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Quality management system sample In this file, you can ref useful information about q uality management system sample such as quality management system sampleforms, tools for quality management system sample, quality management system samplestrategies … If you need more assistant for quality management system sample, please leave your comment at the end of file. Other useful material for quality management system sample:

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I. Contents of quality management system sample ////////////////// laboratory accreditation. 0s each is MOTIVA has introduced a series of information videos on laboratory developed, it is added to the list shon on this page. These videos are in Flash video format .  hey are an ecellent start point to learn about accreditation and ho to prepare and implement a laboratory quality system system conformant to I&'I4 15(2$. 0s soon as the ebinars ebinars have  provided someone ith the learning in 6est +ractice they need, they may come bac" to this page and donload the documents and forms needed.  Sample Documents and Procedures

hese documents are provided free of charge to anyone ho ishes to create a quality manual that conforms to I&'I4 I&'I4 15(2$. hey may also be used for part of the creation of quality manuals required by the other technical competence standards used by Inspection 6odies 7I&'I4 15(2(8, +roduct 4ertification 6odies 7I&'I4 15(-$8, +roficiency esting esting +roviders 7I&'I4 15()38, and 9eference :aterial +roducers 7I&' ;uide 3)8. he manual and its associated procedures are based on the approach identified in MOTIVA s ystem for these types of technical training courses for the creation of a conformant quality system conformity assessment bodies 7406s8. he approach is based on tried and true true strategic  planning processes. In essence, the quality policy is epanded into <*ey 9esult 0reas< 0reas< hich are

the obectives at the beginning of each of ten chapters and the remainder of each chapter is dedicated to the processes by hich the laboratory meets the obective of that chapter. =aboratories, Inspection 6odies and other types of 406s may ma"e use of these approaches in their on Q:& by simply simply donloading the documents and implementing them them directly. hese approaches represent best practice in 406 Q:& implementation. hese documents are  presented in pdf format for ease of donloading. •









MOTIVA Sample Quality Qual ity Manual Man ual . his document forms forms the basis of the MOTIVA Quality Manual Template ourse  and provides a straighforard approach that meets or eceeds current requirements for quality system components. It includes a co mprehensive quality policy and a sample document structure. structure. >ote that it is not ritten in the the clause structure of any of the technical competence standards. here are other quality manual templates offered on the eb that are structured in that fashion. ethics for MOTIVA Sample ode of !thics . his document details a code of ethics implementation ithin a laboratory that meets or eceeds the impartiality requirements, including conflict of interest and confidentiality requirements of I&'I4 15(2$ and the other technical competence standards. MOTIVA Sample "ocument ontrol and ontrol of #ecords $rocedure . his document details an comprehensive approach for the control of laboratory documents and records. It is based primarily primarily on the control of paper based documents and electronic records. It meets or eceeds the the requirements in I&'I4 15(2$ for these to disciplines disciplines as detailed in clauses ).3 and ).13 as ell as the associated clauses for the other technical competence standards. Its companion Master "ocument %ist Form  7described belo8 is also available in$"F or !&!%. MOTIVA Sample ontinual ont inual Improvement Im provement $rocedure . his document details a comprehensive continual improvement approach for use in 406s that ish to meet or eceed the requirements detailed in the applicable clauses of the technical competence standard that governs their on on operation. his approach allos for the the identification of non!conformances, potential!non conformances, and opportunities for improvement from all of these source clauses and describes a congruent approach to addressing them as  prescribed more and more in later revisions of the technical completence standards. It contains all the elements required for a 406 to trac" all non!conformances, potential non! conformances and opportunities for improvment from identification through root cause analysis 7here this is actually required8 to solution and follo up. Included are suggested forms and root cause analysis techniques specifically aimed at supporting 406 operations. &imple yet effective approach that is the basis of the MOTIVA #oot ause ourse  and the other continual improvement disciplines. disciplines. :eets or eceeds all the requirements of all technical competence standards, including I&'I4 15(2$ clauses ).%, ).1(, ).11 and ).12. MOTIVA Sample Feed'ac( $rocedure . his document contains a comprehensive approach in acquiring and addressing feedbac", both positive 7compliments8 and negative 7complaints8 in a single procedure that includes sample forms that can be used by lab staff from reception to determination determination of impact on operations. &imple yet effective approach that is the basis of the :'I?0 training in this specific Q:& discipline. :eets all the requirements of I&'I4 15(2$ clauses ).5 an d ).# and the applicable a pplicable clauses in the







