Scope of the standard

ISO/TS 16949 applies to the design, development, production, and, when relevant, installation and servicing of automotive-related products. The standard primarily applies to suppliers and subcontractor sites that provide  

Certification to the standard will only be awarded to a site that has the capability to meet all the applicable requirements of ISO/TS 16949 for the products and services concerned. If some operations are carried at remote locations (e.g. design centers and corporate headquarters), such locations cannot receive separate certification and must be included within the certification awarded to the parent site possessing production capability. 

It is stated in the standard that the standard can also be applied throughout the automotive supply chain. This implies that vehicle manufacturers should apply the requirements to their own operations, but obviously such application is voluntary. In due course, ISO/TS 16949 will become a condition of any contract to supply products and services to the vehicle manufacturers. The supply chain includes vehicle distribution and dealers. However, it is not intended that ISO/TS 16949 be applied beyond the vehicle manufacturers at this time. 

Section 4 of ISO 9001 is incorporated in ISO/TS 16949 in the form of boxed text under the appropriate headings. The sector-specific requirements are outside the boxes and hence the additional requirements are readily identifiable. The only change to the ISO 9001 text has been the head numbering to facilitate decimal numbering of the additional clauses. Various notes have been added to correct clause numbering within the ISO 9001 text and in 13 cases a requirement has been modified  

1 A note in clause 4.2.1 states that all the quality systems documents should be controlled. 

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In 29 CER 1910.120 (a)(3) it is stated that responses to incidental releases of hazardous substances where the substance can be absorbed, neutralized, or otherwise controlled at the time of release by employees in the immediate release area, or by maintenance personnel, are not considered to be emergency responses in the scope of the standard (HAZWOPER). The term incidental is the key term. Workers need to be trained as to what type of situations would be considered incidental. In general, if the employees actions to clean or control the release do not and likely would not put them in jeopardy (from a safety and health viewpoint), the act would be considered incidental. 

If the assessment does extend to such documents, and the auditors find nonconformities in the areas outside the scope of the standard, will they count ... 

With current densities of 2.36 A/mm2 (70 mm2 cable) and 6.25 A/mm2 (6 mm2 cable), the maximum overtemperature at the branching point (40 K) sets up a limit of 160 W for the thermal losses within the main part of the switchgear. Increased current densities of 2.83 A/mm2 and 7.00 A/mm2 cause an overtemperature of 42 K at the branching point of cable I (6 mm2) even at zero losses, i.e. this will be an impractical solution beyond the scope of the standards. 

The very poor colour rendering property of low pressure sodium vapour lamps is due to the narrow-band emission of the Na lines (at a wavelength of 589.0 and 589.6 nm). Low pressure sodium vapour lamps are generally not within the scope of the standards for explosion protected luminaires... 

In Table 6.23, a survey of lamps is given for general lighting in industrial plants. Sodium vapour low pressure lamps (point 5.1 in Table 6.23) are not within the scope of the standards for explosion protected luminaires. Incandescent lamps (1.1 in Table 6.23) and blended lamps (2 in Table 6.23) are unimportant for general lighting applications in industry due to their poor luminous efficiency. Therefore, the following luminaire-lamp combinations are the state of the art ... 

The science of mechanics constitutes a vast number of sub-disciplines commonly considered beyond the scope of the standard chemical engineering education. However, when dealing with kinetic theory-, granular flow- and population balance modeling in chemical reactor engineering, basic knowledge of the principles of mechanics is required. Hence, a very brief but essential overview of the disciplines of mechanics and the necessary prescience on the historical development of kinetic theory are given before the more detailed and mathematical principles of kinetic theory are presented. 

Alachlor and hexachlorobutadiene are not within the scope of the standard but national monitoring laboratories reported that EN ISO 6468 may be used for the determination of these compounds. 

Although benzo(k)fluoranthene and benzo(b)fluoranthene are mentioned in the scope of the standard, LoQ low enough to allow compliance checking is difficult to achieve or even impossible. 

