NABL 151(T)



NABL 153National Accreditation Board for Testing and Calibration Laboratories (NABL)Application Form for Medical Testing LaboratoriesISSUE NO.: 06ISSUE DATE: 22-Jan-2018AMENDMENT NO.: 03AMENDMENT DATE: 28-Apr-2020AMENDMENT SHEETS. No.Page No.Clause No.Date of AmendmentAmendment ReasonsSignatureQA TeamSignatureCEO19 & 127 & 922.03.2018Change in Payment optionDevelopment of NABL payment gateway/ Cheque/ DD-Sd--Sd-261.920.06.2018a to d from a to ctypographical error-Sd--Sd-311Annexure-A20.06.2018Changes as highlightedStart of Recognition of SCF-Sd--Sd-43128-Apr-2020Following content included ‘fraudulent behavior, false information and concealing the information may lead to rejection of application or termination of the assessment process.Inline with ISO/IEC 17011: 2017 requirements-Sd--Sd-535Reference to NABL 201 deletedNABL 201 has been withdrawn636Type and evidence accepted in support of legal identity document included Align with other application form738Word ‘APLAC’ is replaced with APACDue to merger of APALC in PAC, new organisation name is APAC84,711, 2.2Alignment of Scope of Accreditation as highlightedIn-line with Cl. 7.8.3 of ISO/IEC 17011: 2017 94,715,3.2Rearrangement in the text related to the Proposed person(s) reviewing the results and authorizing the release of the report as highlightedPolicy decision1061.8Inclusion of two new categoriesOutcome of management review1162.1Disciplines are aligned as per NABL 112NABL 112 is implemented.1283.4.1Requirements of 4 days training removed Outcome of management review13CONTENTSS. No.TitlePage No.1Information & Instructions for completing an Application Form32Application Form5Information & Instructions for completing an Application FormApplication shall be made in the prescribed form NABL 153 only. All applied fields of medical testing should be covered in the same application form. The application shall consist of the following:Copy of completed application form Copy of laboratory Quality Manual Prescribed application feesDuly signed NABL-131Incomplete application fraudulent behavior, false information and concealing the information may lead to rejection of application or termination of the assessment process.2.The applicant laboratory shall undertake to carry out its testing activities in such a way as to meet the requirement of ISO 15189:2012, NABL specific criteria, other relevant requirements of NABL and the regulatory authorities, as applicable at all times. 3. Applicant laboratories are advised to ensure that the latest versions of NABL documents are available with them.The application fee and other necessary charges related to accreditation process is given in NABL document NABL 100 ‘General Information Brochure’ under NABL Finance and NABL Fee Structure’. NABL 100 is available on NABL website.Laboratories are advised to familiarize themselves with NABL 100 ‘General Information Brochure’, NABL 216 ‘Procedures for Dealing with Adverse Decisions’ and NABL 131 ‘Terms and Conditions for Obtaining and Maintaining Accreditation’ before filling up this form. The applicant CAB shall provide photocopy of following appropriate document(s) in support of the legal status claimed: Proprietorship firm (Bank passbook, Account statement, ID of the Proprietor) Partnership (Copy of Registration under 1932 Act) Company Act (Copy of Registration under 1956 Act) Societies Registration Act (Copy of Registration under 1860 Act) Indian Trust Registration Act (Copy of Registration under 1882 Act) Limited Liability Partnership (Limited Liability Partnership Act, 2008) Government (Copy of Government Notification / Declaration etc.)The applicant laboratory shall intimate NABL about any change in the information provided in this application such as scope applied for accreditation, personnel, and location etc. within 15 days from the date of changes.NABL expects applicant laboratories that are to be accredited to follow the test methods as mentioned in the current National or International standards and as stipulated by regulatory bodies. Where such methods do not exist, other validated methods are acceptable. In case laboratory uses in-house validated methods the validation data should be submitted along with the application. The applicant laboratory must participate satisfactorily in the Proficiency Testing program / EQAS conducted by APAC or NABL any other national or international accredited/ recognized PT provider. For participation in PT, refer NABL document NABL 163. .The laboratory shall also inform NABL in advance about any reservation regarding appointment of Lead Assessor/ Assessor for the assessment.The applicant laboratory shall be given due notice of any intended changes relating to NABL accreditation criteria and will also be given such time, as in the opinion of NABL is reasonable to carry out the necessary adjustments to its procedure(s). The laboratory shall inform NABL when such adjustments have been completed. The application must be filled up carefully to provide required information in such a manner that further correspondence for seeking clarifications are