PDCA methodology applied to all procedures and processes in the laboratory.
Analysis of data is used to identify opportunities for improvement or potential sources of system
weakness or non-conformity. These data are obtained from many sources including EQA,
Internal and External Audits, Management Reviews, Customer satisfaction surveys and feedback,
IQC, Inter-laboratory comparison, staff Competency Assessment, Staff Orientation, and Quality
Indicators. The identified opportunities for improvement are used to develop improvement plans
and projects.
 The effectiveness of the implemented plans or projects is reviewed, monitored or checked
through the use of Quality Indicators. Based on information obtained through analysis of these
quality measures, the plans/projects are adjusted or modified.
 The QM identifies improvement projects based on analysis of data for continuous
improvement activities mentioned above and assign individual to conduct PDSA.
1 SOP for Continual Improvement MHL/SOP

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4.13 Control of records

 As an indication of the results achieved during execution of its processes and activities, a
number of records are produced at different functions and levels within the laboratory. These
records provide critical information for the efficient and effective implementation of the
Quality Management System.
 MHL laboratory therefore ensures that necessary records are created in the execution of its
QMS and that once developed, the records are appropriately managed to facilitate their
identification, storage, retrieval, retention for the right lengths of time and disposal (Control of
Records Procedure).
 Records retention period are defined on record retention (Annex-II)
 The management ensures that all records made available for discussion in Management review.
 Supporting Documents:
.
1 SOP for Control of Records MHL/OP
4.14 Evaluation and Audits
4.14.1 General
 At least annually, MHL conducts internal audits and evaluate all activities to verify that:
a) The pre-examination, examination and post-examination and supporting processes
continue to comply with the requirements of this QMS, ISO 15189:2012 and users.
b) There is conformity to the QMS
c) There is continual improvement to the effectiveness of the QMS.

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4.14.2 Periodic Review of Requests, and Suitability of Procedures and Sample Requirements
 The Laboratory Handbook and all sample examination procedures are reviewed by MHL
Management at least every year or as needed to verify that the examinations being offered are
still appropriate for clinical needs.
 Quality Officer is required to compile statistics of request received during the year to identify
the most requested test, test requested but not provided and test offered but not requested.
This information is used during management review discussions to shift resources where they
are needed most
 Test statistics form used to capture statistics.
4.14.3 Assessment of user feedback
 MHL Management requests feedback from all their stakeholders for use in evaluating MHL’s
performance in relation to customer needs. The feedback is collected through customer
survey (bi-annually), suggestion box/ book (every two week).
 Customer feedback and the records of the communication are maintained as confidential and
customers have the option to give feedback anonymously.
 QM compiles reports on feedback received. The reports are discussed on staff meeting and
action plan is developed.
4.14.4 Staff suggestions
 MHL Management encourages staff to give feedback on any quality issues or operational
issues that may affect the patient results. Feedback is collected during regular scheduled staff
meetings, face to face discussion with management or through use of the suggestion box
(Customer satisfaction survey and management of complaints Procedure).
 Suggestions are implemented as continual improvement projects and all actions and results are
recorded and feedback provided to staff (Management of nonconformities, preventive action
and continual improvement procedures).

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4.14.5 Internal audit

 MHL has an Internal Audit procedure which describes how the laboratory performs scheduled
periodic audits to ensure compliance to the ISO 15189:2012 and the documented QMS
procedures. Trained and competent internal auditors carry out the audits as per schedule and
procedure, which ensures that all QMS elements are audited at least once every year.
 Corrective and preventive actions are carried out for all non-conformities raised and all actions
are recorded and monitored for effectiveness as per Management of Nonconformities,
preventive action and continual improvement procedures.
4.14.6 Risk Management
 MHL Management evaluates all activities and work processes in the laboratory to determine
their impact on patient results and safety. Management also identified potential risks and
failures, assessed their severity and impact and developed mitigation strategies and actions to be
implemented in the event of any of the risks occurring. The management of these risks is
outlined in the Risk Management Procedure.
4.14.7 Quality Indicators
 MHL Management established key quality indicators for all phases of the QMS, pre-
examination, examination and post-examination, to monitor and evaluate the performance of the
personnel and equipment, and/or methods used.
 The identified quality indicators are monitored and analyzed monthly to compare statistically
against set limits.
 Any indicator that falls outside the set limits is investigated, corrective and preventive actions
implemented and all actions documented as per Management of Non-conformities, preventive
action and continual improvement.
 The collected data is analyzed for effectiveness and also for identification of continual
improvement projects at the Management Review meetings (Management Review Procedure).

