Certification body - meaning

Local certification has a number of advantages, not least that it is one way to reduce costs to producers in developing countries via locally determined fees reflecting local incomes (Barrett et al., 2001). To be accepted by the European Union (EU), local certification bodies are required to demonstrate that their standards of organic production and inspection are equivalent to EU regulations. The standards need not necessarily be identical, however, and as such this means more locally appropriate standards can be set in place. For example, local certification bodies may well allow the use of such natural pesticides that would not normally be allowed under EU Standards (Myers, 2000). 

Every producer or handler is required to submit an organic production and handling system plan , which has to be approved by the certification bodies ( 205.201). In the plan, each farm has to ensure that all requirements of the standards are fulfilled. Strictly speaking, this would mean that sustainability is achieved, as required according to the introductory paragraph quoted above. The priority issues mentioned in this context, however, are rather the avoidance of product contamination and the restriction of substances used in production, and it seems unlikely that salinity control is enforced. 

As the majority of chickens will be killed in a conventional processing plant approved by the certification body, the organic birds will be the first batch of the day to be processed. This means that the birds will need to be caught in the early hours of the morning while it is still dark, which happens to be a good time to catch flighty birds. 

A national Accreditation Body, such as the United Kingdom Accreditation Service (UKAS), accredits a certification body (e.g. Lloyds, BSI, etc.) who in turn certifies individual companies that make a voluntary application to them. This certification is based on successful audits by trained ISO 9000 auditors. The company maintains its ISO standards by means of internal auditors and by annual or biannual audits and regular follow-up audits from the certification body. 

Extremely difficult and time-consiuning equivalence assessment by some countries — in the case of Japan, the assessment procedure was started two years ago and it seems that it will take some more time. As Japan apparently does not base its equivalency assessment for certifying bodies on international standards such as ISO 65 / EN 45011, every single certifying body has to be registered by the competent authorities, which of course is a very complex task to do. For the Swiss certification bodies, this means a loss... 

In specifying the criteria against which the products or the quality system of an organisation are evaluated and how they should be assessed, a certification body has to establish working documents. The working documents are part of a certification scheme that reflects the content and functioning of the certification. Inherent to certification is a structure that should enable the participation of all relevant parties concerned to approve a certification scheme. Representation on an Advisory Board and or in an impartial committee of experts forms the means to take into account the views of the significant interested parties. 

Independence designates a quality or state of not being subject to the rule or control of another i.e. being self-governing. It stresses the state of standing alone not depending on others for one s opinion or livelihood. Impartiality means freedom from favour or prejudice toward the one or other side. Integrity can be described as the state of mind of the staff while independence and impartiality are attributes of the certification body concerned. 

In the above discussion, standard reference materials (SRMs) were mentioned often. A reference material (RM) is a material or substance suitable for use in calibrating equipment or standardizing solutions. A certified reference material (CRM) that a vendor indicates, via a certificate, is an RM. A standard reference material (SRM) is one that is distributed and certified by a certifying body, such as NIST. The SRM is the material to which all calibration and standardization materials should be traceable. A standard material becomes one when it is compared to or prepared from another. Ultimately, it all rests on the SRM — meaning all standard materials are traceable to an SRM (see Figure 5.10). 

Very special quality demands and quality systems are those for the production and certification of kosher and halal products, which at the time are gaining in importance all over the world. Kashrut is the body of Jewish law dealing with what foods Jews can and cannot eat and how those foods must be prepared. Kashrut originates from the ffebrew and means fit , proper or correct . The more commonly known word kosher comes from the same roots and refers to foodstuffs that meet these dietary requirements of Jewish law. Halal is an... 

In 1992 IFOAM established the IFOAM Accreditation Programme to provide a means of harmonising standards and certification worldwide. The programme offered independent evaluation of inspection bodies against the Basic Standards and the developed IFOAM criteria of organic certification programmes. In 1997 they licensed the International Organic Accreditation Service to perform this function. 

The supreme body of supervision and inspection of good manufacturing practice on the territory of the Slovak Republic in the case of human medications is the Ministry of Health of the Slovak Republic, which provides for the performance of supervision and inspection and the issuing of a quality certification for foreign trade by means of the State Institute. 

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)... 

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... 

Due diligence means taking all reasonable steps to ensure conformity. With only a few exceptions, the manufacturer/importer is ultimately responsible for a product s compliance to directives, but with a mark, certificate, or test report from a notified body the suppliers risks are decreased and their defense of due diligence enhanced, should the products safety/EMC conformity come into question. It is the responsibility of notified bodies to accurately interpret directives and standards through testing and certification, thereby ensuring conformity and building consumer confidence. 

The European bodies (especially in Germany) issue certified approvals and marks according to clearly defined standards, which are definitive statements on their assessment results. The European approval term means that the equipment bearing an approval mark has been successfully tested and passed, but more important, approvals are perceived by users and customers as a guarantee that the equipment is safe for use (see Notified Bodies and Certification in Chapter 4). 

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. 

Specifically for Class HI devices, the assessment of conformity rehes in most cases on the submission of clinical data. Nevertheless, according to European directives, manufacturers just have to demonstrate the safety and performance of devices, while evidence of effectiveness is not required at the stage of certification by a notified body. Also, specific requirements for the clinical evaluation of most devices are not available in the guidance. In fact, in most cases, the submission of robust chnical data is limited, and often the evidence submitted is from laboratory testing, literature reviews, or small clinical trials. Typically, this means nomandomized and feasibility studies involving less than 100 patients for which the primary objective is to demonstrate safety (Fraser etal., 2011). 

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