NABL 209

NATIONAL ACCREDITATION

NABL
BOARD FOR TESTING AND
CALIBRATION LABORATORIES

PRE-ASSESSMENT
GUIDELINES AND FORMS

ISSUE NO : 02 AMENDMENT NO : 00
ISSUE DATE: 01.03.2008 AMENDMENT DATE: --
 AMENDMENT SHEET

Sl Page Clause Date of Amendment made Reasons Signature Signature

No. No. Amendment QM Director
1

10

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 209 Pre-Assessment Guidelines and Forms
Issue No: 02 Issue Date: 01.03.2008 Last Amend No: 00 Amend Date: -- Page No: i
 CONTENTS

Sl Title Page Nos.

Amendment Sheet i

Content ii

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

2. Checklist For Review And Verification – NPF 1 4-7

3. Non Conformity observed during Pre-Assessment – NPF 2 8

4. Pre Assessment Report – NPF 3 9

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 209 Pre-Assessment Guidelines and Forms
Issue No: 02 Issue Date: 01.03.2008 Amend No: 00 Amend Date: -- Page No: ii
 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 for evaluating the adequacy of
the Quality Manual, pre-assessment of the laboratory and for conducting the on-site
assessment of the concerned laboratory. Towards the task of on-site assessment, he
shall be assisted by a team of assessors commensurate with the scope of
accreditation.

This document contains Pre-assessment form and Checklist, which will form a part of
the Pre-assessment Report. 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 and has submitted a report to the satisfaction of the NABL & Lead
Assessor, NABL Secretariat shall fix up a date for Pre-assessment 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, Corrective action
report on the adequacy of the Quality Manual and any other information supplied by
NABL Secretariat.

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 209 Pre-Assessment Guidelines and Forms
Issue No: 02 Issue Date: 01.03.2008 Amend No: 00 Amend Date: -- Page No: 1/ 9
 The Lead Assessor, during Pre-assessment shall:

i. check the implementation of the Quality System as per the documented Quality
Manual
ii. study the scope of accreditation so that the time frame, number of assessors
required in various fields 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/ departments.

iii. check whether the laboratory has conducted a comprehensive Internal Audit in
accordance with ISO/ IEC 17025: 2005 or ISO 15189: 2007 which ever is
applicable.
iv. assess the degree of preparedness of the laboratory for the Assessment in
terms of compliance to NPF 1.

v. obtain signatures on NABL 131 – Terms and Conditions for 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 Quality System to verify
compliance with the requirements of ISO/ IEC 17025: 2005 or ISO 15189: 2007 which
ever is applicable. 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), not listed in the
checklist, he is free to assess or go into details where he feels and annex his findings,
to the report.

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 209 Pre-Assessment Guidelines and Forms
Issue No: 02 Issue Date: 01.03.2008 Amend No: 00 Amend Date: -- Page No: 2/ 9
 All Non-Conformity(ies) must be identified and reported, separately 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 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
Issue No: 02 Issue Date: 01.03.2008 Amend No: 00 Amend Date: -- Page No: 3/ 9
 NPF 1
1 of 4

CHECKLIST FOR REVIEW AND VERIFICATION

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. Quality System Documentation

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

3. Quality System Implementation (sample audit)

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

* Mark  in the appropriate box

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 209 Pre-Assessment Guidelines and Forms
Issue No: 02 Issue Date: 01.03.2008 Amend No: 00 Amend Date: -- Page No: 4/ 9
 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: 2005 or ISO 15189: 2007
which ever 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 Independent and competent personnel
Comments on effectiveness of Internal Audit:

5. Management Review
 Availability of Management review Procedure
 All requirements of ISO/ IEC 17025: 2005 or ISO 15189: 2007
which ever is applicable, are incorporated in the agenda of review
in the last one year
 Evidence of at least one review
Comments on effectiveness of review:

6. Personnel
 Training programme on ISO/ IEC 17025: 2005 or ISO 15189:
2007 which ever is applicable, organised for laboratory personnel
 Plan/ Schedule for imparting training to laboratory personnel for
the current year
 Suitability of persons authorised to sign test/ calibration reports
with reference to the field(s) applied
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
Issue No: 02 Issue Date: 01.03.2008 Amend No: 00 Amend Date: -- Page No: 5/ 9
 NPF 1
3 of 4

Sl. Requirement Observation*

Yes No

7. House keeping and Environmental conditions

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

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 estimation 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 fields
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
Issue No: 02 Issue Date: 01.03.2008 Amend No: 00 Amend Date: -- Page No: 6/ 9
 NPF 1
4 of 4

Sl. Requirement Observation*

Yes No

10. Proficiency Testing and Internal Quality Control

 Participation in atleast one Proficiency Testing programme and
corrective action taken, if any, on the PT results
 Schedule for Proficiency Testing covering all sub-major areas of
Scope 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
Issue No: 02 Issue Date: 01.03.2008 Amend No: 00 Amend Date: -- Page No: 7/ 9
 NPF 2

.NON-CONFORMITIES OBSERVED DURING PRE-ASSESSMENT

Laboratory: Date(s) of Visit:

Sl. Non-conformity Remarks

Signature/ Name of Authorised Personnel 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
Issue No: 02 Issue Date: 01.03.2008 Amend No: 00 Amend Date: -- Page No: 8/ 9
 NPF 3

PRE-ASSESSMENT REPORT

Laboratory:
Quality Manager: Date(s) of Visit:
Facility: Testing/ Calibration/ Medical Field(s):
Applicable Standard: ISO/ IEC 17025: 2005 ISO 15189: 2007
Persons Contacted:

Corrective action taken on the adequacy report Yes / No

Latest version of Quality Manual-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, field wise, as
per Scope of Accreditation

 Number of audit days required

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

Signature/ Name of Authorised Personnel 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
Issue No: 02 Issue Date: 01.03.2008 Amend No: 00 Amend Date: -- Page No: 9/ 9
National Accreditation Board for Testing and Calibration Laboratories
3rd Floor, NISCAIR
14, Satsang Vihar Marg
New Mehrauli Road
New Delhi – 110 067
Tel.: 91-11 26529718 – 20, 26526864
Fax: 91-11 26529716
Website: www.nabl-india.org