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Betalink Instrumentation & Calibration Service LLC

Quality Assurance Procedure

Quality Assurance Procedure

Ref. Norm: ISO 17025:2005

Prepared By:

Name:
Design:
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Date:

Reviewed By:

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Approved By:

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COPYRIGHT
No part of this document may be reproduced in any form by print, photocopy, microfilm or any other
means wholly or partially, or disclosed to any person outside BICS without a written permission.

Doc. No. QSP-07 Rev. No.: 00 Issue Date: 15-05-2013 Page 1 of 4


Betalink Instrumentation & Calibration Service LLC

Quality Assurance Procedure

Amendment Record
Page Revision
Sr. No. Summary of Change Authorized By
No. No. / Date

Doc. No. QSP-07 Rev. No.: 00 Issue Date: 15-05-2013 Page 2 of 4


Betalink Instrumentation & Calibration Service LLC

Quality Assurance Procedure

1- OBJECTIVE
The objective of this document is to define the details of the Quality control program to
assure validity of tests and calibrations undertaken.

2- SCOPE:
This procedure is applicable for all procedure related from collection of samples and
conducting calibrations and tests.

3- RESPONSIBILITY:
Management representative, Lab Manager, Department heads are responsible for the
implementation of this procedure.

4- PROCEDURE:
BetaLink has undertaken quality control procedure for monitoring the validity of
calibrations and tests undertaken. The resulting data shall be recorded in such a way
that trends are detectable and, where practicable, statistical techniques will shall be
applied to the review the results. The quality control activities to assure proficiency
include:

 Every 3 months BetaLink will participate in inter-laboratory comparison limits of


detection, confidence intervals, in which a QA sample will be referred to two other
laboratories accredited towards ISO 17025 or approved by the ENAS/DAC for the
Calibrations/tests required and analyzed for scope of works adopted by BetaLink.
The same QA sample will be calibrated / tested in the BetaLink lab to compare
results with other laboratories where QA sample has been sent.
 By the use of certified reference material and reference standards.

* Certified reference material shall be stored in a designated refrigerator properly


identified and locked to prevent loss or damage. Certified reference material shall not be
removed from the lab, unless approval is granted by the Technical In charge and the Lab
manager.

 Laboratory Manager will request a proficiency testing provider to provide samples


to participate in proficiency testing program for all test activities adopted by the lab
on an annual basis.

 Using the same method BetaLink Lab technician and Technical In charge replicate
tests/Calibration on a 3 monthly basis, frequency may be increased when volume
of Calibrations/tests increases.
Doc. No. QSP-07 Rev. No.: 00 Issue Date: 15-05-2013 Page 3 of 4
Betalink Instrumentation & Calibration Service LLC

Quality Assurance Procedure

 Review of laboratory processes and the necessary physical, personnel and


information resources.

 Laboratory's technical personnel continue to have the skills and expertise


necessary for the performance of the calibrations/tests in question.

 Personnel performing tasks requiring special skills are qualified prior to performing
the work. Such personnel are Qualified/Certified based on demonstrated
proficiency of each candidate and periodically thereafter to maintain skills to meet
required practice.

Quality control data shall be analysed and, where they are found to be outside pre-
defined criteria, planned action shall be taken to correct the problem and to prevent
incorrect results from being reported.

5- RELATED DOCUMENTS

All records related laboratory activities shall be maintained by the concerned staff for
at least 5 years.

 Proficiency test reports


 Audit reports

Doc. No. QSP-07 Rev. No.: 00 Issue Date: 15-05-2013 Page 4 of 4

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