Quality Manual

[
QUALITY MANUAL
AROGYA LABORATORY SERVICES

BANGALORE-123456
KARNATAKA
DOCUMENT NO.:1
ISSUE DATE:
COPY NO. : ISSUED BY:
HOLDER’S NAME: QUALITY MANAGER
Prepared By: Quality Approved By: Section a

Manager Designation: Director Copy No.
Signature: Signature:
Issue Date: Version No: 1 Page 1 of 33
Arogya Laboratory Services Release Authorization Quality Manual
RELEASE AUTHORIZATION
This Quality Manual is released under the authority of

Director,
and
is the property of
Arogya Laboratory Services
Bangalore-123456
Karnataka
Prepared By: Quality Approved By: Section B

Manager Designation: Director Copy No.
Arogya Laboratory Services Amendment Record Quality Manual
AMENDMENT RECORD
Section/
Signature of
Clause/
Date of Amendment Reasons of person
Sl Page No. Para/Line
Amendment Made Amendment authorizing
No. (as
Amendment
applicable)
10
Prepared By: Approved By: Section C

Designation: Quality Manager Designation: Director Copy No.
Issue Date : Version No: 1 Page 4 of 33
Arogya Laboratory Services Table of Contents Quality Manual
TABLE OF CONTENTS
Section Particulars Version Page No.

No. No.
A Title Page 1 1 of 32
B Release Authorization 1 2 of 32
C Amendment Record 1 3 of 32
D Table of contents 1 4 of 32
E Distribution List 1 5 of 32
F Quality Policy 1 6 of 32
H Scope 1 7 of 32
I Normative References 1 8 of 32
J Terms and Definitions 1 9 of32
K Organization and Management 1 10 of32
Quality Management System 1 11 of32
Document Control 1 13 of32
Review of Contracts 1 14 of32
External services and supplies 1 15 of32
Resolution of Complaints 1 16 of32
Control of Non Conformities, Corrective and Preventive 1 17 of32
actions
Continual Improvement 18 of 32
Quality and Technical Records 19 of 32
Internal Audits 1 18 of32
Management Reviews 1 19 of32
L Personnel 1 20 of32
Accommodation and Environmental Conditions 1 23 of32
Laboratory Equipment 1 24 of32
Pre-examination Procedures 1 25 of32
Examination Procedures 1 26 of32
Assuring Quality of Examination Procedures 1 27 of32
Post Examination Procedures 1 28 of32
Reporting of results 1 29 of32
Prepared By: Approved By: Section D
Arogya Laboratory Services Distribution List Quality Manual
DISTRIBUTION LIST
The Quality manual is prepared by the Quality Manager and approved by the Director,
Arogya Laboratory Services and the following will have a copy of the Quality manual.
1. Director
2. Head / Lab In charge of respective Sections
3. Quality Manager
4. NABL
The document submitted to NABL is the uncontrolled copy of the Quality Manual while the
Controlled Documents are distributed in the above mentioned list Nos.1 to 3.
Prepared By: Approved By: Section E

