PREFACE Web view24 National Accreditation Board for Testing and Calibration Laboratories Doc. No: NABL 219 Assessment Forms and Checklist (based on ISO/IEC 17025: 2017)*When referring

NABL 219

National Accreditation Board for Testingand Calibration Laboratories (NABL)

Assessment Forms and Checklist(Based on ISO/IEC 17025:2017)

Issue no. : 01Issue date : 25-Jun-2018

Amendment no. : 03Amendment date : 13-Aug-2019

AMENDMENT SHEET

SI. Page No.

Clause No.

Date of Amendment

Amendment Reasons Signature QM

Signature CEO

1. 3/23 -- 20.12.2018 Inclusion of Assessment Scheduled (NAF 1)

Internal -Sd- -Sd-

2. 7/23 NAF-4

11.07.2019

Inclusion of provision for root cause and corrective actions/ correction

Internal review

-Sd- -Sd-

3. 23/23 -- Inclusion of Observation sheet (only for Integrated assessment)

Required by regulators

4. 8/23 NAF-6 added.......satisfactory closure of NCs and …in discipline….as highlighted

Internal review

5. 10/23 Form-72 As highlighted6. -- --

13.08.2019

Removal of Form 71 NABL decision -Sd- -Sd-

7. 8/23 NAF 6 Deletion of text

8.

9.

10.

National Accreditation Board for Testing and Calibration LaboratoriesDoc. No: NABL 219 Assessment Forms and Checklist (based on ISO/IEC 17025: 2017) Issue No: 01 Issue Date: 25-Jun-2018 Amend No: 03 Amend Date: 13-Aug-2019 Page No: 1/22

CONTENTS

SI. Title Page No.Amendment Sheet

Contents

1. NAF 1- Assessment Schedule 3

2. NAF 1A- Attendance Sheet (Opening/Closing Meeting) 4

3. NAF 3- Calibration(s) witnessed by the Assessment Team 5

4. NAF 3A- Details Of Testing / Re-Testing Witnessed During Assessment 6

5. NAF 4- Assessor’s Summary on Non-Conformity 7

6. NAF 6- Assessment Summary 8

7. Form 72- Recommended Scope of Accreditation (Testing)9

8. Form 73- Recommended Scope of Accreditation (Calibration) 10

9. Form 74- Declaration Of Impartiality & Confidentiality 11

10. Checklist – Clause 4 of ISO/IEC 17025:2017 12





15. Observation sheet ( to be used only for Integrated assessment) 22


NAF – 1

ASSESSMENT SCHEDULE

Laboratory:

Authorized Representative of CAB : Date(s) of Visit:

Type of Visit: Assessment / 1st Surveillance / Re-Assessment / Supplementary Visit

Field: Testing / Calibration Discipline (s):

Facility (s): Permanent / Site / Mobile

Assessment Standard: ISO / IEC 17025: 2017Specific Criteria of NABL (If applicable):

Assessment Timings Opening/Closing Meeting Date/Time

Daily Debriefing Date / Time(at the end of each day)

Morning: AM to PM Afternoon: PM to PM

Opening Meeting:Closing Meeting:

Day 1:Day 2:Day 3:

Name and Expertiseof the Assessor

Schedule of Locations/ Department/ Section/ Activity to be Assessed (date wise)Day 1 Day 2 Day 3

Morning Afternoon Morning Afternoon Morning Afternoon

Lead Assessor

Assessor 1

Assessor 2

Assessor 3

Assessor 4

Assessor 5

Assessor 6

Assessor 7

Observer(only for observation)

Signature of Lead Assessor


NAF – 1AATTENDANCE SHEET (OPENING & CLOSING MEETING)

CAB Name:

Date of Opening Meeting :Time of Opening Meeting :

Date of Closing Meeting :Time of Closing Meeting :

SI. Assessors / CAB Personnel Present

Capacity / Designation SignatureOpening meeting Closing meeting


NAF – 3

CALIBRATION(S) WITNESSED BY THE ASSESSSMENT TEAM(To be filled in by each Technical Assessor)

CAB Name: Date(s) of Assessment:

Assessor: Discipline of Calibration:Calibration(s) witnessed * Calibration

Method Used or Standard Referred

Remarks

Signature and Name of Assessor

* No requirement to enclose any attachments / Annexure with this form; only representative CMC estimation to be enclosed.


NAF – 3A

DETAILS OF TESTING / RE-TESTING WITNESSED DURING ASSESSMENT(To be filled in by the Technical Assessor)

CAB Name:

Discipline: Date(s) of Assessment: Test 1 Test 2 Test 3 Test 4

Product / Material of Test

Test Witnessed

Test Method / Standard against which tests are performedRe-testing of Retained Samples / Replicate Testing/ Fresh Sample/ CRMs (No requirement to enclose any attachment/ Annexure with this form)Sample ID

Earlier Reported Results

Results of Test Witnessed

Remark:Deviations Observed, if any

Conclusion on the technical competence of the CAB for the test performed

Name & Signature of Assessor


NAF - 4

ASSESSOR’S SUMMARY ON NON-CONFORMITY

Name of CAB

Name of the AssessorDate(s) of AssessmentSI. Non Conformity

Statement Cl. No. (ISO / IEC 17025: 2017

Classification(Major / Minor)

Acceptance(Signature of CAB’s representative) and propose the required corrections

Root cause analysis (to be submitted later)

Corrective actions (to be submitted later)