not required. Particularly the scope of accreditation (para 2.2) shall be complete to indicate unambiguously:Materials or Products testedComponent, parameter or characteristic tested/ Specific Test Performed/ Tests or type of tests performedTest Method Specification against which tests are performed and/or the techniques/ equipment usedrange of testing/ limit of detection for each test (as applicable) % CV (or) uncertainty of measurement (MU) for each test (wherever applicable) at a confidence probability of 95%.The laboratory locations, tests, which the laboratory intends to cover, vide NABL accreditation must be listed clearly. The tests those are performed at site should be clearly identified in the scope of accreditation (para 2.2).Note: Multilocation laboratory: A laboratory with more than one location in the same city with same legal identity and with overlapping scopes in different locations. The details of each location shall be explicitly mentioned in 1.1 of application form. In events where the laboratory operates from different city/ state, each laboratory shall apply separately for accreditation except those cases where safety or regulatory requirements are there for operation of the laboratory. In such cases, the laboratory shall provide the proper justification. The laboratory shall submit NABL 131 duly signed by the Chief Executive or his/her Authorized Representative to NABL Secretariat along with this application form. By signing NABL 131 the laboratory agrees to comply at all times with Terms and Conditions of NABL. The laboratory shall offer the NABL or its representative cooperation in:undertaking any check to verify testing capability of the laboratory.providing names of all personnel competent to report, review and authorization of results (Signing of test reports) of the laboratoryoffering access to relevant areas of the laboratory including primary sample collection centres for witnessing the activity being performed.examination of all relevant documentation and records. interaction with all relevant personnel.The laboratory shall discharge all non-conformities raised during the assessment within the stipulated time. The same shall be verified to the satisfaction of NABL. The final decision on accreditation shall rest with NABL.The application shall be kept confidential by NABL and information obtained during the processing of application, assessment visit and grant of accreditation shall be safeguarded and dealt with impartiality until required by Law. The procedure for processing of application for accreditation is given in NABL 100. Application Form for Laboratory AccreditationWe apply for NABL accreditation of our medical testing laboratory as per details given below:First AccreditationRenewal of Accreditation Extension of Scope (Apart from the scheduled assessment) (If accredited by NABL, Please provide accreditation certificate no. & validity (if applicable) & CAB ID:____________________________________________________________________________________________1. Laboratory Details1.1Name/ Identification of the Laboratory _______________________________________________ (Permanent Facility) Locations and Address(s)__________________________________________________________Telephone No. _____________________ Fax No. __________________E-mail ________________Note: Refer cl 13 of NABL 153 & cl 3 & 4 of NABL 112 for details on laboratory locations 1.2Does the laboratory operate from different locations having same legal identity within the city?YesNoa.If yes, whether application for accreditation covers all locationsYesNob.If yes, whether complete details have been provided for each location with respect to 1.1, 2.1, 2.2, 3.1.2, 3.1.3, 3.3, 4, 6 of the application form.YesNo1.3Do you conduct Testing in the following Category (if yes, please clearly indicate in the scope of accreditation, sl. no. 2.2, the test conducted)a.Site Facility (when undertaking testing at site of the customer)YesNob.Permanent Facility YesNoc.Mobile LaboratoryYesNoNote: Please refer NABL-130 for requirements on site /mobile facilities 1.4 Name of Parent Organization ________________________________________________________ (if part of an organization) Telephone No. _____________________ Fax No. __________________ E-mail _______________1.5 Legal identity of the laboratory and date of establishment ______________________________ (Please give Registration No. and name of authority who granted the registration. Copy of the certificate shall be enclosed)_________________________________________________________________________________________________1.6 Goods and Service Tax (GST) Number along with PAN/TAN Number ______________________________________________________________________________________1.7 Type of laboratory by service (please tick in appropriate box)open to others partly open to others an in-house activityCategory for which accreditation is being sought Micro LaboratoryMini LaboratorySmall LaboratoryMedium LaboratoryLarge LaboratoryVery Large LaboratoryNote: Refer section 4 for details on category1.9 Does laboratory gets samples