Standard guaranteed achievement

All these standards have since been adopted by the member countries as their national standards, fully or in slightly modified forms, to suit their own requirements and working conditions. These standards define and clarify the quality norms and aim at in-house quality disciplines, to automatically and continually produce a product, provide a service or programme to the stipulated specifications, quality norms and customer needs. They guarantee a product or service with a minimum quality. The envisaged quality systems thus aim at a work culture that pervades all those involved in different key activities or processes, to achieve the desired goal through carefully evolved systems. 

To guarantee shipment on time, you either need to maintain an adequate inventory of finished goods for shipment on demand or utilize only predictable processes and obtain sufficient advanced order information from your customer. When you examine some of the requirements in ISO/TS 16949, you may be tempted to question how you can continually improve performance, reduce costs, and minimize space, material travel, equipment downtime, process variation, etc. and meet 100% on-time shipments. You can t, unless you have a partnership with your customer in which there is mutual assistance to meet common objectives. Without sufficient lead time on orders you will be unlikely to meet the target. However, the standard does acknowledge that you may not always be successful. There will be matters outside your control and matters over which you need complete control. It is the latter that you can do something about and take corrective action should the target not be achieved. 

The main objective of this directive is to attain a sustainable supply of natural water, to improve its quality over current standards, and to guarantee sufficient supply. This is to be achieved by detailed monitoring in Member States and in a steady improvement by prescribed measures. The regulation load will therefore increase. Based on this directive, the national law in Germany has been amended. 

One or more of these bias components are encountered when analyzing RMs. In general, RMs are divided into certified RMs (CRMs, either pure substances/solu-tions or matrix CRMs) and (noncertified) laboratory RMs (LRMs), also called QC samples [89]. CRMs can address all aspects of bias (method, laboratory, and run bias) they are defined with a statement of uncertainty and traceable to international standards. Therefore, CRMs are considered useful tools to achieve traceability in analytical measurements, to calibrat equipment and methods (in certain cases), to monitor laboratory performance, to validate methods, and to allow comparison of methods [4, 15, 30]. However, the use of CRMs does not necessarely guarantee trueness of the results. The best way to assess bias practically is by replicate analysis of samples with known concentrations such as reference materials (see also Section 8.2.2). The ideal reference material is a matrix CRM, as this is very similar to the samples of interest (the latter is called matrix matching). A correct result obtained with a matrix CRM, however, does not guarantee that the results of unknown samples with other matrix compositions will be correct [4, 89]. 

Even though one can obtain good agreement between the measured and calculated light intensity profiles for sedimentation equilibrium experiments, this method has drawbacks for the routine assessment of the performance of the optical system. There is not commercially available a standard solute with guaranteed purity and certified sedimentation behavior. Moreover each experiment requires a correction baseline obtained from the cells spun with both sectors filled with solvent. Since a time period of 8 hr or more is required to achieve equilibrium, it becomes a formidible task to investigate the effect of a number of parameters. 

CRMs to finalise the method development, to validate analytical procedures and finally control in time the accuracy of procedures, are rare and valuable materials, in particular matrix CRMs. They should tell the analyst how his entire measurement procedure is performing. He will receive information on precision as well as on trueness. CRMs are primarily developed to check for trueness, which is the most difficult property to verify. Precision can be tested on RMs or can be estimated from published data e.g. the performance required by a standard method, whereas the evaluation of trueness is possible only with external help a CRM or a properly organised interlaboratory study. Having a CRM allows one to perform the verification of trueness whenever the operator wants it. The analyst should never forget that only when accurate results (precise and true) are achieved, comparability in space and over time is guaranteed. But to exploit to a maximum the information on trueness delivered by the CRM, the precision must also be sufficient and verified. 

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