Quality Management Systems definition

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],... 

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. 

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 outcome of the team s hard work will be the definition of the organization s best practices. One of the major benefits for an organization embarking upon the development of a quality management system such as the ISO 9000 is that it has to put its operations under close scrutiny. The saying if it isn t broken, don t fix it obviously applies in this situation, but often there is a tendency to be too conservative and attempt to certify the situation as-is rather than using the opportunity to... 

In ANSI/ISO/ASQ Q9001-2000, the American National Standard on Quality Management Systems—Requirements, reference is made to The model of a process-based quality management system, and the methodology known as Plan-Do-Check-Act. The standard gives a brief but adequate definition of the PDCA processes, as follows ... 

What are the benefits of applying a quality management system (QMS) as opposed to a traditional more informal approach simply relying on normal supervision The application of an effective QMS, by its definition of procedures, its recording of inspection and test results, and its mechanisms for detecting and correcting anomalies, apart from its direct benefits, will give the necessary assurance that quality ... 

Nonconformities are defined as the nonfulfilment of specified requirements in the ISO 9000 standards for quality management systems (see ISO, 1994). To avoid confusion with this definition, we will here use the term deviation instead. It covers those aspects of the accident sequence that represent a mismatch between our norms for a faultless production process and what actually happened. Nonconformities are one type of deviations, where the norm has been defined and documented. 

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

The management system for process definition documentation should ensure that the contents of the process documentation package are accurate and complete. A suitable review and quality assurance program should be implemented for the process documentation. This may involve a hierarchical review process, and/or using external experts in a review capacity. 

Medication errors have been defined in many ways, depending on research methodologies, incident reporting systems, risk management, or total quality improvement systems. USP uses the broad definition of medication error from the NCC MERP ... 

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. 

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. 

The diversity of products, organizations, culture, and social and political frameworks focusing on a product-specific absolute quantity seemed to make it virtually impossible to achieve a uniform and globally accepted definition of Quality. However, in the 1970s, the term Quality was normed for the first time as a term in the concept of quality management (European Organization for Quality Control 1972). In the 80s the ISO 9000-Standard was established and defined quality based on former definitions like the compliance of requirements to test nominal and actual conditions of a product. After revisions the norm ISO 9000 2000 came up with a definition, which was adopted by the CIRP Dictionary of Production Engineering 2004, that defined quality as the totality of properties and characteristics of an entity that bear on its ability to satisfy stated and implied needs. The present definition set by the ISO 9000 2005 states that quality represents the level in which a set of inherent product characteristics meets the customers demands. This definition includes, but is not limited to, physical products or immaterial services and addresses processes and systems as well (Eig. 1). 

The writers of ANSI7AIHA ZlO-2005, the Occupational Health and Safety Management Systems (OHSMS) Standard, emphasized that the OHSMS continual improvement cycle [is] based on the recognized quality concept of Plan-Do-Check-Act (PDCA). A depiction of the PDCA concept appears at the beginning of each of the Scope, Purpose, Application, and Definitions sections. Figure 1 duplicates that depiction. 

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