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NABL 216

NABL

NATIONAL ACCREDITATION
BOARD FOR TESTING AND
CALIBRATION LABORATORIES

PROCEDURES
for DEALING WITH ADVERSE
DECISIONS

ISSUE NO : 05
ISSUE DATE: 02.07.2012

AMENDMENT NO : 00
AMENDMENT DATE: --

AMENDMENT SHEET
Sl

Page
No.

Clause
No.

Date of
Amendment

Amendment made

Reasons

Signature Signature
QO
Director

10

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 216
Issue No: 05

Procedures for Dealing with Adverse Decisions


Issue Date: 02.07.2012
Last Amend No: 00

Amend Date: --

Page No: 1/ 15

CONTENTS

Sl

Title

Page

Amendment Sheet

Contents

1.

Scope

2.

Classifications of Adverse Decisions

3.

Procedure to be followed for taking Adverse Decisions against the Applicant


Laboratories

4.

Procedure to be followed for taking Adverse Decisions against the Accredited


Laboratories

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 216
Issue No: 05

Procedures for Dealing with Adverse Decisions


Issue Date: 02.07.2012
Last Amend No: 00

Amend Date: --

Page No: 2/ 15

PROCEDURES FOR DEALING WITH ADVERSE DECISIONS

1.

SCOPE
The document lists the adverse decisions and the conditions under which these
decisions are taken.

2.

CLASSIFICATIONS OF ADVERSE DECISIONS


The various types of adverse decisions addressed in this document are:
A.

Adverse decisions against Applicant Laboratories


1
2
3

B.

Change in status to inactive


Change in status to closed
Denial of Accreditation

Adverse decisions against Accredited Laboratories


1
2
3
4
5

Denial of Accreditation
Scope Reduction
Abeyance
Suspension
Forced Withdrawal

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 216
Issue No: 05

Procedures for Dealing with Adverse Decisions


Issue Date: 02.07.2012
Last Amend No: 00

Amend Date: --

Page No: 3/ 15

3.

PROCEDURE TO BE FOLLOWED FOR TAKING ADVERSE


DECISIONS AGAINST THE APPLICANT LABORATORIES

3.1

CHANGE IN STATUS TO INACTIVE

Condition

1.

When the laboratory has not submitted complete application within two months time after
the deficiencies has communicated to the laboratory.

Action by NABL

1.

The laboratory is notified in writing.

2.

The inactive status is imposed.

3.

The laboratory during the inactive status, at any time, may respond to the outstanding
issues raised by NABL but not later than 03 months from the date of imposition.

Restoration to active status

1.

The status of the laboratory is changed to active after the laboratory has satisfactorily
resolved the issues raised by NABL within 03 months from the date of imposition of
inactive status.

2.

The laboratory need not pay additional application fees, while it returns to active
status.

3.

The Lab ID remains the same. However, the effective date for application shall be the
date of restoration to 'active status'.

The laboratory can be put to inactive status only once during the processing of application.

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 216
Issue No: 05

Procedures for Dealing with Adverse Decisions


Issue Date: 02.07.2012
Last Amend No: 00

Amend Date: --

Page No: 4/ 15

3.2

CHANGE IN STATUS TO CLOSED

Conditions

1.

When the laboratory continues to be in the inactive status for 3 months.

2.

When the adequacy audit of the laboratory has been conducted for which the
comments/ deficiencies have been communicated and the laboratory has not taken
action on them within a maximum of two months.

3.

When the pre-assessment of the laboratory has been conducted for which the nonconformities have been communicated and the laboratory has not taken proper
corrective actions to close the non-conformities within maximum of three months.

4.

When the initial assessment of the laboratory has been conducted for which the nonconformities have been communicated by the assessment team at the time of initial
assessment and the laboratory has not taken corrective actions/ closed the nonconformities within a maximum time period of three months.

5.

When the laboratory does not co-operate with NABL or refuses to allow examination of
documents and records or denies access to testing and calibration areas or misleads
its users or brings NABL into disrepute in any manner.

6.

When the assessment report has been evaluated by NABL for which clarifications have
been sought or verification visit has been planned and the laboratory has not provided
appropriate clarifications/ agreed for verification visit with in a maximum period of two
months.

7.

When the laboratory voluntary withdraws the application.

Action by NABL
1.

If no response is received from the laboratory, the status of the applicant laboratory
shall be changed to closed.

2.

The closed status is imposed on the laboratory and is notified in writing.

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 216
Issue No: 05

Procedures for Dealing with Adverse Decisions


Issue Date: 02.07.2012
Last Amend No: 00

Amend Date: --

Page No: 5/ 15

Re-enrollment by laboratory

1.

The laboratory can apply afresh with relevant application forms, quality manual and
application fees applicable at that time along with any other outstanding charges.

