Conformity assessments

A broad range of technical requirements is important in a laboratory quality system. These include aspects such as the selection of appropriately qualified and experienced personnel sampling, sample handling and preparation laboratory accommodation and environmental conditions equipment and reagents calibration reference standards and reference materials traceability (of standards and of samples) the selection or development, validation, and control of methods estimation of the uncertainty of measurements reporting of results and quality control and proficiency testing. 

Detailed guidance on the technical elements of a quality system is available in several published guidelines and standards. Some of those of relevance to residues laboratories are discussed in the following sections of this chapter. 

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From 1985 three major changes have been introduced to do away with the disadvantages encountered with the old approach . In 1985 the European Council adopted a New Approach to technical harmonisation and standards , in 1989 it adopted the Global Approach to conformity assessment which was amended in 1993 and in 1987 the legal basis for... 

In adopting that New Approach, the European Council was aware that this decision had to be accompanied by a policy on assessment of conformity. The Global Approach to conformity assessment provides for procedures to prove compliance of a product with the essential requirements in New Approach directives. 

That set of modules includes alongside the traditional procedures related to product control, quality assurance procedures for conformity assessment. The intervention of a third party in these procedures comprises an initial audit of the manufacturer s quality system which must include both the specific technological aspects of the products concerned and the methodology of the quality assurance procedures. Furthermore the manufacturers are subject to periodic audits to ensure that the systems are maintained. Finally, on the occasion of unexpected visits, the notified body can carry out tests on the products. 

The principles referred to so far are common to all New Approach directives. The individual directives obviously need to be specific on topics such as the scope, the essential requirements, the classification of the products and on the use of modules for conformity assessment. The pressure equipment directive includes some additional sector specific dispositions which relate to recognised third party organisations , the European approval for materials , a committee for pressure equipment and the user inspectorates . 

The scope of the directive covers the design, manufacture and conformity assessment of pressure equipment and assemblies with a maximum allowable pressure greater than 0,5 bar. A pressure equipment in the sense of the directive is any vessel, piping, safety accessory or pressure accessory. An assembly means several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional whole. It is important to be aware that the directive relates exclusively to the pressure risk and that therefore other directives, such as for machinery, low voltage may be applicable to the equipment concerned. 

Based on these considerations, the conformity assessment tables comprise 4 tables for vessels and 4 tables for piping. A further table relates to fired or otherwise heated equipment. Specific procedures are set out for the assessment of assemblies and of safety accessories. 

Where conformity assessment involves intervention of third party, that task is normally carried out by the notified body. The pressure equipment directive enables in addition the national authorities to authorise in their territory user inspectorates for the carrying out of conformity assessment procedures which relate to product verification. These inspectorates shall act exclusively on behalf of the group of which they are part. The placing on the market and putting into service of equipment which has undergone such assessment is however limited to the territory of the authorising Member State and to those Member States which have also proceeded to such authorisation. The equipment concerned shall therefore not bear the CE-marking. 

The user inspectorate must fulfil the same technical criteria as the notified body. In addition, it must be organisationally identifiable and demonstrate its impartiality. It must not engage in any activities that might conflict with its independence of judgement and integrity. Given that the authorisation of user inspectorates to carry out conformity assessment is an innovation for technical harmonisation at Union level, the Commission shall monitor the application of this measure and evaluate its effects three years after the coming into force of the directive. 

The basic mark is illustrated in Eigure 9.2. Depending on the type of product, it may be accompanied by the identification number of the Notified Body responsible for performing specified conformity assessment tasks (see Chapter 10). 

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. 

Different conformity assessment options are available, depending on the type of device and the level of associated risk. For lotv-risk devices, the manufacturer can make a declaration of conformity based solely on self-assessment, without the need for the involvement of a Notified Body. For all other devices Notified Bodies are required to perform one or more of the tasks outlined in Table 10.2. HIV and hepatitis tests and blood grouping tests represent the highest risk devices, as they are critical to ensuring the safety of blood and blood products. For example, a defective HIV test device could result in widespread infection in an unsuspecting population, whereas the detrimental effects ofan AIMD or a Class III device failure will just be confined to the individuals treated by the device. At this end of the risk spectrum. Notified Bodies are required to verify the applied quality system, the specific device design, and the... 

