Accreditation process

ABET. (2009). Criteria for accrediting computing programs. Baltimore, http //www.abet.org/up-loadedFiles/Accreditation/Accreditation Process/Accreditation Documents/Archive/criteria-cac-2010-2011.pdf. 

ISO/IEC 17025 1999 Accreditation is the formal recognition of the competence of a body or an organization for a well-defined purpose. In contrast with the ISO 9001 processes, accreditation of a laboratory to ISO/IEC 17025 involves assessment of the technical competence and capability of the laboratory and its personnel. In practice, it is the procedure by which a laboratory is assessed to perform a specific range of tests or calibration measurements. Specific areas examined include infrastructure and staff qualifications, in addition to checks that an adequate quality management scheme is in place. The accreditation covers the range of materials tested or analyzed, the tests carried out, the method and equipment used, and the accuracy or precision expected, and is specific to the facility and the test. 

UKAS Laboratory Accreditation Standards, http //www.ukas.com/about/about-acciedita-tion/the-accreditation-process/accreditation-standards/ (accessed 22 January 2016). 

Checking is performed in accredited laboratories on procedures developed in compliance with stated requirements and approved in the process of testing implementation on CTB 8001-93 or metrological attestation on CTB 8004-93. 

Effective specification control often can be estabUshed other than through requirements placed on the end use material, ie, the specification may beat on the taw materials, the process used to produce the material, or ancillary materials used in its processing. Related but supplementary techniques ate approved vendor Hsts, accredited testing laboratories, and pteptoduction acceptance tests. 

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. 

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. 

The FDA are allowed 90 days to review a Traditional or Abbreviated 510(k) notification, and just 30 days for a Special 510(k). With the introduction of the Medical Device User Fee and Modernization Act of2002, provision was made for the participation of third-party organisations in the review process. This represents a partial adoption of the concept of Notified Bodies, which prevails in Europe. The FDA have accredited a number of commercial organisations to conduct primary 510(k) reviews of670 types of device. The FDA must then give a final determination within 30 days of receipt of the recommendation of a third-party reviewer. Because they are commercial, third-party reviewers will seek to offer faster review times in return for their review fee. If using a third-party reviewer, the FDA user fee does not apply. The outcome of a successful 510(k) notification is a letter from the FDA clearing the device for commercial sale. 

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. 

Is there a difference between the processes of certification and accreditation ... 

In large laboratories, where dozens or even hundreds of different types of analyses are carried out, an additional internal process to test the quality system is particularly important. An external assessment team can only hope to observe and assess in detail a relatively small number of the analyses during each visit, so there may be years between any one of a laboratory s externally assessed analyses being re-examined in detail. Laboratories may not have entered all of the analyses that they carry out in their scope of external accreditation. If they wish to ensure quality is maintained in these other areas of their work, an internal... 

Since the first edition was published, many universities have developed courses or course content in chemical process safety. This new emphasis on process safety is the result of the positive influences from industry and the Accreditation Board for Engineering and Technology (ABET). Based on faculty feedback, this textbook is an excellent application of the fundamental topics that are taught in the first three years of the undergraduate education. 

Several specific aspects of laboratory management which are essential in the process of accreditation are discussed in the following sections. These topics are also very important for laboratories not seeking formal accreditation but concerned about the quality of their work, their credibility and the safety of their employees. 

Sampling is just the beginning of the analytical process. On the way from sampling to the test report a lot of different requirements for high quality measurements have to be considered. There are external quality assurance requirements on the quality management system (e.g. accreditation, certification, GLP), internal quality assurance tools (e.g. method validation, the use of certified reference material, control charts) and external quality assurance measures (e.g. interlaboratoiy tests). 

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. 

The NVLAP is comprised of a series of laboratory accreditation programs (LAPs), depending on what is requested and what is needed. Each LAP includes specific calibration and/or test standards and related methods and protocols assembled to satisfy the unique needs for accreditation in a field of testing or calibration. NVLAP accredits public and private laboratories based on evaluation of their technical qualifications and competence to carry out specific calibrations or tests. All are based on the ISO/IEC Guide 25 discussed in Section 2. The process involves an application and the payment of fees. This is followed by an on-site assessment. If deficiencies are found, these must be resolved to the satisfaction of the assessment team. The laboratory then participates in proficiency testing (Section 5.7) and a technical evaluation. 

To assure that the best technology is available and that personnel are qualified, forensic science laboratories should undergo accreditation processes with periodic proficiency testing. This will assure some uniformity in procedure among different laboratories, and provide assurance that samples are analyzed correctly and data are interpreted accurately. 

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