ISO 13485 Section 8.1, 21CFR 820.250 (b)

Sampling plans, when used, shall be written and based on valid statistical rationale. Each manufacturer shall establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed.

客人根据这个，给我们开了一个不符合项，因为我们有的来料检查，是按批次直接取5个测量尺寸之类的。
不知有没有人碰到类似的问题？