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ACCAB-ASM-14.0-G RD-01-01/01/13© ACCAB Page 1 of 5

Note:
1.
The applicant should read and understand ACCAB’s Accreditation Scheme Manual especially the Requirements for
Granting and Maintaining Accreditation and the Current Fee Structure before submitting the application in the prescribed format.
2.
It is expected that the applicant Medical Laboratories have a specific & assured plan of action for obtaining the
ACCAB accreditation and nominate a senior & accountable person to co-ordinate all activities related to the accreditation process.
3.
The person nominated should be familiar with the laboratories documented quality system and applicable legal & statutory requirement.
4.
Please type or print clearly and attach extra sheets if needed with clear cross references.
5.
This form may be obtained and submitted electronically.
6.
An application form for accreditation cannot be accepted unless it is completed fully and accompanied with the requisite application fee.
7.
In case of application for the Extension or change in scope, please highlight the relevant information.
8.
Duly filled application form, required documents and requisite fess must be sent to The Chief Executive Officer of
ACCAB.
Accreditation Standard: ISO 15189:2012
Initial Assessment Extension of Scope Reassessment Transfer Change in Scope
Part - I GENERAL INFORMATION
Name of the Applicant
Laboratory:
Main Address
(Permanent Facility) :
Location of Additional Sites
/Locations To Be Assessed Under
Accreditation Scope Includes Site
Facility & Mobile Laboratory
(If Applicable):
Primary Nominated Person: Mobile:
Email:
Position:
Person Responsible in absence of
the Primary Nominated Person:
Mobile:
Position: Email:
Fax No:
Telephone No:
Website: Email:
Legal
Status:
Government Department
An Unlimited Company
A Sole-Proprietor Organization
A Statutory Body
A Public Listed Company
Trust
Name of the Parent Organization
(If part of an organization) :
Telephone No.: Fax No:
A Private Limited Company
Limited Liability Partnership
Any Other
E-mail:
ACCAB-ASM-14.0-G RD-01-01/01/13© ACCAB Page 2 of 5

Type of Laboratory by Service:
Open to Others Partly Open to Others An In-house Facility
Details of primary sample collection facilities at sites other than the permanent facility
(please provide list of all facilities complete with contact details, you may use separate sheet):
Filed(s) / Area(s) of Testing, the Accreditation Applied for (please tick the appropriate box, separate application to be filled for each discipline): (Please refer Guide ASM- GD-4.0 for further details)
Pathology
Hematology
Microbiology
Imaging
Chemistry
Histocompatibility
Point Of Care Testing
Any Other , Pl. Specify
Cytogenetics
Immunology
Immunohematology
Scope of Accreditation:
Please complete the following table accurately as possible and include:
1.
Tests/Examinations undertaken at site;
2.
Laboratories may support their application by providing estimates of measurement of Uncertainty (MU) %
CV. MU should be calculated at a confidence probability of 95%;
3.
Location - in the laboratory or an offsite location;
4.
Please use separate sheet if required.
Medical Field Biological Samples
Examination
Technique
Components /
Analytes
Examination
Procedure
Reason for seeking ACCAB
Accreditation:
It is an Independent, Impartial and Non-Governmental Body
Responsiveness & Non Bureaucratic Attitude
Technical Approach to the Accreditation
Market Reputation
Cost Effectiveness
Any Other(Pl. Specify)
Consultant Details
(if services utilized):
Number of employees: Professional/Technical: Administrative:
Part -II ATTACHMENT CHECKLIST
Sr.
No.
Documents Required
Attached-
Yes/No
Document
No./Reference
Confirmed by
ACCAB
Date: By:
ACCAB-ASM-14.0-G RD-01-01/01/13© ACCAB Page 3 of 5