from Sample Collection Centres/ Facilities YesNo(If yes, please furnish details of Sample Collection Centres/ Facilities (Refer Annexure-A Attached with Application. List of collection centres / facilities shall be segregated as defined in clause 6 (a to d) of NABL- 112.1.10Details of other source(s) of sample collection other than the medical testing laboratory or sample collection centre/ facility(Provide list of all facilities with complete contact details with address) 1.11 Other accreditations ______________________________________________________1.12 Indicate exactly how the name of the laboratory and the centres (if any) are to appear on the certificate In English __________________________________________________________________________________________________________________________________________________________2. Accreditation Details2.1 Disciplines for which accreditation is sought (please tick the appropriate box, separate application to be filled for each discipline, refer to NABL 112 for details on scope)Clinical BiochemistryClinical PathologyHaematology Microbiology and Infectious Disease SerologyHistopathology CytopathologyFlow CytometryCytogeneticsMolecular Testing2.2 Scope of Accreditation S. No. Materials or Products testedComponent, parameter or characteristic tested/ Specific Test Performed/ Tests or type of tests performedTest Method Specification against which tests are performed and/or the techniques/ equipment usedRange of testing/ Limit of detection%CV / MU( )Note 1. Laboratories applying for Point of Care testing shall clearly identify the specific tests/examination performed.Note 2. Laboratories are encouraged to provide estimates of Measurement of Uncertainty (MU) / % CV. MU should be calculated at a confidence probability of 95%.3. Organization 3.1 Senior Management (Name, Designation, Telephone, Fax, E-mail)3.1.1 Chief Executive of the laboratory _________________________________________________3.1.2 Laboratory Director _________________________________________________3.1.3 Person responsible for the management system _____________________________________3.1.4 Person responsible for technical operations ________________________________________Contact person for NABL _______________________________________________________Proposed personnel competent to report, review and authorization of results (Signing of test reports) 3.2.1 Proposed personnel competent to report, review and authorization of results (Signing of test reports) of CABs(Please refer to NABL 112 for qualification and experience details)S. No.Laboratory/ Department/ SectionName & Designation of SignatoryQualification with SpecializationExperience in years related to present workRelevant Training Part time / Full time (timings if part time)Authorised for which specific area of testing Specimen Signature3.3Organization Chart3.3.1.Indicate in an organization chart the operating departments of the Medical testing laboratory for which accreditation is being sought (please append)3.3.2Indicate how the testing laboratory is related to external organizations or to its own parent organization (where applicable)3.4 Employees 3.4.1 Details of staff S. NoNameDesignationAcademic and Professional Qualifications*Experience related to present work (in years)* Please clearly indicate the field of specialization Note: Laboratory operating in shifts shall clearly identify the staff working in shifts 4. Equipment and Reference MaterialsList of major test equipment available for use S. NoName of equipmentModel/ type/ year of makeReceipt date & date placed in serviceRange and accuracyDate of last calibrationCalibration due on *Calibrated by**List of reference materials available for use S. No.Name of reference material/ strain/ cultureSourceDate of expiry/ validity Traceability* the laboratory to decide the calibration interval based on NABL-112 & ISO 10012 or ILAC-G24 ** Please mention name of calibration agency. In case the equipment is calibrated in-house, same needs to be clearly indicated under this column.5. Internal Audit and Management Review 5.1 Date /schedule of last Internal Audit _________________________________________________5.1.1Whether all requirements of ISO15189:2012 covering all activities of laboratory have been audited at least once in last one year YES/NO5.1.2Whether various locations (including collection centres) were covered in the audit: YES /NO5.1.3 Whether pre and post examination activities were included in the audit schedule: YES/NODate of last Management Review ___________________________________________________6. Proficiency TestingParticipation in PT / any other Inter Laboratory Comparison/EQAS (for details and requirements please refer to ISO/ IEC 17043, & NABL 163, NABL 112)S.No.Product/ MaterialDetails of Test(s)/ examinationDate of Testing/ examinationOrganizing body Performance in terms of z score or any other criteriaCorrective action taken (if required)7. Application Fees Application fees (Rs).