Quality Management Systems ISO

The only standard in this family that may be used for registration of a quality management system is ISO 9001. In previous editions there were three such reqrrirements standards, ISO 9001,9002, turd 9003. The 9001 standard was the most complete in that it covered all parts of a quality management system. ISO 9002 was identical to 9001 except that the design function was not included. Several other functions were omitted from the 9003 standard. The 2000 edition of ISO 9001 allows for the tailoring of the standard to delete requirements such as design when they do not apply to an organization. 

The general criteria set by WHO have been published [11] although they are applied on a ease-by-ease basis. These criteria have been incorporated by the Standards Division into its Quality Management System (ISO 9001) and are a routine requirement for all fills undertaken. The criteria ean be redueed for individual fills where they are not deemed necessary. Some examples of how these eriteria are met are shown below. 

Is any processes quality management system certified under the requirements of an ISO 9000 or ISO 14000 standard If yes, skip question number 5. ... 

ISO 14000 / ISO 9000 Standards published by the International Organization for Standardization. ISO 14000 standards are for companies establishing an environmental management system. ISO 9000 standards are for companies establishing a quality management system. 

The ISO 9000 series of standards has been used for illustrative purposes throughout this book. However, all the leading Quality Management systems have similar structures so you will find the concepts familiar regardless of which system your company has adopted. Chapter 9 summarizes the principal differences and similarities between ISO 9000 and other commonly used Quality Management systems. 

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. 

Q The basis for the integration will be ISO 9000 why this and not another quality management system ... 

There are many different management system frameworks that can be used for integrating PSM and ESH. All the concepts presented in this book can be applied to other systems or templates, and the frameworks of different Quality Management systems can even be combined. For example, some one might wish to use the basic elements of ISO 9004 plus a management of change element as their template. 

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

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

Quality Management Systems - Fundamentals and Vocabulary , ISO 9000 2005, International Organization for Standardization (ISO), Geneva, Switzerland, 2005. 

In terms of documentation, the requirements of ISO/IEC 17025, ISO 9001 and ISO 15189 are very similar and so will be dealt with together. For a quality management system to be effective, all of the components (policies, systems, programmes, procedures, instructions, etc.) must be clearly documented so that everyone in the organization knows what is expected of them. Figure 9.1 shows... 

A system for auditing and reviewing quality procedures is a specific requirement of ISO/IEC 17025, ISO 9001 and GLP. This is a critically important aspect of any quality management system so we will consider these activities in some detail. The first, and most important, thing to realize about Quality Audit and Management Review is that they are two completely different activities. This section deals with auditing while Section 9.5 deals with management review. 

And further, that the responsibilities for quality-related activities of the contract giver and contract acceptor should be specified in a written agreement . Similarly, ISO 9001 (2000) states that, Where an organization chooses to outsource any process that affects product conformity, the organisation shall ensure control over such outsourced processes. Control of such outsourced processes shall be identified within the quality management system. ... 

This confirmation is often provided by an external audit or assessment (u.s.). Quality management systems are often certified for conformation with ISO 9000. Probably the most common term with respect to our topic here is certified reference materiaT (CRM). 

ISO/IEC 17025 is the basic standard that is utilised by testing and calibration laboratories for implementing a quality management system and they are accredited for their implementation of this standard. This standard contains the general requirements for the competence of testing and calibration laboratories. It is one of the most important standards for the worldwide globalization of trade. 

The ISO 9000 series describes a quality management system applicable to any organization. In this chapter we present the requirements of the standard in a way that is as close as possible to the needs of analytical laboratories. The sequence of the requirements follows that in the ISO 9001 2008 standard. In addition, the guidelines for performance improvement set out in the ISO 9004 are reviewed. Both standards should be used as a reference as well as the basis for further elaboration. 

The requirements of the standard can be split into four major groups, which are those mentioned as activities in the quality management process. A fifth group is the quality management system per se. The model shown in the slide, taken from the ISO 9004 2000 standard, illustrates the process linkages as well as the interactions between the interested parties and the laboratory. Monitoring the satisfaction of interested parties requires the evaluation of information as to whether the laboratory has met their requirements. 

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