Conformity assessment processes

Before a device can be legally placed on the market in Europe, it must go through an appropriate conformity assessment process to establish that it meets all the essential requirements of the applicable directive. This enables the manufacturer to make a formal declaration of conformity and apply the CE mark of conformity to the device. The manufacturer, or an authorised representative (EC Rep), who takes on the responsibilities imposed by the directives on behalf of the manufacturer, must be established in the EU. 

Conformity assessment processes (international verification processes)... 

Purchasers and consumers ask for a structured and transparent conformity assessment process in which impartiality and competency is crucial for their trust. Accreditation can provide impartial and independent evidence of the ability of conformity assessment organisations e.g. certification bodies to provide satisfactory certification. Conformity declarations, which are issued under accreditation, express the confidence that organisations work in accordance with a pre-determined standard so that the infrastructure is demonstrably present for supplying high-quality services and products. 

Conformity assessment can be considered as any action that is undertaken to determine whether a product, a service or a process meets specified requirements. It has been realised that the creation of an international technical language is of high priority to this end emphasis has been given to enhance cooperation, both on regional and international levels in various fields related to conformity assessment activities. 

To improve the competitive position of all sectors of European industry (including SMEs) by promoting better measurements at the research and development levels, better definition and control of the quality of products, more efficient in-process measurements and technical assistance to the mutual recognition of certificates in accordance with the Global Approach to Conformity Assessment... 

Conformity assessment refers to the demonstration that specified requirements relating to a product, process, or system are fulfilled or conform to specific requirements or standards. Conformity assessment helps to ensure that requirements of standards for consistency, compatibility, effectiveness, and safety are met. Conformity to these requirements can be demonstrated through mechanisms such as regular audits and inspections, and is best affirmed through third-party certification or accreditation. 

For most products and machines, the self-declaration process (module A) is possible. In practice the manufacturer performs the complete product assessment according to EU standards, issues the declaration, and affixes the CE marking to the product. A technical file or documentation must also be available on demand for national enforcement authorities. Keep in mind that this is an internal self-assessment process, a do-it-yourself approach, that results in issuance of the manufacturer s declaration of conformity and the CE marking (Figure 2-6). The buyer may demand proof of safety/EMC compliance in the form of a mark, certificate, or test report from a European notified or competent body. 

The hardware item used for conformance assessment is built to comply with the associated lifecycle data. o o Hardware Process Assurance Plan 10.1.6 HC2 HC2 NA NA... 

ABSTRACT Any product marketed in the European Union must comply with the European directives for which it is submitted. Some complex systems may be subjected to several directives. Because of technological innovation and the use of new processes, some products are not yet covered by a harmonized standard making the proof of conformity to directives more difficult. The conformity assessment of such new products is however necessary in order to be eUgible for the EC marking. This article deals with the compliance of such new products based on the specific case of a heUcopter-bome preventive avalanche release system using hydrogen. This article stresses the difficulties in interpretation of the directives. 

ANSI oversees the development and nse of voluntary consensus standards and conformity assessment systems for almost every U.S. indnstry by accrediting the procednres of standards development organizations, which work to develop standards through ANSI s requirements for openness, balance, consensus and due process. ... 

Fitting its commitment to safety and reliability, a formal validation process exists based on an ISO (International Standards Organization) standard (ISO 1999). Ada is the only language for which such a validation standard exists. An Ada Conformity Assessment Test Suite (ACATS) (ACAA 2005) has been developed for this conformity testing, which exercises both the compiler and the run-time system. 

Although neither the BBN or GSN approaches above atteii t to encapsulate how conformance can be achieved in a software safety standard such as IEC61508-3, a major benefit of both approaches is that they provide a strong visual aid that improves transparency in an assessment process. 

A number of standards require a system to be accompanied by a safety case, and a SoS should be no different. The safety case communicates an argument, supported by evidenee, that a system is acceptably safe in a given operational context. The safety ease eaptures the underlying reasoning and evidence that support claims made about the safety of a system. We believe that the hazard assessment process we have proposed is compatible with the creation of a safety case. We also believe that it will be possible to produce a manageable SoS safety case which takes ae-count of SoS specific issues and which conforms to relevant standards. 

The self-declaration process is that provided by Module A of the Conformity Assessment Procedures of Annex II of Decision 768/2008/EC of 9 July 2008 (EC 2008). Conformity assessment procedures (Modules) cover both design and production phases and shown in Table 1. 

The Regulations provide a range of means for assessing conformity. However, as far as electrical equipment is concerned, conformity assessment through a notified body will be the norm, following much the same EC type examination processes and procedures that have been used in the past. There are, however, additional requirements for product quality control and third party audits. In the UK, the Electrical Equipment Certification Service (EECS) and SIRA Test and Certification Ltd already provide conformity assessment services, basing their assessments on the harmonised standards that already exist for explosion-protected electrical equipment the main standards are identified in Chapter 15. 

One consequence of the increasing realisation that competence has a direct impact on health and safety has been the development of conformity assessment schemes covering competence. Conformity assessment, in its generality, is an activity concerned with determining directly or indirectly that relevant requirements have been met, and is most commonly used to determine if a product, system, process or a person s competence meets a defined specification. In the context of this chapter, conformity assessment relates to the process of determining whether people working in the electrical or safety-related control systems sectors can perform to the required level of competence. 

A wide variety of analytical techniques, such as wide-angle X-ray scattering (WAXS), FTIR, DSC, thermogravimetric analysis (TGA), solid-state NMR and mass spectrometry, are used to characterize the structures of polymer samples coalesced from their CD-IC crystals. The results of these observations are always compared with those obtained for as-received or as-synthesized, or melt or solution processed samples of the same polymers. In this manner, we attempt to assess process-dependent differences in their organization, such as morphologies, crystallinities and even the conformations adopted by their constituent polymer chains. 

The link with FMEA brings into play the additional dimension of potential variability into the assessment of the failure modes and the effects on the customer. The Conformability Matrix also highlights those bought-in components and/or assemblies that have been analysed and found to have conformance problems and require further communication with the supplier. This will ultimately improve the supplier development process by highlighting problems up front. 

To limit the potential for deficiencies to escape detection before the product is released, special processes should be documented in the form of procedures and specifications that will ensure the suitability of all equipment, personnel, and facilities, and prevent varying conditions, activities, or operations. Qualification in the context of special processes means that you need to conduct a thorough assessment of the processes to determine their capability to maintain or detect the conditions needed to produce conforming product consistently. The limits of capability need to be determined and the processes only applied within these limits. In qualifying the processes you need to qualify the personnel using them by training and examination as well as the materials, equipment, and facilities employed. It is the combination of personnel, materials, equipment, and facilities which ensure qualified processes. 

For low-risk devices the manufacturer may make a declaration of conformity with the essential requirements on the basis of a self-assessment, without any input from a Notified Body. In the case of Clas s I devices that are sterile or have a measuring function. Notified Body involvement is required, to provide assurance as to the effectiveness of the sterilisation process or the meteorological traceability of values as appropriate. 

The 510(k) pre-market notification process is not as onerous as the pre-market approval procedure, as clearance to market a device is not based on actual assessment of the safety and effectiveness of the particular device in question. Instead, devices can be cleared on the basis that they are substantially equivalent to existing devices that have been recognised as safe and effective, or that they conform to specific device standards promulgated or recognised by the FDA. There are four procedural variations to the 510(k) notification process. 

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