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 Planning of QIs includes defining objectives, methodology, duration, action threshold, and
interpretation and action plan. A Quality indicator planning form is in place.
 The laboratory management, in consultation with the users, establishes and evaluates turnaround
times for each of its examinations that reflect clinical needs.
4.14.8 Reviews by external organizations
 MHL is evaluated by various external organizations such as external auditors, donor agencies
EFDA, EPHI, FMOH and other stakeholders.
 When these evaluators identify nonconformities or potential non-conformities that may
indicate non-compliance to the ISO 15189:2012 and other standards, the laboratory analyses
them, determine appropriate corrective and preventive actions, assign responsibilities for the
actions and evaluate effectiveness.
 All corrective actions are handled as per Management of Non-conformities, preventive action
and continual improvement and reviewed at the Management Review meetings (Management
Review Procedure).
1 SOP for Customer Satisfaction Survey MHL/SOP-01
2 SOP for Internal Audit MHL/SOP-02
3 SOP for Establishment and Monitoring of Quality MHL/SOP-01
Indicators
4 SOP for Risk Management MHL/SOP-01
5 Periodic Review of request, suitability of procedures MHL /CL-01
and sample requirements monitoring checklist

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4.15 Management Review

4.15.1 General
 At least annually, MHL Management and the Hospital Management Team review the QMS and
all its medical services, including examination and other activities to assess if it continues to be
suitable and effective in achieving the laboratory objectives and complying with ISO
15189:2012 as per Management Review Procedure. The laboratory management at its discretion
may invite other relevant stakeholders to be part of these reviews.
4.15.2 Review input
 The input to management review(annual laboratory quality management system implementation
report) include information from the results of evaluations of at least the following:
a) The periodic review of requests, and suitability of procedures and sample requirements.
b) Assessments of user feedback.
c) Staff suggestions.
d) Internal audits.
e) Risk management.
f) Use of quality indicators.
g) Reviews by external organizations.
h) Results of participation in Inter-laboratory comparison programmes (PT/EQA).
i) Monitoring and resolution of complaints.
j) Performance of suppliers.
k) Identification and control of nonconformities.
l) Results of continual improvement including current status of corrective actions and
preventive actions.
m) Follow-up actions from previous management reviews.
n) Changes in the volume and scope of work, personnel, and premises that could affect the
quality management system.

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o) Recommendations for improvement, including technical requirements.
4.15.3 Review activities

The Management Review involves the analyses of the input information to identify any causes of
non-conformities, trends and patterns that are an indication of problems or potential problems
with the QMS. The non-conformities are used as opportunities to develop continual
improvement projects that may include changes to the QMS, Quality policy and quality
objectives (Management Review Procedure).
4.15.4 Review output
 The output form the Management Review is tabulated in an action table that lists decisions
reached, identified actions, assigned responsibilities and timelines. The decisions and actions
from the review are in relation to:
a) Improvement of the effectiveness of the QMS and its processes and procedures.
b) Improvement of services to users.
c) Resources needed to effectively comply with the QMS.
 All decisions reached, findings and ensuing actions are communicated to laboratory personnel
during the monthly QMS meetings and all actions are completed effectively within the set
timeframe.
 At least two members of Laboratory management set every quarter to review progress on
agreed action item.
1 SOP for Management Review MHL/SOP

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5. TECHNICAL REQUIREMENTS
5.1 Personnel
5.1.1 General
 MHL Management has defined an orientation, and training plan for personnel management to
ensure that performance and competence are compliant with the ISO 15189:2012 and regulatory
requirements as defined in the Personnel Management, Personnel Training, and Competency
Assessment Procedure.
5.1.2 Personnel qualifications
 MHL employs only qualified staffs who are registered with EFDA to perform tests, evaluate
results and sign test reports. MHL Management maintains records of all qualifications,
orientations, trainings, assessments, work experience and skills in personnel folders as described
in the Personnel Management Procedure.
5.1.3 Job descriptions
 MHL Management maintains job descriptions that describe responsibilities, authorities and
tasks for all personnel in the personnel folders. All personnel attest to understanding their roles
by signing on the job description as per Personnel Management Procedure.
5.1.4 Personnel introduction to the organizational environment
 All personnel new to MHL undergo an introduction and orientation process before commencing
their employment tenure at MHL and before training in respective departments described in the
Personnel Training Procedure. The orientation includes an awareness of the terms and
conditions of employment, employee facilities, occupational health services and health and
safety requirements, e.g. vaccinations, fire and emergency preparedness.
5.1.5. Training
MHL has a training program for all personnel as outlined in the Personnel Training and Competence
Assessment Procedures. The training includes:
a) QMS awareness

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b) Assigned work processes and technical procedures.