The second edition consists of an introduction, four sections, and two appendices. (The appendices present examples and are not part of the consensus document.) Section 1 identifies the scope of the standard and section 2 lists definitions for particular terms. Thus, paraphrasing, adequate ventilation refers to a condition in which air contaminant concentrations are below levels that cause injury or illness, or, that the vapors of flammable liquids are well below the lower flammable limit. A toxic chemical has an oral LD50 for edbino rats greater than 50 mg/kg but not greater than 500 mg/kg, or a 24 hr. skin contact LD50 for albino rabbits more than 200 mg/kg but not more than 1000 mg/kg, or an inhalation LC50 for albino rats more than 200 ppm but not more than 2000 ppm of gas or vapor or more than 2 mg/f but not more than 20 mg/f of dust or mist, provided that such exposures are reasonably likely to be encountered by humans in their use of the chemical. 

Note that the standard is not intended to be used for assuring networks which provide the infrastructure for general HIT products which are not medical devices. Thus a network used only to support a simple Electronic Patient Record, email and internet access in a healthcare organisation would not typically be included within the scope of the standard. 

The Chemical Safety Board has made recommendations that the scope of the standard be expanded with regard to reactive chemicals. OSHA s suggestion is to use the New Jersey TCPA as an example and also to follow the approach used by the Chemical Safety Board, which is performance based. 

Type of product. Check the scope of the standard to determine if it refers to the product. 

This standard was initially published in January 1995 as a trial-use standard. During the two-year trial-use period, users of the standard gained experienee with applying the doeument within their enterprises. In January 1998, the document was revised and balloted for full pubhcation. The comments submitted by the ballot-ers were considered, and those within the scope of the standard were incorporated. The revision was completed in July 1998 and submitted to the IEEE Standards Office for publication. 

One of the most important limitations of ISO 11064 was that the scope of the standard was inappropriate for lO. This supports the opinion of some of the interviewees who stated that the standard was out of date compared to current technology. This finding supports our proposal to shift to a more goal-based approach. 

ISO 11064 appears not to handle technological changes too well. One example of this is the introduction of 10, where the organization of work goes out of the scope of the standard. The main reason is a simple definition that can easily be changed. Another reason can be that the standard is too prescriptive, and should be more goal-based. 

It was pointed out that the standard may be tmsuit-able for modifications of CCs. Modifications do however not appear to be within the scope of the standard and is thus rather wrong application of the standard than limitations within the standard itself. 

Increase the scope of the standard to supersede TID 7016, Rev. 1, Nuclear Safety Guide, and to cover recent developments in interaction and current practices. 

In 1968, members of the Criticality Safety Division within ANS Subcommittee 8 appointol a work group to examine the status of data and develop the scope of a proposed standard for pipe iiitersections. In 1970, the work group limited the scope of the standard to 93.5 wt% enriched uranyl nitrate solutions due to the paucity of critical experiment data available for pipe intersections containing solutions of fissile material... 

One of the most important requirements when using this method is to determine that the process equipment clearly falls within the scope of the standard. When equipment or process varies from the standard scope, additional analysis using other techniques for determining applicability of grandfathering are required. An example of a variation would be a waste fuel that is not included in the scope of a standard governing a burner management system. Any special requirements for handling the waste fuel... 

At the outset, it is better to keep in mind that although shown here, Box 11 pertinent to safety related systems and other risk reduction facilities, it is out of scope of the standard so it is shown by the dotted line in Fig. VI/4.0.2-1. 

This clause has been included only to highlight some of the key features in the scope of the standard, but not to detail out the entire scope for which readers need to refer Clause 1 of the standard. Major features are ... 

The scope of the standard covers the operation and maintenance of electric power generation, control, transformation, transmission, and distribution lines and equipment. If an employer is not engaged in any of these activities, the requirements would not apply. An employer is also exempt if they have supplementary electric generating equipment that is used to supply a workplace for emergency or standby purposes only. 

The Regulations in this chapter lay out the broad scope of the standard, as already explained above. Regulation 110-04-01 advises that adherence to the standard is also intended to ensure compliance with statutory requirements. There is a list of the relevant statutory Regulations in Appendix 2 of the standard. 

In doing so, the failure rate X plays an important role, several roles respectively, and it a priori assumes pure random failures. For the scope of the standard, which is safety related parts of control systems , this is a very simple comparison standard. It fits quite well, if a constant failure rate X can be suggested, e g. for electronical products, which can be connected to the horizontal part of the bathtub curve . In the VDW s study on operational dependability, by contrast, the Weibull distribution is used, because at machine tools the failures are not purely random, but the failure rate rises as the operating hours increase (as a consequence of wear and tear, ageing). 

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