Quality internal standard

The Green Book," International Standards of Quality and Packingfor Natural Bubber Grades, Rubber Manufacturers Association, Inc., Washington,... 

Presently efforts of Ukrainian scientists in field of analysis of toxic organic substances directed on harmonization of the developed methods of analysis with the requirements of international standards and on wide introduction in practice of the quality control system in chromatographic researches. 

This section covers only the tests that are essential on a completed motor, irrespective of the manufacturing procedure and stage quality checks. If ISO 9000 guidelines are assimilated, practised and enforced by a manufacturer so that a customer s trust is obtained, a final pre-despatch inspection by the customer may not be necessary. The customer, having gained confidence in the practices and Quality Assurance Systems of the manufacturer, may issue an authorization to the manufacturer to despatch the material under their own inspection certificate, rather than an inspection by the customer. We discuss below the test requirements procedure and the acceptance norms prescribed by various national and international standards for such machines and adopted by various manufacturers. 

The international standard ISO 1940 is based on a linear equation similar to Equation 9.3 [3]. The specification calls for balance quality level by Grade Numbers with the lower the number the lower the permissible... 

ISO 9000 (1994). Quality Management and Quality Assurance Standards—Guidelines for Selection and Use. Geneva, Switzerland International Organization for Standardization. 

ISO i) I 992) Air Quality—Particle Size Fraction Definitions for Health-Related Sampling. ISO/ Cl) 7708 International Standardization Organization, Geneva. 

The main purpose for the heating and air conditioning of work spaces is to provide an environment that is acceptable and does not impair the health and performance of the occupants. During production processes and in the external environment it may be necessary to work in unacceptable conditions for a limited time period. However, it must be ensured that these conditions do not impair the health of the employees. Light, noise, air quality, and the thermal environment are all factors that influence the acceptability of conditions for and performance of the occupants. This section will only deal with the thermal environment. Several standards dealing with methods for the evaluation of the thermal environment have been published by international standard organizations such as ISO and CEN. 

In 1983, BSI approached the International Organization of Standardization in Geneva with a view to developing an international quality system standard and eventually a committee was formed. Using BS 5750 as its basis, the ISO 9000 series of standards was born. 

The certification business has grown enormously in the last ten years. The International Accreditation Forum (lAF) recorded 616 accredited certification bodies in January 1999. The experience of the vehicle manufacturers with ISO 9000 certification led them to question the wisdom of so many certification bodies chasing the same business in a competitive market. The results seemed to indicate that cost reductions by the certification bodies led to a decline in the quality of auditing and that was the opposite of what the vehicle manufacturers wanted. The vehicle manufacturers had not seen a significant rise in product quality as a result of ISO 9000 and they believed this was partially due to the quality of the accreditation and certification schemes being operated as well as inadequacies in the quality system standard. When the four national automotive schemes were launched, great emphasis was placed on regulating more closely the accreditation and certification schemes. From a customer perspective, the ISO 10011 scheme had some particular problems ... 

The standard requires the supplier to prepare documented procedures consistent with the requirements of this international standard and the supplier s stated quality policy. 

The ISO 9000 series has been chosen because it is the most widely used Quality Management system and is a recognized international standard. The use of ISO 9000 in this book is not an endorsement of ISO 9000 over other systems. Rather, it is a practical decision based on the need to select one system to consistently illustrate the ideas contained in the book. 

Many manufacturers are registered to ISO (International Standards Organization), which is reported to be the toughest industrial quality assurance standards in the world and covers design, development, production, installation, and service. 

The other method for quality assurance inspection of pellet wt in the primer eliminates the need for a comparator oxygen-containing standard. Here, the Cu in the cup-anvil combination in the primer is used as an internal standard by comparing the 0.511 MeV positron annihilation radiation from 62Cu produced by the 63Cu(n,2n)62Cu reaction to the 6.1 MeV 7 from l6N produced by oxygen activation. In this case the actual determination of pellet wt is not required the ratio of Cu to O, which should be fixed for a pro-... 

This feasibility study shows that determination of pellet wt by fast neutron oxygen activation analysis can be used for quality assurance inspection of M34 primers. Either direct oxygen analysis, where a comparison standard (such as lucite) is used, or a ratio method, utilizing the Cu in the cup-anvil combination as an internal standard, can be applied. In general, the uniformity of production primers is quite satisfactory, as is usually the case where production procedures are standardized. It seems likely that the light pellet is one which has been improperly manufd and will probably be well below specifications in pellet wt. Production experience with such primers indicates that only one in 3x10s primers is expected to show low pellet wt therefore, one would not expect to find a reject in a small sampling. Nevertheless, detection and rejection of this one bad unit is critical for the prevention of weapon malfunctions and possible injuries to personnel... 

International Standards Organization, ISO 9000 2005 Quality Management Systems Fundamentals and Vocabulary, 3rd ed., Geneva, 2005. 