c) The Laboratory Information Management System
d) Health and safety
e) Ethics and confidentiality
 All trainees are supervised until they are deemed competent and MHL Management evaluates
the effectiveness of the training program to ensure only competent personnel are performing the
examinations and releasing results.
5.1.6 Competency assessment
 All laboratory staff undergo competence assessments for the examination procedures they
perform according to the Personnel Training and Competency Assessment Procedures.
 New personnel are assessed after the deemed training period is complete and if they are deemed
competent they are re-assessed after one year and thereafter at least every two years using
various assessment tools such as direct observation, EQA performance or examination of
previously examined samples with known results.
5.1.7 Reviews of staff performance
 All MHL technical and managerial personnel develop personnel development plans at the
beginning of each calendar year and agree with their Laboratory Head on targets to be met. At the
end of the year these Personal Development plans are used to assess performance of personnel
and to determine continual improvement opportunities.
5.1.8 Continuing education and professional Development
 All technical and managerial personnel at MHL take part in continuing education programs that
include workshops, in-house training, external meetings, conference and further academic
educational courses. All the knowledge and skills acquired is documented on the Personnel
Training Record Form which is used to review the effectiveness of the continuing education.
5.1.9 Personnel Records

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 MHL Management maintains records of all personnel in personnel folders and the contents
include relevant educational and professional qualifications, experience, competence assessments
and health and safety records as specified in the Personnel Management Procedure.
.
1 SOP for Personnel Management MHL/SOP
2 SOP for Training MHL /SOP
3 SOP for Competency Assessment MHL /SOP
5.2. Accommodation and environmental conditions
5.2.1 General
 MHL Management evaluates the laboratory space and developed a layout that provides adequate
space for performance of their duties in a safe environment which does not present a hazard to
staff, visitors and the environment.
 The layout is reviewed when new methods or equipment are introduced to ensure maintenance of
the safe environment.
5.2.2. Laboratory and office facilities
MHL has adequate laboratory and office space that meet the requirements of ISO 15189:2012 and
ensure the following:
a. Access to the examination areas is controlled. This ensures patient samples, laboratory resources
and medical information is safeguarded from unauthorized access.
b. Safety and warning signage is appropriately placed.
c. Examination department allow for correct performance of examinations with adequate
environmental conditions such as ventilation, lighting, power and low noise.
d. Staff communicates effectively with each other through telephone, email and notice board
memos.

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e. Waste disposal bins and sharp containers are also available for safe disposable of solid waste
while designated drainage system is used for disposing liquid waste.
f. Fire extinguishers, fire alarm, eye wash, emergency shower, first aid kits and spill kits are
provided.
g. The above Safety equipment are verified for functioning as per checklist attached to them
 Backup generator and water reservoir are available in case of any interruptions.
5.2.3. Storage facilities
 MHL has adequate storage facilities that allow the maintenance of the integrity of sample s,
documents, records, reagents, equipment, patient results and other items that may affect the
quality of results as described in the Monitoring Environmental Conditions Procedure.
 Samples are stored separately from each other and from reagents and other products to prevent
cross contamination.
 Infectious and no-infectious waste is isolated and disposed of as specified in the Waste
Management Procedure.
5.2.4 Staff facilities
 MHL has separate rooms for staff conferences outside examination areas. Personal lockers,
washroom, adequate water supply are also available. All personnel are provided with personal
protective equipment (PPE).
5.2.5 Patient sample collection facilities
 MHL have separate reception and collection areas from other testing area and collects patient
samples and receive samples in already in designated containers from the various sending
sites. MHL provides guidelines for sample collection in the form of the Laboratory Hand book
and also carry out regular training of staff at the sites to ensure the correct samples received at
the laboratory.
 Enough privacy in sample collection room and also there is waiting area for people
accompanying the patients.

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 First aid kit is available at collection area.

5.2.6 Facility maintenance and environmental conditions
 MHL maintains a clutter-free, clean and safe environment. The laboratory personnel monitor
the environment daily or as required and described in the Monitoring Environmental
Conditions Procedure. Examination areas are separated from storage areas to prevent accidents
due to incompatible processes being carried out in close proximity.
 All environmental conditions that are monitored are recorded and reviewed regularly by
laboratory management.
 Regular and comprehensive laboratory safety audits are performed to evaluate the laboratory's
conformance to the Laboratory Safety Manual (MHL /-01), the National policy on Laboratory
safety and ISO 15190 standards.
1 Laboratory Safety Manual MHL/SMN
2 SOP for Environmental Monitoring MHL/ SOP
3 SOP for Waste Management MHL/ SOP
4 SOP for Post Exposure Prophylaxis (PEP) MHL/ /SOP
5 SOP for prevention of cross-contamination MHL/ SOP-01
5.3 Laboratory equipment, reagents and consumables

5.3.1 Equipment
5.3.1.1 General
 MHL has procedures for the Management and Calibration of equipment. However, all
equipment is purchased by the EPSA and the laboratory’s role is to provide statistics on the
workload in order to guide EPSA on the relevant throughput required in the equipment of
choice and specification.