other technical competence standards. 6ased, in part, on I&'+0 I&'+0& & 15((3 !Conformity ! Conformity assessment — Complaints and appeals appea ls — Principles and requirements requirements.. MOTIVA Sample onflict of Interest and onfidendiality )uideline . his document contains a comprehensive committment that has been referenced in the &ample 4ode of thics regarding integrity. integrity. his guideline is separate separate from both the Sample Quality Manual and theSample ode of !thics , but is refered to in the &ample & ample 4ode of thics hich allos for committment to both the 4ode and these ;uidelines by staff signature.  his approach meets all the requirements of I&'I4 15(2$ clauses ).1 and ).2, and the applicable clauses of the other technical competence standards regarding these issues. 6ased, in part, on o n I&'+0& I&'+0& 15((1 ! Conformity assessment — Impartiality — Principles and requirements and I&'+0& I&'+0& 15((2 ! Conformity assessment — Confidentiality —  Principles and requirements. requirements. MOTIVA Sample Internal Interna l Audit and Management #evie* #evi e* $rocedure+   his document forms the basis of the MOTIVA MOTIVA Internal Audit ourse  and provides a straighforard approach that meets or eceeds the requirements provided in applicable clauses of all the technical competence standards, I&'I4 15(2$. he procedure describes a process based approach for internal auditing au diting and contains reference to the forms need ed for such activity ac tivity.. MOTIVA Sample ,o' , o' -a.ard Assessment $rocedure . his document forms the basis of the :'I?0 :'I?0 @ob AaBard 0ssessment 4ourse and provides a straighforard approach that meets or eceeds current 'A&0 guidelines regarding the need to inform laboratory staff  of potential haBards and have them participate in appropriate solutions.

 Sample Forms

=aboratories may ma"e use of these forms in their on Q:& by simply donloading them and implementing them directly. directly. hese approaches represent best practice in laboratory Q:& implementation. •









ontinual Improvement Form+ his form trac"s an identified departure from the quality system 7hether or not it has already occured8 or a potential improvement, from identification through assessment of impact, root cause analysis 7here necessary8, development and implementation of solution, to follo up 7again, here necessary8. his form is used in the MOTIVA Internal Audit ourse . It is also available in Cord Cord format here+ Feed'ac( Form  ! his form trac"s both positive and negative feedba c" from any person or organisation ith respect to any aspect of the opera tion of the laboratory. It is also available in Cord Cord format here+ Internal Audit Forms . his set of forms forms allos for a laboratory laboratory to conduct an internal audit conformant to I&'I4 15(2$, clause ).1 ), using a process based approach. hese forms are used in the MOTIVA Internal Audit ourse . It is also available in Cord Cord format here+ Master "ocument %ist . Chile this appraoch to controlling documents has been phased out of the neest versions of standards such as I&'I4 15(2( and 15(-$, it still lives in

15(2$ and it provides a very simple approach to controlling the documents ithin a management system. If e understand that the the entire aim of document control control is to ensure that only the most appropriate version of a document is available to everyone ho may need it, then the :aster Document =ist approach described in ).3.2 of I&'I4 15(2$ is a pretty straightforard ay to do that. >o thin"ing required, ust list list them and trac" trac" them. his form allos a laboratory to list the status and location of all internally!generated documents and all eternally!generated documents, including the the formats of laboratory laboratory forms. It also allos the laboratory quality system personnel to record the authorities for creating and authoriBing documents, trac"ing revie dates, and indicating hen a document needs to be revieed again to determine its continued suitability in the laboratory management system.  It is also available in its !/cel format here . //////////////////

III. Quality management tools

1. Check sheet he chec" sheet is a form 7document8 used to collect data in real time at the location here the data is generated. he data it captures can be b e quantitative or qualitative. Chen the information is quantitative, the chec" sheet is sometimes called a tally sheet. he defining characteristic of a chec" sheet is that data are recorded by b y ma"ing mar"s 7<chec"s<8 on it. 0 typical chec" sheet is divided into regions, and mar"s made in different regions have different significance. Data a re read by observing the location and number of mar"s on the sheet. 4hec" sheets typically employ a heading that ansers the Eive CsF



Cho filled out the chec" sheet Chat as collected 7hat each chec" represents,



an identifying batch or lot number8 Chere the collection too" place 7facility, room,



apparatus8 Chen the collection too" place 7hour, shift, day of 



the ee"8



Chy the data ere collected

2. Control chart

4ontrol charts, also "non as &hehart charts 7after Calter Calter 0. &hehart8 or process!behavior charts, in statistical process control are tools used to determine if a manufacturing or business  process is in a state of statistical statistical control. If analysis of the control chart indicates that the  process is currently under control 7i.e., is stable, stable, ith variation only coming from sources common to the process8, then no corrections or changes ch anges to  process control parameters are needed or desired. In addition, data from the process can be used to  predict the future performance of the process. If the chart indicates that the monitored process is not in control, analysis of the chart can help determine the sources of variation, as this ill result in degraded process p rocess performance.G1H 0  process that is stable but operating outside of desired 7specification8 limits 7e.g., scrap rates may be in statistical control but above desired limits8 needs to be improved through a deliberate effort to understand the causes of current  performance and fundamentally improve the  process. he control chart is one of the seven basic tools of  quality control.G3H ypically control charts are used for time!series data, though they can be b e used for data that have logical comparability 7i.e. you ant to compare samples that ere ta"en all at the same time, or the performance of different individuals8, hoever the type of chart used to do this requires consideration.

