NABL 209

National Accreditation Board for Testing

and Calibration Laboratories (NABL)

Pre-Assessment Guidelines and Forms

(based on ISO/IEC 17025)

ISSUE NO. : 04 AMENDMENT NO. : 03

ISSUE DATE : 19-Apr-2016 AMENDMENT DATE : 21-Dec-2018
 AMENDMENT SHEET

Sl Page Clause Date of Amendment Reasons Signature Signature

No. No. Amendment QM CEO
1 2,3, 4 2&3

2 5, 6, 7 NPF-1 21.12.2018 As highlighted Policy decision -Sd- -Sd-

3 10 NPF-3

10

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 209 Pre-Assessment Guidelines and Forms ( based on ISO/IEC 17025)
Issue No: 04 Issue Date: 19-Apr-2016 Amend No: 03 Amend Date: 21-Dec-2018 Page No: 1/11
 CONTENTS

Sl. Title Page Nos.

Amendment Sheet 1

Contents 2

1. Guide to use Pre-Assessment Forms & Checklist 3

2. Pre Assessment Checklist – NPF 1 5

3. Non Conformities Observed during Pre-Assessment – NPF 2 9

4. Pre Assessment Report – NPF 3 10

5. Declaration of Impartiality & Confidentiality – Form 74 11

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 209 Pre-Assessment Guidelines and Forms ( based on ISO/IEC 17025)
Issue No: 04 Issue Date: 19-Apr-2016 Amend No: 03 Amend Date: 21-Dec-2018 Page No: 2/11
GUIDE TO USE PRE-ASSESSMENT FORMS & CHECKLIST

1. INTRODUCTION

It is presumed that the Lead Assessor, who has been nominated by the NABL Secretariat, is fully aware
of the NABL Accreditation process, its objectives and the on-site Assessment procedure. The Lead
Assessor shall have the overall responsibility of conducting the assessment and shall be responsible pre-
assessment of the laboratory and for conducting the on-site assessment of the concerned laboratory.
Towards the task of on-site assessment, the lead assessor shall be assisted by a team of assessors
commensurate with the scope of accreditation.

This document contains Pre-assessment forms and Checklist, which shall be used to report the pre-
assessment findings. The document shall guide the Lead Assessor in completing various forms &
checklists and compiling the report.

2. PRE-ASSESSMENT

After the laboratory has taken the corrective action on the concerns expressed in the adequacy report
after the document review and has submitted a report to the satisfaction of the NABL, NABL Secretariat
shall fix up a date for Pre-assessment (if desired by the laboratory as pre-assessment is optional) in
consultation with the laboratory and the Lead Assessor.

While the Lead Assessor proceeds to the laboratory for Pre-assessment, he should be in possession of
the laboratory’s Applications Forms, Quality Manual/ Management system document, Corrective action
report on the adequacy of document review and any other information supplied by NABL Secretariat.

The Lead Assessor, during Pre-assessment shall:

i. check the overall implementation of the management system as per the documented Quality
Manual/ Management system document.
ii. study the scope of accreditation so that the time frame, number of assessors required in various
fields/ disciplines and visits to Site testing/ calibration facilities, if applicable, for the assessment
can be determined. The Lead Assessor shall also assess whether the Assessment is required to
be split, based on the location of laboratory or the number of fields/ disciplines and departments.
iii. check whether the laboratory has conducted a comprehensive Internal Audit in accordance with
ISO/ IEC 17025 .
iv. assess the degree of preparedness of the laboratory for the Assessment in terms of compliance
to NPF 1.

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 209 Pre-Assessment Guidelines and Forms ( based on ISO/IEC 17025)
Issue No: 04 Issue Date: 19-Apr-2016 Amend No: 03 Amend Date: 21-Dec-2018 Page No: 3/11
 v. obtain signatures on NABL 131 – Terms and Conditions for Obtaining and Maintaining
Accreditation, from the laboratory, if not submitted by laboratory earlier
vi. explain to the laboratory regarding the methodology to be adopted for Assessment and the
obligations of the laboratory
vii. submit a report to NABL Secretariat

3. COMPILATION OF PRE-ASSESSMENT FORMS & CHECKLIST

The Lead Assessor must review the Laboratory’s documented management system to verify compliance
with the requirements of ISO/ IEC 17025. He should complete the Checklist NPF 1 by recording his
observation – ‘Yes’ or ‘No’ (by marking a  in the appropriate box), related to the requirements of
respective clause number of the checklist and offering brief comments. If the Lead Assessor has a doubt
in other area(s), even though not listed in the checklist, he is free to assess or go into details where he
feels and annex his findings, to the report.