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5.3.1.2 Equipment acceptance testing

 MHL Management verifies all equipment received at the laboratory regardless of whether it is
an outright purchase or on loan, to ensure that the equipment meets the specific requirements
in performance for the examination concerned. Equipment is verified as per
Equipment/Method Verification Procedure.
5.3.1.3 Equipment instructions for use
 Only trained and authorized personnel operate MHL equipment according to current versions
of documented operation manuals and procedures. MHL also has procedure for equipment
management to prevent deterioration, contamination or compromising the quality of results.
5.3.1.4 Equipment calibration and metrological traceability
 MHL has a procedure for equipment management and calibration, which describes need for
the calibration and preventive maintenance according to the manufacturer’s instructions.
 All calibrations of ancillary equipment are subcontracted to an external service provider who is
either accredited or with evidence of fulfilling requirements of ISO 17025, ensuring there is
traceability of reference material is used.
 Assay calibration of diagnostic equipment is either done by engineers during schedule service
or by technical staff as needed. Procedure for calibration is stated in respective technical
procedure and equipment manual. The laboratory keeps leaflet for calibrators to keep track of
factors used
5.3.1.5 Equipment maintenance and repair
 MHL maintains all their equipment in safe working order in order to prevent damage and
contamination. The laboratory has Equipment management procedure for scheduling of service
of equipment and all work done on the equipment by the service engineer is documented as per
Equipment calibration and management procedures. Defective equipment is put out of use
until repairs are done while obsolete equipment is decontaminated and disposed of as per

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FMOH policy. All equipment that is loaned out is verified on return before being put back into
use.
5.3.1.6 Equipment adverse incident reporting
 In the event of an adverse incident occurring, MHL Management investigates the cause of the
occurrence and notifies the manufacturer or local supplier/agent. All incidents are recorded.
5.3.1.7 Equipment records
 MHL maintains records for each specific equipment for the full life span of the equipment as
specified. The records include the details such as:
a) Equipment make, model and unique identification.
b) Contact details of supplier and service engineer
c) Status of equipment on receipt, verification results and analysis
d) All service and repair reports for work done during its lifetime including calibration
certificates.
e) All equipment records are stored and maintained as described in the Control of Records
Procedure.
5.3.2 Reagents and Consumables
5.3.2.1 General
 MHL receives reagents and consumables from the EPSA warehouse and the laboratory has
described the reception, storage, acceptance testing, and inventory management in the
procedures for Reagent and consumable supplies Management.
5.2.3.2 Reception and storage
 MHL stores received reagents and consumables according to manufacturer’s specifications as
stated in the Reagent and consumable supplies Management Procedure. The items are stored in
temperature monitored store rooms, refrigerators and cold rooms to prevent damage and
deterioration.

Page: 50 of 68
5.2.3.3 Acceptance testing

 On receipt of reagents and consumables MHL verifies the kits to ensure that the laboratory
does not accept compromised materials which may affect the quality of examination. The
reagents are verified as per the Reagent and consumable supplies Management Procedure.
5.3.2.4 Reagents and consumables — Inventory management
 The laboratory has a procedure on Reagent and consumable supplies Management. The
laboratory ensures that uninspected and unacceptable reagents and consumables are kept
separate from those that have been accepted for use. Expired reagents or supplies are disposed
following documented procedure.
5.3.2.5 Instructions for use
 All reagents are received with supporting documentation with instructions for handling and
use. The information is included in the relevant SOPs and the manufacturer’s documents are
maintained and controlled as source documents.
5.3.2.6 Adverse Incident reporting
 In the event of an adverse incident MHL management will investigate and notify the
manufacturer or supplier. The incident may be failure of examinations due to reagents and
consumables being compromised or it may be a safety related incident. MHL Management
will record the incident as per Reagent and consumable supplies Management Procedure if the
incident is caused by compromised reagents. The occurrence is recorded as per Management
of Non-Conformities, preventive action and continual improvement.
5.3.2.7 Records
 MHL maintains records for all reagents and consumables as per Control of Records Procedure.
The records include but are not limited to:
a) Identity of the reagent or consumable
b) Manufacturer’s name and contact, lot number, Batch number.

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c) Status of reagent or consumable on receipt, e.g. expiry, receipt, verification

and in-use dates.
d) Manufacturer’s instructions and safety data sheets
e) Results of lot verification.
f) Name of technical person who prepared reagents where applicable.
S.No Document Title Document ID
.
1 SOP for Equipment Management AUARTHL/ALS/SOP
2 SOP for Equipment Calibration AUARTHL/ALS/SOP
3 SOP for Reagent and consumable supplies AUARTHL/ALS/SOP
Management
5.4 Pre-examination processes
5.4.1 General
 MHL has documented all pre-examination activities in Laboratory Handbook, Specimen
Management Manual and Specimen management procedure.
5.4.2 Information for patients and users
 MHL Laboratory Handbook and the Specimen Management Manual provide customers and
other stakeholders with all the details of the operations and services provided by the
laboratory.
 MHL Management also authorizes technical staff to provide information and advice to
customers on request and all communication is documented as described the laboratory’s
Communication and Advisory Service Procedure.