Arogya Laboratory Services Quality Policy Quality Manual
QUALITY POLICY
The Arogya Laboratory Services (ALS), carry out its medical testing activities meeting the
requirements of:
(1) ISO 15189:2007
(2) NABL Specific criteria
(3) Regulatory Authorities
The ALS, is totally dedicated and committed to provide diagnostic services, giving top
priority to the quality of the results for all the samples received by the laboratory.
ALS takes adequate measures to ensure that quality care is given to all patients without
showing any discretion. The services offered by the ALS is cost effective and fine tuned to
ensure that utmost care is taken so that the results are reliable, accurate and dependable to
assure that the results are close to the true value.
All the staff members are made to imbibe this philosophy and are part of our endeavor to
maintain quality at every level. It is the responsibility of all the staff to familiarize themselves
with the content of the Quality manual and comply with the policies and procedures laid
down in the manual and associated documents at all times.
Quality manager has the overall responsibility for implementation and control surveillance of
Management system.
Director
Arogya Laboratory Services,
Bangalore.
Prepared By: Approved By: Section F
Issue Date : Version No: 1 Page 7 of 33
Arogya Laboratory Services Scope Quality Manual
1.0 SCOPE
The ALS constitutes the following sections: Clinical Biochemistry, Clinical Pathology,
Hematology, Cytogenetics, Histopathology, Cytopathology, Immunopathology, Microbiology
and Serology.
ALS has adequate facilities and technical competence to carry out the tests as mentioned in
the Scope of Accreditation as appended to the application form under the clause 2.2 of the
application.
This Quality Manual is applicable to the various sections of ALS as mentioned earlier (refer
Section G) for performing the tests as mentioned in the appendix that has been attached to the
application form under the clause 2.2 of the application form.
The Quality manual is for use by ALS in developing their quality, administrative and
technical system that governs our operations. Laboratory Clients, Regulatory authorities and
accreditation bodies also use it in confirming or recognizing the competence of laboratories.
The regulatory and safety requirements on the operation of laboratories are not covered by
this Quality Manual.
Our lab shall by comply with the requirements of the International Standard ISO 15189:2007,
to operate a Management system for their testing activities.
Prepared By: Approved By: Section H
Arogya Laboratory Services Normative References Quality Manual
2.0 NORMATIVE REFERENCES
ALS has developed and implemented Management System that is documented in this Quality
Manual as per the guidelines and standards provided by NABL in its ‘Medical Laboratories –
Particular requirements for quality and competence’ ISO 15189:2007.
Prepared By: Approved By: Section I
Signature: Signature :
Arogya Laboratory Services Terms and Definitions Quality Manual
3.0 TERMS AND DEFINITIONS

The terms and definitions are used as mentioned in ISO / IEC Guide 2 under the guidance of
ALS Quality Manager. In addition, certain abbreviations which are used throughout the
Quality Manual and other document of Management system are mentioned and decoded in
abbreviations.
Prepared By: Approved By: Section J
Issue Date: Version No:1 Page 9 of 33
Arogya Laboratory Services Organization and Quality Manual
Management
ALS, Bangalore is registered under society registration act with registration No. 9818783849
ALS being a clinical testing laboratory considers as customers:

1. Clinical Doctors
2. Walk – in patients (Self testing)
3. Corporate organizations (Health Check)
4. Referral Laboratories / Hospitals / Nursing Homes
ALS in all these will keep the interests of the patient (the final affected party) uppermost in
all issues related to the Quality of tests, their reports, confidentiality issues and release of test
results regardless of internal or external pressures – financial, administrative or any other.
ALS has scientific staff / technical manager, who has overall responsibility of testing
activities. He has provided with adequate resources needed to ensure required Quality of
laboratory operations.
ALS has appointed Quality Manager. He has direct access to the Director – ALS.
Deputy Quality manager and Deputy technical managers have been appointed in various
sections.
Prepared By: Approved By: Section K

Arogya Laboratory Services Quality Management System Quality Manual
ALS has established, implemented and maintains a Quality Management System appropriate
to the scope mentioned earlier. ALS has documented its policies, process, program, procedure
and instructions and has communicated this to all relevant personnel. The respective
Department Head / In Charge will ensure that all the personnel working in the laboratory
have understood the Quality Policy, quality Management System and the objective for
adopting this Management System.
Policies and objectives of the Quality Management system has been defined in a quality
policy statement under the authority of the Director which has been documented in the
Quality Manual
Laboratory has an established program that ensures regular monitoring, proper calibration
and function of instruments, reagents and analytical systems. It also maintains document on
program of preventive maintenance and calibration, which, at a minimum, follows
manufacturer’s recommendations. Respective sections maintain the document for
maintenance of equipment that belongs to their section.
Issue Date: Version No: 1 Page 12of 33
Arogya Laboratory Services Quality Management System Quality Manual
Quality Manager has the overall authority, responsibility and commitment to communicate,
implement, control and supervise the compliance of this Management system with ISO
15189:2007.
The roles and responsibilities of the Quality manager include:

 Establishing and maintaining a Management system
 Document control
 Documentation of all Management system activities
 To ensure that Quality Manual is updated.
 Schedule and conduct of internal audit
 Schedule and conduct of Management Review Meeting
 Ensuring corrective and preventive action arising from the above
The roles and responsibilities of Technical Manager:

 Overall responsibility for testing activities
 Maintaining internal quality checks
 Participation in proficiency testing or inter-laboratory quality checks
 Review of requests
 Subcontracting activities and correct assessment of the same
 Identification of non conforming work and documenting the corrective action required
 Correct recording and storage of test data for easy retrievability
 Assessing training needs of personnel and arranging the same
 Ensuring correct functioning of equipment and documentation related
 Input on purchasing and storage of materials
 Providing additional service to clients by way of interpretations and advice
 Generating reports of tests and validation by affixing his/her signature
All personnel are instructed on the use and application of the Quality Manual and its
supporting documents. The Quality Manual is updated under the authority and responsibility
of the Quality Manager.

