Proposal for Supplement 3 to the 05 series of amendments Regulation No. 22
Proposal to modify the frequency of conformity of production inspections and random sampling. Absent ISO 9002 certification, inspections would change from “3 times a year” to “1 time a year” (i.e. annual). For ISO 9002-accredited facilities, the amendment would offer authorities flexibility for inspections every 1-2 years depending upon the results of previous inspections.