QUALITY MANUAL FOR HLS ERA MEDICAL COLLEGE WRITTEN BY DR VISHNU KUMAR AWASTHI

HOSPITAL LABORATORY SERVICES,

ERA’S LUCKNOW MEDICAL COLLEGE & HOSDPITAL, SARFARAZ

GANJ, HARDOI ROAD, LUCKNOW - 226003

QUALITY MANUAL(Written by Dr Vishnu Kumar)

QUALITY MANUAL

HOSPITAL LABORATORY SERVICES,

ERA’S LUCKNOW MEDICAL COLLEGE & HOSDPITAL (ELMC&H),

SARFARAZ GANJ, HARDOI ROAD, LUCKNOW - 226003

DOCUMENT NO. : NABL 160

ISSUE DATE : dd/mm /yy

COPY NO. :

ISSUED BY : Dr……………..

HOLDER’S NAME :

QUALITY MANAGER : DR VISHNU KUMAR

Prepared By: Dr Vishnu Kumar Designation: Quality ManagerSignature:

Approved By:Designation: DirectorSignature:

Section - ACopy No.

Issue Date: Version NO. 1 Page 1 of 32

Hospital LaboratoryServices

Release Authorization Quality Manual

RELEASE AUTHORIZATION

This Quality Manual is released under the authority of

Director

And is property of

Hospital Laboratory Services

ELMC&H, Lucknow –226003

Uttar Pradesh, India



Section - BCopy No.



Amendment Record Quality Manual

AMENDMENT RECORD

S.N.

PageNo.

Sect./Clause/Para/

Line (asapplicab

le)

Dateof

Amendment

Amendment Made Reasons ofAmendment

Sig.of

Person

Technical

Requirements.

Amendment

1

2

3

4

5

6

7

8

9

10



Section - CCopy No.



Table of Contents Quality Manual

TABLE OF CONTENT

SectionNo.

Particulars VersionNo.

Page No.

A Title Page 1 1 of32

B Release Authorization 1 2 of32

C Amendment Record 1 3 of32

D Table of content 1 4 of32

E Distribution List 1 5 of32

F Quality Policy 1 6 of32

G Scope 1 7 of32

H Normative Reference 1 8 of32

I Terms and Definitions 1 9 of32

J 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 andPreventive Actions

1 17 of32

Continual improvement 1 18 of32

Quality and Technical Records 1 19 of32

Internal Audits 1 20 of32

Management Reviews 1 21 of32

K Technical Requirements, Personnel 1 22 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



Section - DCopy No.



Distribution List Quality Manual

DISTRIBUTION LIST

The Quality Manual is prepared by the Quality Manager andapproved by the Director, HOSPITAL LABORATORY SERVICES, ELMC&H,Lucknow – 226003 and the following will have a copy of QualityManual.

1. Director2. Lab In charge of respective Sections3. Quality Manager4. 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.



Section - ECopy No.


Hospital Laboratory Quality Policy Quality Manual

Services

QUALITY POLICY

The Hospital Laboratory Services (HLS), carry out its medical testing activities meeting the requirements of:

1. ISO 15189: 20122. NABL Specific criteria3. Regulatory Authorities

The HLS is totally dedicated and committed to provide diagnostic services, giving top priority to the quality of the results for all the samples received by laboratory.

HLS takes adequate measures to ensure that quality care is given to all patients without showing any discretion. The services offered by HLS is cost effective and fined 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 to our endeavor to maintain quality at every level. It is responsibility of all the staff to familiarize themselves with the content of the Quality Manual and comply with the policies and procedures lay down in the manual and associated documents atall times.

Quality manager has the overall responsibility for implementationand control surveillance of Management system.

Director

Hospital Laboratory Services, Era’s Lucknow Medical College & Hospital, Sarfaraz Ganj,



Section - FCopy No.



Scope Quality Manual

1.0 SCOPE

The HLS constitutes the following sections: ClinicalBiochemistry, Clinical Pathology, Hematology, Cytogentics,Histopathology, Cytopathology, Immunology, Microbiology andSerology.