Arogya Laboratory Services Document Control Quality Manual
All the documents of the laboratory are reviewed by technical manager and approved by
Director. Quality Manager issues these documents to the laboratory personnel. Laboratory
personnel are responsible for retaining the authorized editions and removing the obsolete
copies. Quality Manager maintains the distribution list. Any user of the document can
propose the amendments, These amendments are reviewed by Technical Manager and
approved by the Director. Quality manager retains a copy of the obsolete document for
records.

Arogya Laboratory Services Review of Contracts Quality Manual
ALS has established and maintains procedures for the review of contracts. ALS keeps the
stated and implied needs of its clients uppermost in discharging all contracts made to it. The
detailed procedures outlining such reviews are outlined in ALS/SOP/05.
(a) The methodology and allied technology to be employed in delivery shall be

understood, defined and documented.
(b) ALS will undertake survey & study of its capability and resources to perform any new
tests (not defined in its directory of services) or any proposed significant increase in
workload.
(c) The test method finally selected to be undertaken (for new tests) must be appropriate
for clients needs and mutually agreed upon. In all situations for which the tests are
defined in the directory of services (ALS/FRM/01), the method of testing is indicated.
(d) Any deviation from published or agreed upon methodology shall be duly notified to
the customer inclusive of any subcontracting undertaken.
All records of review are maintained which is inclusive of significant changes that is outlined
in ALS/SOP/05. (Subcontractor's Procedures)
IBDC shall review and cover investigation that is subcontracted by the laboratory.
ALS informs the Customer of any deviation from the contract.
If contracts are amended after commencement of work, the changes will be communicated to
all personnel concerned.
Arogya Laboratory Services External Services and Quality Manual
Supplies
All the purchases are made by the purchase dept. The materials are purchased through on
sending an indent form ALS/FRM/01. The lab assistant initiates the indent, technical manager
approves it. Then the Purchase dept initiate the purchase activities.
On receipt of the material the Lab asst. shall inspect the material. If the quantity is less,
purchase dept. shall be informed.
Arogya Laboratory Services Resolution of complaints Quality Manual
ALS will recognize in totality every complaint received from its customers and will strive to
redress them at the earliest practicable date.
The detailed procedure for resolution of complaints and other feedback received from
clientele, patient or other parties are outlined in ALS/SOP/RCC/08. The record of complaints
and of investigations and the corrective actions taken by the laboratory is maintained in a
register (ALS/REG/RCC/02).
Designation: Quality Manager Designation: Lab In charge Copy No.
Arogya Laboratory Services Control of Non conformities, Corrective Quality Manual
actions and Preventive actions
The staff of ALS is empowered to recognize the non-conforming work and bring to the notice
of the technical manager. The TM manager verifies the detail of the non-conformity and plan
the action to arrest the non-conformity. Dy, technical manager takes necessary corrections to
arrest the non-conformity.
If required, the technical manager will take corrective and preventive actions.
Arogya Laboratory Services Continual Improvement Quality Manual
4.12 CONTINUAL IMPROVEMENT
4.12.1
Deputy technical manager of the respective section will systematically review all operational
procedures annually in order to identify any potential sources of non-conformances or for any
opportunities for improvement. Action plans developed for improvement shall be
documented and implemented (ALS/SOP/CI/09).
4.12.2
A focused audit will be conducted on the proposed changes that were done as a result of
review of procedures. An evaluation is done for the effectiveness of the changes made.
4.12.3
The results of audit will be submitted to deputy technical manager of the respective section
for review. Further it will be discussed with Director and the Quality Manager about the
needed changes in the operational procedures. The needed changes shall be documented and
implement in the Quality Management system (ALS/FIL/RCI/07).
4.12.4
ALS management will implement quality indicators like internal QC, triplicate testing,
participation in EQAS for systematically monitoring and evaluating the laboratory’s
contribution to patient care. Whenever there is scope for improvement, lab management will
address it appropriately.
4.12.5
ALS management continuously encourages and ensures that the lab personnel undergo
training programs and attend C.M.E for their continual improvement in their technical
expertise.
Arogya Laboratory Services Quality and Technical Records Quality Manual
4.13 QUALITY AND TECHNICAL RECORDS (Work Instructions)
4.13.1
ALS has ensured the identification, collection, indexing, access controls, filing, storage,
maintenance and disposal of quality and technical records as outlined in ALS/SOP/CR/10.
4.13.2
All records in any media such as hard copy or electronic media are legible and are stored in a
pre-identified filing cabinets with an index displaying the pattern of filing so that they are
easily retrievable and are protected from damage, deterioration and loss.
4.13.3
Retention times of records depends on the close-out of each projects described in
ALS/SOP/CR/10.

