Accreditation, standardization

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. 

Thus, as for the European Union, the requirements are based on accreditation, proficiency testing, the use of validated methods of analysis and, in addition, the formal requirement to use internal quality control procedures which comply with the Harmonised Guidelines. Although the EU and Codex Alimentarius Commission refer to different sets of accreditation standards, the ISO/IEC Guide 25 1990 and EN 45000 series of standards are similar in intent. It is only through these measures that international trade will be facilitated and the requirements to allow mutual recognition to be fulfilled will be achieved. 

As shown above, these include a laboratory to be third-party assessed to international accreditation standards, to demonstrate that it is in statistical control by using appropriate internal quality control procedures, to participate in proficiency testing schemes which provide an objective means of assessing and documenting the reliability of the data it is producing and to use methods of analysis that are fit-for-purpose . These requirements are summarised below and then described in greater detail later in this chapter. 

Broadening of accreditation standard to cover management issues for the whole activity of the laboratory... 

The fact that ISO 9001 is a generic standard for quality management applicable to all organizations, no matter what the specific type of activity, implies that a laboratory needs also to meet quality management requirements in the way specified. The new accreditation standard provides for this in a very clear way, i.e. including relevant provisions. 

The accreditation standard specifies that in the case of a laboratory operating as a part of a larger organization performing activities other than testing and/or calibration, appropriate arrangements should be made to avoid conflict of interest and ensure the independence and integrity 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. 

Meeting GLP standards improves the overall quahty of the work produced by the contract lab and makes meeting other accreditation standards easier. 

Radiation monitoring laboratories seeking to achieve optimum proficiency test results with an accreditation standard must use calibration methods that duplicate or at least closely approximate the irradiation protocols described in the accreditation standard. This requirement is particularly important for calibrations using photons with energies below 200 keV where irradiation conditions must recreate the scattered radiation that contributes significantly to the response of the monitoring device. 

Measurement uncertainty is increasingly gaining attention, in particular in the framework of accreditation. The new accreditation standard ISO/IEC 17025 [17], which has been in force from December 2002 on, contains clear requirements on the estimation of MU and when and how it should be stated in test reports. ISO/IEC 17025 requires MU to be reported when required by the client and when relevant to the application and interpretation of the measurement results in the framework of certain specifications or decision limits. The MU should be readily available and reported together with the result as X U, where U is the expanded uncertainty [17, 47, 51, 54]. Also Eurachem and CCMAS within the Codex Alimentarius deal with MU as a separate issue [14,18-20]. Some even claim that MU will become the main unifying principle of analytical data quality [37]. 

Not many terms covering concepts in measurement have circulated over the last ten years in the chemical measurement community around the world so intensely as the term trace-ability. It appears in the title of CITAC (Cooperation on International Traceability in Analytical Chemistry) since 1993. It is addressed almost yearly in Workshops of EURACHEM (A Focus for Analytical Chemistry in Europe). Documents of ILAC (International Laboratory Accreditation Cooperation) require it to be used in the process of accreditation. Standards and Guides of ISO (the International Organisation for Standardization) mention them frequently and insistingly. 

Accreditation Accreditation body Accreditation standard Certificate of accreditation Certification Certification body Compliance... 

The most general laboratory accreditation standard is ISO 17025. This standard was published in December 1999 and is set to become the first truly international standard for laboratory accreditation. In this respect it replaces the UK s NAMAS MlO/Mll (National Accreditation of Measurement and Sampling) standard. In the UK the United Kingdom Accreditation Service (UKAS) acts as the accrediting body for the NAMAS standard and will continue to do so for ISO 17025 when the NAMAS standard is superseded. 

With Medicare s Hospital Insurance Trust Fund, also known as Medicare Part A, workers make required contributions to the fund while fhey are employed. Upon retirement, workers receive health care benefits. By law, employers and their employees are required to pay equal portions of a payroll tax, which totals 2.9% of earned income.In 1997, almost 90% of the trust fund s income was from payroll taxes. The remaining income was generated from fhe inferesf earned from the trust fund. A beneficiary s Medicare Parf A insurance is limifed to only those hospitals accredited by the Joint Commission on Accreditation for Healthcare Organizations (JCAHO). The JCAHO accreditation standards include explicit and extensive professional pharmacy acfivifies, indirectly supporting professional trends for clinical pracfice (see Chapfer 18). 

The ACPE has established accreditation standards for organizations fhaf approve the content and conduct of pharmacy education programs thaf meef ACPE criteria. The majority of ACPE-approved providers are professional pharmacy organizations, colleges of pharmacy, and pharmaceutical companies. Each program is reviewed every 6 years by the ACPE. Boards of pharmacy in 48 sfafes accepf CE credif from ACPE provider organizations to meet their CE requirements for license renewal. ... 

One criterion for vendor qualification should be whether the vendor has a documented Quality Assurance program that follows recognized quality standards, for example, ISO 9001. This registration is usnally snfficient for those laboratories that must comply with ISO 9001 or with a laboratory accreditation standard snch as ISO 17025. However, it is the author s experience that... 

ISO 17025 ° is ISO s laboratory accreditation standard for testing and calibration laboratories. This includes requirements for competence in addition to requirements for documentation. Requirements for use of computer systems are approximately the same as the GxP requirements, but the enforcement is far less rigorous than for GxP. This standard also has requirements for validation. 

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