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 216
Issue No: 05

Procedures for Dealing with Adverse Decisions


Issue Date: 02.07.2012
Last Amend No: 00

Amend Date: --

Page No: 6/ 15

3.3

DENIAL OF ACCREDITATION

Conditions

1.

When the Accreditation Committee has not recommended accreditation based on the
recommendation of the assessment team.

2.

When the Accreditation Committee has not recommended accreditation though same
was recommended by the assessment team.

Action by NABL

1.

The laboratory is notified in writing giving reasons of denial and file shall be closed.

Re-enrollment by laboratory

1.

The laboratory can apply a fresh by submitting a new application and giving valid
justification on earlier denial. The laboratory will have to pay full application fees and
assessment charges applicable at that time.

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 216
Issue No: 05

Procedures for Dealing with Adverse Decisions


Issue Date: 02.07.2012
Last Amend No: 00

Amend Date: --

Page No: 7/ 15

4.

PROCEDURE TO BE FOLLOWED FOR TAKING ADVERSE


DECISIONS AGAINST THE ACCREDITED LABORATORIES

4.1

DENIAL OF ACCREDITATION

Conditions

1.

When the Accreditation Committee has not recommended accreditation based on the
recommendation of the assessment team.

2.

When the Accreditation Committee has not recommended accreditation though same
was recommended by the assessment team.

Action by NABL

1.

The laboratory is notified in writing giving reasons of denial. The laboratory is instructed
not to use NABL symbol or claim accreditation.

2.

The web-site is updated by removing the scope of the laboratory and by removing the
name of the laboratory from relevant directory of accredited laboratories.

Re-enrollment by laboratory

1.

The laboratory can apply a fresh by submitting a new application and giving valid
justification on earlier denial. The laboratory will have to pay full application fees and
assessment charges applicable at that time.

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 216
Issue No: 05

Procedures for Dealing with Adverse Decisions


Issue Date: 02.07.2012
Last Amend No: 00

Amend Date: --

Page No: 8/ 15

4.2

SCOPE REDUCTION

Conditions

1.

When the assessment team during surveillance (including desktop) or re-assessment


observes major non-conformities in the technical competence of specific test(s)/
calibration(s) with reference to ISO/ IEC 17025: 2005 or ISO 15189: 2007 whichever is
applicable, which is expected to adversely influence the test/ calibration results.

2.

When a laboratory is not able to close non-conformities within specified time after
surveillance

(including

desktop)

re-assessment

related

to

specific

test(s)/

calibration(s).
3.

In the event of a laboratorys performance in a proficiency testing programme


conducted by NABL/ APLAC or any other national or international accredited/
recognized PT provider, being unsatisfactory or is declared an outlier or in terms of
Z 3 or En>1 or any other criteria depending on the programme design and
laboratory does not take appropriate corrective actions within specified time on two
consecutive occasions.

4.

When a laboratory voluntarily withdraws test/calibrations from the accredited scope.

Action by NABL

1.

Decision on scope reduction will be formally communicated by NABL to the laboratory.

2.

The laboratory will be required to return the concerned pages of the original annexure
and in lieu of which a new one will be issued with reduced scope.

3.

Website will be updated to reflect scope reduction.

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 216
Issue No: 05

Procedures for Dealing with Adverse Decisions


Issue Date: 02.07.2012
Last Amend No: 00

Amend Date: --

Page No: 9/ 15

Restoration of Scope

1.

When the laboratory has fully addressed to the deficiencies which had originally led to
scope reduction, it may make a request to NABL and undergo a fresh assessment, at
their cost. If granted, the scope of accreditation is appropriately amended on the
certificate, indicating the effective date. The effective date is based on the date of
approval by the competent authority.

2.

In all cases of scope restoration, the expiry date of the certificate will remain same.

3.

The web-site will be updated to reflect the scope restoration.

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 216
Issue No: 05

Procedures for Dealing with Adverse Decisions


Issue Date: 02.07.2012
Last Amend No: 00

Amend Date: --

Page No: 10/ 15

4.3

ABEYANCE

Conditions

1.

When a total system failure or gross negligence in technical aspects is identified at the
time of surveillance, desktop surveillance or re-assessment.

2.

When a laboratory had undergone a surveillance, desktop surveillance or reassessment and has not taken any corrective action within 3 months after surveillance/
re-assessment.

3.

When a laboratory delays acceptance of surveillance visit or delays submission of


documents required for Desktop Surveillance for more than 2 months beyond the
scheduled due date.

4.

When a laboratory has not paid the Accreditation / membership fees and the
accreditation charges in response to bill raised by NABL.

5.

When a laboratory has not appropriately responded to the queries as requested by


NABL, even after repeated reminders.

6.

When there is no NABL approved authorized signatory available with the laboratory for
more than 30 days.

Action by NABL

1.