Designation: Quality Designation: Director Copy No.
Manager Signature:
Signature:
Arogya Laboratory Services Internal Audit Quality Manual
To verify the compliance of operations and activities with the requirements of quality
management system, IA is carried out. IA is carried out by persons whose routine activities
are not related to that of the audit area allotted to them. IA is scheduled at least once in 12
months to cover all areas of the lab. Internal audit will cover and address all elements of the
Management System and testing activities.
The Quality Manager Plans schedules and implements a comprehensive Internal Quality
Audits to verify the compliance of its operations and activities to IS0 15189: 2007 and the
requirements of the documented Management System. Detailed procedure of internal audit is
outlined in ALS/SOP/IA/11. When audit findings cast any doubt on effectiveness of the
Management system or on the correctness of test values, corrective action is taken and
customers are notified in writing.
All activities of internal audit including the area of audit, the audit findings and corrective
actions are recorded and records are maintained by the quality manager / deputy
(ALS/FIL/IAF/08). All the audit findings are recorded in the nonconformity review form
(ALS/FRM/NC/03).
Follow up audits will verify and record the implementation of corrective action taken on
previous audits. Follow up audit will also check on the effectiveness of corrective actions
taken and the need to review if not effective (ALS/FIL/IAR/09).

Arogya Laboratory Services Management Reviews Quality Manual
4.15 MANAGEMENT REVIEWS
ALS and its management conduct management review meetings to:

 Review effectiveness of the Management System
 Introduce necessary changes or improvements
Director is responsible for conducting the Management Review and the Quality Manager will
coordinate this.
Management Review is held once in twelve months attended Director, Quality Manager,
concerned unit heads / Technical managers and other invitees as appropriate.
The management review meeting will incorporate any or all of the following:
 The suitability of policies and procedures to the current scenario
 Reports from Technical managers or unit heads
 Report of internal audit (s)
 Corrective and preventive action to be taken and implementation authority
with deadlines
 Further assessment by external bodies
 The results of inter-laboratory comparisons or proficiency testing and actions
arising there from
 Increase / decrease in the volume and methodology of testing activities
 Customer feedback and Complaints
 Internal quality control / split sample testing, resources and staff training
 Monitoring of them around time
 Occurrence of any non conformities and the corrective action taken
 Monitoring of Continuous improvement
 Evaluation of Suppliers
Arogya Laboratory Services Technical Requirements Quality Manual
TECHNICAL REQUIREMENTS
PERSONNEL
ALS ensures that all staff in its service is competent to meet the needs of their job
description. Basic qualifications of various cadres of staff and their job descriptions are
maintained in by the Personnel Department under their individual contracts. Staff in ALS is
employed on a full time basis as employees or under contract. Part time employment is not
encouraged.
Technical staffs employed in Hematology, Clinical Pathology and Clinical Biochemistry is

basically posted on rotation between these sections. Technical staff in histopathology and
Cytopathology is rotated between the sections. While in the other sections, staff is not under
rotation.
All staff employed as trainees undergo a period of training, which is based on their
qualification, experience, current skills and competence as certified by the Head of the
laboratory. The training is provided when the staff is posted on rotation in different sections.
Records of such training are maintained in the file their respective sections.
Prepared By: Approved By: Section L
Signature : Signature:
The laboratory director of ALS is the Director. Head of the Department or the Deputy
Technical manager of the various sections assume the complete responsibility for the services
provided.
The responsibilities of the laboratory director comprises of professional, scientific,