0+ $areto chart

0 +areto chart, named after ?ilfredo +areto, is a type of chart that contains both bars and a line graph, here individual values are represented in descending order  by bars, and the cumulative total is represented by the line. he left vertical ais is the frequency of occurrence,  but it can alternatively represent cost or another important unit of measure. he right vertical ais is the cumulative percentage of the total number of occurrences, total cost, or total of the particular unit of  measure. 6ecause the reasons are in decreasing order, the cumulative function is a concave function. o ta"e the eample above, in order to loer the amount of late arrivals by 5#, it is sufficient to solve the first three issues. he purpose of the +areto chart is to highlight the most important among a 7typically large8 set of factors. In quality control, it often represents the most common sources of defects, the highest occurring t ype of defect, or the most frequent reasons for customer complaints, and so on. Cil"inson 72((-8 devised an algorithm for producing statistically based acceptance limits 7similar to confidence intervals8 for each bar in the +areto chart.

). Scatter plot Method

0 scatter plot, scatterplot, or scattergraph is a type of mathematical diagram using 4artesian coordinates to display values for to variables for a set of da ta. he data is displayed as a collection of points, each having the value of one variable determining the position on the horiBontal ais and the value of the other variable determining the position on the vertical ais.G2H his "ind of plot is also called a scatter chart, scattergram, scatter diagram,G3H or scatter graph. 0 scatter plot is used hen a variable eists that is under the control of the eperimenter. If a parameter eists that is systematically incremented andor decremented by the other, it is called the control parameter or independent variable and is customarily plotted along the ho riBontal ais. he measured or dependent variable is customarily  plotted along the vertical ais. If no dependent variable eists, either type of variable can be plotted on either ais and a scatter plot ill illustrate only the degree of correlation 7not causation8 beteen to variables. 0 scatter plot can suggest various "inds of correlations  beteen variables ith a certain confidence interval. Eor eample, eight and height, eight ould be on  ais and height ould be on the y ais. 4orrelations may be  positive 7rising8, negative 7falling8, 7falling8, or null 7uncorrelated8. If the pattern of dots slopes from loer left to upper right, it suggests a positive correlation beteen the variables  being studied. If the pattern of dots slopes from upper left to loer right, it suggests a negative co rrelation. 0 line of  best fit 7alternatively called JtrendlineJ8 can be dran in order to study the correlation beteen the variables. 0n equation for the correlation beteen the variables can be determined by established best!fit procedures. Eor a linear  correlation, the best!fit procedure is "non as linear regression and is guaranteed to generate a correct solution in a finite time. >o universal best!fit procedure is guaranteed to generate a correct solution for arbitrary relationships. 0 scatter plot is also ver y useful hen e ish to see ho to comparable data d ata sets agree ith each

other. In this case, an identity line, i.e., a y/ line, or an 1F1 line, is often dran as a reference. he more the to data sets agree, the more the scatters tend to concentrate in the vicinity of the identity lineK if the to da ta sets are numerically identical, the scatters fall on the identity line eactly.

1+Ishi(a*a diagram

Ishi"aa diagrams 7also called fishbone diagrams, herringbone diagrams, cause!and!effect diagrams, or Eishi"aa8 are causal diagrams created by *aoru Ishi"aa 71%-#8 that sho the causes of a specific event. G1HG2H 4ommon uses of the Ishi"aa diagram are product design and quality defect prevention, to identify potential factors causing an overall effect. ach cause or reason for imperfection is a source of variation. 4auses are usually grouped into maor categories to identify these sources of variation. he categories typically include • •

+eopleF 0nyone involved ith the process :ethodsF Ao the process is performed and the specific requirements for doing it, such as policies,  procedures, rules, regulations and las



:achinesF 0ny equipment, computers, tools, etc. required to accomplish the ob



:aterialsF 9a materials, parts, pens, paper, etc. used to produce the final product



:easurementsF Data generated from the process that are used to evaluate its quality



nvironmentF he conditions, such as location, time, temperature, and culture in hich the process operates

-. Aistogram method

0 histogram is a graphical representation of the distribution of data. It is an estimate of the probability distribution of a continuous variable 7quantitative variable8 and as first introduced by *arl +earson.G1H +ea rson.G1H o construct a histogram, the first step is to <bin< the range of  values !! that is, divide the entire range of values into a series of small intervals !! and then count ho man y values fall into each interval. 0 rectangle is dran ith height proportional to the count and idth equal to the bin siBe, so that rectangles abut each other. 0 histogram histogram may also be normaliBed displaying relative frequencies. It then shos the proportion of cases that fall into each of several categories, ith the sum of the heights equa ling 1. he  bins are usually specified as consecutive, non!overlapping intervals of a variable. he bins 7intervals8 must be adacent, and usually equal siBe.G2H he rectangles of a histogram are dran so that they touch each other to indicate that the original variable is continuous.G3H

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