HLS has adequate facilities and technical competence to carry outthe tests as mentioned in the Scope of Accreditation as appendedto the application form under the clause 2.2 of the application.

This Quality Manual is applicable to the various sections as HLSas mentioned earlier (refer Section G) for performing the testsas mentioned in the appendix that has been attached to theapplication from under the clause 2.2 of the application form.

The Quality manual is for use by HLS in developing their quality,administrative and technical system that governs our operation.Laboratory Clients, Laboratory Clients, Regulatory authorities

and accreditation bodies also use it in confirming or recognizingthe competence of laboratories.

The regulatory and safety requirements on the operation oflaboratories are not covered by this Quality Manual.

Our lab shall by comply with the requirements of theInternational Standard ISO 1518:2003, to operate a Managementsystem for their testing activities.



Section GCopy No.

Issue Date: Version NO. 1 Page 7 of 32Hospital Laboratory

ServicesNormative References Quality Manual

2.0 NORMATIVE REFERENCES

HLS 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:

2012.



Section HCopy No.



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 HLS 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.



Section ICopy No.



Organization andManagement

Quality Manual

Hospital Laboratory Services, Era’s Lucknow Medical College&Hospital, Sarfaraz Ganj, Hardoi Road, Lucknow – 226 003, UttarPradesh, India is registered with Medical Council of India.

HLS being a clinical testing laboratory considers as customers:

1. Clinical Doctors2. Walk – in patients ( Self testing)3. Corporate organizations (Health Check)4. Referral Laboratories/ Hospital/ Nursing Homes

HLS in all these will keep the interests of the patient (thefinal affected party) uppermost in all issues related to theQuality of tests, their reports, confidentiality issues andrelease of test results regardless of internal or externalpressures, financial, administrative or any other.

HLS has scientific staff/ Technical Manager, who has overallresponsibility of testing activities. He has provided with

adequate resources needed to ensure required quality oflaboratory operations.

HLS has appointed Quality Manager. He has direct access to theDirector – HLS.

Deputy Quality Managers and Deputy Technical Managers have beenappointed in various sections.



Section JCopy No.



Quality Management System

Quality Manual

HLS has established, implemented and maintains a QualityManagement System appropriate to the scope mentioned earlier. HLShas documented its policies, process, program, procedure andinstructions and has communicated this to all relevant personnel.The respective Department Head/ In Charge will ensure that allthe personnel working in the laboratory have understood theQuality Policy, Quality Management System and the objective foradopting this Management System.

Policies and objectives of the Quality Management System havebeen defined in a Quality Policy Statement under the Authority ofthe 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.



Section JCopy No.



Quality ManagementSystem

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: 2012.

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 meetings 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

interpretation and advice Generating reports of tests and validation for affixing

signature

All personnel are instructed on the use and application of theQuality Manual and its supporting documents. The Quality Manual is updated under the authority and responsibility of the Quality Manager.



Section JCopy No.



Document Control Quality Manual

All the documents of laboratory are reviewed by Technical Managerand approved by director. Quality Manager issues these documentsto the laboratory personnel. Laboratory personnel are responsiblefor retaining the authorized editions and removing the obsoletecopies. Quality Manager maintains the distribution list. Any userof the document can propose the amendment; these amendments arereviewed by Technical Manager and approved by the Director.Quality Manager retains a copy of the obsolete Document forrecords.



Section JCopy No.



Review of Contracts Quality Manual

HLS has established and maintains procedures for the review of contracts. HLS keeps the stated and implied needs its client uppermost in discharging all contracts made to it. The detailed procedures outlining such reviews are outlined in concerning SOP.

(a) The methodology and allied technology to be employed intesting shall be understood, defined and documented.

(b) HLS will undertake a feasibility study of its capability and resources to perform any new tests (not defined in 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, the method of testing is indicated.

(d) Any deviation from published or agreed upon methodologyshall be duly notified to the customer inclusive of any subcontracting under taken.

All records of review are maintained which is inclusive of significant changes that is outlined in concerned SOP.