consultative or advisory organizational, administrative and educational matters relevant to
services offered by the laboratory. It includes
a) Proving advises to those requesting information about the choice of tests, the use of
the laboratory service and the interpretation of laboratory data.
b) An active member of the medical staff
c) To relate effectively with
- Applicable accrediting and regulatory agencies
- Administration or management
- Clinicians and health care coordinators
- Patient population
d) To define and implement the standard of performance and actively monitor the
performance and quality improvement
e) Implement Quality Management system
f) Monitor the laboratory performance
g) Ensure that sufficient Qualified personnel are available to meet the requirements of
the laboratory
h) To plan, develop and allocate resources
i) Budget planning and other administrative matters
j) To encourage laboratory staff to attend Conferences/ Seminars/ Symposia’s/
Instructional Course
k) Plan and direct research and development in accordance with facilities available
l) Selection of referral laboratories for Quality of service
m) Implement a safe laboratory environment in compliance with good laboratory practice

n) To address complaints / requests / suggestions of all the clients
o) Ensure good staff morale
Version No: 1 Page 24 of 33
Staffs of ALS have been trained to identify non-conformities in the testing activities. Staff of
ALS has been assessed for their performance annually. If a need arises for retraining of
personnel, the reassessment will be done following training. Personnel employed for
interpretation of reports are the qualified professionally who are educated and trained to make
opinions/ interpretations/ predictions. This will be in accordance with regulatory bodies. All
staff of ALS has been made to understand and maintain the confidentiality of the patient’s
information.

Arogya Laboratory Services Accommodation and Environmental Quality Manual

conditions
ACCOMMODATION AND ENVIRONMENTAL CONDITIONS
ALS has ensured that adequate accommodation and environmental conditions are provided
for all testing activities. ALS and its management ensure that these conditions facilitate
correct performance of testing activities and in no way invalidate test results or adversely
affect their quality. The technical head / head of the lab monitors, controls and records
environmental conditions as per the requirement of the test method /procedure or in cases
where they influence the quality of results in their respective sections. All parameters as
appropriate to technical activity concerned are documented and in case conditions jeopardize
the results of tests, the activity will be stopped and necessary corrective action is taken. Lab is
free from electro-magnetic disturbances, radiation, loud noise, vibration etc. Access to and
use of testing areas are controlled and only authorized persons are allowed to access. ALS has
provided all the sections with intercom facilities and easy accessibility to telephone for
making out going calls to ensure efficient transfer of messages. ALS has an infrastructure
which provides adequate storage space to prevent the deterioration of samples, slides,
histology blocks, retained micro-organisms, documents, files, manuals equipments, reagents,
laboratory supplies, records and results.

