Specified requirements meaning

Harmonised standards are technical specifications adopted by one of the European standards organisations following a mandate issued by the European Commission on which Member States were consulted. When published by the Commission in the Official Journal of the European Communities, the hamionised standards give presumption of confomiity to the essential requirements they specify. This means that manufacturers applying these standards do not have to demonstrate the compliance of the manufactured products with the relevant requirements of the directive. 

Most ISO 9000 registered organizations claim to provide quality products and services, so why should there be so many dissatisfied customers when there are over 270,000 organizations in the world certified to ISO 9001, 9002, or 9003 One of the principal requirements in the standard is for the supplier to establish a quality system as a means of ensuring that product or service meet specified requirements. If an organization s products or services do not meet specified requirements then clearly the system has failed, but the failure is no fault of the standard - it is a fault of the way the standard has been applied and interpreted both by the organizations themselves and by the auditors who determine conformity. If the specified requirements are less than those of the customers, it is inevitable that products will bring dissatisfaction. This realization has, in the case of the automotive industry, led to two distinct needs ... 

Are the means used to ensure that product conforms to specified requirements documented in the form of a quality manual and quality system procedures ... 

The requirement does not cross refer to clause 4.16 on Quality records, clearly indicating that there is no requirement in this clause for problems to be recorded, as other clauses such as 4.10, 4.13, and 4.14 cover this. However, these clauses only relate to problems in not meeting the specified requirements and therefore may exclude types of problems not governed by specified requirements. So having identified the responsibilities of these personnel there may be no compulsion to provide a means for such problems to be documented, resolved, and prevented from recurrence. 

The standard requires suppliers to establish and document a quality system as a means of ensuring that product conforms to specified requirements. 

To accomplish this, you need to specify either in the quality plan or the documented procedures, the inspections and tests you intend to carry out to verify that the product meets specified requirements. In Part 2 Chapter 4 there is a description of a Design Verification Plan and this includes a specification of the tests and inspections to be performed on each production item as a means of ensuring that the qualified design standard is being maintained. This requires that you produce something like an Acceptance Test Plan which contains, as appropriate, some or all of the following ... 

Don t stamp any document unless there is a proper location to place the stamp because it could mean anything - a stamp has to indicate that the specified requirements have been met. 

When details are given they should be checked, if only by comparison with equivalent wind speeds derived from first principles, to ensure that they are reasonable. Depending on the specified requirements, the wind speeds may or may not utilize gust wind speeds as in CPS (3) or mean hourly wind speeds, v, with applied gust factors. 

The complete specification of a random process requires us to have some way of writing down an infinite number of distribution functions. For practical reasons, this is an impossible task unless all the distribution functions can be specified by means of a rule that enables one to calculate any distribution function of interest in terms of a finite amount of prespecified information. The following examples will illustrate these ideas by showing howr some particular stochastic processes of interest can be defined. 

Verification means confirmation by examination or direct measurement that specified requirements are met. 

A whole range of precautions may be based on the principles summarized earlier. However, general precautions, applicable to the majority of work situations, are listed in Table 5.13, many of which are included in legal requirements. For example, in the UK The Fire Precautions Act 1971 specifies requirements for fire resistance of surfaces and building structure, assessment of risk, means of escape, means for giving warning, firefighting equipment, and fire instruction and drills. 

The relative sizes of batch equipment are specified by means of size factors Shj for a hypothetical product. The production requirements and characteristics of each product are converted to the equivalent data for the hypothetical product and the equipment sized to achieve the required production of the hypothetical product. The method proceeds in three steps (I) calculation of exact equipment sizes for a fixed number of units of the same size mj, (2) conversion of exact equipment sizes to standard sizes, and (3) choice of mj. 

The term quality is used in many industries and in everyday Ufe and can have various meanings depending on context. For the purposes of discussion here quality means the product requirements or attributes that have a bearing on the product s specified requirements. Quality assurance activities are those processes and activities conducted to assure that a product or service consistently satisfies its requirements and is fit for its intended use. In the pharmaceutical manufacturing environment, this means the activities conducted to assure that the pharmaceutical product s identity, strength, purity, potency, and other quality attributes conform to approved specifications. 

Conformity means the state of a product satisfying specified requirements. 

Quality surveillance means the continued monitoring and verification of the status of procedures, methods, conditions, processes, products and services, and analysis of records in relation to stated references to ensure that specified requirements for quality are being met. 

ISO/DIS 13485 The supplier shall establish, document, and maintain a quality system as a means of ensuring that product conforms to specified requirement. The supplier shall prepare a quality manual covering the requirements of ISO 9001. The quality manual shall include or make reference to the quality system procedures and outline the structure of the documentation used in the quality system. 

The blank entries represent situations that are either impossible (e.g., deleting an entry in one model and adding it in another) or where no change is required (e.g., if the element stays the same in both models). The entries that specify row mean that the version of the element from the model represented in the row should be taken, and similarly column indicates that the column s version should be taken. So, for example, if a sequence were unchanged in model A and deleted in model B, the action would be dictated by the entry at (no change, delete element), which, in this case is to delete the sequence since that is the action performed in model B, the one represented by the column. 

Another basis for classification of models of population dynamics is provided by the observation that cells may be assumed to be either structured or unstructured. In a segregated model, we assume a cell to be structured if we specify some means of distinguishing it from its fellows. This means may be visual, by comparison of morphology and size under the microscope, or it may be indirect, by comparison of the mass and chemical composition of cells. When we deal with a distributed model, the population will be structured if the composition of the population varies with the conditions of propagation. In other words, specification of the state of the population requires more than specification of a single quantity. 

How much low-temperature impact performance is needed In automotive applications, parts are often specified to resist violent impacts at -20° to -40°C without shattering into pieces. These impact requirements mean that specialized commercial grades of compounded TPO or reactor-modified TPO may... 

Behavioural safety requirements means those safety requirements that specify the need for the behaviour of the system to be constrained to a valid set of behaviours, usually those associated with achieving the absence or handling of failure conditions. 

Records — Documents which furnish objective evidence of the quality of items or services and of activities affecting quality, by means of which it may be determined whether the specified requirements are satisfied. 

Specification of the preferred or required means to allow for thermal expansion. Often expansion joints or bellows are considered impermissible on grounds of reliability, and the provision of inherently flexible piping design (incorporating sufficient bends) is specified. 

Verifying that a product with several million variants satisfies all the requirements, is only possible with complete methods. Completeness means that all possible variants are respected and checked that they fulfill all specified requirements and satisfies all interfaces to all involved parties. This procedure is called a consistency check. 

Geometrical/functional integration as well as system integration serve for the gradual assembly of components, subsystems and complete vehicles. A gradual concept serves for the execution of necessary verification methods (test and validation) on a cost effective level. By virtual means as well as on the base of physical prototypes verification is understood as validation against specified requirements. The validation process checks against client expectations until the final approval of the complete vehicle. 

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