HLS shall review and cover investigation that is subcontracted bythe Laboratory.

HLS 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.



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External Services andSupplies

Quality Manual

All the purchases are made by the purchase Department. The materials are purchased through on sending an indent form. The Lab assistant initiates the indent, technical manager approves it. Then the purchase department initiates the purchase activities.

On receipt of the material the Lab Assistant shall inspect the material. I the quantity is less, purchase department shall be informed.



Section JCopy No.



Resolution ofComplaints

Quality Manual

HLS 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 complaint register. The record of complaints and of and of investigations and the corrective actions taken by laboratory is maintained in a register.



Section JCopy No.



Control ofNonconformities,

Corrective actionsand Preventive

actions

Quality Manual

The staff of HLS is empowered to recognize the non conforming work and bring to the notice of the Technical Manager. The Technical Manager verifies the detail of the nonconformity and plan the action to arrest the nonconformity. Director, Technical Manager takes necessary corrections to arrest the nonconformity.

If required, the technical manager will take corrective and preventive actions.



Section JCopy No.



Continual Improvement Quality Manual

4.12 CONTINUAL IMPROVEMENT

4.12.1

Deputy Technical Manager of the respective section willsystematically review all operational procedures annually inorder to identify any potential sources of non-conformances orfor any opportunities for improvement. Action plans developed forimprovement shall be documented and implemented(ELMC/HLS/SOP/CI--).

4.12.2

A focused audit will be continued on the proposed changes thatwere done as a result of review of procedures. An evaluation isdone for the effectiveness of the changes made.

4.12.3

The results of audit will be submitted to deputy TechnicalManager of the respective section for review. Further it will bediscussed with Director and Quality Manager about the neededchanges shall be documented and implement in the QualityManagement System (ELMC/HLS/SOP/..)

4.12.4

HLS Management will implement quality indicators like internalQC, triplicate testing, participation in EQAS for systematicallymonitoring and evaluating the Laboratory’s contribution topatients care. Whenever there is scope for improvement, labmanagement will address it appropriately.

4.12.5

HLS Management continuously encourages and ensures that the labpersonnel undergo training programs and attend C.M.E. for theircontinual improvement in their technical expertise.



Section JCopy No.



Quality and TechnicalRecords

Quality Manual

4.13 QUALITY AND TECHNICAL RECORDS

4.13.1

HLS has ensured the identification, collection, indexing, access controls, filing, storage, maintenance and disposal quality and technical records as outlined in HLS/SOP.

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.

4.12.3

Retention times of records are described in HLS/SOP’S



Section JCopy No.



Internal Audit Quality Manual

To verify compliance of operations and activities with therequirements of quality management systems, IA is carried out. IAis carried out by persons whose routine activities are notrelated to that of the audit area allotted to them. IA isscheduled at least once in 12 months to cover all areas of thelab. Internal audit will cover and address all elements of theManagement system and testing activities.

The Quality Manager plans schedules and implements acomprehensive Internal Quality Audits to verify the compliance ofit operations and activities to ISO 15189: 2012 and therequirements of the documented Management System. Detailedprocedure of Internal Audit is outlined in HLS/SOP/IA/2014. WhenAudit findings cast any doubt on effectiveness of the Management

system or on the correctness of test values, corrective action istaken and customers are notified in writing.

All activities of internal audit including the area of audit, theaudit findings and corrective actions are recorded and recordsare maintained by the Quality Manager/ Deputy Quality Manager(HLS/ IA/2014). All the audit findings are recorded in thenonconformity review form (HLS/FRM/NC/2014).

Follow up audits will verify and record the implementation ofcorrective action taken on previous audits. Follow up audit willalso check on the effectiveness of corrective actions taken andthe need to review if not effective (HLS/FIL/IAR/2014)



Section JCopy No.



Management Reviews Quality Manual

4.15 MANAGEMENT REVIEWS

HLS and its management conduct management review meeting to:

Review effectiveness of the Management System Introduce necessary changes or Improvements

Director is responsible for conducting the management review andthe Quality Manager will coordinate this.

