A Quality Management System

Making the decision to implement a quality management system (QMS) is only the first step of the process of having a documented quality system in place in the workplace. The next step in the process will be to decide which accreditation body best suits the needs of the organisation. The quality management system comprises  

The policy document defines the aims of the accreditation relative to the company the rest of the quality management system will be based on this documentation. 

The quality manual outlines the policy statement, the roles and responsibilities of the employees and management, and the procedures involved in the rimning of the organisation. 

The documents included in the procedures manual are all of the SOPs that relate to specific activities, methods, and instrumental techniques within the organisation. They are set out such that they provide step-by-step instructions for use. 

The benefits of having a quality management system are that we have a form of internal quality control that allows us to have consistency of the service we provide. Our work will be verified, documents checked, and internal quality audits conducted. This means that we are continually assessing the practices set down in the documents of the quality management system. 

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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. 

If your organization does not have a Quality Management system, you can still apply many of the concepts described in these guidelines. However, you will still need to identify a pervasive, consistent management system within which to conduct the integration. 

The intended audience for these guidelines includes those responsible for developing and implementing PSM and ESH management systems which could benefit from incorporation into a Quality Management system. This... 

To understand the importance of setting up a quality management system. 

The analyst provides scientific evidence on which important decisions are made. The work of an analyst is devalued if it is merely considered to be making measurements and reporting results. There has to be some added value. This is provided when it can be demonstrated that the results produced have been obtained in an organization that operates a quality management system. It is because of the importance of the work that the quality has to be assured. This means that all of the necessary actions have been taken to make sure that any factor which has an influence on the final result has been considered, understood and reported in a permanent record - that the appropriate measurements have been made and these have been carried out correctly using a validated method. 

Implement a quality management system or at least the elements of such a system. 

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. 

Although the providers of proficiency testing schemes should have a quality management system in place, on occasions problems can arise which will affect the quality of the data evaluation being carried out. These can include transcription errors during data entry, mistakes in the report, software problems and inappropriate criteria for evaluation being used. Such problems should be remedied by the provider once the problem has been identified. 

To understand the difference between auditing a quality management system and conducting a quality system review. 

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 Standards that are most relevant to laboratories have already been mentioned in Chapter 2. The management staff of a laboratory will look at all possibilities, decide on the Standard which best suits their organization and then design a quality management system to meet the chosen Standard s requirements. One has to remember that in terms of the management standard, quality means fitness for purpose. Senior staff in an organization will decide on the management standard that is most appropriate for their business. 

You are employed in an analytical laboratory in a group measuring the concentration of residues of pesticides. Your company is developing tests for a new pesticide to determine the amount that is left in food after harvesting. You are asked to set up a quality management system, because your laboratory s management has decided that the quality of your group s analytical work should be assessed by an appropriate independent authority. 

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... 

The example of the textile chain demonstrates (i) how much the techni-cal/aesthetic quality of products and chemicals-related product security are interdependent and (ii) what requirements exist for a quality management system beyond the supply chain level. Only the major brands can take this initiative on a global scale. For cosmetic, medical devices and food products, as well as technical products with high safety requirements (such as aircraft), management systems beyond supply chain level have now become a matter of survival. The same holds true for products that are subject to special waste and design regulations in Europe (such as automotive vehicles and electronic equipment). 

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. 

Chapter 4.2 demands that the laboratory must have a quality management system appropriate to the scope of its activities. This must be documented in a quality manual which is written in an imderstandable form and available to all persoimel (see chapter 7 in this book). 

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. 

ISO 9000 as a quality management system sets out the basic requirements that are necessary for an organization to administer its management activities in an effective and efficient manner. 

In order for a laboratory to achieve lehabihty and demonstrate its competence, it needs to proceed with some basic steps, starting with the preparation and implementation of a quality management system. Other steps are as follows... 

The basic starting point for a laboratory trying to establish reliability is the preparation and implementation of a quality management system. The standard to be used is either ISO 9001 where all management issues are addressed or ISO/IEC 17025. This step does not impose the need for certification and does not reflect the competence of the laboratory. 

A development of the last years is expected to serve more efficiently the need for clarification. Following the joint ISO-ILAC-IAF Communique of June 2005, a statement could be included on accreditation certificates. According to this statement, the accredited laboratory has demonstrated both its technical competence for the defined scope and the operation of a quality management system. 

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