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NABL NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES NABL 216 PROCEDURES for DEALING WITH

NABL

NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES

NABL 216

PROCEDURES for DEALING WITH ADVERSE DECISIONS

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National Accreditation Board for Testing and Calibration Laboratories

 

Doc. No: NABL 216

Procedures for Dealing with Adverse Decisions

 

Issue No: 05

Issue Date: 02.07.2012

Last Amend No: 00

Amend Date: --

Page No: 1/ 15

Sl

Title

CONTENTS

Page

Amendment Sheet

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Contents

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1. Scope

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2. Classifications of Adverse Decisions

3

3. Procedure to be followed for taking Adverse Decisions against the Applicant Laboratories

4

4. Procedure to be followed for taking Adverse Decisions against the Accredited Laboratories

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National Accreditation Board for Testing and Calibration Laboratories

 

Doc. No: NABL 216

Procedures for Dealing with Adverse Decisions

 

Issue No: 05

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 Change in status to inactive

2 Change in status to closed

3 Denial of Accreditation

B. Adverse decisions against Accredited Laboratories

1 Denial of Accreditation

2 Scope Reduction

3 Abeyance

4 Suspension

5 Forced Withdrawal

National Accreditation Board for Testing and Calibration Laboratories

 

Doc. No: NABL 216

Procedures for Dealing with Adverse Decisions

 

Issue No: 05

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

Procedures for Dealing with Adverse Decisions

 

Issue No: 05

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 non- conformities 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 non- conformities have been communicated by the assessment team at the time of initial assessment and the laboratory has not taken corrective actions/ closed the non- conformities 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

Procedures for Dealing with Adverse Decisions

 

Issue No: 05

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

Procedures for Dealing with Adverse Decisions

 

Issue No: 05

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

Procedures for Dealing with Adverse Decisions

 

Issue No: 05

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

Procedures for Dealing with Adverse Decisions

 

Issue No: 05

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 laboratory’s 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

Procedures for Dealing with Adverse Decisions

 

Issue No: 05

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

Procedures for Dealing with Adverse Decisions

 

Issue No: 05

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 re-

assessment 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

Procedures for Dealing with Adverse Decisions

 

Issue No: 05

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

Procedures for Dealing with Adverse Decisions

 

Issue No: 05

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 working days

to be replied within 10

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

Procedures for Dealing with Adverse Decisions

 

Issue No: 05

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 re- enrollment

National Accreditation Board for Testing and Calibration Laboratories

 

Doc. No: NABL 216

Procedures for Dealing with Adverse Decisions

 

Issue No: 05

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

Procedures for Dealing with Adverse Decisions

 

Issue No: 05

Issue Date: 02.07.2012

Last Amend No: 00

Amend Date: --

Page No: 15/ 15

National Accreditation Board for Testing and Calibration Laboratories 3 rd Floor, NISCAIR 14, Satsang Vihar Marg New Mehrauli Road New Delhi – 110 067 Tel.: +91-11 46499999 Fax: +91-11 26529716 Website: www.nabl-india.org