Competence conformity assessment

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. 

The conformity assessment body could be a laboratory, the third-party could be the accreditor coming to your laboratory to inspect, whether the required documentation, manuals, procedures, or personnel are appropriate to perform the specific conformity assessment task e.g. determine PAHs by HPLC. If the laboratory (the conformity assessment body) and the personnel can do the job then accreditation might be granted. Being accredited can be of competitive advantage for laboratories. Sometimes contractors require the (analytical) work to be carried out in an accredited laboratory. Accreditation gives confidence to the customer that the laboratory will fulfil the requirements that are necessary for the work to be done competently. You find more about accreditation in chapter 2 of this book. 

Third-party attestation reiated to a conformity assessment body conveying formai demonstration of its competence to carry out specific conformity assessment tasks [ISO/IEC 17000 2004]... 

The ECMRA applies to medical devices manufactured in the EC, Australia and New Zealand. It recognises the competence of designated conformity assessment bodies (CABs) in the EC to undertake conformity assessment of medical devices to Australian regulatory requirements, and the competence of the TGA to undertake assessment of medical devices for compliance with the requirements for certification (CE Marking) for entry onto the EC market. 

The knowledge that conformity assessment organisations are accredited by UKAS gives the confidence that they have been independently evaluated for their impartiality, competence and performance capability. 

Accreditation at the European level is a relatively new concept and dates back to the early 1980s. Accreditation means the recognition of the competence of a laboratory, certification, or inspection body by independent accreditors. The accreditation bodies are typically sanctioned by a member state government to perform audits of testing and certification institutions. The audited body must be able to demonstrate that it meets the criteria described in the annexes to the directives to become recognized at the state level and notified to the European Commission and the member states. The bodies that are notified are designated to carry out conformity assessment as set out in the directives. As an assessment technique, accreditation is an... 

Several studies have raised questions about the value of quality, environmental and occupational health and safety management system certification [audits]. Many of the concerns raised in these studies have focused on the competency of the auditors performing conformity assessment audits. [Author s note The foregoing comments pertain principally to audits made for management system certifications with respect to quality, environmental, and occupational safety and health by persons external to an organization. Nevertheless, similar questions have been raised for many years about the value of comparable audits made by in-house personnel.]... 

In this chapter, the topic will be examined in the context of both electrical safety and the safety of electrotechnical control systems employing electrical, electronic and programmable electronic safety-related control systems. In addition, the increasingly common practice of using conformity assessment to demonstrate competence will be considered. 

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. 

Anticipating the requirement for FSA services the established certifying organizations already offer FSA services. In the UK a new company has been formed to specialize in providing training for conformity assessment and has taken the name The CASS Scheme Ltd . The implications of this scheme are that competency guidelines and training schemes are in place for persons to be trained as Functional Safety Assessors. 

In this proposal, a manufacturer could also have the option of using a third party to assess conformance with the recognized standard. The third party could perform an assessment of conformance with the standard and provide the manufacturer with a statement to this effect, and the S10(k) application could then include the statement as well as summary on declaration of conformity. The abbreviated 510(k) submissions may compete with routine 510(k)s, and it is anticipated that their review and processing will be more efficient and timely than those of routine (traditional) submissions, which tend to be intensively data driven (Fig. 2). 

The stereochemistry of the reactions of chiral carbonyl compounds with nucleophiles has been a topic of considerable theoretical and synthetic interest since the pioneering study by Cram appeared in 1952. The available predictive models focus entirely on the conformational and stereoelectronic demands of the chiral carbonyl substrate, the implicit assumption being that the relative stabilities of the competing transition states are determined only by stereoelectronics and the minimization of nonbonded interactions between the substituents on the chiral center and the nucleophile. These models totally ignore the possibility, however, that the geometric requirements of the nucleophile may also have an effect on reaction diastereoselectivity. Considerable evidence is now available, particularly in the reactions of Type I (Z)-crotylboronates and Z(0)-metal enolates, that the stereochemistry of the nucleophile is indeed an important issue that must be considered when assessing reaction diastereoselectivity. 

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 Council resolution of 7 May 1985 showed the way by accepting that there could be more than one means of proof of conformity to a directive. It provided for presumption of conformity to a directive on the basis of a European harmonized standard, or, during a transition period, of national standards which have submitted and recognized as equivalent under Community control procedure. When the manufacturer complies with these standards, the directives allow him to make use of simplified certification mechanisms. When the product does not conform to a standard, however, either because the standards do not exist or because the manufacturer, for in the case of innovation, prefers to apply other manufacturing criteria of his own choice, the assessment of conformity to the essential requirements must [may] involve a third party either by certification or by third party testing [via notified/competent body]. (OJEC 89/C267/03)... 

Note. In some cases a type C product standard may not exist for a particular machine or product. In this case type A and B standards are used, along with the relevant EU national standards (if available), to assess the machine for safety or EMC, and these standards are then listed on the declaration of conformity for the CE marking. Use of a EU-notified/competent body may be required for products where no type C standard exists. 

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