All Non-Conformity (ies) must be identified and to be reported, in NPF 2. Additional sheets may be added,
if required. The Lead Assessor should finally summarise the conduct of Pre-Assessment and record the
recommendations in NPF 3. The Lead Assessor must carefully fill the forms and check list and sign all
pages of the Pre-Assessment Report. He should also obtain signature of the authorised person of the
laboratory on NPF 2 & 3. The report should be compiled in the order NPF 3, 2, 1 & Form 74 and any
other additional pages or annexure thereafter.

The Lead Assessor shall submit the Pre-Assessment Report to NABL Secretariat within 10 days of
completion of Pre-Assessment.

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 209 Pre-Assessment Guidelines and Forms ( based on ISO/IEC 17025)
Issue No: 04 Issue Date: 19-Apr-2016 Amend No: 03 Amend Date: 21-Dec-2018 Page No: 4/11
 NPF 1
1 of 4

PRE-ASSESSMENT CHECKLIST

Laboratory: Date(s) of Visit:

Sl. Requirement Observation*

Yes No

1. Review of Application Form(s)

 for correctness of contents
 for Scope of accreditation
Comments on Application Form:

2. Management System Documentation

 Document review – cross-reference to Procedures and other documents
 Availability of all required cross-referenced Procedures (list enclosed) (wherever
applicable)
 Availability of other documents like Standards, Codes, Calibration/ Test
methods, Operating Instructions etc. (list enclosed)
 Availability of NABL documents (list enclosed)
Comments on Management System Documentation:

3. Management System Implementation (sample audit)

 Availability of relevant documents at place of work
 Are procedures being followed
 Awareness of Management System and NABL requirements
Comments on Implementation and effectiveness of Management System:

* Mark  in the appropriate box

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 209 Pre-Assessment Guidelines and Forms ( based on ISO/IEC 17025)
Issue No: 04 Issue Date: 19-Apr-2016 Amend No: 03 Amend Date: 21-Dec-2018 Page No: 5/11
 NPF 1
2 of 4

Sl. Requirement Observation*

Yes No

4. Internal Audit
 Availability of Audit Procedure
 Availability of Audit Plan
 All requirements of ISO/ IEC 17025 is applicable, covering all activities of
laboratory audited at least once in the last one year
 Timely corrective action on non-conformities
 Audit conducted by qualified, trained and Independent personnel
Comments on effectiveness of Internal Audit:

5. Management Review
 Availability of Management review Procedure
 All requirements of ISO/ IEC 17025 are incorporated in the agenda of review in
the last one year
 Evidence of at least one Management review
Comments on effectiveness of Management review:

6. Personnel
 4 days training programme for designated Quality Manager on ISO/ IEC 17025
(refer Policy document NABL 165)
 Training programme on ISO/ IEC 17025, organised for laboratory personnel
 Plan/ Schedule for imparting training to laboratory personnel for the current year
 Suitability of persons authorised to sign test reports/ calibration certificates with
reference to the applied scope
Comments on Personnel and Training:

* Mark  in the appropriate box

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 209 Pre-Assessment Guidelines and Forms ( based on ISO/IEC 17025)
Issue No: 04 Issue Date: 19-Apr-2016 Amend No: 03 Amend Date: 21-Dec-2018 Page No: 6/11
 NPF 1
3 of 4

Sl. Requirement Observation*

Yes No

7. Facilities and Environmental conditions

 Does the laboratory demonstrate adequate house keeping
 Maintenance of necessary environmental conditions (sample audit)
Comments on facilities :

8. Equipment/ Reference Standards

 Availability of equipment commensurate with the scope applied for
 Availability of Calibration Schedule
 Availability of CRMs with respect to scope applied for
 Traceability established as per NABL policy
 Intermediate Checks
 Maintenance Schedule – maintenance check-list
Comments on Equipment/ Reference Standards:

9. Evidence of evaluation of Uncertainty of measurement

 Preliminary check whether the laboratory has taken any action regarding
estimation of Uncertainty in measurement
 Ranges covered for all Products/ Parameter/ measured quantity for all
disciplines
Comments on Uncertainty of measurement:

