International Standardization Organization certification

ISO GUIDE 35 (1989) Certification of reference materials - General and statistical principles. International Standards Organization, Geneva. 

The FDA s access to documentation supporting the QAP and reports must be defined in an SOR All corrective actions are open for inspection under the International Standards Organization (ISO) certification. The ISO notified body is not concerned with regulatory follow-up, as is required by the FDA. 

Inspection and certification of compliance with a quality system (such as the applicable International Standardization Organization (ISO) series, or national or international guidelines) by external bodies is recommended. Such certification should not, however, be seen as a substitute for... 

The International Standards Organization (ISO) has defined a reference material as a material or substance one or more properties of which are sufficiently well established to be used for the calibration of a method, or for assigning values to materials. The ISO definition of a certified reference material is a reference material one or more of whose property values are certified by a technical procedure, accompanied by or traceable to a certificate or other documentation that is issued by a certifying body. 

An international accreditation process is operated by standards organizations in individual countries. The standard is universal under the leadership of the International Standards Organization (ISO). The standard is ISO/lEC 17024 covering certification of persons. In the United States, the American National Standards Institute (ANSI) handles accreditation under this standard. 

The CC for Information Technology Security Evaluation is an International Standards Organization/Intemational Electrotechnical Commission (ISO/ lEC 15408) for computer security certification. CC is a framework in which computer system users can specify their security functional and assurance requirements, vendors can then implement and r make claims about the security attributes of their products, and testing laboratories can evaluate the products to determine if they actually meet the claims. CC provides assurance that the process of specification, implementation, and evaluation of a computer security product has been conducted in a rigorous and standard manner. The EAL level does not measure the security of the system itself, it simply states at what level the system was tested to see if it met all the requirements. 

ISO 9000,9001,9002,9003 Standards set by the International Organization for Standardization. ISO 9000, 9001, 9002 and 9003 are the highest quality certifications awarded to organizations that meet exacting standards in their operating practices and procedures. 

A detailed description of the methods used is given in the certification report [33], including the internal standards used, GC conditions, calibration techniques etc. Clean-up procedures were based on well proven techniques to remove the bulk of the mineral oil and other organic compounds which would interfere with the chromatographic determination, e.g. decomposition with concentrated H2SO4, adsorption chromatography, separation on silica gel, or separation with Florisil or potassium silicate. For the separation, each CB was identified and confirmed using at least two capillary columns coated with different stationary phases to compare the relative retention times or... 

The ISO (International Organization for Standardization) develops and publishes international standards on scientific and technical issues in industry. Many institutions in developing countries are increasingly seeking to attain certification in international laboratory standards set by ISO, such as the Quality Management Systems standard (ISO 9001) and the general requirements for the competence of testing and calibration laboratories... 

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