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Nabl 201

This document from the National Accreditation Board for Testing and Calibration Laboratories (NABL) outlines the procedures for dealing with changes in an accredited conformity assessment body's (CAB's) operations. It addresses procedures for changes in name/legal identity, acquisition/merger/takeover, premises, authorized signatories, key personnel, equipment, scope of accreditation, accreditation standards, and NABL requirements. It also covers dealing with natural disasters impacting a CAB's operations and voluntary withdrawal of accreditation.

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100% found this document useful (1 vote)
760 views13 pages

Nabl 201

This document from the National Accreditation Board for Testing and Calibration Laboratories (NABL) outlines the procedures for dealing with changes in an accredited conformity assessment body's (CAB's) operations. It addresses procedures for changes in name/legal identity, acquisition/merger/takeover, premises, authorized signatories, key personnel, equipment, scope of accreditation, accreditation standards, and NABL requirements. It also covers dealing with natural disasters impacting a CAB's operations and voluntary withdrawal of accreditation.

Uploaded by

Ankit Dhaka
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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NABL 201

National Accreditation Board for Testing


and Calibration Laboratories (NABL)

Procedure for dealing with Changes in Accredited


Conformity Assessment Body’s Operations

ISSUE NO. : 01 AMENDMENT NO. : 04


ISSUE DATE : 13-May-2016 AMENDMENT DATE : 02-Apr-2018
AMENDMENT SHEET

Sl. Page Clause Date of Amendment Reasons Signature Signature


No. Amendment QM CEO
No.

1 6/9 IV – 1.1 08.06.16 Reworded Typo error Sd/- Sd/-


& 1.2

2 7/9 VII – 09.03.17 Deletion of Cl. 1.4 & 1.5 Once accreditation Sd/- Sd/-
1.4 & certificate to one
1.5 CAB
deleted

3 4/9 II 10.07.17 Inclusion of ‘De-Merger Clarity in Merger/ Sd/- Sd/-


de-Merger

4 4/9 & II & III 02.04.18 Procedural change in Change in NABL Sd/- Sd/-
5/9 case of takeover/ policy
merger/ de-merger and
city to district in
premises etc.

10

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 201 Procedure for dealing with Changes in Accredited Conformity Assessment Body’s Operation
Issue No: 01 Issue Date: 13-May-2016 Amend No: 04 Amend Date: 02-Apr-2018 Page No:1 /11
CONTENTS

Sl. Title Page

Amendment Sheet 1

Contents 2

Introduction 3

I. Dealing with change in Name / Legal Identity 4

II. Dealing with Acquisition, Merger, Take over and purchase / 4


selling of CAB

III. Dealing with change in CAB’s premises 5

IV. Dealing with change in CAB’s authorized signatory 6

V. Dealing with change in CAB’s key personnel other than 6


Authorized Signatories

VI. Dealing with Change in CAB’s Equipment not affecting scope 7


of accreditation

VII. Dealing with change in CAB’s scope of accreditation 7


Dealing with change in CAB’s scope extension during re-
VIII. 8
assessment

IX. Dealing with change in accreditation Standard 8

X. Dealing with change in NABL requirements 8

XI. Dealing with Natural disaster impacting CAB’s operations 8

XII. Dealing with voluntary withdrawal of accreditation 9

Appendix-A 10

Appendix-B 11

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 201 Procedure for dealing with Changes in Accredited Conformity Assessment Body’s Operation
Issue No: 01 Issue Date: 13-May-2016 Amend No: 04 Amend Date: 02-Apr-2018 Page No:2 /11
INTRODUCTION

Accredited CAB may undergo certain changes which may affect its operations / functions. This
procedure addresses the procedure to implement the various changes in a CAB and also
specifies the process by NABL on such matters. These changes may include change in
ownership / legal identity, premises, authorised signatory, key personnel, scope of accreditation,
change / addition of major equipment within the valid accreditation period etc.

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 201 Procedure for dealing with Changes in Accredited Conformity Assessment Body’s Operation
Issue No: 01 Issue Date: 13-May-2016 Amend No: 04 Amend Date: 02-Apr-2018 Page No:3 /11
I. Dealing with change in Name / Legal Identity

If an accredited CAB desires to change its name under the same ownership; the following
procedure shall be followed.