____________________________________________________________DD / At par Cheque* number___________________________________________________________(Please refer Specific Criteria for Medical Testing Laboratories; NABL 112) *All payments made through Cheques or Demand Draft shall be made in favor of ‘Quality Council of India' payable at Gurgaon. Note: Kindly make all kind of payments preferably through the ‘Payment Gateway’ available on NABL website (nabl-)8. Declaration by the laboratoryWe declare that 8.1We are familiar with the terms and conditions of maintaining accreditation (NABL 131), which is enclosed and will abide by them.8.2 We have conducted internal audit of our Sample Collection Centre/ facility (ies) at least once during the last one year.8.3We agree to comply fully with ISO15189:2012 and relevant specific criteria for the accreditation of testing laboratory and associated Sample Collection Centre/ Facility (ies).8.4We agree to comply with accreditation procedures, pay all costs for pre-assessment, assessment, verification visit (if any), surveillance and reassessment irrespective of the result.8.5We agree to co-operate with the assessment team appointed by NABL for examination of all relevant documents by them and their visits to those parts of the laboratory that are part of the scope of accreditation.8.6We satisfy all national, regional and local regulatory requirements for operating a laboratory. 8.7__________________________________________________________________ has provided consultancy for preparing towards NABL accreditation. (Information regarding any individual or organization who provided consultancy (if any) for NABL accreditation shall be declared)8.8 No adverse action has been initiated / taken against the laboratory in the past. (If yes, please provide the details with present status ………………………………………………………..) 8.9 Self declaration shall be submitted by the laboratory on the basis of the internal audit conducted by them, to confirm to NABL that their collection centres / facilities are complying with NABL norms and relevant clauses of ISO 15189.8.10 All information provided in this application is true.Signature of Laboratory Head/ Laboratory Director _________________________________________Name & Designation ________________________________________________________________Date & Place ______________________________________________________________________Annexure - ASample Collection Centre/ Facility (SCF) (To be submitted by lab declaring SCFs)Lab IDLab NameCertificate No. (M-/MC-)Issue Date (dd.mm.yyyy)Valid Date (dd.mm.yyyy)No. of Sample Collection entreStateCityPINLocation of LabComplete Lab AddressMode of Payment (Drop Down - DD/ Cheque/ UTR/ Receipt)Name of BankDD/Cheque/ UTR/ Receipt NoDate (dd/mm/yyyy)AmountFirst NameLast NameEmailGive Details of Sample Collection Centre/ Facility (Add rows for more SCFs)Lab IDName of Collection Centre/FacilityType of Collection centre/facility (Refer clause 6 (a to c) of NABL- 112Owner/Contact PersonEmailPhoneMobile NumberLast Internal Audit Date dd/mm/yyyyAv. No. Patient/ DayAreas of SCF (in Sqm)Distance from Laboratory (in Km)Type of Transport(Rail/Road/Air)Logistics arrangementDoes centre/ facility complies with latest Biomedical waste management rules - Y/NTentative assessment (Fortnight 1/2)Month for the assessmentStateCityPINLocationLandmarkAddress9. Application Form - Check ListS. rmation / details provided as part of applicationAvailabilityThree copies of Application FormsTwo copies of Quality Manual (latest issue) according to ISO 15189 : 2012 Application feesInformation on size of the laboratory & number of Collection Centres applied for accreditationEstimated applicable fees as per NABL 100Demand Draft / At Par Cheque in favor of Quality Council of India’ & details of payment made through Payment Gateway of NABLCopy of Legal Identity (Registration Details of the Laboratory)Goods and Service Tax (GST) Number along with PAN/TAN NumberDetails of Sample Collection Centre/ Facility as per Annexure-A (if applicable)Scope of Accreditation with Test Methods, Range of Testing and MU/ % CVDetails of Senior Management with Designation and Contact Details List of Staff and proposed Authorized SignatoriesOrganization Chart enclosed List of Equipments / Reference Material used with details of TraceabilityDetails of PT/EQAS / ILC participationDates of Internal Audit and Management ReviewSelf declaration to confirm that laboratory’s collection centres/ facilities are complying with NABL norms and relevant clauses of ISO 15189 on the basis of the internal audit conducted by laboratory.Declaration about the Consultant (if any)Signed copy of NABL 131 ( latest issue)Verified the above details and confirmed the availability of all required documents/ details as part of application form.Signature of Laboratory Head / Director Name & Designation Date & Place __________________________________________________________________________National Accreditation Board for Testing and Calibration Laboratories (NABL)NABL House,Plot No. 45, Sector- 44, Gurugram– 122003, HaryanaTel.: +91-124 4679700Fax: +91-124 4679799Website: ................
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