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ISO Certification and the Medical Device Industry Part 2 – Common ISO Terminology

December 10, 2012

Picking up where we left off in our last blog, here is an explanation of some of the terminology encountered is the ISO “world:”

 

Certification – the provision by an independent body of written assurance (a certificate) that the product, service or system in question meets specific requirements.

Registration – certification is very often referred to as registration in North America.

Accreditation – the formal recognition by an independent body, generally known as an accreditation body, that a certification body is capable of carrying out certification. Accreditation is not obligatory but it adds another level of confidence, as ‘accredited’ means the certification body has been independently checked to make sure it operates according to international standard.

Accredited Registrar – (Certification Body) – an organization accredited by a recognized accrediting body for its competence to audit and issue certification confirming that an organization meets the requirements of a standard (e.g. ISO 9001 or ISO 13485). Accreditation means that certification and inspection bodies have been assessed against recognized standards to demonstrate their competence, impartiality and capability.

Notified Body – an organization that has been accredited by a Member State to assess whether a product meets certain preordained standards. Assessment can include inspection and examination of a product, its design and manufacture. For example, a Notified Body may designate that a medical device conforms to the EU Medical Devices Directive, which defines the standards for medical devices. With this Declaration of Conformity, the manufacturer can label the product with the CE Mark, which is required for distribution and sale in the EU.

 

In our next blog we’ll look specifically at the ISO certifications possessed by NASP.

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