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Desktop Surveillance: National Accreditation Board For Testing and Calibration Laboratories (NABL)

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NABL 218

National Accreditation Board for Testing


and Calibration Laboratories (NABL)

Desktop Surveillance

ISSUE NO. : 03 AMENDMENT NO. : 03


ISSUE DATE : 19-Apr-2016 AMENDMENT DATE : 17-Dec-2019
AMENDMENT SHEET

Sl Page Clause Date of Amendment Reasons Signature Signature


no No. No. Amendment QA Team CEO
1 -- - -Inclusion of latest version Publication of
of ISO/IEC 17025:2017. ISO/IEC
-ISO Guide 34:2009 17025:2017 &
replaced by ISO ISO 17034:2016 -Sd- -Sd-
15.10.2019 17034:2016. version
2 3 1 Text-‘last reassessment’ Procedural
replaced by ‘on-site requirements
assessment’ as
highlighted.
3 2, 3, - 16.12.2019 Inclusion of ISO/IEC To process the
4, 6 17025:2005 desktop
documents (as
per ISO/IEC -Sd- -Sd-
17025: 2005
version)
4 5, 6 - 16.12.2019 Removal of term NABL policy
authorized signatory decision

5 2 - 17.12.2019 Preface revised as NABL policy -Sd- -Sd-


highlighted decision

10

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 218 Desktop Surveillance
Issue No: 03 Issue Date: 19-Apr-2016 Amend. No: 03 Amend Date: 17-Dec-2019 Page No:1/6
PREFACE

For an accredited Conformity Assessment Body (CAB) to maintain its accreditation status, it is mandatory that the
CAB continues to comply with the requirements of ISO/IEC 17025:2005 or2017 or ISO: 15189: 2012or ISO/IEC
17043:2010 or ISO 17034:2016 (whichever is relevant) and NABL policies, for which NABL conducts annual
surveillance. Once a CAB has been accredited, NABL may conduct onsite surveillance visit to verify the continued
compliance.

For the purpose of desktop surveillance, the CAB should provide the information as per this document and the same
will be considered to verify the continued compliance for maintaining accreditation. The information provided by the
CAB is evaluated at NABL secretariat and if the information is conforming to the requirements; the CAB is allowed to
continue its accreditation status based on desktop surveillance. However; if the information provided is insufficient to
establish the continued compliance; an onsite assessment may be conducted.

The CABs are therefore advised to provide the desired information accurately as per the format. The
informationprovided is subject to verification at onsite surveillance (if conducted) or in subsequent reassessment visit.
Any wrong information provided may lead to adverse decision by NABL.

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 218 Desktop Surveillance
Issue No: 03 Issue Date: 19-Apr-2016 Amend. No: 03 Amend Date: 17-Dec-2019 Page No:2/6
INFORMATION TO BE FURNISHED BY CABFOR DESKTOP SURVEILLANCE

CAB 's name, address&ID:

Field: Testing/ Calibration/ Medical / PTP / RMP

Discipline(s):

Accreditation validity period:

Period of the report:

1. Status of implementation and monitoring the effectiveness of corrective actions(s) taken on non-conformities raised
during last on-site assessment: (please provide details in tabular format)
Non-conformities raised during last on- Brief Summary of corrective actions Evidence of continued compliance
site assessment taken of corrective actions (as on date)

2. Summary of last internal audit findings and corrective actions taken on non-conformities raised during the audit
a) Availability of audit scope and plan/schedule Yes/No
b) Frequency of internal audit as per procedure for internal audit._____________________________________
c) Dates of last two internal audit conducted _____________________________________________________
d) Particulars of persons who have conducted last internal audit
Name(s) ofQualification Affiliation Training status Details of training organization & duration
auditors(s) & (Internal/ External) (whether trained as of training
designation per ISO/IEC 17025
/ ISO 15189 /
ISO /IEC 17043 /
ISO 17034)

e) Comment on independence of activities audited_________________________________________________


f) Whether all the activities (as required by standard) were covered in the audit Yes / No
g) Whether various locations (including site testing / calibration, mobile, collection centres etc) were covered in
the audit Yes / No

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 218 Desktop Surveillance
Issue No: 03 Issue Date: 19-Apr-2016 Amend. No: 03 Amend Date: 17-Dec-2019 Page No:3/6
h) Whether the all the requirements of ISO/IEC 17025:2005 or2017or ISO 15189: 2012or ISO/IEC 17043:2010
or ISO 17034:2016were covered in audit Yes/ No
i) Number of NCs raised...........
j) Whether NCs are monitored for its closure as agreed time frame Yes / No
k)
Sl. Non-conformities raised during Brief Summary of corrective actions taken Status
No. last Internal audit (Closed/Open)

3. Management Review Meeting


3.1 Summary of last Management Review
a) Date of last Management Review____________________________________________________________
b) Whether all the agenda points as required by the relevant standard (ISO/IEC 17025:2005 or 2017/ ISO
15189: 2012 / ISO/IEC 17043: 2010 / ISO 17034:2016 were discussed including quality policy and objectives
Yes/ No
c) Whether minutes of the meeting and with actions points thereon were recorded Yes/No
d) Whether the action plan implemented as targeted Yes/ No
3.2 Minutes of last Management Review Meeting (Annexure......)

