nabl 209

NABL 209

NABL

NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES

PRE-ASSESSMENT

GUIDELINES AND FORMS

ISSUE NO : 02 ISSUE DATE: 01.03.2008

AMENDMENT NO : 00 AMENDMENT DATE: --

AMENDMENT SHEET Sl

Page Clause Date of No. No. Amendment

Amendment made

Reasons

Signature Signature QM Director

1 2

3

4

5

6

7

8

9

10

National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 209 Issue No: 02

Pre-Assessment Guidelines and Forms 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 Issue No: 02

Pre-Assessment Guidelines and Forms 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 onsite 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 Issue No: 02

Pre-Assessment Guidelines and Forms Issue Date: 01.03.2008 Amend No: 00

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The Lead Assessor, during Pre-assessment shall: i.

check the implementation of the Quality System as per the documented Quality

ii.

Manual 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

iii.

location of laboratory or the number of fields/ departments. check whether the laboratory has conducted a comprehensive Internal Audit in accordance with ISO/ IEC 17025: 2005 or ISO 15189: 2007 which ever is

3.

iv.

applicable. assess the degree of preparedness of the laboratory for the Assessment in

v.

terms of compliance to NPF 1. obtain signatures on NABL 131 – Terms and Conditions for Maintaining

vi.

Accreditation, from the laboratory, if not submitted by laboratory earlier explain to the laboratory regarding the methodology to be adopted for

vii.

Assessment and the obligations of the laboratory submit a report to NABL Secretariat

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 Issue No: 02

Pre-Assessment Guidelines and Forms Issue Date: 01.03.2008 Amend No: 00

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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 Issue No: 02

Pre-Assessment Guidelines and Forms Issue Date: 01.03.2008 Amend No: 00

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NPF 1 1 of 4

CHECKLIST FOR REVIEW AND VERIFICATION

Laboratory:

Date(s) of Visit:

Sl.

Requirement

Observation* Yes

1.

No

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 (list enclosed)



Availability of other documents like Standards, Codes, Calibration/ Test methods, Operating Instructions etc. (list enclosed)



Availability of NABL documents (list enclosed)

all

required

cross-referenced

Procedures

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 Issue No: 02

Pre-Assessment Guidelines and Forms Issue Date: 01.03.2008 Amend No: 00

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NPF 1 2 of 4

Sl.

Requirement

Observation* Yes

4.

No

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 Issue No: 02

Pre-Assessment Guidelines and Forms Issue Date: 01.03.2008 Amend No: 00

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NPF 1 3 of 4

Sl.

Requirement

Observation* Yes

7.

No

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 Issue No: 02

Pre-Assessment Guidelines and Forms Issue Date: 01.03.2008 Amend No: 00

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NPF 1 4 of 4

Sl.

Requirement

Observation* Yes

10.

No

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 Issue No: 02

Pre-Assessment Guidelines and Forms Issue Date: 01.03.2008 Amend No: 00

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NPF 2 .NON-CONFORMITIES OBSERVED DURING PRE-ASSESSMENT

Laboratory: Sl.

Date(s) of Visit: Non-conformity

Signature/ Name of Authorised Personnel of Lab. & Date

Remarks

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 Issue No: 02

Pre-Assessment Guidelines and Forms Issue Date: 01.03.2008 Amend No: 00

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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 based on locations of laboratory or number of fields/ departments. If yes, elaborate

Yes / No



Is the Laboratory ready for Assessment. If no, specify estimated time for taking corrective actions

Yes / No



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 Issue No: 02

Pre-Assessment Guidelines and Forms 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