Certificates defined

Miscellaneous Colorants. Other colorants not requiring certification have been defined in the Code of Federal Regulations. Most of these ate of only minor to moderate importance and have only limited usage. 

Arrester Testing and Standards Regulatory and approval agencies and insurers impose acceptance testing requirements, sometimes as part of certification standards. The user may also request testing to demonstrate specific performance needs, just as the manufacturer can help develop standards. These interrelationships have resulted in several new and updated performance test procedures. Listing of an arrester by a testing laboratoiy refers only to performance under a defined set of test conditions. The flame arrester user should develop specific application requirements based on the service involved and the safety and risk criteria adopted. 

Rupture discs are typically manufactured to order, where each order represents a lot. The ASME Code defines three mediods of acceptance testing for rupture discs. The most common method requires dial at least two discs from the lot be burst tested at the specified disc temperature. The results of these tests must fall within the rupture tolerance. Table 12-5 shows the changes between the old requirements and the new sizing methodology and certification process. 

Applying defined criteria to the selection of certification bodies that can award ISO/TS 16949 certificates... 

You need to develop documented procedures that define your subcontractor evaluation and selection process and in certain cases this may result in several closely-related procedures for use when certain conditions apply. Do not try to force every purchase through the same selection process. Having purchasing policies that require three quotations for every purchase regardless of past performance of the current subcontractor is placing price before quality. Provide flexibility so that the policies and procedures complexity match the risks anticipated. Going out to tender for a few standard nuts and bolts would seem unwise. Likewise, placing an order for lm of equipment based solely on the results of a third party ISO 9000 certification would also seem unwise. 

Ensure that a current report, signed by a competent person, gives details of examinations and tests on the tank, and the interval before which further examinations and tests must be performed. This report should confirm that the tank is suitable for the purposes stated in the certificate or otherwise define its suitability. 

Synthetic colorants are classified by the FDA as certified color additives and are defined as synthetically produced organic molecules that have their purities checked by the FDA. " A second category, colorants exempt from certification, includes naturally derived (animal, vegetal, mineral) compounds or their synthetic duplicates. Table 7.3.2 presents a summary of synthetic colorants and their utilization as food additives. 

The most important document, accompanying a CRM is its certificate. ISO Guide 31 (1981) provides guidance for the establishment of certificates, labeling of CRMs, and certification reports. The certificate contains among other information the certified values and their respective uncertainties. As important as this information is the traceability statement, which defines to what references the CRM is traceable. Ideally, a CRM is traceable to a suitable (combination) of SI units. This is not always possible, so other stated references may appear here. Especially when certifying matrix reference materials, making the measurements traceable to SI does not imply that the CRM is traceable to SI as well. The steps necessary to transform the sample into a state that can be measured may have a serious impact on the traceability of the values, and thus on the traceability statement. 

All of the major RM characterization/certification approaches, for total concentrations of constituents, can be classified in one of four categories. A fifth approach deals with method-spedfic schemes in which characterization is by a defined method giving a method-spedfic assessed property value. The following is a dassifi-cation based on the author s interpretation and adaptation of descriptions of RM certification procedures in the literature (see summary in Table 3.1). 

Examples of approaches followed by a small selection of the major RM developers are provided below and summarized in Table 3.2. It must be emphasized that these assignments are based on the author s interpretation of approaches described in the literature that placing into one of the approaches defined in this paper is not always feasible due to cross-over between different modes, fusion of ideas from one and another, elimination of steps, selective choices of parameters, modification of parameters, and streamlining of the overall procedure. Variations on a theme are unavoidable. In assigning certification approaches, the numbers refer to the approaches defined above multiple numbers indicate a blending of two or more modes with a asterisk indicating the author s assignment of the dominant mode of certification. 

The three historical approaches to certification mentioned above were recently expanded to identily seven modes that are used at NIST for value assignment for chemical composition (May et al. 2000). These seven modes and the resulting values are summarized in Table 3.13. The basic principles of value assignment remain unchanged however, these modes now provide a well-defined link between the process used for value assignment and the definition of the assigned value (i.e. certified, reference, or information value). The terms described above provide a clear indication of the level of confidence that NIST has in the accuracy of the assigned value. The definition of a certified value implies that NIST must be involved in the measurement process for the value to be classified as a NIST certified value (see modes 1-3 in Table 3.13). Thus, modes 4 and 7, which do not involve NIST measure-... 

Pharmacopoeial standards and substances are established and distributed by pharmacopoeial authorities following the general principles of this Guide. It should be noted, however, that a different approach is used by the pharmacopoeial authorities to give the user the information provided by certificates of analysis and expiration dates. Also, the uncertainty of their assigned values is not stated since it is negligible in relation to the defined limits of the method-specific assays of the pharmacopoeias for which they are used. ... 

Since the CRSs and BRPs are officially certified by the European Pharmacopoeia Commission, which adopts the reports establishing their suitability for the intended use, it should be noted that neither certificates of analysis nor data which are not relevant to the use of the substances as defined by the Ph. Eur. monograph, are provided with the reference products or substances. Information required for the correct use of the chemical reference substance or biological reference preparation is provided. The label on the vials or ampoules gives ... 

Major steps included, for example, plant production, transport, processing and retail. Each major step was subdivided into activities called substeps , which were defined in common categories. For example, the major step transport from processor to retailer could contain substeps in the following categories certification/inspection management labour packaging/labelling equipment pest control contact to supplier/customer. 

A detailed and comprehensive system of record keeping is necessary, including, for example, worksheets, notebooks, computer output and reports, and all of these should be retained for a reasonable period of time or as required by the customer. A period of six years is often chosen. The content of reports and certificates is tightly defined, to ensure that customers receive all relevant information and that the laboratory does not make exaggerated claims about which parts of its work have been accredited. A documented system for dealing with any customer complaints and for informing customers if discrepancies in results are subsequently discovered must be available and in place. 

Through the use of this clause, the design time can be reduced and the problem of certification can be eliminated. It now becomes a matter of defining the problem to be solved, defining the environment, selecting commercially available equipment which is rated as compatible for the task, following the manufacturer s instruction for installation and verifying the cable characteristics. 

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