Certification requirements recognition

The 1982 White Paper on Standards, Quality and International Competitiveness was concurrent with increasing interest in the techniques of quality assurance and the need for international harmonization of standards and the reciprocal recognition of certification. It is worth noting that the ISO 9000 series of standards on Quality Systems 1987 followed the layout of BS 5750 1979 almost clause by clause. ISO Guide 39 covers the general requirements for inspection bodies. Auditing on behalf of certification bodies is part of the inspecting authorities role. 

In the EEC, applications or notifications for clinical trials have to be lodged with the individual national authorities. A common procedure or even mutual recognition of clinical trial certificates does not exist. A list of the different national requirements is provided in "The Rules Governing Medicinal Products in the European Communities" Volume III, Annex 1. A discussion paper (III/ 3044/91) released in 1991 by the EEC Division for Pharmaceuticals (DG III) addresses various issues on the harmonization of approval of clinical trials and may eventually lead to common, non-binding recommendations. 

The standards of training in science have evolved over the years, but currently an earned doctorate from a reputable university is the usual requirement for professional status in most fields. Scientists without a doctorate, however, can be recognized after publication of credible research in refereed journals. Formal certification is not common in the sciences, so recognition comes from accomplishments rather than a professional license. There are a few exceptions, such as clinical chemistry, mostly in fields closely related to medicine. 

The IFOAM Accreditation Program s provision for multi-lateral agreements between IFOAM Accredited certifiers through recognition of functional equivalence (on the basis of the IFOAM International Basic Standards) and bilateral acceptance between two certification bodies (based on products and bilateral additional requirements) ... 

Directives are the European laws published in the Official Journal that give us the essential health and safety requirements (EHSRs) that shall be followed by product suppliers. These are commonly called the Essential Requirements (ERs). The directives deal with legal and procedural issues, such as assessment procedures, certification, implementation, enforcement, technical files, declarations, CE marking, and other basic concepts. Examples of primary directives are the Low-Voltage, Machinery, and EMC directives. The General Product Safety and Product Liability Directives are basic directives dealing with enforcement and civil prosecution that are applied to all products. The directives also mandate the publication and mutual recognition of harmonized standards. 

Because of the almost universal acceptance of the European standards (EN and lEC) around the world many suppliers now offer components that are EU type-approved, in addition to the U.S. recognition. The U.S. is also moving toward acceptance of the European product standards. Unfortunately, at this time U.S. and EU product and component standards are different. The United States focuses on fire hazards and materials, whereas Europe stresses shock hazards and construction. Because of these and other substantial safety differences, component suppliers realize the need for dual approvals to satisfy both the U.S. and International requirements. As a minimum, one mark for North America (UL) and one for Europe (VDE) should be considered. Many component suppliers now offer components with this dual certification. A certificate and test report from the testing and certification body supports the type approval mark. The mark is affixed to the component and is visually recognized by interested parties as positive evidence of compliance. 

Activity of the Board of Certified Safety Professionals and the American Society of Safety Engineers (ASSE) over many years resulted in the arrangements made with ABET to accredit safety science degree programs that met ABET requirements. It is a mark of status and recognition for a university to meet those requirements and obtain accreditation. An audit team visits the school for the initial accreditation and on a 5-year schedule thereafter if continued certification is sought. Recommendations are made by the audit team, if necessary, for continuous improvement in the curriculum and the educational objectives for the program. 

To (re)certify tools, process compliance is required. Manufacturers have to show that the qualification process mandated by the standard has been performed. When moving from one domain to another, it is crucial to reuse certification data in order to reduce time and cost. To do that, the first necessary step is the recognition that certification data related to a process line exhibits commonalities and variabilities. Thus, a compositional approach based on product line-oriented practices enabling the selection and composition of commonalities and variabilities is the key solution for showing process compliance. 

Certification Certification means the legal recognition by the certification authority that a product, service, organisation or person complies with the applicable requirements. Such certification comprises the activity of technically checking the product, service, organisation or person and the formal recognition of compliance with the applicable requirements by issue of a certificate, licence, approval or other documents as required by national laws and procedures. In particular, certification of a product involves ... 

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