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Question 46.5 IAF MD1, Sampling size

IAF MD1 § 6.1 and 6.2 give minimum requirements for the sampling of sites.

If an organization has its central function and two production sites (same processes), there is no random sampling of 25% of the sites possible (as in §  6.1 required), and § 6.2 of IAF MD1 is applicable.

6.2 Methodology for Auditing Multi-Site Organizations Where Site Sampling Using Section 6.1 is not appropriate:

6.2.1 The audit program shall consist of an initial audit and a recertification audit of all sites. In surveillance audits, 30% of sites, rounded up to the whole number, shall be covered in a calendar year. Each audit will include the central function. The sites selected for the second surveillance audit will normally be different from the sites selected for the first surveillance audit.

Q1: Is it acceptable that the minimum requirement for sampling, as detailed in § 6.2.1, can fall below the minimum requirement as follows:

New certification: all sites

First surveillance: first site + central function

Second surveillance: second site+ central function

Recertification: first site + central function

etc. (continuously alternating)?

Q2: Is there any option to accept continuously alternating sites instead of auditing all sites for the recertification audit?

March 2023

The described situation falls under § 6.1 of IAF MD1 ; organizations with a number of sites (apart from central function) greater than 1 (N>1) are eligible for the application of IAF MD1, which addresses the situation where sampling is appropriate (§6.1).

A1: No, the minima sampling pattern shall be as follows, according to 6.1 :

Initial audit: central function + all (2) sites

First surveillance: central function + 1 site (0.6 x square root of 2)

Second surveillance: central function + 1 site (0.6 x square root of 2)

Recertification: central function + 2 sites (0.8 x square root of 2), which means all sites.

A2: No
In application of § 6.1 of IAF MD1, 2 sites shall be audited, which means that alternating is not acceptable.