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5.4.3 Request Form Information

 MHL developed the Laboratory Request Form after discussion with the Clinicians and also
consulting with the ISO 15189:2012 standard to ensure that the form enables adequate data to
be collected to assist in decision making when carrying out examinations and also to ensure
that the format complies with the standard. Information on completion of the form is provided
in Laboratory Handbook.
 MHL Management included the handling of verbal requests in the Laboratory Handbook and
Specimen management Procedure in the event that a customer requests for services verbally.
5.4.4 Primary sample collection
5.4.4.1 General
 MHL collect samples in any form and provides the customers with the Laboratory Handbook
and Specimen Management Manual which gives instructions for the correct methods for
collection of samples. Authorized laboratory technical personnel also provide guidance when
requested by customers.
5.4.4.2 Instructions for pre-collection activities
 The Laboratory Handbook and Specimen Management Manual provide guidance to site
personnel on pre-collection activities.
5.4.4.3 Instructions for collection activities
 The Laboratory Handbook and Specimen Management Manual provide guidance to site
personnel on collection activities.
5.4.5 Sample Transportation
 The MHL Laboratory Handbook and Specimen Management Manual provides instructions for
post-collection activities that include sample packaging for transportation and monitoring to
ensure that they are transported:
a) Within a time frame appropriate to the nature of the requested examinations and the
laboratory discipline concerned.

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b) Within a temperature interval specified for sample collection and handling and with
the designated preservatives to ensure the integrity of samples.
c) In a manner that ensures the integrity of the sample and the safety for the carrier, the
general public and the receiving laboratory in compliance with established
requirements.
 In the event that the sample arrives at the MHL sample reception in a compromised state, the
laboratory personnel will immediately notify the sender and reject the sample giving reasons
for the rejection. A fresh sample may be requested if applicable as per Sample Management
Manual.
5.4.6 Sample Reception
 Patient samples are traceable, by use of the laboratory number which is assigned at the reception.
Patient samples without identification are not accepted or processed by the laboratory, in
compliance with the criteria for sample acceptance and rejection.
 All patient samples are registered at the reception in specimen log book, worksheet, and
computer/LIS, capturing the date and time of receipt of samples, and the identity of the person
receiving the samples.
 MHL has put in place a criterion for sample acceptance and rejection. The rejection criteria take
into account irreplaceable samples like cerebrospinal fluid or samples from neonates.(refer to
laboratory handbook)
 It is a policy of MHL to prioritize urgent samples. Once processed, results of urgent samples are
immediately communicated to the requesting clinician/facility.(refer to laboratory handbook)
 Whenever a sample has to be split for different tests, sample portions/aliquots are labeled with
the original sample identification number for easy traceability.
 AUARTHL accepts verbal requests for additional test/s on already submitted samples. This is
done according to procedure for sample management..(refer to laboratory handbook)

Page: 54 of 68
5.4.7Pre-examination handling, preparation and storage

 On receipt of a sample at the laboratory sample reception, the laboratory personnel will secure it
to avoid deterioration, loss or damage by following the instructions described in the Sample
Management Manual for the handling, preparation and storage of the sample prior to
examination.
.
1 Laboratory Handbook AUARTHL/ALS/MN
2 Specimen Management Manual AUARTHL/ALS/MN
3 SOP for Verbal Request MHL/SOP
4 SOP for Urgent Specimen Processing MHL/SOP
5.5 Examination processes
5.5.1 Selection, verification and validation of examination procedures
5.5.1.1 General
 MHL does not select examination methods since the procedures used in the state facilities in
Ethiopia are decided at FMOH level. The methods in use are those that have already been
validated at manufacturer level so MHL only performs method verification to ensure that their
method, equipment and personnel are performing in compliance with the specified standards as
per Equipment/Method Verification Procedure. Other sources of methods used are textbooks,
peer-reviewed texts or journals or in international consensus standards or guidelines, or national
or regional guidelines.
5.5.1.2 Verification of examination procedures
 The methods used at MHL are adopted at national level so they are used without modification;
therefore the laboratory acquires the values, limits or ranges from manufacturer’s performance

Page: 55 of 68
claims and performs verification according to the Equipment/Method and Verification