Management Review is held once in twelve months attendedDirector, Quality Manager, Concerned unit heads/ Technicalmanagers and other invitees as appropriate.

In management review meetings will incorporate any or all of thefollowing:

The suitability of policies and procedures to the currentscenario

Reports from Technical Managers or unit heads Report of Internal Audits 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



Section JCopy No.



TechnicalRequirements

Quality Manual

Technical Requirements

PERSONNEL

HLS ensures that all staff in its service is competent to meetthe needs of their job description. Basic qualifications ofvarious cadres of staff and their job descriptions are maintainedin by the Personnel Department under their individual contracts.Staff in HLS is employed on a full time basis as employees orunder contract. Part time employment is not encouraged.

Technical staff employed in Hematology, Clinical Pathology, andClinical Biochemistry is basically posted on rotation betweenthese sections.

All staff employed as trainees undergo a period of training,which is based on their qualification, experience, current skillsand competence as certified by the Head of the Laboratory. Thetraining is provided when the staff is posted on rotation indifferent sections. Records of such training are maintained inthe file in their respective sections.



Section KCopy No.




Quality Manual

The laboratory director of HLS, 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 laboratory. It includes

a) Providing advises to those requesting information about the choice of tests, the use of the laboratory service and interpretation of laboratory data.

b) An active member of the medical staffc) 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 systemf) Monitor the laboratory performanceg) Ensure that sufficient Qualified personnel are available to

meet the requirements of the laboratoryh) To plan, develop and allocate resourcesi) Budget planning and other administrative mattersj) To encourage laboratory staff to attend conferences/

Seminars/ Symposia’s/ Instructional coursek) Plan and direct research and development in accordance with

facilities availablel) Selection of referral laboratories for quality of servicem) Implement a safe laboratory environment in compliance with

good laboratory practicen) To address complaints/ requests/ suggestions of all the

clientso) Ensure good staff morale

Prepared By: Dr Vishnu Kumar Designation: Quality


Section KCopy No.

ManagerSignature:Issue Date: Version NO. 1 Page 23 of 32



Quality Manual

Staffs of HLS have been trained to identify non-conformities in

the testing activities. Staff of HLS has been assessed for their

performance annually. If a need arises for retraining of

personnel, re assessment will be done following training.

Personnel employed for interpretation of reports are qualified

professionally who are educated and trained to make opinions/

interpretations/ predictions. This will be in accordance with

regulatory bodies. All staff of HLS has been made to understand

and maintain the confidentiality of the patient’s information.



Section KCopy No.



Accommodation andEnvironmentalconditions

Quality Manual

ACCOMMODATION AND ENVIRONMENTAL CONDITIONS

HLS has ensured that adequate accommodation and environmental

conditions are provided for all testing activities. HLS 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 and in case conditions jeopardize the results

of tests, the activity will be stopped and necessary corrective

action is taken. Lab is free from electromagnetic disturbances,

radiation, loud noise, vibration etc. Access to and use of

testing areas are controlled and only authorized persons are

allowed to access. HLS has provided all the sections wit intercom

facilities and easy accessibility to telephone for making

outgoing calls to ensure efficient transfer of messages. HLS has

an infrastructure which provides adequate storage space to

prevent the deterioration of samples, slides, retained micro-

organisms, documents, files, manuals, equipment, reagents,

laboratory supplies, records and results.



Section KCopy No.



Laboratory Equipment Quality Manual

LABORATORY EQUIPMENT

HLS is furnished with all items/ equipment required for correct

performance of the tests. All equipment used to perform test in

HLS is within it premises. Technical Heads of the respective

sections maintains records of equipment history and maintenance.

The records are maintained and easily available for life span of

the equipment. HLS 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. HLS

ensures test equipment (hardware and software) is safeguarded

from adjustments that would invalidate the test results.



Section KCopy No.