(a) Inform NABL about the name change in writing along with relevant documents (such
as legal identity / resolution etc.) and applicable fee for name change (refer NABL 100
for information on applicable fee). If the documents are found satisfactory; NABL will
issue the accreditation certificate with new name but with same accreditation certificate
number. The effective date of issue of certificate will be the date of approval from the
competent authority and the validity of accreditation shall remain the same as that of
the previous certificate. CAB shall return the existing accreditation certificate to NABL.

(b) CAB will not claim to be NABL accredited and will not use NABL symbol till the new
name is approved by NABL.

II. Dealing with Acquisition, Merger, De-Merger, Take over and Purchase / Selling of CAB

In cases of acquisition/ takeover/ merger/ De-merger of any accredited CAB by or with a


different firm / company / entity, the following procedure shall be followed.

(a) During the process of acquisition or merger; the applicant / accredited CAB shall
inform NABL in advance about such matter.

(b) On completion of acquisition or merger, the CAB shall inform NABL within 15 days
time and will discontinue all claims related to NABL accreditation till the further
approval from NABL.

(c) The new firm / company / entity acquiring the CAB or merging with the accredited
CAB, desires to continue NABL accreditation of the CAB; the new top management
shall submit the declaration as specified in Appendix A and submit the enclosures as
per Appendix-B. In this case -

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 201 Procedure for dealing with Changes in Accredited Conformity Assessment Body’s Operation
Issue No: 01 Issue Date: 13-May-2016 Amend No: 04 Amend Date: 02-Apr-2018 Page No:4 /11
(i) If the documents submitted by CAB are found satisfactory; NABL will issue the
accreditation certificate as the case may be, if necessary, with same
accreditation certificate number. The effective date of issue of certificate will be
the date of approval from the competent authority and the validity of
accreditation shall remain the same as that of the previous certificate. CAB
shall return the existing accreditation certificate to NABL.

(ii) If the new firm/ company / entity fails to submit the declarations as specified in
Appendix A & B; the accreditation status of the CAB will be withdrawn and CAB
file will be closed by NABL. If the new firm/ company / entity desires to get their
CAB accredited by NABL; they may apply a fresh. In such cases, NABL will
process the application as a fresh application.

III. Dealing with change in CAB’s premises -

If an accredited CAB wishes to change its premises; the accredited CAB shall inform NABL
in advance about its planning to do so. Subsequently the following procedure shall be
followed -

(a) If the CAB shifts its location within the same district, inform NABL in writing within 15
days along with evidence pertaining to the address change / legal identity and
applicable fess for name change / address (refer NABL 100 for information on
applicable fee). NABL will conduct an onsite visit to verify the adequate infrastructure
and implementation of management system at the new premises w.r.t scope. NABL
will issue the new accreditation certificate with same accreditation certificate number.
The effective date of issue of certificate will be the date of approval from the
competent authority and the validity of accreditation shall remain the same as that of
the previous certificate. CAB shall return the existing accreditation certificate to NABL.

(b) If the accredited CAB shifts its location to another district, the existing CAB
accreditation status will be withdrawn and CAB file will be closed. If CAB wishes
accreditation in new district, they have to apply a fresh with relevant application fees.

The application will be treated as new application and new CAB ID will be given.
However Quality manual adequacy checks and pre-assessment may be considered
for wavier if CAB is operating the same management system and personnel as

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 201 Procedure for dealing with Changes in Accredited Conformity Assessment Body’s Operation
Issue No: 01 Issue Date: 13-May-2016 Amend No: 04 Amend Date: 02-Apr-2018 Page No:5 /11
earlier. NABL will conduct the complete on site assessment to verify the
implementation of the management system before grant of accreditation to the new
CAB.

A new certificate will be issued to the CAB once assessment process is completed
and decision on grant of accreditation is taken. The certificate will be issued valid for a
period of two years with new certificate number.

In both the cases, the CAB shall not claim NABL accreditation at the new premises till
decision on grant is communicated by NABL to the CAB.

IV. Dealing with change in CAB’s authorised signatory

For any change in Authorized Signatory (s) the following procedure shall be followed:

Inform NABL about the proposal to change the authorised signatory(s) in writing along with
his / her bio data and applicable fee (refer NABL 100 for information on applicable fee).