1 Evidence of Laboratory is legally identifiable
( details of statutory, regulatory or any other relevant permission to operate officially as a clinical laboratory)
2 Quality Manual
3 Reference/List to Procedures, Lower Level
Documents & Records maintained by Laboratory
4 Organization chart with key positions clearly identified
5 List of Equipments / Reference Material used with details of Traceability.
6 Details of the Senior Management Such as
Laboratory Manager, Quality Manager,
Administration Manager or by any other designations.
7 List of Staff & Proposed Authorized Signatories.
8 Current list of Subcontractors (If applicable)
9 Current list of Subcontractors / Technical Staff
(Technical competence against the scope being applied for)
10 Record of the latest Internal Audit Report
11 Record of the latest Management Review
12 Laboratory Mark/Logo copyright ownership evidence (If applicable)
13 Scope of Accreditation with Calibration Methods,
Range of Calibration and MU to be Assessed as detailed in the Application Form
14 Details of Proficiency Testing/Inter Laboratory
Comparison
Sr.
No.
Product /
Material
Details of
Test(s)/Examination
Date of
Testing/Exa mination
Organizing
Body
15
Copy of the most recent Accreditation report, if any
ACCAB-ASM-14.0-G RD-01-01/01/13© ACCAB
Performance in terms of Z score or any other criteria
Corrective action required
Page 4 of 5

16 Requisite Application Fee
17 Any Other
Please give detailed justification, if you have not attached any particular document with the time line of its submission to ACCAB.
Part - III ESSENTIAL DECLARATIONS BY THE APPLICANT MEDICAL LABORATORY
Sr.
No.
Description
1
2
3
4
5
6
7
8
9
We have read and understood the ACCAB accreditation requirements and shall continually fulfill the requirements of accreditation set by ACCAB for the areas where accreditation is applied for. We have documented and implemented the quality management system as per ISO 15189:2012.
We offer our unconditional support to the mission and objectives of the ACCAB, and shall ensure that we shall always act in accordance with that.
We confirm that there is no current legal processes or allegations concerning the compliance of the applicable legal and statutory requirements and should we become aware at any time following accreditation being granted that legal proceedings have been initiated or other allegations concerning the legal compliance arise, we shall notify the ACCAB as soon as it is practicable and within a maximum of seven Days, and shall advise the
ACCAB of the outcome of any such proceedings and the statement shall be signed by the top management;
We understand and accept that the ACCAB provides no guarantees to the applicant MEDICAL
LABORATORYs that their application for accreditation shall be successful. In such cases the ACCAB reserves the right to forfeit the application fee.
We confirm that that we have informed ACCAB of any matter that may be deemed significant when adjudicating the application should it come to light at a later date.
We shall host, make necessary arrangements and cooperate with the ACCAB assessors and shall provide all the necessary assistance, including access to the our facilities, documents, records, authorized personnel, relevant areas for witnessing the tests being performed, in any accreditation, surveillance, special or re-accreditation audits.
We have necessary resources to pay ACCAB accreditation fee in accordance with the current ACCAB Schedule of Fees.
We shall not make any claims to be accredited for those services for which accreditation has not been granted, nor issue any ACCAB accredited tests/examination reports prior to our accreditation.
We shall not act in any manner as to bring ACCAB into disrepute, nor make any public statement regarding our accreditation that ACCAB may consider misleading or unauthorized.
10
11
We confirm that we are aware that ACCAB does not accept liability for mistakes that accredited MEDICAL
LABORATORYs may make in terms of their accreditation nor does ACCAB accepts liability for any mistakes that may possibly occur on the certificates or reports issued by ACCAB accredited MEDICAL
LABORATORIES. Further we confirm that liability of ACCAB is limited to the fees charged by ACCAB for the accreditation application.
Our Laboratory is:
Small Laboratory (Up to 100 Patients /Day)
Medium Laboratory (101-400 Patients/ Day)
Large Laboratory (400-1000 Patients/ Day)
Very Large Laboratory (more than 1000 Patients/ Day)
12
Number of Collection Centers:
Up to 25 > 26-100 More than 100
13 The information provided by us in this application is correct.
SIGNATURE OF LABORATORY HEAD/DIRECTOR:
Position: Date: Name:
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