Quality management, definition

An extensive range of definitions in the field of quality management is provided in ISQ 8402 1994 and Appendix A includes over 150 commonly-used terms, less verbose but consistent with the definitions found in ISQ 8402 1994. 

Overview of Definitions from ISO 9004 Quality Management and Quality Systems Elements—... 

Briefly, the quality management system is a combination of quality management, quality control and quality assurance. Quality assurance and quality control are components of the laboratory s quality management system. There is often confusion over the meaning of quality control and quality assurance and regrettably they are often used interchangeably. This is possibly because some quality control and quality assurance actions are interrelated. The definition of the terms can be found in the International Organization for Standardization (ISO) Standard, ISO 9000 2005 [2],... 

Total Quality Management (TQM) is a eompany enltnre that allows it to provide qnality goods and services at the lowest cost in order to achieve cnstomers satisfaction and, at the same time, ensnre satisfactoiy business development by continuous improvements. The definition of TQM shown in this shde is taken from the British Standard 7850. 

The terms and definition taken from ISO 9004 2000, Fig. 1, Quality management systems-guidelines for performance improvements, are reproduced with the permission of the International Organization for Standardization, ISO. This standard can be obtained from any ISO member and from the Web site of the ISO Cental Secretariat with the following address www.iso.org. Copyright remains with ISO. 

To avoid misunderstanding, it is crucial to use the correct terms and expressions during quality management. A list of definitions can be found in the appropriate section. 

There are several reasons why a quality system must be fully documented. Firstly it is a pre-requisite of most quality standards. Secondly, in most laboratories it would be impossible to accurately remember and hence communicate all of the analytical methodology and quality management procedure to staff. This would lead to the quality system becoming compromised due to slalT turnover. Thirdly the process of audit (see Section 5.1) requires a precise definition of the planned quality system. This is provided by the documentation. 

Conversely, if the supplier s Quality Management System is very well written and there is documented evidence that the supplier adheres to it, the definition of risk levels might be relaxed a bit in the Function Risk Assessment. If the supplier s own acceptance testing is well documented and thorough, the Validation Plan should document the intent to reference some of the supplier testing in lieu of internal tests. It is not necessary to specify exact tests to be used at this point that can wait until the test plans are being prepared later on. 

The ISO 9000 Quality Management and Quality Assurance Standards, Guidelines for Selection and Use, provide basic definitions and concepts and explain how to use the rest of the series (9001, 9002, 9003, and 9004). 

DIN EN ISO 8402 - Definitions Quality Management, in English, French and German, August 1995, Beuth, Berlin, Germany... 

By definition, it is proposed that the future plans for promoting VAM to producers of analytical data should concentrate on the individual or department with responsibility for the production and overall quality of an analytical measurements . In some cases these individuals may be senior decision makers but in the majority of cases these are more likely to be bench analysts, quality managers and laboratory team leaders. This suggests that an appropriate base for segmentation of the producer audience for VAM is by job function, with the target segments ranging from those individuals who actually make the measurements (producer analysts) to those who have overall responsibility for their quality (senior decision-makers), but who may not actually carry out any analysis themselves. 

ISO 9000 2005 (2005) defines quality management as "The coordinated activities to direct and control an organization with regard to quality . ICH GCP does not contain a definition for QM. 

According to ISO 9000 2005 (2005), QA activities are not confined to auditing, but comprise all activities suitable to ensure that company procedures are designed so that the product or service will comply with pre-established quality requirements The part of quality management focused on providing confidence that quality requirements will be fulfilled . This definition emphasizes that QA activities are future-oriented and should focus on improving systems and procedures to be followed to ensure that these are set up in such a way that produces a quality result or service. 

An official definition of essential oils and related products is available in ISO 9235 1997 Aromatic natural raw materials - Vocabulary . In this standard not only essential oils but also related solvent extracts like oleoresins, concretes, absolutes and resinoids are defined. To stress the impact of ISO standards for the quality management in the flavour industry, an overview of all relevant standards concerning essential oils is given in Table 3.27 at the end of this chapter. ... 

Quality assurance Definition of supplemental indicators, such as specific pollutants, for example to identify causes and sources of impairments and targeting appropriate source controls Development maintain and review of Quality Management Plans and Quality Assurance Project Plans according to EPA policy, in relation with an appropriate level of data quality for an efficient decision... 

Council on Practice, Quality Management Committee. Identifying patients at risk ADA s definitions for nutrition screening and nutrition assessment. J Am Diet Assoc 1994 94 838-839. 

Process definition ISO 9000 type of quality management. Ensuring effectiveness and efficiency of processes by use of performance measures... 

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