4. Summary of complaints received and status of their resolutions


S.N Complaint No. Complaint Investigation findings Corrective action Status settled/
o. & date details taken unsettled

5. Details of internal quality control (IQC) checks practiced by the CAB (wherever applicable)
a) Which of the following quality control measures are used by the CAB, please tick appropriate column(s).
i. Use of Certified reference material/reference material.
ii. Use of internal quality control material
iii. Replicate testing using same or different method.
iv. Retesting of retained item
v. Replicate calibration using same or different method
vi. Recalibration of retained items.
vii. Use of control charts using control samples
viii. Use of control charts using check standards
ix. Correlation of results for different characteristics of an item
x. Any other technique(s); Please specify......
b) Details of IQC plans of the CAB as per accredited scope mentioning frequency of IQC checks
(Annexure: _______________)
c) Whether the compliance criterion isdefined, met and corrective actions taken if required Yes/ No

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 218 Desktop Surveillance
Issue No: 03 Issue Date: 19-Apr-2016 Amend. No: 03 Amend Date: 17-Dec-2019 Page No:4/6
6. Details of participation in EQAS/ PT/ ILC and initiation of ILC by the CAB (wherever applicable)
a) Availability of EQAS/ PT/ ILC plan as per requirements of NABL163 Yes/ No
b) Whether the ILC/PT activities complied as per the plan submitted Yes/ No
c) Please provide clarifications of lapses in implementation (if any) ____________________________________
Results of EQAS/ PT/ ILC participation

EQAS/ PT providers PT programme No. Parameter Z Score/ En Details of root cause analysis
(or) ILC/ Value / SDI in case of unsatisfactory
coordinatingCAB performance

7. Please furnish detail of the reference standards,CRM, equipments, held by the CAB
S.No. Reference standard/ CRM/ equipments (Make Date of calibration (reference Metrological
&Model No. if applicable) standard/ equipments)/ Date of traceability/ calibration
validity (CRM) agency

Note: Equipments, CRM, Reference standards details shall be given separately wherever applicable

8. Details of Training provided to CABpersonnel since last assessment


a) Does the CAB identify training needs of its employees and prepare an annual training plan Yes/No
b) Whether the training plan implemented Yes/ No
c) Please provide clarifications of lapses in implementation (if any) __________________________________
d) Whether the effectiveness of training is evaluated and records are maintained Yes/ No

9.Has there been a change in the following aspects of the CAB operations since last assessment?
a) Legal Status : Yes/No (If yes, give details thereof)
b) Ownership : Yes/No (If yes, give details thereof)
c) Top Management : Yes/No (If yes, give details thereof)
d) Key CABPersonnel : Yes/No (If yes, give details thereof)
e) Policies : Yes/No (If yes, give details thereof)
f) Resources : Yes/No (If yes, give details thereof)
g) CABPremises : Yes/No (If yes, give details thereof)
h) Major Test/ Calibration equipment : Yes/ No (If yes, give details thereof)
i) Personnel declared for report, review and : Yes/ No (If yes, give details thereof)
authorize the results
Note: For any of above stated changes; CABshould have informed NABL within 15 days of its change as defined in NABL
131. The above declarations cannot be considered as an application for change

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 218 Desktop Surveillance
Issue No: 03 Issue Date: 19-Apr-2016 Amend. No: 03 Amend Date: 17-Dec-2019 Page No:5/6
10. Does the CAB want a change/ addition in personnel declared for report, review and authorize the results? If yes please
furnish the details of proposed personnel for report, review and authorize the results along with specimen signature.

11. Desktop surveillance fee details: __________________________________________________________

Note: Provide the DD number/ bank details along with the amount paid. All payments shall be payable at New Delhi

12.Self declarations
12.1 (a) Please give a self declaration confirming the valid calibration status of various equipments and reference
standards held by the CAB. The declaration should also focus on compliance to metrological traceability policy as
given in NABL 142.Annexure.....
(b) Incase the CABhas enhanced the periodicity of calibration of any equipment(s), please give detailed technical
justification for the same.Annexure....
Note: The self declaration to be given by a competent authority on CAB’sletter head
12.2Please furnish a self declaration by the head of the CAB / CAB director for continued compliance of the CAB to
ISO/IEC 17025: 2005 or 2017/ ISO15189: 2012/ ISO/IEC17043:2010 or ISO17034:2016(whichever is applicable)
and relevant NABL specific criteria (s) (wherever applicable) since last on site assessment. Annexure...
Note: The self declaration to be given on CAB’s letter head

13. All information provided above is true and I am aware that any wrong information / declaration given therein may lead
to adverse actions by NABL

Signature of CAB Head/CAB Director__________________________________________________________


Name&Designation_________________________________________________________________________________
Date & Place _______________________________________________________________________________________

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 218 Desktop Surveillance
Issue No: 03 Issue Date: 19-Apr-2016 Amend. No: 03 Amend Date: 17-Dec-2019 Page No:6/6
National Accreditation Board for Testing and Calibration Laboratories (NABL)
NABL House
Plot No. 45, Sector 44,
Gurugram - 122003, Haryana
Tel. no.: 91-124-4679700 (30 lines)
Fax: 91-124-4679799
Website: www.nabl-india.org

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