(a) In case of change in only available authorized signatory, the on-site verification visit
by TA to be conducted to see the competence of the new proposed authorized
signatory.

(b) In case of change / addition of new signatory to the existing list of approved
signatories NABL will conduct a telephonic interview of the proposed signatory by a
technical assessor / expert to judge the competence of the proposed signatory in the
specified discipline. In case the person is not found competent or a decision could not
be arrived at during the telephonic discussion, an on-site visit of technical assessor to
be conducted to verify the technical competence of the authorized signatory.

V. Dealing with change in CAB’s key personnel other than Authorized Signatories

The following procedure to be followed in case of changes in the key personnel (Head of the
CAB / Section, Quality Manager, Technical Manager) which affects the CAB operations.

(a) Inform NABL in writing about the change along with information in case of key staff
other than Authorized signatory.

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 201 Procedure for dealing with Changes in Accredited Conformity Assessment Body’s Operation
Issue No: 01 Issue Date: 13-May-2016 Amend No: 04 Amend Date: 02-Apr-2018 Page No:6 /11
(b) For change the quality manager, CAB shall submit the training records of 4-days
training program on management system and internal audit based on applicable
standard as mentioned in NABL 131.

VI. Dealing with Change in CAB’s Equipment not affecting scope of accreditation

(a) In case of change in equipment or addition of new equipment not affecting the scope
of accreditation, CAB shall inform NABL in writing about the change or addition of
equipment.

(b) NABL may conduct the on-site verification visit only in cases, where there is a new
technology involved and an additional expertise is required to operate the equipment.

VII. Dealing with change in CAB’s scope of accreditation

The CAB at any time while holding valid accredited status may apply for extension of scope.
The extension of scope may add test(s) / calibration(s) / PTP / RMP Scope to existing
accredited group(s) or add new group(s) to the existing discipline (s) or add a new
discipline(s) and/ or field(s).

(a) Application: The request for scope extension within the accredited discipline can be
made by providing additional information to the already submitted application form
NABL 151 / NABL 152 / NABL 153 / NABL 190 / NABL 180. The applicable fees for
scope extension need to be submitted along with application. However for addition of
new field or discipline; a separate application form NABL 151 / NABL 152 / NABL 153
/ NABL 190 / NABL 180 is required to be submitted.

(b) Assessment Visit: The assessment for the scope extension may be clubbed with the
forthcoming scheduled on-site assessment, if the assessment visit is planned within 3
months. If the planned visit is more than 3 months away or CAB wants to add the
scope on an urgent basis, NABL consider to organize a special assessment visit in
consultation with the CAB to assess the competence of the CAB for the scope
extension;
(c) Issue of Accreditation Certificate: On decision on grant of accreditation; for the scope
extension, NABL will issue revised annexures as amendment to the existing
accreditation certificate, to include the extension of the scope. The effective date of

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 201 Procedure for dealing with Changes in Accredited Conformity Assessment Body’s Operation
Issue No: 01 Issue Date: 13-May-2016 Amend No: 04 Amend Date: 02-Apr-2018 Page No:7 /11
scope extension is the approval date of competent authority of NABL. The date of
expiry of the extended scope will be the same as of the existing certificate.

VIII. Dealing with change in CAB’s scope extension during re-assessment

The extension of scope can be included in the application form NABL 151 / NABL 152 /
NABL 153 / NABL 180 / NABL 190. It should explicitly be marked. However any scope
extension requested at the time of on-site assessment will not be considered.

IX. Dealing with change in accreditation Standard

If there is a change in the general accreditation criteria ISO/IEC 17025 or ISO 15189 or
ISO/IEC 17043 or ISO Guide 34 / ISO 17034 as applicable. The CAB will be informed about
it and an appropriate transition time shall be given for changeover. Once the CAB has
implemented its system in accordance with the changes, the same shall be assessed as per
NABL policy at that point of time.

X. Dealing with change in NABL requirements

If there is a significant change in any of the NABL policy or Specific requirements, the CAB
will be informed about it and an appropriate transition time shall be given for compliance.
Once the CAB has implemented the changes, the same shall be assessed as per NABL
policy at that point of time.

