FAQ11

Consider that an inspection body is found to be using an inadequate sampling procedure for selecting the number of samples inspected. The inspection body then claims that the sampling size was determined by its client and that it is the client who takes responsibility for determining conformity of the batch and subsequently certifying the batch containing the inspected items. The inspection body claims it is merely reporting the results of the examination of the samples as required by the client specification. According to 7.1.2 of ISO / IEC 17020:2012, IBs are required to use statistically sound sampling procedures for selecting samples of inspected items. Is it allowed to use an inadequate sampling procedure for selection of samples when the IB’s client has accepted the sampling procedure?

STANDARD: ISO/IEC 17020  ·  CLAUSE: 7.1.2  ·  TOPIC: Determining statistically sound sampling procedures  

Answer:

ISO/IEC 17020 clause 7.1.2 requires inspection bodies to use statistically sound sampling procedures for selecting samples of inspected items only where the absence of such [procedures] instructions could jeopardize the effectiveness of the inspection process. As stated in Note 2 to clause 3.1 of the standard, “Inspection procedures or schemes can restrict inspection to examination only”. Where there is no conformity assessment, by the inspection body, there can be no criteria for making a decision on what constitutes an appropriate sampling procedure. • If the terms of the contract between the inspection body and its client states that the inspection body must inspect a sample suitable for establishing the compliance of a batch of product, then there may be a non-conformity against clause 7.1.2 of ISO/IEC 17020. • If the inspection body is aware of the use to which the client is going to put the inspection results, e.g. establishing compliance of a batch of product, then there may be a non-conformity against clause 7.1.1 of ISO/IEC 17020. • If the contract with the client clearly states, inspect a specified sample size and report observations, then there is no non-conformity. However, in this case it would be appropriate for the inspection body to make a declaration in the inspection report (or by other explicit means) to indicate that the inspection body is not taking any responsibility for any subsequent decisions on the conformity of the batch concerned, as the sampling was not based on a sampling procedure accepted by the inspection body.