ASSESSOR CHECKLIST 1 - For Lead Assessor - ISO 15189:2022

Sep 1, 2026

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This document compiles amendment and content sections for a laboratory assessment process under NABL. It includes forms for assessment schedules, attendance and opening/closing meeting sheets, detailed records of fresh and re-testing/replicate testing, and summaries of non-conformities. It further provides assessor checklists aligned with ISO 15189:2022 for lead assessors, technical assessors, medical laboratory collection centres, and medical imaging conformity assessment bodies, specifying completion requirements, remark entry, and submission as part of the assessment report.

LanguageEnglish

CategoryForms

FormatDOCX

Pages85

Reading Time30 min

AccessFree to download

AMENDMENT SHEET

CONTENTS

NAF - 1

ASSESSMENT SCHEDULE

ATTENDANCE SHEET (OPENING & CLOSING MEETING)

DETAILS OF TESTING / RE-TESTING / REPLICATE WITNESSED DURING ASSESSMENT

Summary on Non-Conformities

SUMMARY OF ASSESSMENT

Form 72

RECOMMENDED SCOPE OF ACCREDITATION

Form 74

DECLARATION OF IMPARTIALITY & CONFIDENTIALITY

Assessor Checklist 1 - For Lead Assessor

ASSESSOR CHECKLIST 2 - For Technical Assessor

Assessor Checklist 3 - For Medical Laboratory Collection Centres / Facilities

Assessor Checklist 4 - For Medical Imaging-Conformity Assessment Bodies

AMENDMENT SHEET CONTENTS NAF – 1 ASSESSMENT SCHEDULE NAF – 1A ATTENDANCE SHEET (OPENING & CLOSING MEETING) NAF 3A DETAILS OF TESTING / RE-TESTING / REPLICATE WITNESSED DURING ASSESSMENT (To be filled in by the Technical Assessor) Fresh Sample Re-testing/replicate testing of Retained Sample Testing of CRM / SRM Remarks: (Enclose/upload all supporting data sheets for tests witnessed) (Signature & Name of Technical Assessor) NAF 4 Summary on Non-Conformities (Please use separate sheet for raising each Non-Conformity) NAF 6 SUMMARY OF ASSESSMENT Form 72 RECOMMENDED SCOPE OF ACCREDITATION Form 74 DECLARATION OF IMPARTIALITY & CONFIDENTIALITY (to be filled in by each Assessor and enclosed with the Assessment report) *CAB – Conformity Assessment Body (Testing / Medical / Calibration laboratory / Proficiency Testing Provider (PTP) / Reference Material Producer (RMP)) I _______________________________________________________, hereby declare that I have not offered any consultancy, guidance, supervision or other services to the CAB (e.g. internal audit), in any way. I am / am not* an ex-employee of the CAB and am/ am not* related to any person of the management of the CAB. I got an opportunity to go through various documents like Quality Manual/Management System document, Procedural Manuals, Work instructions, Internal reports etc. of the above CAB and other related information that might have been given by NABL. I undertake to maintain strict confidentiality of the information acquired in course of discharge of my responsibility and shall not disclose to any person other than that required by NABL. *Strike out which is not applicable Assessor Checklist 1 - For Lead Assessor ASSESSOR CHECKLIST 1 (ISO 15189: 2022) (To be filled in by the Lead Assessor) The following pages present a checklist of the criteria from ISO 15189: 2022, which is the basis for NABL to decide accreditation for laboratories. The laboratory’s policies and procedures must meet full requirements of ISO 15189:2022, NABL 133, NABL 142, NABL 163 and NABL specific criteria where ever applicable. The actual standard must be referred for the definitive language and interpretation. #The Lead Assessor must complete this checklist, put initials on each page. The following symbols may be used for completing this checklist. The Lead Assessor must review the laboratory’s documented system to verify compliance with the requirements of ISO 15189: 2022 assess to verify that the documented management system is indeed implemented as described, record conclusion/comments related to any requirements. All non-conformity(ies) must be identified and reported separately on NAF a4. This checklist be submitted as a part of the assessment report. #-Applicable for Offline Assessments Assessor shall enter comment in “REMARK” box for each sub clause. Comments of Assessor on compliance against: - Assessor Checklist 2 - For Technical Assessor ASSESSOR CHECKLIST (ISO 15189: 2022) (To be filled in by the Technical Assessor) The following pages present a checklist of the criteria from ISO 15189: 2022, which is the basis for NABL to decide accreditation for laboratories. The laboratory’s policies and procedures must meet full requirements of ISO15189: 2022 and specific criteria where ever applicable. The actual standard must be referred for the definitive language and interpretation. The Technical Assessor must complete this checklist. #The Technical Assessor must complete this checklist, put initials on each page. The following symbols may be used for completing this checklist. The Technical Assessor must review the laboratory’s documented system to verify compliance with the requirements of ISO 15189: 2022 assess to verify that the documented management system is indeed implemented as described, record conclusion/comments related to any requirements. All non-conformity (ies) must be identified and reported separately on NAF-4. This checklist be submitted as a part of the assessment rep

FAQs

What is the purpose of the assessor checklists in this document?

They provide criteria-based checklists aligned with ISO 15189:2022 so NABL can decide laboratory accreditation. Lead and technical assessors are required to complete them and submit them with the assessment report.

How should the Lead Assessor complete and submit the checklist?

The Lead Assessor must complete the checklist, put initials on each page, and record conclusion/comments for applicable requirements. Any non-conformities must be reported separately on the specified NAF form.

What information is required for collection centres and medical imaging assessment bodies?

For collection centres, it covers accommodation and environmental conditions, equipment, material, staffing, documentation, health and safety, waste disposal, specimen transport, packaging, and complaints/feedback. For medical imaging bodies, it covers accommodation, staffing, labeling, imaging protocols, and reporting.

Sep 1, 2026

Upload by Mason