Issue Date: Version No: Page 25 of 33
Arogya Laboratory Services Laboratory Equipment Quality Manual
LABORATORY EQUIPMENT
ALS is furnished with all items / equipment required for correct performance of the tests. All
equipment used to perform tests in ALS is within its premises. Technical Heads of the
respective sections maintains records of equipment history and maintenance. The records are
maintained and easily available for the life span of the equipment. ALS management takes
adequate care to maintain equipment in safe working condition. There are established
procedures for safe handling of equipment and disposal of chemicals and biological
materials. Details are maintained at respective sections. A list of precautionary measures that
needs to be taken to prevent or reduce contamination will be documented and shall be
provided to the staff working the equipment. The list is maintained at their respective
sections. Measures are taken to provide adequate space for repair of the equipment. ALS
ensures test equipment (hardware and software) is safeguarded from adjustments that would
invalidate the test results.
Version No: 1 Page 27 of 33
Arogya Laboratory Services Pre-Examination Procedures Quality Manual
PRE-EXAMINATION PROCEDURES
The request forms or an electronic equivalent contains adequate information to identify the
patient and the clinicians requesting for the investigations. The request form or an electronic
equivalent includes
- Unique identification of the patient of the requesting clinician. In case of
references from outside the hospital, the name and address of the requesting
clinician will be mentioned.
- Type of primary sample and also indication of anatomic site of origin
wherever appropriate.
- Examinations or the investigations requested
- Gender, age and minimal clinical information
- Date and time of sample collection
- Date and time of receipt of samples by the laboratory
ALS has defined procedure for transporting, receipt, handling, protection, retention and/or
disposal of test items, including all provisions necessary to protect the integrity of test item
and to protect the interest of ALS and the customer. The detailed system procedure is outlined
in ALS/SOP/HTT/15 and ALS/SOP/SD/16.
The individual sections where all pertinent data is maintained maintain a sample collection
register. The laboratory has established a system for identification of test items. Unique
hospital numbers / referral numbers are written on the sample label and verified on receipt.
Individual sections assign and affix unique specimen numbers (lab numbers) to each
specimen and these are referred to prevent physical confusion of test items and are
maintained throughout the life of the item in the individual labs. These identification numbers
are referred to in technical records or documents maintained. In situations wherein samples
have to be shared between the different sections of the lab, each individual section maintain
unique sample ID for shared specimen.
Individual laboratories may accept or reject samples based on their suitability for testing.
Individual laboratories may request resample based on specific criteria for acceptance or
rejection or verification requirement. Records for re-sampling are maintained. Any deviation
Arogya Laboratory Services Pre-Examination Procedures Quality Manual
in laid down procedure for sampling is documented on the request form and/or sample
collection register. In cases where there is a doubt as to the suitability of a sample for test or
when a sample doesn’t conform to description provided, or test required is not specified in
sufficient details, ALS or its specific laboratory staff consults the patient and/or the referring
doctor of the deviation, seeks clarifications before proceeding and records the discussion.
ALS and its sections have a well-documented and established procedure for the receipt,
labeling, processing and reporting of primary samples received by the laboratory and
specifically marked as urgent.
All verbal requests for adding the investigation or changing the investigation requested for
shall be recorded on the request form with the identity of the requesting person. The reports
will be released only after the written orders or requests reach the lab.
ALS and its individual sections have outlined procedures for avoiding deterioration,
loss/damage to the test items during storage, handling and preparation.
Arogya Laboratory Services Examination Procedure Quality Manual
5.5 EXAMINATION PROCEDURES
ALS uses test methods that are standard methods appropriate to serve the purpose and meet
the needs of the customers. The test method used for all tests is available to customers
through a directory of services and requests are based on the acceptance of these
(ALS/FRM/DOS/01).
ALS selects appropriate method that has been published by reputed scientific organizations,
relevant scientific text or journal or as specified by manufacturer of the equipment / reagent.
The details are maintained in their respective sections. ALS at this juncture does not offer in
in-house developed methods.
The clients will be informed or made aware of the changes in the examination procedures
prior to its introduction.
Performance specifications for each procedure will be followed as per manufacturer’s

recommendations.

Arogya Laboratory Services Assuring the Quality of Quality Manual

Examination Procedure
ASSURING THE QUALITY OF EXAMINATION PROCEDURES
ALS has a well planned and an established program for internal quality control to monitor
and maintain the intermediate checks of quality of results. All the staff members are trained to
check and monitor for the compliance of internal quality control. Additional care has been
taken to ensure the minimization of the pre- and post-analytical errors that could occur and
affect the analysis of the sample.
ALS participates in Inter laboratory comparison and/or External Quality Assurance program.
The resulting data is recorded resulting trends and statistical analyses are reviewed by the
individual section head / technical managers.
Whenever a formal interlaboratory comparison program is not available, ALS shall

participate in evaluation of samples by exchanging with other laboratories. ALS and its
sections will monitor the results of the interlaboratory comparison. In case of a requirement
of corrective action, the same will be implemented and recorded.