Procedure.
 The laboratory technical personnel document their verification performance and record the
results obtained, then they are reviewed by laboratory management. Examination of patient
samples will begin when the results have been verified as being within the manufacturer’s
claims.
5.5.1.3 Validation of examination procedures
 MHL does not use any non-standard methods, nor does it design, develop or modify any
methods. Therefore MHL does not perform any validation of methods.
5.5.1.4 Measurement of uncertainty of measured quantity values
 MHL determines the uncertainty of measurement for all quantitative procedures in the
examination phase during which quantity values on patient samples are used to report the
measured quantity values according to the Uncertainty of Measurement Procedure. MHL
Management regularly reviews the estimates of the measurement uncertainty.
 MHL Management will provide estimates of uncertainty of measurement to their clients on
request.
5.5.2 Biological reference intervals or clinical decision values
 MTHL uses biological references from published textbooks which were generally approved by
the clinicians. No verification study of these values has been done in the laboratory. Changes are
only made when consultation with the clinicians has been done and a consensus has been
reached based on clinical significance of the values.
5.5.3 Documentation of examination procedures
 MHL has documented all examination procedures used in its different sections and available at
each work station. Job aids used for quick reference at some work stations have ID numbers
which correspond to a documented procedure. All examination procedures and job aids are
controlled according to document control procedure.

Page: 56 of 68
 All examination procedures are written in standard format as defined in document control
procedure. If MHL intends to change any examination procedures such that results or their
interpretations could be significantly different, the implications are explained to clinicians and
health facilities before putting new procedure in service.
1 SOP for Clinical Chemistry MHL/CHES/SOP
2 SOP for Hematology MHL/HEMS/SOP
3 SOP for Serology MHL/SERS/SOP
4 SOP for Urinalysis MHL/URIS/SOP
5 SOP for Microbiology MHL/MICS/SOP
6 SOP for Immunohematology MHL/IMHS/SOP
7 SOP for Parasitology MHL/PARS/SOP
8 SOP for Molecular MHL/MOL/SOP
9 SOP for Quantitative Method/Equipment MHL/ALS/SOP
Verification
10 SOP for Qualitative Method/Equipment HL/ALS/SOP
Verification
11 SOP for Measurement Uncertainty MHL/ALS/SOP
5.6 Ensuring quality of examination results
5.6.1 General
 MHL Management has defined the conditions in which examinations are performed from sample
reception to the release of quality results. Appropriate pre- and post-examination processes are
implemented as defined in sections 4.14.7, 5.4, 5.7 and 5.8 of this manual. MHL does not
fabricate any results.

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5.6.2 Quality control

5.6.2.1 General
 MHL has developed the Internal Quality Control Procedure and it is implemented in all
examinations to verify that the laboratory attains the intended results.
5.6.2.2Quality Control materials
 MHL utilizes quality control materials that react to the examining system in a manner as close as
possible to patient samples. Generally MHL uses commercial controls supplied by the equipment
or reagent kit manufacturer but selected patient controls are also examined as described in the
Internal Quality Control Procedure.
 The frequency of examining quality control materials is defined in each technical standard
operating procedure and is based on stability of the procedure and risk of harm to the patients
from erroneous results.
5.6.2.3 Quality Control data
 MHL only examines patient samples when the daily internal quality control (IQC) has been
examined, the data analyzed and found to be within acceptable limits. The Internal Quality
Control Procedure defines the rules to be observed and the criteria to use to determine if the IQC
has passed or not. If the IQC is outside acceptable limits, an investigation is initiated and the root
cause identified and corrected before proceeding with examinations of patient samples.
 All data and investigations are reviewed by laboratory management daily to ensure detection of
trends in real time.
5.6.3 Inter-laboratory comparison
5.6.3.1 Participation
 MHL participates in external quality assessment (EQA) for its examination methods
according to schedules provided by EQA bodies. The Quality Manager ensures that technical
staff who run the EQA samples review feedback and implement corrective actions when
results are unacceptable.

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 Procedure for participation in EQA has been developed which defines instructions for
participation and review of the performance. The EQA programs are adequate to check the
entire examination process including pre-examination, examination and post-examination
process in a manner that resembles as close as possible to patient samples.
5.6.3.2 Alternative approaches
 For the examination procedures that have no EQA program, MHL shares samples with other
FMOH facilities in the region and compare the results. Acceptable limits are sourced from
agreed sources such as CLIA.
5.6.3.3 Analysis of Interlaboratory comparison samples
 MHL analyses Interlaboratory comparison examinations as closely as possible to the routine
patient samples and the examinations are performed by the same technical personnel who
examine the routine patient samples. MHL does not discuss, compare their results with or send
for confirmation to other participating laboratories before submission of results.
5.6.3.4 Evaluation of laboratory performance
 The Quality Officer and technical staff who run the EQA samples are responsible for
reviewing feedback and implement corrective actions when results are unacceptable.
 Quality Officer monitors the effectiveness of corrective action taken by ensuring that
subsequent internal quality control and EQA are within acceptable limits.
 The quality officer compiles annual report on performance in EQA which is used as
preventive actions to detect trends. The reports are presented and discussed in management
reviews.
5.6.4 Comparability of examination results
 MHL performs a comparison of procedures, equipment and methods used for patient sample
examinations and establish the comparability of results for patient samples throughout the
clinically appropriate intervals according to the Equipment/Method and Verification Procedure.

