Accreditation body

ISO 9000 is not a statutory requirement and neither is certification, hence certification is voluntary. However, suppliers may be under pressure to obtain registration to ISO 9001, ISO 9002, or ISO 9003 in order to tender for contracts. Within the ISO 9000 certification scheme, the certification industry is regulated by accreditation bodies. An International Accreditation Forum (lAF) attempts to harmonize accreditation practices world-wide through ISO Guide 61. The accreditation bodies authorize certification bodies to conduct certification to prescribed standards - a process that is called accreditation. The accreditation body performs witness audits and desk audits of the certification body to ensure compliance with the conditions of accreditation. 

In many countries, there is no law prohibiting an organization setting up as either an accreditation body or a certification body. 

Demand that the accreditation body is recognized by the national government. 

The accreditation body rather than the industry determines which certification bodies are qualified to issue certificates. 

You can expect to receive both accreditation body witness auditors and lATF witness auditors on any initial audit and subsequent surveillance audit but not at the same time. 

The application of EN 45011 led to a strong reduction in the number of certification bodies in several countries, like France. In some EU countries the inspection bodies have to be accredited by the national accreditation body, in others they do not (Michaud et al 2004). 

Examples of Quality Audit report forms are shown in Tables 9.5 and 9.6 at the end of this chapter. Table 9.5 shows Report Form 1 which includes a record of what has been examined, so that subsequent audits can examine other aspects of the laboratory s operations. Note that when improvement actions are required, the form records not only what needs to be done, but also by when it must be completed, as shown in Table 9.6 (Report Form 2). The form is signed by the auditor and the responsible person from the area being audited. In the UK, the accreditation body UKAS refers to the corrective action as improvement action . This further emphasizes the continual improvement aspect of the ISO/IEC 17025 and ISO 9001 Standards. The examples shown in Tables 9.5 and 9.6 will probably have to be modified to meet a laboratory s particular requirements. It should also be remembered that both report forms should indicate (usually as a footer or header) the title of the document, its issue date, issue number, who authorized the document, page number and total number of pages. 

The consequences of nonconformities are different for the different categories. Minor nonconformities will be noted and checked at the next assessment but will not normally appear in the written report. Major nonconformities can result in a total suspension of accreditation or suspension of accreditation for particular work. The intentional misuse of the accreditation body logo or mark is considered to be a serious nonconformity. If, after a previous warning, a laboratory continues to issue test reports showing the accreditation logo when the tests are outside the scope of the accreditation it can result in withdrawal of accreditation. Accreditation can be withdrawn for a particular area if it is found that accommodation is inappropriate and it is impossible to avoid cross contamination of samples. 

An accreditation body logo is not being used inappropriately. 

Member States shall designate bodies responsible for the assessment of laboratories as referred to in Article 7 of Directive 89/397/EEC. These bodies shall comply with the general criteria for laboratory accreditation bodies laid down in European Standard EN 45003.6... 

European committee for standardization, General Criteria for Laboratory Accreditation Bodies - European Standard EN45003, Brussels, CEN/CENELEC, 1989. 

Accreditation is the confirmation of the competence of a testing or calibration laboratory by an independent third party, the accreditation body. 

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. ... 

Usually there are national regulations for one or several accreditation bodies in each country... 

There is cooperation between accreditation bodies in international organisations... 

This slide shows the members of an International Multilateral agreement between Accreditation bodies worldwide, which ensures the mutual recognition of the accreditation for testing and calibration results in the cooperating countries. 

Accreditation bodies from all over the world signed an International MRA on recognition and acceptance of testand calibration results... 

These are the elements of an aeeredita-tion proeednre. The first step for the laboratory is to eontaet the aeeredita-tion body, whieh in response informs the laboratory abont the details of the accreditation proeeditre. When the contract between the laboratory and the accreditation body is signed, assessors will be nomirrated. They will carry out technical andits of the application document and on-site laboratory... 

The standard ISO/IEC 17025 focuses on the technical competence for specific tests and this is attested by the accreditation body. 

Addresses the technical competence of laboratories to carry out specific tests and Is used worldwide by laboratory accreditation bodies as the core requirement for the accreditation of laboratories... 

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

The first documents dealing with the competence of laboratories were ISO/IEC Guide 25 and EN 45001 standard. They were issued to provide the necessary basis to be used by laboratories and by the bodies that assess their technical performance. In parallel, accreditation bodies nnder-took additional tasks with regard to the assessment of other activities (certification of products and systems) as specified in other EN 45000 series standards. The ISO/IEC 17025 has replaced EN 45001 (see slide 40), while other standards within EN 45000 series have been replaced by the ones in ISO/IEC 17000 series. 

EUROLAB Technical Report 2/2002 Customer satisfaction with European accreditation bodies available from http //www.emolab.org... 

In such cases, which are the most commort, there is a need to provide objective evidence that the validation was carried out, using appropriate and approved methodology. The use of Certified Reference Materials or the comparison against a previously validated method is highly recommended in order for a vahdation to be recognized by regulatory or accreditation bodies. 

Accreditation bodies recognize the benefit of these schemes and encourage laboratories to participate in PT. Regular participation in proficiency testing schemes is a recognised way to monitor laboratory performance (see chapter 15). 

Why should a laboratory participate in PT schemes First there is the possibility to uncover errors that couldn t be found with other quality control measures and second a successful participation can be used as a certificate of competence for clients, authorities and accreditation bodies. 

Proficiency tests first of all should help the laboratories improve their performance. But often they are also used as a control tool for accreditation bodies, customers and authorities. Thus, there may be a tendency among some participants to try to report a better performance than is justified. 

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