Arogya Laboratory Services Reporting of Results Quality Manual
5.8 REPORTING OF RESULTS
ALS takes responsibility for generating Test Report format that has been designed to meet the
requirements of the clients. ALS takes the responsibility to ensure that reports are received by
the clients as per the specified turn around time in the directory of services
(ALS/FRM/DOS/01).
The results of each test or series of tests carried out by all the sections of ALS is reported
accurately, clearly, unambiguously, objectively, and in accordance, with any specific
instructions required by specific tests. The test report generated for each test / group of
related tests will include all information requested by the customer, necessary for the
interpretation of the test result and all information required to be mentioned for the test
method used.
Each test report includes the following information,
 The title of the test performed
 The name and address of the laboratory.
 Unique identification of the test report (Laboratory number), and on each page an
identification in order to ensure that the page is recognized as a part of the test report,
and a clear identification of the end of the test report.
 Unique identification parameter of the client by means of a hospital number or
referral number linked to the Hospital information System and records maintained by
the Medical record department.
 A description / condition and unambiguous identification of the sample(s) tested.
 The date of receipt of the sample(s) where and the date(s) of performance of the
test(s).
 The test results with, where appropriate, the units of measurement
 The name(s), function(s) and signature(s) or equivalent identification of person(s)
authorizing the test report;
Arogya Laboratory Services Reporting of Results Quality Manual
The jargons used for the tests and the reports will be simple and in accordance with the
system followed and accepted by the International & regulatory bodies.
In case the Quality of the primary sample was found to be unsuitable or not completely
satisfactory, the same will be indicated in the test report format.
Copies of reported results will be archived for a period as defined in ALS/SOP/RA/19. The
reports are stored in such a way so that it can be easily retrieved.
ALS and its individual sections have procedures for establishing the critical limits for certain
investigation that requires urgent clinical notification.
The ALS maintains a chart on the critical limits that has been prepared after consulting the
clinicians.
A final report is always issued in case an interim report has already been released to the
client.
ALS & its individual sections follow a procedure for reporting of results in critical Intervals.

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AROGYA LABORATORY SERVICES

Prepared By: Quality Approved By: Section a

This Quality Manual is released under the authority of

Prepared By: Quality Approved By: Section B

Prepared By: Approved By: Section C

Arogya Laboratory Services Table of Contents Quality Manual

Section Particulars Version Page No.

Prepared By: Approved By: Section E

Arogya Laboratory Services Quality Policy Quality Manual

2.0 NORMATIVE REFERENCES

3.0 TERMS AND DEFINITIONS

ALS being a clinical testing laboratory considers as customers:

Prepared By: Approved By: Section K

The roles and responsibilities of the Quality manager include:

The roles and responsibilities of Technical Manager:

Prepared By: Approved By: Section K

Arogya Laboratory Services Document Control Quality Manual

Prepared By: Approved By: Section K

Arogya Laboratory Services Review of Contracts Quality Manual

(a) The methodology and allied technology to be employed in delivery shall be

ALS informs the Customer of any deviation from the contract.

Arogya Laboratory Services Resolution of complaints Quality Manual

Arogya Laboratory Services Continual Improvement Quality Manual

4.12 CONTINUAL IMPROVEMENT

4.13 QUALITY AND TECHNICAL RECORDS (Work Instructions)

Prepared By: Approved By: Section K

Arogya Laboratory Services Internal Audit Quality Manual

Prepared By: Approved By: Section K

4.15 MANAGEMENT REVIEWS

ALS and its management conduct management review meetings to:

Arogya Laboratory Services Technical Requirements Quality Manual

Technical staffs employed in Hematology, Clinical Pathology and Clinical Biochemistry is

The responsibilities of the laboratory director comprises of professional, scientific,

m) Implement a safe laboratory environment in compliance with good laboratory practice

Arogya Laboratory Services Technical Requirements Quality Manual

Prepared By: Approved By: Section L

Arogya Laboratory Services Accommodation and Environmental Quality Manual

ACCOMMODATION AND ENVIRONMENTAL CONDITIONS

Prepared By: Approved By: Section L

Arogya Laboratory Services Pre-Examination Procedures Quality Manual

Arogya Laboratory Services Pre-Examination Procedures Quality Manual

Arogya Laboratory Services Examination Procedure Quality Manual

5.5 EXAMINATION PROCEDURES

Performance specifications for each procedure will be followed as per manufacturer’s

Prepared By: Approved By: Section L

Arogya Laboratory Services Assuring the Quality of Quality Manual

ASSURING THE QUALITY OF EXAMINATION PROCEDURES

Whenever a formal interlaboratory comparison program is not available, ALS shall

Prepared By: Approved By: Section L

5.8 REPORTING OF RESULTS

Arogya Laboratory Services Reporting of Results Quality Manual

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