Page: 59 of 68
 If there are any differences in comparability of results MHL Management notifies the users and
discusses any implications for clinical practice when measuring systems provide different
measurement intervals for the same measured and when examination methods change.
Appropriate corrective action is implemented for identified problems and all actions are
recorded.
1 SOP for Internal Quality Control Testing MHL/ALS/SOP-01
2 SOP for Inter Laboratory Comparison MHL/ALS/SOP
3 SOP for Comparability of Examination of Results MHL/ALS/SOP
5.7 Post-examination processes

5.7.1 Review of results
 Only authorized personnel review and release results at MHL as described in the management of
patient report Procedures. The reviewers ensure that there are no transcription errors, missing
results and they evaluate the results against IQC, available clinical information and previous
results where applicable.
 The laboratory information system used by MHL does not automatically select and report
results.
5.7.2 Storage, retention and disposal of clinical samples
 MHL implements the identification, collection, indexing, access, storage, maintenance and safe
disposal of clinical samples, according to the Specimen Management Manual.
 The manual also defines the retention times for samples and storage conditions after testing of
the samples based on the nature of the sample, the examination and any applicable requirements
and also the disposal as per FMOH policy.

Page: 60 of 68

1 SOP for Management of Patient MHL/ALS/SOP
Report
5.8 Reporting of results
5.8.1 General
 MHL’s result reporting format ensures that results of each examination are reported accurately,
clearly, unambiguously and in accordance with any specific instructions in the examination
procedures.
 All results are issued out on paper and are signed off by the tester and an authorized reviewer
who cross-checks the result report and the results captured in the results register to avoid any
transcription errors as described in the management of patient report Procedures.
 Reports are released with reference ranges, in SI unit, with clinic history of patient and
accompanied by any relevant comments on integrity of sample. This ensures correct
interpretation of laboratory results. Reception staff or laboratory head notifies clinics, health
facilities and patients of any delay in processing sample that could compromise patient care.
5.8.2 Report attributes
 To ensure that the MHL result report communicates laboratory results and meets the users’
needs the following attributes are included in the report:
a) Comments on sample quality that might compromise examination results.
b) Comments regarding sample suitability, with respect to acceptance/rejection criteria.
c) Critical results where applicable.
d) Interpretive comments on results, where applicable.
5.8.3 Report content
 MHL ensures that the result report includes but not limited to the following:
a) A clear, unambiguous identification of the examination including, where appropriate the
examination procedure.

Page: 61 of 68
b) The identification of the laboratory that issued the report.

c) Identification of all examinations that have been performed by a referral laboratory.
d) Patient identification and patient location on each page.
e) Name or other unique identifier of the requester and the requester’s contact details
f) Date of primary sample collection and time where relevant.
g) Type of primary sample.
h) Measurement procedure, where appropriate.
i) Examination results reported in SI units, units traceable to SI units, or other applicable
units.
j) Biological reference intervals, clinical decision values, or diagrams/monograms
supporting clinical decision values, where applicable.
k) Interpretation of results, where appropriate.
l) Other comments such as cautionary or explanatory notes.
m) Identification of examinations undertaken as part of research or development
programme.
n) Identification of the person(s) reviewing the results and authorizing the release of the
report (if not contained in the report, should be readily available when needed).
o) Date of the report and time of release (if not contained in the report, readily available
when needed).
p) Page number to total number of pages, e.g. 1 of 5.
S.No. Document Title Document ID

1 SOP for Result Reporting, Verifying and Releasing MHL//ALS/SOP
2 SOP for corrected or amended result MHL//ALS/SOP
3 SOP forManagement of Patient Report MHL/ALS/SOP

Page: 62 of 68
5.9 Release of results

5.9.1 General
 A procedure for management of patient reports has been developed which guide authorized
technical staff on how to release results and to whom.
 Staff ensures that when suitability of primary sample was compromised, it is indicated in the
report. Laboratory technical staffs are responsible for communicating critical results to
requesting clinician immediately.
 When interim reports are issued pending confirmatory test, laboratory technical staff ensure the
final report is issued in the shortest possible time.
 When results are communicated through telephone, the laboratory technical staff asks the
identity of the receiving person to ensure that results reach only authorized personnel. Such
communications are captured in communication log.
5.9.2 Automated selection and reporting of results
 MHL has no automated transmission of results. All results are issued out on paper or by phone
and then followed by the paper result report as described in the Management of Patient Report
Procedure.
5.9.3 Revised reports
 MHL’s procedures for Management of Patient Report describe the handling of revised
laboratory results. The procedure outlines the steps which include the following:
a) Identification of the report as a revised version
b) Notification of the user about the revision.
c) Identification of the authorized personnel who revised the report
d) Retention of all records for audit trail purposes.