Pre- ExaminationProcedures

Quality Manual

PRE-EXAMINATION PROCEDURE

The request forms or an electronic equivalent contains adequate information to identify the patient and the clinicians requestingfor 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

HLS has defined procedure for transporting, receipt, handling, retention and/or disposal of test items, including all provisionsnecessary to protect the integrity of test items and to protect the interest of HLS and the customer. The detailed system procedure is outlined in HLS/SOP/2014.

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 t prevent physical confusion of test items andare 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, eachindividual 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 samples based on specific criteria for acceptance or rejectionor verification requirement. Records for re-sampling aremaintain. Any deviation

: Prepared By: Dr Vishnu Kumar Designation: Quality ManagerSignature:


Section KCopy No.



Pre- ExaminationProcedures

Quality Manual

In laid down procedure for sampling is documented on the request form and/or sample collection register. In cases where there is adoubt as to the suitability of a sample for test or when a sampledoesn’t conform to description provided, or test required is not specified in sufficient details, HLS or its specific laboratory staff consults the patient and/or the referring doctor of the deviation, seeks clarifications before proceeding and records thediscussion.

HLS 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 formwith the identity of the requesting person. The reports will be released only after the written orders or requests reach the lab.

HLS and its individual section have outlined procedures for avoiding deterioration loos/damage to the test items during storage, handling and preparation.



Section KCopy No.



Examination Procedure Quality Manual

5.5 EXAMINATION PROCEDURES

HLS 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 though a directory of services and requests are based on the acceptance ofthese (HLS/FRM/DOS/2014).

HLS selects appropriate method that has been published by reputedscientific organizations, relevant scientific text or journal or as specified by manufacturer of the equipment/ reagent. The details are maintained in their respective section, HLS 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 asper manufacturer’s recommendation.



Section KCopy No.



Assuring the Qualityof Examination

Procedure

Quality Manual

ASSURING THE QUALITY OF EXAMINATION PROCEDURES

HLS has a well planned and an established program for internalquality control to monitor and maintain the intermediate checksof quality results. All the staff members are trained to checkand 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 theanalysis of the samples.

HLS participates in inter laboratory comparison and/or ExternalQuality Assurance program. The resulting data is recordedresulting trends and statistical analyses are reviewed byindividual section head/technical managers.

Whenever a formal interlaboratory comparison program is notavailable, HLS shall participate in evaluation of samples byexchanging with other laboratories. HLS and its sections willmonitor the results of the interlaboratory comparison. In case ofa requirement of connective action, the same will be implementedand recorded.



Section KCopy No.



Reporting of Results Quality Manual

REPORTING OF RESULTS

HLS takes responsibility for generating Test Report format thathas been designed to meet the requirements of the clients. HLStakes the responsibility to ensure that reports are received bythe clients as per the specified turnaround time in the directoryof services (HLS/FRM/DOS/01)

The result of each test or series of tests carried out by all thesections of HLS is reported accurately, clearly, unambiguously,objectively, and in accordance, with any specific instructionsrequired by specific tests. The test report generated for eachtest / group of related tests will include all informationrequested by the customer, necessary for the interpretation ofthe test result and all information required to be mentioned forthe 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 identificationin order to ensure that the page is recognized as a part ofthe test report, and a clear identification of the testreport.

Unique identification parameter of the client by means of ahospital number or referral number linked to the Hospitalinformation System and records maintained by the Medicalrecord department

A description / condition and unambiguous identification ofthe sample(s) tested.

The date of receipt of the sample(s) where and the date(s)of performance of the test(s).

The tests results with, where appropriate, the units ofmeasurement.

The name(s), function(s) and signature(s) or equivalentidentification of person(s) authorizing the test report.



Section KCopy No.



Reporting of Results Quality Manual

The Jargons used for the tests and the reports will be simple andin 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 HLS/SOP/RA/2014. The reports are stored in such a way so that it can be easily retrieved.

HLS and its individual sections have procedures for establishing the critical limits for certain investigation that



Section KCopy No.


QUALITY MANUAL FOR HLS ERA MEDICAL COLLEGE WRITTEN BY DR VISHNU KUMAR AWASTHI

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