The purpose of all the conformity assessment procedures is to ensure that the device as designed and as subsequently manufactured will meet the essential requirements. For most devices where Notified Body involvement is required, the manufacturer may choose between the strategies of relying on the application of appropriate quality systems or independent testing to demonstrate this. 

Figure 10.8 Conformity assessment options available to manufacturers for different types of device.

Assembling technical documentation that provides evidence of conformity with the essential requirements is a fundamental part of all conformity assessment procedures. The appropriate essential requirements annex may be used as a checklist, against which documents demonstrating the adopted solutions may be identified... 

Risk Clinical Data Authorisation of Clinical Investigations Instructions for Use Conformity Assessment Procedure... 

A new 510(k) paradigm provides guidance for sponsors of 510(k)s to consider and use national and international standards and a mechanism for declaration of conformity assessment criteria for these standards. It is expected that many domestic and international standards will address, in part or full, certain aspects of... 

Interestingly, we were intrigued by the ESI mass spectrum of the compound, as the observed base peak consisted of [M-S02+Na]+. This led us to explore a thermal retro-Diels-Alder reaction that could afford the desired enone 69. It is noteworthy that the chemistry of cyclic enol-sulfites would appear to be an under-explored area with a few references reporting their isolation being found [57]. At last, we were also able to prepare epoxy ketone 70 from 69 in three steps, albeit epoxidation did not take place unless the TES group was removed. Spartan models reaffirmed our initial conformational assessment of enone 69 and epoxy ketone 70, which contain sp3-hybridized C8a and s/r-hybridized C8b (p s e u d o-. v/r - h y b r i d i zed C8b for 70) at the AB-ring junction (Fig. 8.12) and displayed the desired twisted-boat conformation in A-ring. 

Conformity Assessment - Vocabulary and General Principles , ISO/IEC 17000 2004 International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC), Geneva, Switzerland, 2004. 

Office of Management and Budget (OMB). 1998. Federal Conformity Assessment Activities, Circular No. A-119. Washington, DC Office of Management and Budget. 

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]... 

Whilst audit" applies to management systems, assessment applies to conformity assessment bodies as well as more generally. 

Certification is applicable to all ob]ects of conformity assessment except for conformity assessment bodies themselves, to which accreditation is applicable. 

The structure of the accreditation bodies in each country may be different and the procedures for accreditation can also vary to some extent. But nevertheless they all have to fulfil the requirements of ISO/IEC 17011 2004 Conformity assessment -General requirements for accreditation bodies accrediting conformity assessment bodies . To further harmonize these procedures and to guarantee. ... 

ISQ/IEC 17011 2004 - Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment bodies... 

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. 

How can suppliers and customers worldwide be sure that products and services meet relevant criteria When they meet standard specifications. How can they be sme that products and services meet such specifications By conformity assessment. 

But how can they be sure that conformity assessment activities are reliable When they comply with the criteria laid down in ISO/IEC standards and guides. 

By conformity assessment , i.e. checking that products and services meet the reievant standard s specifications... 

In official documents of the Emopean Commission it is stated that accreditation should be seen by public authorities, by the accreditors, by the certifiers and by the industry as the highest level of control of conformity assessment activities, from a technical point of view. The diagram illustrates the correlation of various activities and the role of the stakeholders. Accreditation provides the highest level of recognition of activities within conformity assessment. 

Various activities come under conformity assessment all of them are based on sampling, testing and reporting. First-party testing is carried out by manufacturers and suppliers. Second-party testing is performed by buyers, users or consumers. Third-party testing is carried out by organizations independent of the above parties. 

ISO (2000) Aligning intentions and implementation in conformity assessment , ISO Bulletin 31 6... 

Measurement uncertainty especially is interesting when it comes to conformity assessment. In the graph the results of four different measurements are shown together with a specification limit. Without knowing the uncertainty of the measurements the situation seems to be veiy clear. Results 1 and 2 are below the specification, results 3 and 4 are above the limit. 

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