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1 SOP for Final Patient Result Report MHL/ALS/SOP

2 SOP for Management of Patient Report MHL/ALS/SOP
5.10 Laboratory Information Management

5.10.1 General
 MHL manages all information pertaining to patient results in a paper based system as
described in the Information Management Procedure. Patient results are either printed out from
the analyzer printer or transcribed to the Laboratory Report Form. However copies of the
results are retained in the laboratory by transcription into departmental result registers.
 MHL management restricts access to these records and they are maintained in the store where
no unauthorized visitors are allowed.
 When authorized, the visitors sign an oath of confidentiality to ensure that they understand that
the information they acquire from the laboratory is not for divulging.
5.10.2 Authorities and responsibilities
 MHL has defined the authorities and responsibilities for the management of the information
system, including the maintenance and modification to system that may affect patient care.
Through the Personnel Substitution Matrix, MHL Management defined the authorities and
responsibilities of all personnel who use the system, in particular those who:
a) Access patient data and information.
b) Enter patient data and examination results.
c) Change patient data or examination results.
d) Authorize the release of examination results and reports.
5.10.3 Information System Management
 The Information Management Procedure describes the collection, processing, recording,
reporting, storage or retrieval of examination data. The procedure ensures that patient
information is:

Page: 64 of 68
a) Only available to authorized users

b) Protected from unauthorized access
c) Safeguarded against tampering or loss
d) Handled in conditions that safeguard the accuracy of manual recording and transcription
e) Maintained in a manner that safeguards integrity of the data and information and
includes the recording of failures and the appropriate immediate and corrective actions
f) In compliance with national and international requirements regarding data protection.
 All copies of result reports and registers are maintained and stored as per Control of Records
Procedure.
1 SOP for Ensuring Confidentiality of Patient Information MHL/ALS/SOP
2 SOP for Laboratory Information System Management MHL/ALS/SOP
Annexes
Annex-I: Organogram of MHL Laboratory
Annex-II: Document Retention time
Document/Record Name Retention/Storage Time Remark
Policy Manuals 2 years

Accreditation documents For a minimum of one Document No: MHL/QPM
Title: Quality Policy Manual
accreditation cycle Version No: 01
 Records of inspections ,
 Internal and external audits (3 years) Effective Date: Sep.2021
Page: 65 of 68
 Management reviews
Laboratory Registers/ worksheets 5years
Patients reports 2 year

Patients reports of instrument/printout
Results e-mails or SMS
Working Copies of external surveys 2 years
Records of telephoned reports 2 years
Quality Improvement records 3 years
Equipment maintenance and service Life time of Instrument

records
Instrument method validation data Lifetime of instrument
Software Application validation records Lifetime of instrument
Meeting Minutes and management 3 years

review
Communication logs/memos 5 years
Customer surveillance questionnaire & 3 years

Suggestion box comments
Complaints summary 3 years
Court cases Indefinitely
Internal QC records
 Instrument printouts/ IQC logs 2 years
(manually entered)
External QA records 5 years
Calibration records Machine life time


Page: 66 of 68
REFERENCE
1. International Organization for Standardization. Quality Management Systems – Requirements.

ISO 15189. Geneva: 2012
2. NCCLS. A Quality Management System Model for Health Care; Approved Guideline—Second
Edition. NCCLS document HS1- A2 (ISBN 1-56238-554-2). NCCLS, 940 West Valley Road,
Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.
3. CLSI/NCCLS. Application of a Quality Management System Model for Laboratory Services;
Approved Guideline—Third Edition. NCCLS document GP26-A3 [ISBN 1-56238-553-4].
NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2004.
Declaration
I, the undersigned laboratory personnel, certify that I am conducting every steps of the policy
incorporated in this Quality Policy Manual after a prior reading.
S.No. Staff Name Signature Date

1
2
3
4
5
6
7
8

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Quality Policy Manual

Compiled by: Bedane Midekso Signature:

Approved by: Fikru Yadeta Signature:

Effective Date Sept. 20, 2021 GC Version: 01

Document Number: MH/LQPM Copy Number:

Date of discontinue: _____________________________-

Effective Date: Sep.2021

REVISION AND AMENDMENT

B. Version Change History/Description

Effective Date: Sep.2021