165x Filetype DOCX File size 0.11 MB Source: nabl-india.org
NABL 153 National Accreditation Board for Testing and Calibration Laboratories (NABL) Application Form for Medical Testing Laboratories ISSUE NO.: 06 AMENDMENT NO.: 04 ISSUE DATE: 22-Jan-2018 AMENDMENT DATE: 11-Jan-2022 AMENDMENT SHEET S. Page Clause Date of Amendment Reasons Signature Signature No. No. No. Amendment QA Team Competent Authority 1 9& 7& 9 22.03.2018 Change in Payment option Development of -Sd- -Sd- 12 NABL payment gateway/ Cheque/DD 2 6 1.9 20.06.2018 a to d from a to c typographical -Sd- -Sd- error 3 11 Annexu Changes as highlighted Start of -Sd- -Sd- re-A Recognition of SCF 4 3 1 28-Apr- Following content included In line with -Sd- -Sd- 2020 ‘fraudulent behavior, false ISO/IEC 17011: information and concealing 2017 the information may lead to requirements rejection of application or termination of the assessment process. 5 3 5 Reference to NABL 201 NABL 201 has deleted been withdrawn 6 3 6 Type and evidence accepted Align with other in support of legal identity application form document included 7 3 8 Word ‘APLAC’ is replaced Due to merger with APAC of APALC in PAC, new organisation name is APAC 8 4, 11, Alignment of Scope of In-line with Cl. 7 2.2 Accreditation as highlighted 7.8.3 of ISO/IEC 17011: 2017 9 4, 15, Rearrangement in the text Policy decision 7 3.2 related to the Proposed person(s) reviewing the results and authorizing the release of the report as highlighted 10 6 1.8 Inclusion of two new Outcome of categories management review 11 6 2.1 Disciplines are aligned as NABL 112 is per NABL 112 implemented. 12 8 3.4.1 Requirements of 4 days Outcome of training removed management review 21 4, 5 - 11.01.2022 As highlighted For better -Sd- -Sd- clarity/ internal review 22 7 1.3 Requirements for Mobile Van Internal review and Movable container included 23 8 1.9 Text revised for better clarity 24 9 2.1 Medical imaging discipline National Accreditation Board for Testing and Calibration Laboratories Doc. No.: NABL 153 Application Form for Medical Testing Laboratories Issue No.: 06 Issue Date: 22-Jan-2018 Amend. No: 04 Amend. Date: 11-Jan-2022 Page No.: 1 of 17 included 25 10, 3.2, As highlighted 11, 4, 5, 12 8 26 15 - Declaration Form included National Accreditation Board for Testing and Calibration Laboratories Doc. No.: NABL 153 Application Form for Medical Testing Laboratories Issue No.: 06 Issue Date: 22-Jan-2018 Amend. No: 04 Amend. Date: 11-Jan-2022 Page No.: 2 of 17 CONTENTS S. No. Title Page No. Amendment Sheet 1 Contents 2 1 Information & Instructions for completing an Application Form 4 2 Application Form 7 Declaration Form 15 National Accreditation Board for Testing and Calibration Laboratories Doc. No.: NABL 153 Application Form for Medical Testing Laboratories Issue No.: 06 Issue Date: 22-Jan-2018 Amend. No: 04 Amend. Date: 11-Jan-2022 Page No.: 3 of 17
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