Signature & Name of Technical Assessor Signature & Name of Lead Assessor


NAF - 6

ASSESSMENT SUMMARY

SI. Item Details1. CAB Name

2. Date of Assessment3. Field4. Discipline(s) 5. Facility Permanent/ Site/ Mobile6. Type of Assessment Final Assessment/ Surveillance/ Re-assessment / Supplementary visit 7. Assessment Team

13. Date of earlier visit: Non-Conformities during earlier visit have/ have not been discharged. (Yes or No)

14. Total no. of Non-conformities

Major MinorClause 4Clause 5Clause 6Clause 7Clause 8

Total21. Comment(s) of Assessment Team on compliance of CAB to:

NABL 133 NABL 142 NABL 143NABL 163

26. Recommendation of Assessment team as per ISO/IEC 17025: 2017

27. Only if accreditation is recommended, date by which the Corrective Action to be submitted by the CAB for the above Non-conformities (Max. 30 days):

28. The requirements of NABL 133 have been explained by the Lead Assessor and understood by the CAB

Enclosures NAF 6

NAF 4

NAF 3/3A

NAF 1

NAF 1A

Checklist

Form 72

Form 74

Form 45

TA/DA

Forms

PT/ILC record

s

Any other docs.

No. of Pages

Acknowledgement by Authorised Representative of CAB& Date Signature of Lead Assessor& Date


Form 72

RECOMMENDED SCOPE OF ACCREDITATION(For Testing Laboratories)

CAB Name: Date(s) of assessment:

Discipline: Location:SI.

Product(s) / Material of test(including Group Name & Sub- Group name)

Tests/ parameters/ Components/characteristics performed

*Test Method /Techniques against which tests are performed

Range of Testing/ Limits of detection

Uncertainty of Measurement+() at Observed Value

*When referring to publications like APHA, CLSI, IP, BP, USP, ASTM, AOAC etc. kindly mention the clause / chapter / page number, as appropriate.

+The value at which uncertainty of measurement estimated shall also be specified. CAB performing site testing shall clearly identify the Specific tests on products(s) / material performed at permanent facility and / or at site. Refer NABL 130 for details.

Signature, Date & Nameof CAB Representative

Signature, Date & Nameof Assessor(s)

Signature, Date & Nameof Lead Assessor


Form 73

RECOMMENDED SCOPE OF ACCREDITATION(For Calibration Laboratories)

CAB Name:- Date(s) of Visit:

Discipline:-

SI. Parameter / Device Under Calibration (DUC)*

Master Equipment Used

Range(s) of Measurement

Calibration and Measurement Capability ** Remarks / Method used+Claimed

by CABObserved

by Assessor

Recommended by Assessor

* Only for Electro-technical discipline; scope shall be recommended parameter vise (where applicable) and the ranges may be mentioned frequency vise.** NABL 143 shall be referred for the recommendation of CMC + Remarks shall also include whether the same scope is applicable for site calibration as well. NABL 130 shall be referred while recommending the scope for site calibration.

Signature, Date & Name of CAB Representative

Signature, Date & Name of Assessor(s)

Signature, Date & Name of Lead Assessor


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 AssessmentType of Assessment

QM Adequacy / Pre-Assessment / Final assessment / Onsite Surveillance / Re-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, 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


Checklist (Clause 4 of ISO/IEC 17025:2017)

Name of CABName of the AssessorDate of AssessmentActivity AssessedAuditee

Remarks / Comments of Assessor for compliance with citation of objective evidence verified.(Documents / records to be annexed / enclosed only where a non-compliance is to be supplemented)

4. General requirements4.1 Impartiality

4.2 Confidentiality



Name of CAB Name of the AssessorDate of AssessmentActivity AssessedAuditee


5 Structural requirements



Name of CABName of the AssessorDate of AssessmentActivity AssessedAuditee


6 Resource requirements6.1 General6.2 Personnel

6.3 Facilities and environmental conditions

6.4 Equipment


6.5 Metrological traceability

6.6 Externally provided products and services





7 Process requirements7.1 Review of requests, tenders and contracts

7.2 Selection, verification and validation of methods7.2.1 Selection and verification of methods

7.2.2 Validation of methods

7.3 Sampling


7.4 Handling of test or calibration items

7.5 Technical records

7.6 Evaluation of measurement uncertainty

7.7 Ensuring the validity of results

7.8 Reporting of results


7.8.1 General7.8.2 Common requirements for reports (test, calibration or sampling)

7.8.3 Specific requirements for test reports

7.8.4 Specific requirements for calibration certificates

7.8.5 Reporting sampling – specific requirements

7.8.6 Reporting statements of conformity


7.8.7 Reporting opinions and interpretations

7.8.8 Amendments to reports

7.9 Complaints

7.10 Nonconforming work

7.11 Control of data and information management





8 Management system requirements8.1 Options8.1.1 General

8.1.2 Option A

8.1.3 Option B

8.2 Management system documentation (Option A)

8.3 Control of management system documents (Option A)


8.4 Control of records (Option A)

8.5 Actions to address risks and opportunities (Option A)

8.6 Improvement (Option A)

8.7 Corrective actions (Option A)

8.8 Internal audits (Option A)

8.9 Management reviews (Option A)


OBSERVATION SHEET (To be used only for Integrated assessment)

Sl.No. Observations Remarks


National Accreditation Board for Testing and Calibration Laboratories (NABL)NABL House

Plot No. 45, Sector 44,Gurugram - 122002, Haryana

Tel. no.: 91-124-4679700 (30 lines)Fax: 91-124-4679799

Website: www.nabl-india.org

http://www.nabl-india.org/