The laboratory is notified in writing. The laboratory is informed not to use NABL symbol
and claim accreditation during abeyance status.

2.

The abeyance status is given to a laboratory for no longer than three months, before
further action is taken.

3.

The abeyance status is not published, however if inquires are received the laboratory
is referred to as under abeyance and working towards re-accreditation.

4.

Only in condition 6 under the Abeyance can be imposed for a particular discipline. In
all other situations the laboratory as a whole is put under abeyance.

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 216
Issue No: 05

Procedures for Dealing with Adverse Decisions


Issue Date: 02.07.2012
Last Amend No: 00

Amend Date: --

Page No: 11/ 15

Re-enrollment by laboratory

1.

To regain accreditation status, the laboratory in abeyance status must notify to NABL
of its desire and agree to undergo assessment after taking appropriate corrective
actions. Abeyance status will continue till assessment is completed and a decision is
taken. In cases where the accreditation cycle expired during the abeyance period; the
laboratory while applying for renewal of accreditation shall submit evidences that all the
issues to invoke the abeyance are addressed and effectively implemented.

2.

The validity date remains unchanged after accreditation is restored, however the issue
date shall be the date of revoking the Abeyance status. Where accreditation cycle
expired in the abeyance period new accreditation cycle will be given after re-enrollment

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 216
Issue No: 05

Procedures for Dealing with Adverse Decisions


Issue Date: 02.07.2012
Last Amend No: 00

Amend Date: --

Page No: 12/ 15

4.4

SUSPENSION

Conditions

1.

When a laboratory continues to be in Abeyance status for three months

2.

The laboratory can be suspended in view of following reasons:


-

non co-operation with NABL

refusal to allow examination of documents & records

denial of access to testing and calibration areas

wrong representation of scope of accreditation

willful and/ or repeated misuse of NABL symbol

misleading reporting of facts

brings NABL into disrepute in any manner etc.

repeated valid complaints against the laboratory.

actions taken by Statutory / regulatory bodies against laboratory' operation

Action by NABL

1.

A show cause notice is issued to the laboratory by NABL to be replied within 10


working days

2.

If the reply is found unsatisfactory (or) laboratory has not responded, a suspension
letter is issued. The laboratory is informed not to use NABL symbol or claim
accreditation.

3.

The suspension status is imposed for a maximum period of three months for the
entire laboratory activities under accreditation, however the minimum suspension
period is one month.

4.

NABL will announce the suspension of accreditation. Laboratory status will be updated.
The web-site is also updated by removing the scope of the laboratory and by removing
the name of the laboratory from relevant directory of accredited laboratories.

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 216
Issue No: 05

Procedures for Dealing with Adverse Decisions


Issue Date: 02.07.2012
Last Amend No: 00

Amend Date: --

Page No: 13/ 15

Re-enrollment by laboratory

1.

To regain accreditation status during the suspension period (ie. within three months of
suspension), the laboratory in suspended status must notify to NABL the corrective
actions taken and its desire to undergo assessment, paying the assessment charges
and other outstanding payments. Suspension status will continue till assessment is
completed and a decision is taken. In cases where the accreditation cycle expired
during the suspended period; the laboratory while applying for renewal of accreditation
shall submit evidences that all the issues invoke the suspension of the laboratory are
addressed and effectively implemented.

2.

The validity date remains unchanged after accreditation is restored, however the issue
date shall be the date of revoking the Suspension status. Where accreditation cycle
expired in the suspension period new accreditation cycle will be given after reenrollment

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 216
Issue No: 05

Procedures for Dealing with Adverse Decisions


Issue Date: 02.07.2012
Last Amend No: 00

Amend Date: --

Page No: 14/ 15

4.5

FORCED WITHDRAWAL

Condition

1.

When a laboratory remains in suspended status for three months and has not met the
condition for lifting the suspension even after three months.

Action by NABL

1.

The laboratory is notified in writing. The laboratory is informed not to use NABL symbol
or claim accreditation.

2.

The withdrawal status is published by NABL.

3.

In case the forced withdrawal status is imposed on the laboratory, the laboratory is
debarred from re-applying for a minimum period of one year.

Re-enrollment by laboratory

1.

The laboratory can be re-enrolled in the programme by giving valid justification of


earlier withdrawal by applying as a new laboratory and paying full application fees and
assessment charges, applicable at that time.

2.

New Lab ID will be provided.

National Accreditation Board for Testing and Calibration Laboratories


Doc. No: NABL 216
Issue No: 05

Procedures for Dealing with Adverse Decisions


Issue Date: 02.07.2012
Last Amend No: 00

Amend Date: --

Page No: 15/ 15

National Accreditation Board for Testing and Calibration Laboratories


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Tel.: +91-11 46499999
Fax: +91-11 26529716
Website: www.nabl-india.org