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Suguna Management System       Ver 1.0 / SOP / FQL / P1 - 01  Page  1 of 2



























           1. Quality Assurance General Instructions


                                                                   reagents used to produce a reaction is omitted.
           INTRODUCTION
           This manual has been prepared to describe a Quality   FCoefficient  of  Variation  (Relative  Standard
           Management  System  that  may  be  used  by  feed       Deviation): The standard deviation divided by the
           analysis laboratories and serve as a reference source   mean and multiplied by 100.
           which  specific  laboratories  can  use  to  implement
           protocols appropriate to their specific situations. The   FDocument: A controlled written policy, procedure,
           Quality Management System described in this manual      or work instruction that defines what people do and
           is  based  on  help  laboratory  personnel  maintain  the   how to do it. Controlled means that the document
           standards  expected  while  providing  a  consistent,   states  who  wrote  or  authorised  the  policy  or
           reliable, efficient and professional service with the level   procedure,  when  it  was  issued  and  states  any
           of quality required by the laboratory's customers. The   version number to avoid the use of a document that
           laboratory personnel must have an understanding of      is  no  longer  valid.  Control  of  documentation  will
           the principles underlying quality assurance and must    normally  be  the  responsibility  of  the  Quality
           apply them in all areas of their work. Only in this way can   Assurance Manager.
           they maintain credibility, which is the most important   FPrecision: A measure of the scatter of the data
           attribute  of  any  laboratory.  This  manual  provides  a   around the average.
           strong foundation for laboratories on which they can
           develop a Quality Management System which will meet   FProficiency Sample: (External Quality Assurance
           the requirements of the international standard.         Sample). Samples provided by external source in
                                                                   order  to  compare  laboratory  results  between
                                                                   laboratories and may be used as an internal quality
           GLOSSARY OF TERMS
                                                                   control sample.
           FAccuracy: The difference between an observed or
              measured value and the accepted or "true value".   FQuality  Assurance:  Planned  and  systematic
              Since accuracy is affected by both random and        activities  implemented  within  the  laboratory  that
              systematic errors, accuracy can also be defined as   provide confidence in the accuracy and reliability of
              the sum of systematic plus random error.             results generated.

           FBlank: A sample containing no added analyte or a    FQuality  Control:  Activities  used  to  monitor  a
              sample treated in such a manner that the desired     process or to check a result and provide assurance
              reaction  does  not  take  place,  e.g.  one  of  the   that  all  activities  are  performing  within  pre-





          Prepared by :                                                             Approved by :
                                                             9                                     Director - Technical
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