Quality system international standards

ISO, 1990/91/92. Guidelines for Auditing Quality Systems. International Standards ISO 10011-1-3. International Organization for Standardization, Geneva. 

A quality system may be defined as an organizational structure that encompasses the procedures, processes, and resources needed to implement quality management. There are various reasons why laboratories implement quality systems. Internally, implementing a quality system can increase the efficiency of laboratory operations. Analysis and documentation of the operations within the laboratory can help standardize processes, achieve more transparency, retain knowledge, improve the work environment and staff morale, and reduce costs. 

The ISO 9001 standard was originally based on BS 5750. A primary objective of this standard is to ensure the commitment of management to quality with respect to the business as well as to customer needs. The Quality Systems Management standard recognizes that employees require measurable objectives. In addition to a detailed record system that shows the origin of raw materials and how the products were processed, it includes auditing (both internal and external, in the form of certification) at defined intervals to check and ensure conformity and effectiveness. 

ISO 9000 series standards—A set of five individual but related international standards on quality management and quality assurance developed to help companies effectively document the quality system elements to be implemented to maintain an efficient quality system. The standards, initially published in 1987, are not specific to any particular industry, goods or service. The standards were developed by... a specialized international agency for standardization composed of the national standards bodies of 91 countries. 

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. 

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 principles outlined in the standard can be applied to any creative activity and while the standard primarily addresses the design of automotive products for onward sale to customers, the principles can be applied to internal systems such as an information technology system, an inventory control system, and even the quality system. 

The standard requires the supplier to investigate the cause of nonconformities relating to product, process, and quality system and record the results of the investigation. The supplementary requirements require the supplier to use problem-solving methods when an internal or external nonconformity occurs. 

The requirements for internal audits apply to audits of the quality system, including the policies, practices, products, and services to which the quality system relates. They are not limited to audits of procedures. In order to determine whether the quality system is effective in maintaining control, you need to check that the resultant products and services meet the specified requirements and that prescribed quality objectives are being achieved. If the products and services are not meeting the specified requirements, or the prescribed objectives are not being achieved, something is clearly amiss with the quality system. The requirements do not apply to audits of suppliers or subcontractors as they are covered in clause 4.6 of the standard. 

Since 1994, the automotive industry in the USA and Europe has been operating quality system certification schemes that extended the requirements of ISO 9001, ISO 10011, and EN 45012. One of these schemes was addressed by my QS-9000 Quality S /stems Handbook, published in 1996. In the same year the automakers of the USA and Europe formed the International Automotive Task Force (lATF) which, in cooperation with the technical committee of the International Organization of Standardization (TO 176), produced ISO/TS 16949. Use of and registration to this new standard is currently voluntary. It is intended that following the first revision to incorporate ISO 9000 2000, the ISO/TS 16949 certification scheme will be mandated by all major vehicle manufacturers on their Tier 1 suppliers. As a result, the standard will be cascaded along the supply chain, ultimately reaching all suppliers to the global automotive industry. 

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. 

The 1982 White Paper on Standards, Quality and International Competitiveness was concurrent with increasing interest in the techniques of quality assurance and the need for international harmonization of standards and the reciprocal recognition of certification. It is worth noting that the ISO 9000 series of standards on Quality Systems 1987 followed the layout of BS 5750 1979 almost clause by clause. ISO Guide 39 covers the general requirements for inspection bodies. Auditing on behalf of certification bodies is part of the inspecting authorities role. 

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

ISO Guide 34 (1996) Quality system guidehnes 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 Organization for Standardization, Geneva. 

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. 

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. 

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. 

The endpoint measurement of the ideal test system must be objective, so that a given compound will give similar results when tested using the standard test protocol in different laboratories. If it is not possible to obtain reproductive results in a given laboratory over time or between various laboratories, then the historical database against which new compounds are evaluated will be time- and laboratory-dependent. Along these lines, it is important for the test protocol to incorporate internal standards to serve as quality controls. Thus, test data could be represented utilizing a reference scale based on the test system response to the internal controls. Such normalization, if properly documented, could reduce intertest variability. 

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