Registration manual

The requirements for product approval are defined in the reference manuals. You may not need to prepare product approval submissions for all the parts you supply. The applicability of product approval procedures is affected by several factors so definitive solutions cannot be offered. The fundamental requirement is that if you supply product to the automotive customers you need a product approval procedure in place to gain ISO/TS 16949 registration. If you have been supplying parts for some time without product approval then you should confirm with your customer that you may continue to do so. 

The files are compressed on the CD in the same form as they are available on the Internet. Information on registering MADONNA is contained in the files. Registration is optional since all the examples in the book can be run with the unregistered version. Registration makes available a detailed manual and is necessary for anyone who wants to develop his or her own programs. 

For companies already in compliance with the ISO 9000 series of standards, and who are registered, certified, and have long since developed and adopted the quality manual and SOPs, this manual will help them have an easy transition to the new international standard ISO 9001 2000 requirements. This ISO 9001 2000 Document Development Compliance Manual A Complete Guide and CD-ROM will be of enormous value to recently emerged companies with a big investment in the slogan of quality. While these companies are few, if any, they will have the expertise to fully understand the elements of quality and achieve registration/certification. 

The contents of the manual are divided into three major sections objectives, quality manuals, and standard operating procedures. The first section addresses the definition of quality, basic changes, correspondence between international standard ISO 9001 (1994) and ISO 9001 2000, and the process of documentation development and application for registration and certification. 

The ISO 9000 series of standards has been adopted by thousands of companies worldwide since the introduction of registration and certi-hcation. Considering the fact that transition to the revised standard ISO 9001 2000 will take time, Model-2 can be used where quality manual ISO 9001 already exists and needs to be revised in accordance with the requirements of ISO 9001 2000. Reference is made to the applicable clauses of ISO 9001 and ISO 9001 2000. No exclusions are permitted in Model-2. 

This model was developed for companies already holding ISO 9002 registration/certihcation and intending to immediately comply with the changes recommended in international standard ISO 9001 2000. Model-3 represents the revision of the ISO 9002 quality manual in accordance with the applicable clauses of the ISO 9001 2000 standard. Sub-clause 7.3 of design and/or development is excluded from the Model-2 quality manual. 

Don t reinvent the wheel when applying for your ISO 9001 registration or updating to the new 2000 standards. ISO 9001 2000 Document Development Compliance Manual A Complete Guide and CD-ROM shows you how to develop ond implement a documented quality management system based on the ISO 9001 2000 standards. 

The ISO 9001 2000 Document Development Compliance Manual A Complete Guide and CD-ROM provides guidelines to those involved in the development of quality system manuals and applicable standard operating procedures (SOPs) to comply with the requirements of international standard ISO 9001 2000 and proceed with the registration/certihcation process. The quality manuals (models) and SOPs provided in the CD-ROM are also a valuable tool for the companies to transform their existing ISO 9001, ISO 9002, and ISO 9003 quality manuals and SOPs to meet the requirements of revised standards. 

This manual takes into account documentation of quality manuals and applicable procedures based on quality elements described in international standard ISO 9001 2000. No other manual in print deals exclusively with the key elements of quality and provides hands-on templates to be tailored to achieve ISO 9000 registration/certification. 

Quality Manuals Four template quality manuals are provided as models. Quality manual Model-1 can be directly adopted by a company planning for the first time for registration/certification to an international standard ISO 9001 2000. Model-2 will be useful for a... 

The second aspect of the method is selection by surveilance. This would involve running even larger numbers of compounds through the model, perhaps all new Chemical Abstracts registrations. Under these conditions, only the high scoring compounds would be reviewed manually. In contrast, under the first aspect, even the lowest scoring can be reviewed. 

Table 2 Comparison of the manual, robotic, and registered methods for content uniformity (Manual, Unit operations in the robotic method were performed manually Registered, Manual assay method using HPLC cited in the registration document)...

The serum constituents were determined, using either AutoAnalyser or work-simplified manual methods. While blood specimens were being prepared for analysis, three punched cards were automatically reproduced for each patient from the punched card delivered from the registration department the previous evening. Each of two cards had space for the entry of eight biochemical results and the third card had space for the coded answers to questions which the clinicians were asked to answer on receipt of a duplicate report form. 

Figure 7.2 Principle of the project database. The register database comprises three cross-tables Bs, , Man, and Man 2. All serum TSH, T3, and T4 results are imported into Bs, where primarily TSH and, in case of abnormal value, T3 and T4 are evaluated. Cases of biochemical overt hyper- or hypothyroidism are copied to cross-table Man, which consists of two subsections known cases (already registered in the database) and possible new case (without any prior database registration). All possible new cases are manually cross-checked (see text). All new cases are copied to cross-table Man 2 and after that registered as known cases. Data taken from Pedersen et al., (2002) with permission from Elsevier.

Unlike the other systems, this system employs removable cassettes, which can be used in the bucky tray of a standard mammography unit While there are capital cost savings to this approach, it does require that phosphor plates be manually transported to the reader for processing. Because there are multiple detector plates, flat-fidd correction is normally not performed for the plates, but only for the plate reader. In principle, correction for nonuniformity of the individual plates could be done, but this would require precise registration within the reader and would be time-consuming. 

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