independent certification bodymeans a body which is independent from the organisation that manufactures or distributes the alternative method and which provides a written assurance, in the form of a certificate, testifying that the validated alternative method meets the requirements of EN ISO 16140-2;
production process assurance of the manufacturermeans a production process whose management system guarantees that the validated alternative method remains conform to the characteristics required by EN ISO 16140-2 and ensures that mistakes and defects in the alternative method are prevented;