Nabl 134
Nabl 134
Nabl 134
NABL
PROCEDURE for DEALING WITH APPEALS AGAINST ADVERSE DECISIONS TAKEN BY NABL
AMENDMENT SHEET
Sl
1
Amendment made
Reasons
Signature QM
Signature Director
10
CONTENTS
Sl. Chapter Amendment Sheet Contents 1. 2. 3. 4. 5. Purpose Scope Responsibility References Procedure 5.1 5.2 5.3 6. Receipt and Acknowledgement Deliberation of the Appeals Committee and Recommendations Decision on Appeals Page No. 1 2 3 3 3 3 4 4 4 5 5 6
PROCEDURE FOR DEALING WITH APPEALS AGAINST ADVERSE DECISIONS TAKEN BY NABL
1.
1.1
PURPOSE
The document describes the procedure for dealing with appeals received from the laboratories against adverse decisions / actions taken by NABL.
2.
2.1
SCOPE
This procedure covers handling of appeals received from laboratories against NABL decisions.
2.2
The procedure includes appeals by laboratories, (both applicant and accredited laboratories) against adverse decision taken by NABL in respect of refusal to accept an application; refusal to proceed with an assessment; corrective action requests; changes in accreditation scope; decisions to deny, put in abeyance, suspend, or forced withdrawal of accreditation; and any other action that impedes the attainment of accreditation.
3.
3.1
RESPONSIBILITY
Primary responsibility for handling of appeals rests with Complaints & Appeals Officer. He is also the convener of the Appeals Committee.
3.2
Appeals committee is responsible for considering the appeal and give its recommendations after thoroughly investigating the matter under consideration.
3.3
Director is responsible for forwarding the recommendation to the Chairman, NABL of the appeals committee after necessary review to ensure that the same is within the framework of NABL rules and regulations. Director is also responsible for monitoring progress of action on appeals.
4.
4.1 4.2
REFERENCES
Quality Manual Clause Nos. 4.2 and 7.10. Procedure for taking Adverse Decisions (NABL 216).
5.
5.1 5.1.1
PROCEDURE
Receipt and Acknowledgement All appeals against adverse decisions taken by NABL shall receive due consideration. Appeals are generally addressed to the Chairman NABL.
5.1.2
Complaints & Appeals Officer shall acknowledge the receipt of appeals from a laboratory. The Officer shall maintain record pertaining to all appeals including important details like date of receipt, name and address of the laboratory, details of appeal, outcome and final disposal in form 26B.
5.1.3
The Appeals shall be examined and if prima-facie they appear to be valid and having some substance, they are taken up for further actions.
5.2 5.2.1
Deliberation of the Appeals Committee and Recommendations Appeals Committee shall then consider the appeals. The representative from the Accreditation Committee involved in the decision appealed against, may provide technical inputs but shall not be involved in formulation of recommendations of the Appeals Committee.
5.2.2
After examination of the appeal, the committee may seek clarifications and information from all appropriate sources. If considered necessary the Committee shall ask NABL to depute its staff or an assessor or an expert to the laboratory to investigate the matter. All expenses for such visits shall be borne by NABL.
5.2.3
The Appeals Committee may recommend a fresh assessment, which shall be organized by the designated Accreditation Officer. It shall be ensured that the same assessors who had assessed the laboratory in the earlier assessment shall not be used for fresh assessment. NABL shall not levy fresh charges to the laboratory. The cost of travel of assessors shall be entirely borne by NABL, in such cases.
5.2.4
On the basis of the fresh assessment, the relevant accreditation committee shall give an independent view on the status of the laboratorys quality management system and technical competence as well as on the subject matter of the appeal.
5.2.5
Based on the data gathered through any of the above stated means, the Appeals committee shall form its recommendations and along with detailed report submit the recommendations for the consideration of the Chairman NABL through Director within a reasonable time, for his decision.
5.3 5.3.1
Decision on Appeals Chairman, NABL shall take decisions on the appeals by laboratories based on the recommendation of the Appeals Committee.
5.3.2
Decision of Chairman, NABL, shall be final and the laboratory shall be informed accordingly.
6.
6.1 6.2 6.3
RECORDS
Appeals Register (Form 26B). Agenda and Minutes of Appeals Committee meeting. Appeals file maintained by Complaints & Appeals Officer where all correspondence in respect of complaints received, Chairmans decisions, and any other relevant documents are filed date-wise.
6.4
They shall maintain all records pertaining to the appeals received from laboratories as listed above and shall keep form 26B updated.
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