* Mark  in the appropriate box

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 209 Pre-Assessment Guidelines and Forms ( based on ISO/IEC 17025)
Issue No: 04 Issue Date: 19-Apr-2016 Amend No: 03 Amend Date: 21-Dec-2018 Page No: 7/11
 NPF 1
4 of 4

Sl. Requirement Observation*

Yes No

10. Proficiency Testing and Internal Quality Control

 Participation in at least one Proficiency Testing programme and corrective action
taken, if any, on the PT results
 Availability of 4-year Proficiency Testing plan covering all groups under each
discipline of Accreditation
 Is the Quality Control programme extensive and cover the product/ test range
being tested/ calibrated
 Does the laboratory retain samples for quality checks
 Where P.T. Programmes are not readily available, has the laboratory attempted
interlaboratory comparisons on its own
Comments on Proficiency Testing and Internal Quality Control:

11. Discussions with the Laboratory on Final Assessment

 Overview of the methodology to be adopted
 Task/ role of Lead Assessor, Technical Assessor(s) and Observers
 Obligations of the laboratory
Record any special discussion:

* Mark  in the appropriate box

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 209 Pre-Assessment Guidelines and Forms ( based on ISO/IEC 17025)
Issue No: 04 Issue Date: 19-Apr-2016 Amend No: 03 Amend Date: 21-Dec-2018 Page No: 8/11
 NPF 2

NON-CONFORMITIES OBSERVED DURING PRE-ASSESSMENT

Laboratory: Date(s) of Visit:

Sl. Non-conformity Corrective Action proposed by the laboratory

(to be filled by lab)

Signature/ Name of Authorised representative of Lab. & Date Signature/ Name of Lead Assessor & Date
Note: Use additional sheets of this form, if required

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 209 Pre-Assessment Guidelines and Forms ( based on ISO/IEC 17025)
Issue No: 04 Issue Date: 19-Apr-2016 Amend No: 03 Amend Date: 21-Dec-2018 Page No: 9/11
 NPF 3

PRE-ASSESSMENT REPORT

Laboratory:
Quality Manager: Date(s) of Visit:
Field : Testing/ Calibration Discipline(s):
Applicable Standard: ISO/IEC 17025
NABL Specific Criteria (if applicable)-

Persons Contacted:

Corrective action taken on the document review report Yes / No

Latest version of Quality Manual/ Management system document
-issue no. & date
-amend no. & date
Submission of NABL 131 (Terms & Conditions) Submitted earlier/ Enclosed/ Not submitted

No. of Non-conformities during Pre-assessment

Summary of Pre-Assessment:

Recommendations of Time Estimation and Readiness of Laboratory

 Number of Assessors required, discipline wise, as per
scope of accreditation

 Number of audit days required

 Whether the Assessment is required to be split based on Yes / No
locations of laboratory or number of fields/ departments. If
yes, elaborate
 Is the Laboratory ready for Assessment? If no, specify Yes / No
estimated time for taking corrective actions (Max 15 days):
 Any specific recommendations:

Signature/ Name of Authorised representative of Lab. & Date Signature/ Name of Lead Assessor & Date

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 209 Pre-Assessment Guidelines and Forms ( based on ISO/IEC 17025)
Issue No: 04 Issue Date: 19-Apr-2016 Amend No: 03 Amend Date: 21-Dec-2018 Page No: 10/11
 FORM 74

DECLARATION OF IMPARTIALITY & CONFIDENTIALITY

(to be filled in by each Assessor and enclosed with the Assessment report)

Name Assessor ID:

(To be filled in by NABL Sect.)
Designation

Organisation

Address

Capacity Lead Assessor / Technical Assessor / Technical Expert / Observer

CAB* Assessed

Date of
Assessment
Type of Document review / Pre-Assessment / Assessment / 1st Surveillance / Re-Assessment /
Assessment Supplementary visit
* 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

Date:

Place : Signature

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 209 Pre-Assessment Guidelines and Forms ( based on ISO/IEC 17025)
Issue No: 04 Issue Date: 19-Apr-2016 Amend No: 03 Amend Date: 21-Dec-2018 Page No: 11/11
National Accreditation Board for Testing and Calibration Laboratories (NABL)
NABL House
Plot No. 45, Sector 44,
Gurgaon - 122002, Haryana
Tel. no.: 91-124-4679700 (30 lines)
Fax: 91-124-4679799
Website: www.nabl-india.org