What is the idea behind this actual discussion? The term “Accreditation” describes the certificate of competency that an organization – the accredited body – is qualified to confirm to a third party by certificate, that this third party complies professionally and formally correct with an official standard. The accredited body gains the certificate of competency through a formal inspection and approval of a superordinated, authorized organization – the accreditor. It checks whether the accredited body possesses the necessary technical know-how in its field of activity, whether it has an infrastructure suitable for its tasks and whether it can guarantee through valid procedures the quality of its services on a long term basis. The accreditor additionally carries out annual inspections of the accredited body and is also responsible for the re- accreditation in up to quinquennial intervals. Germany disposes of a total of eleven accreditors which are united in the German accreditation-council (DAR).
Indeed, accredited bodies are established worldwide and are needed in a huge number of areas. Material testings and type checks belong in the technical area – from the fire prevention classification for plastics up to EC-type check for vehicle parts. In the pharmaceutical field, for instance, analytical laboratories which carry out toxicity studies are regularly accredited according to DIN EN ISO/IEC 17025. In the adjoining field of medical devices the so-called “Notified Bodies”, which carry out the required evaluation of conformity by EC directive 93/42, must be accredited according to DIN EN ISO/IEC 17011.
However, in the area of GMP inspections and qualification of active ingredient manufacturers the number of accredited bodies is still extremely clear in Europe. The relevant norm here is DIN EN ISO/IEC 17020. The German contract auditor blue inspection body GmbH is accredited according to this norm for the scope ”Inspections of excipient and active pharmaceutical ingredient manufacturers for pharmaceutical products and determination of the conformance with international GMP rules“ – nowadays, still being the only service provider in the European Union. Apart from blue, only the Swiss competent authority Swissmedic is accredited for “Inspections of manufacturers and wholesalers of medicinal products according GMP-and GDP guidelines”.
ISO 17020 defines the criteria for the conduction of different types of bodies which carry out inspections. Accordingly, the organizations accredited according to this norm are called “Inspection bodies”. European competent authorities responsible for GMP inspections are also acting on the basis of this norm. It forms the basis of the “Quality Systems Framework for GMP Inspectorates”, the common collection of procedures for inspections and information exchange published by the European commission. 
Swissmedic explains the purpose of the accreditation according to ISO/IEC 17020 as follows: “An accreditation according to this norm increases the acceptance of the Swiss inspection system from other competent authorities for medicinal products (EU, Canada, Australia, etc.). […] a missing international acceptance could imply a substantial additional expenditure for the exporting local manufacturers because these would be inspected, in addition, by different competent authorities of the individual importing countries.” 
The possibility of such an international acceptance is based on the certificate of competency which the inspection body gains with the accreditation. Amongst others, the professional competence of the auditors of the inspection body is examined. In addition, the natural requirement of the nominated auditors must be qualified, e.g., by the qualification as a qualified person, witness-audits must be graduated. These are examinations during audits conducted by the accredited body performed by approved professional GMP experts of the accreditor itself, e.g. inspectors of competent authorities for medicinal products.
The suitability and implementation of the quality management system of the inspection body is examined during the accreditation. The confidentiality, impartiality, integrity and independence are also checked. ISO/IEC 17020 identifies three classes for inspection bodies, from which the highest, type A, implicates a total objective and economic independence from the contract giver and the object of the audit: Auditors of an inspection body type A should not experience conflicts of interest, neither to the contract giving manufacturer of medicinal products (= Marketing authorization holder; MAH) nor to the manufacturer of active pharmaceutical ingredients, through possible business connections, investments, former (or following) employment contracts. An overview of all test criteria for an accreditation has been published by the German accreditation system inspection department (DAP).