Accreditation Practice

ISO 9000 is not a statutory requirement and neither is certification, hence certification is voluntary. However, suppliers may be under pressure to obtain registration to ISO 9001, ISO 9002, or ISO 9003 in order to tender for contracts. Within the ISO 9000 certification scheme, the certification industry is regulated by accreditation bodies. An International Accreditation Forum (lAF) attempts to harmonize accreditation practices world-wide through ISO Guide 61. The accreditation bodies authorize certification bodies to conduct certification to prescribed standards - a process that is called accreditation. The accreditation body performs witness audits and desk audits of the certification body to ensure compliance with the conditions of accreditation. 

One of the remaining questions concerns the QA of chemical reference materials and the competence of RM producers. Whilst laboratory accreditation normally requires the use of physical measurement standards that have been produced in accredited calibration laboratories, the situation regarding chemical measurement standards is, so far, much less formal. General Requirements for the Competence of Reference Material Producers (3,4) have been available since 1996, but the implementation of accreditation based on these requirements is still in its infancy. There is a need for a more balanced approach to accreditation practice related to measurement standards. For example, should only reference materials produced by accredited producers be used as measurement standards in accredited test laboratories Or, does the whole system of the QA of measurement standards need to be re-examined ... 

One continually reassesses the accreditation practice Accreditors are required to undertake self-scrutiny of their accrediting activities. 

American licensing and accreditation practice in engineering requires the definition of a body of knowledge that registered practitioners mnst possess. The lEEE-CS and the ACM are also working together to produce a definition of this. ... 

In compliance with the requirements stated in the System of accreditation to the practical experience and qualification the technical manager in NDT must have at least level 2 on each of NDT methods used in the laboratory seeking accreditation, where not more than 3 NDT methods are in practice, and level 3 on the basic method used in the laboratory where there are more than 3 methods. Moreover all specialists must be certified in relevant NDT method and industrial sector. 

Due to their wide range of analytical challenges centralized analytical laboratories are required to adopt a series of QM systems simultaneously. For example, the Competence Center Analytics of BASF AG in Ludwigshafen is certified and accredited to operate under four different QM systems. Undoubtedly, QM systems play a vital role in a modern industrial analytical laboratory. The sale of many products of the chemical industry is not possible without a GLP-certified analytical laboratory. However, in practical tenus the different QM systems can potentially reduce the efficiency of the analytical process and lead to increased costs. 

The Centers for Medicare and Medicaid Services has incorporated pneumococcal and influenza immunization rates into some of their quality standards. Patients admitted to a hospital for community-acquired pneumonia should be screened for, offered, and vaccinated with pneumococcal and influenza vaccines prior to discharge if not previously administered. In physicians office practice, all persons over 65 years of age who have been hospitalized in the past year should be screened for, offered, and vaccinated with pneumococcal and influenza vaccines if not previously administered. Both of these standards will affect payment if the standard is not met. The Joint Commission on Accreditation of Healthcare Organizations has also incorporated these standards into their accreditation reviews of health care facilities. 

The publisher s policy is to use permanent paper from mills that operate a sustainable forestry policy, and which has been manufactured from pulp processed using acid-free and elementary chlorine-free practices. Furthermore, the publisher ensures that the text paper and cover board used have met acceptable environmental accreditation standards. 

The OPCW expert group found however that the procedures for environmental sample analysis were too inflexible to achieve the desired outcome. A separate approach would be needed to enable a system that would provide the necessary level and quality of information, but be practical and also recognise the very infrequent likelihood of a requirement for this capability. Compared to the current OPCW approach to environmental samples, that for biomedical samples would likely use a laboratory with a research rather than a routine focus, the accreditation procedures would be less stringent, and the methods used would focus on high quality results at the lowest limits of detection, rather than high throughput. It is not expected that more than a few laboratories will wish to maintain all or some of the necessary expertise to perform these tasks. 

Good laboratory practice (GLP) is a set of procedures within which the overall performance of a laboratory can be monitored. It is applicable to the organization and functioning of any laboratory but it is particularly relevant to the pharmaceutical industry. Compliance with GLP may be required for accreditation of a laboratory by an external regulating agency. 

STL are accredited by the Department of Trade and Industry via the National Measurement Accreditation Scheme (NAMAS). This covers all aspects of laboratory operations, such as organization of the laboratory and methodology, equipment and staff training, quahty-control systems and storage of data. The company acquired the first accreditation in the UK for the analysis of organic compounds by GC-MS. It also operates appropriate procedures to conform with the Department of Health s Good Laboratory Practice (GLP) recommendations. 

Wilson S, Weir G (1995) Food and Drink Laboratoiy Accreditation A Practical Approach, Springer-Verlag, Berlin... 

This presentation is focused on explaining the significance of accreditation and certification for laboratories and illustrates the usefulness of both procedures. The implementation of these procedures in laboratories is described, pointing out their similarities and differences. Reference is made to some publications. The discussion reflects the existing practice. 

Why do the laboratories need to demonstrate their competence and the reliability of their results Because they need to have competitive advantage and, at the same time, comply with legislation, where, more and more, reference is made to the need for reliable results and compliance with specific requirements (Accreditation, Good Laboratory Practice etc.)... 

A usual practice for laboratories is to include in the scope of their accreditation a selection of methods they use. The standard provides for certain rules to be followed in reports including results from other methods as well in any relevant declarations. However, the management issues addressed in the quality management system, following ISO/IEC 17025, cover the overall operation of the laboratory. 

Furthermore, the equivalence in the way both the laboratoiy accreditation standard and the certification standard deal with the management system requirements illustrates that an accredited laboratory meets, in practice, these requirements as specified in ISO 9001. After a proposal made via Eurachem and EA to ILAC, a similar joint Communique was agreed and signed in September 2009 by ILAC, lAF and ISO for medical laboratories against ISO 15189 2007. 

The principles of Good Laboratory Practice (GLP) in conjunction with the principles of Total Quality Management (see chapter 6) ensure the quality and reliability of the laboratory results, which in turn help to ensure the protection of the environment and human health and safety. A step further is the accreditation of laboratories to ISO 17025 (see chapter 2) to perform specified activities. 

Compliance with the GLP principles covers many aspects of accreditation to ISO 17025. The European Union has adopted the procedures for Good Laboratory Practice of the Organization for the Economic Cooperation and Development (OECD) and calls on member states to take all measures necessary to ensure that laboratories carrying out tests on chemical products comply with the GLP principles. The OECD s GLP principles are part of the Eiuopean Commission Directive 2004/10/EC (http //eur-lex. europa.eu). 

Laboratories can become independently accredited. In this case, accreditation means that some independent auditor has reviewed the laboratory s staff, capabilities, and procedures against some set of requirements and standard practices and judged the laboratory and the workers in the laboratory capable of routinely performing some kind of laboratory work while adhering to those requirements and practices. Some accreditations are for a specific task or for a specific process others are for laboratory work in general. 

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