ISO GUIDE 34 1996) Quality system guidelines for the production of reference materials. (Revised March 1998 as ISO/REMCO document No 464 General requirements for the competence of reference material producers . The revised Guide 34 will appear early 2000.) International Standards Organization, Geneva. 

Effective management of microbiology collections requires that the cultures meet current and future international standard requirements of biotechnology industries. The knowledge and competence of the scientists performing cell culture work obviously impact the quality of the cultures. 

ISO Guide 34 (1996) Quality system guidelines for the production of reference materials. International Standards Organization, Geneva. 

Low Resolution Nuclear Magnetic Resonance (LR-NMR) systems are routinely used for food quality assurance in laboratory settings [25]. NMR based techniques are standardized and approved by the American Oil Chemist s Society (AOCS) (AOCSd 16b-93, AOCS AK 4-95), the International Union of Pure and Applied Chemistry (IUPAC) (solid fat content, IUPAC Norm 2.150) and the International Standards Organization (ISO) (oil seeds, ISO Dis/10565, ISO CD 10632). In addition to these standardized tests, low resolution NMR is used to measure moisture content, oil content and the state (solid or liquid) of fats in food. Table 4.7.1 summarizes common food products that are analyzed by low-resolution NMR for component concentration. 

Pesticides produced in the USSR were usually supplied to farms in extremely inconvenient sizes and packaging (in 100- to 200-liter containers, or in 20- to 50-kilogram bags), with labels that were not in accordance with international standards. The concentration of working solutions of pesticides did not hold up. The pesticide delivery technology did not meet requirements. Because of insufficient packaging and specialized technology, up to 20% of the pesticides were lost on the way to the field. Because sprayer construction was of low quality, 30% of the pesticides used were lost. 

International Standards Organisation (1997) ISO 5667-13 1997, Water quality - Sampling -Part 13 Guidance on sampling of sludges from sewage and water-treatment works. ISO,... 

The recognised body in the United Kingdom for the preparation of specifications for quality, performance or dimensions, methods of test, definitions and symbols, codes of practice, etc. British Standards are prepared under the guidance of representative committees and are widely circulated before they are authorised for publication. BSI co-operates in preparing international standards for rubber and plastics through ISO/TC45 and ISO/TC61 respectively. See ISO. 

The remaining latex is processed into dry rubber as sheets, crepes and bales. There is an International Standard for the Quality and Packing for Natural Rubber grades, the so-called Green Book , published by the Rubber Manufacturers Association. The following grades of NR listed in the Green Book are sold to visual inspection standards only ... 

The accuracy of the inductively-coupled plasma procedure was assessed by analysing waters of known sulfate composition, and by comparing measured sulfate values for a wide range of samples with those obtained for the same waters by an automated spectrophotometric procedure. Good agreement is obtained between the derived sulfate measurements and the normal values for International Standard Sea Water and an EPA Quality Control Standard. 

The International Standard, ISO 9001 2000, Quality Management Systems -Requirements, is a general standard that applies to all types of organizations,... 

This chapter outlines the means by which results which are fit for purpose are achieved. There are examples of how unreliable results can affect all of our lives. It explains some of the nomenclature encountered in quality management and why a quality management system is important. There is a brief description of the international standards that are applicable to a chemical analysis laboratory. 

Method validation is defined in the international standard, ISO/IEC 17025 as, the confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use are fulfilled. This means that a validated method, if used correctly, will produce results that will be suitable for the person making decisions based on them. This requires a detailed understanding of why the results are required and the quality of the result needed, i.e. its uncertainty. This is what determines the values that have to be achieved for the performance parameters. Method validation is a planned set of experiments to determine these values. The method performance parameters that are typically studied during method validation are selectivity, precision, bias, linearity working range, limit of detection, limit of quantitation, calibration and ruggedness. The validation process is illustrated in Figure 4.2. 

There are two uses of chemical standards in chemical analysis. In the first place, they may be used to verify that an instrument works correctly on a day-to-day basis - this is sometimes called System Suitability checking. This type of test does not usually relate to specific samples and is therefore strictly quality assurance rather than quality control. Secondly, the chemical standards are used to calibrate the response of an instrument. The standard may be measured separately from the samples (external standardization) or as part of the samples (internal standardization). This was dealt with in Section 5.3.2. 

In the previous chapters of this book, we have looked at many aspects of quality in laboratories. Some of the relevant Standards have been mentioned and their similarities and differences outlined. This chapter aims to give more detail on the components of the Standards and show how a quality management system can be achieved in the laboratory. The documentation required and the processes necessary to demonstrate that the management system operates to the requirements of International Standards will be explained. It is important to be clear that the overall management system of a laboratory or organization will cover all of their operations this includes quality, administration and technical systems. 

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