XI. Dealing with Natural disaster impacting CAB’s operations

The CAB will inform NABL about the impact on its operations in view of natural disaster like
flood, earth quake, fire, storm etc. The CAB will keep NABL informed and will not issue any
report till it is fully functional.

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 201 Procedure for dealing with Changes in Accredited Conformity Assessment Body’s Operation
Issue No: 01 Issue Date: 13-May-2016 Amend No: 04 Amend Date: 02-Apr-2018 Page No:8 /11
XII. Request for Voluntary Withdrawal of accreditation

(a) Where a NABL accredited CAB intends to withdraw its accreditation, the CAB shall
apprise NABL in writing about its willingness to withdraw the accreditation. Till such
time, the request for withdrawal is processed; the accredited CAB will be bound by
NABL rules and regulations.

(b) Voluntary withdrawal is not permissible if CAB is facing any kind of justified adverse
action due to malpractices. Please refer NABL 216.

The CAB once voluntary withdraws the accreditation and desires to get the accreditation
again, they may apply a fresh. In such events NABL will process the application as a fresh
application.

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 201 Procedure for dealing with Changes in Accredited Conformity Assessment Body’s Operation
Issue No: 01 Issue Date: 13-May-2016 Amend No: 04 Amend Date: 02-Apr-2018 Page No:9 /11
Appendix A
Declaration
Name of the new CAB:

Address of the CAB:

Field of Accreditation with Current


Accreditation Cycle :
Name & Address of the Acquiring
(or) Merger Firm / Company/ Entity:

In the matter of ‘Acquisition/Takeover’ of accredited CAB (irrespective of the size) by a new


Firm / Company / Entity OR ‘Merger’ of ‘accredited CAB’ with another ‘Firm / Company / Entity’,
following declarations shall be submitted by the new top management of the acquiring (or)
Merger Firm / Company / Entity:

By signing this declaration, I/we confirm the followings:


1. There is no change in the scope of accreditation, staff, responsibilities, authorities, or any
other specific changes affecting existing accreditation and functioning of the CAB as a
result of the ‘Acquisition / Takeover’’ or ‘Merger’.
2. ...................................... (Acquiring Firm / Company / Entity) shall undertake all the
responsibilities and liabilities pertaining to existing accredited CAB after
‘Acquisition/Takeover’’ or ‘Merger’.
3. The new entity/company ............................................agrees to accept responsibility for any
complaints that NABL is investigating with respect to the existing accredited CAB.
4. The existing accredited CAB is not under litigation or prosecution threat as a results of legal
actions taken against its accredited services.
5. The new CAB accepts all contractual, legal, financial and other obligations which is
pertained to the accredited activities of the existing accredited CAB / Enitity.
6. We will abide by the Terms and Conditions for maintaining NABL accreditation as specified
in ‘NABL-131’ document (signed copy to be enclosed).

Name & Designation of Top Management...................................................................................

Signature & Date..........................................................................................................................

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 201 Procedure for dealing with Changes in Accredited Conformity Assessment Body’s Operation
Issue No: 01 Issue Date: 13-May-2016 Amend No: 04 Amend Date: 02-Apr-2018 Page No:10 /11
Appendix B
Declaration

Name of the new CAB:

Address of the CAB:

Field of Accreditation with Current


Accreditation Cycle :
Name & Address of the Acquiring
(or) Merger Firm / Company/ Entity:

Following documents are attached:

 Copy of legally valid agreement pertaining to ‘Acquisition/Takeover’’ (or) ‘Merger’ which


explicitly states the ‘Acquisition/Takeover’’ or ‘Merger’ of the accredited CAB by the new
Firm/ Company / Entity:
 Document citing the current Legal status of the accredited CAB after
‘Acquisition/Takeover’’ or ‘Merger’.
 Certificate of Incorporation or articles of association ( if applicable)
 Evidence that new company / entity’ organization shall accept all liabilities arising out of
the accredited activities of the existing accredited CAB/entity.
 Applicable Fee

Name & Designation of Top Management................................................................................


…………………………………………………………………………………………………………..
Signature & Date.......................................................................................................................

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 201 Procedure for dealing with Changes in Accredited Conformity Assessment Body’s Operation
Issue No: 01 Issue Date: 13-May-2016 Amend No: 04 Amend Date: 02-Apr-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

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