Clause, definition

Work instructions are identified in a Note to clause 4.2.2 of ISO 9001 and in clause 4.9.2 in ISO/TS 16949 where it states that job instructions are equivalent to work instructions. In ISO 9001 it implies that work instructions define how an activity is performed but in ISO 8402 1994 a procedure is defined as a specified way to perform an activity. There isn t enough difference between these two definitions to warrant a change in the term and its inclusion may well create much confusion, especially as ISO 9004-1 does not refer to work instructions or any other type of instructions. The list of topics that should be addressed by job instructions in clause 4.9.2 of ISO/TS 16949 certainly does not by itself imply that job instructions define how an activity is performed ... 

The definition of nonconformity in ISO 8402 states that it is the nonfulfillment of specified requirements therefore a nonconforming product is one that does not conform to the specified requirements. Specified requirements are either requirements prescribed by the customer and agreed by the supplier in a contract for products or services, or are requirements prescribed by the supplier which are perceived as satisfying a market need. This limits the term nonconformity to situations where you have failed to meet customer requirements. However, ISO 8402 1987 suggests that nonconformity also applies to the absence of one or more quality system elements, but clearly the requirements of clause 4.13 cannot be applied to nonconformity with quality s /stem requirements. Both ISO 9001 and ISO 9004 only address nonconformity in the context of products, processes, and services and when addressing quality system elements the term deficiencies is used. Some auditors use the term nonconformity to describe a departure from the requirements of ISO 9001 but it would be preferable if they chose the term noncompliance to avoid any confusion. The requirements of clause 4.13 therefore only apply to products, processes, and services and not to activities, quality system elements, or procedures. 

Returning to the standard, this clause also only addresses the correction and prevention of nonconformities, i.e. departures from the specified requirements. It does not address the correction of defects, of inconsistencies, of errors, or in fact any deviations from your internal specifications or requirements. As explained in Part 2 Chapter 13, if we apply the definition of nonconformity literally, a departure from a requirement that is not included in the Specified Requirements is not a nonconformity and hence the standard is not requiring corrective action for such deviations. Clearly this was not the intention of the requirement because preventing the recurrence of any problem is a sensible course of action to take, providing it is economical. Economics is, however, the crux of the matter. If you include every requirement in the Specified Requirements , you not only overcomplicate the nonconformity controls but the corrective and preventive action controls as well. 

The corrective action requirements fail to stipulate when corrective action should be taken except to say that they shall be to a degree appropriate to the risks encountered. There is no compulsion for the supplier to correct nonconformities before repeat production or shipment of subsequent product. However, immediate correction is not always practical. You should base the timing of your corrective action on the severity of the nonconformities. All nonconformities are costly to the business, but correction also adds to the cost and should be matched to the benefits it will accrue (see later under Risks). Any action taken to eliminate a nonconformity before the customer receives the product or service could be considered a preventive action. By this definition, final inspection is a preventive action because it should prevent the supply of nonconforming product to the customer. However, an error becomes a nonconformity when detected at any acceptance stage in the process, as indicated in clause 4.12 of the standard. Therefore an action taken to eliminate a potential nonconformity prior to an acceptance stage is a preventive action. This rules out any inspection stages as being preventive action measures - they are detection measures only. 

Some auditors believe that any document generated or used by the quality system is a quality record and will attempt to apply the requirements of clause 4.16. Whilst it can be argued that any documented output is a record of an activity, the reader is referred to ISO 8402 for a definition of records in the context of the quality system. ISO 8402 states that a record is a document which furnishes objective evidence of activities performed or results achieved. A quality record provides objective evidence of the fulfillment of the requirements for quality (e.g. product quality record) or the effectiveness of the operation of a quality system element (e.g. quality system record). 

The impact of this requirement depends upon what constitutes the specified requirements. The standard does not require you to demonstrate conformance with every requirement of ISO 9001. However, if your customer has invoked ISO 9001 in the contract, this clause requires that you maintain sufficient records to demonstrate compliance. As stated elsewhere in this book, there is no definition clarifying what specified requirements are. If specified requirements are a//the requirements that you have specified in your quality system, your plans, procedures, specifications, etc., this requirement may well be viewed as the most onerous in the standard. A pragmatic approach to take is to declare in your quality manual that the specified requirements are specified customer requirements . 

The following clause should mean that the class implements the type represented by its superclass as well as extending the definition of its code. 

These essentially colourless compounds have been defined as substances that, when added to an uncoloured or a coloured substrate, increase the reflectance of the substrate in the visible region by converting UV radiation into visible light and so increase the whiteness or brightness of the substrate . The air of uncertainty in the final clause of this definition... 

A. There has been an attempt in the bill to recognize the disabilities, the extra burdens, on the small inventor in that there is a provision which says that for an individual inventor, or those who meet the definition of a small business as defined in our laws, there is an upper limit on the filing and issuance fees of the patent. That upper limit is 100. That same clause says that there will be a minimum lower limit of 200 for the corporate applicant. Now that difference does not solve the question that you raised, but it is as far as the sponsors of the bill are apparently willing to go. I think that when associations of big business tell the government that they are worried about how this is going to help or hurt the small inventor, they don t receive much attention. It isn t remembered that most big business started small. 

The Definite Clause Grammar (DCG) formalism [7] is utilized throughout this project. Grammar rules are used in the expert system rules to recognize the general class of the parent molecule in the disconnection (c.y., cyclohexene). The class determines the patterns used to construct the resultant synthons (discussed in Section 4). 

Pereira, F.C.N., D.H.D. Warren, Definite Clause Grammars for Language Analysis - a Survey of the Formalism and a Comparison with Augmented Transition Networks , Artificial Intelligence, 13, (1980), pp. 231-278. 

Clause 1 Scope of the Code and Definition of Certain Terms... 

Here is a masterpiece of logic which makes some sense out of sloppy law. It must be remembered that the purpose of all of this is to determine if one, or two, or three definitions must be applied to establish just what is an analogue. This court declared that a substance may be a controlled substance analogue only if it satisfies clause (i) and at least one of clauses (ii) or (iii). 

The constructive ambiguities in Annex 2C may be definitively settled only under the AUSFTA dispute resolution chapter 21, by an unelected panel of three nominated trade lawyers (Article 21.7). Perhaps of great importance for the PBS in this context is Article 21.2(c). This is what is known in international trade law as an NVNB clause. NVNB provisions allow dispute resolution proceedings to be commenced where only the "spirit" of the treaty had been broken or, more technically, the "legitimate expectations" have been nullified or impaired (no technical violation) by a "measure" of the other party. 

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