The organization shall document validation plans that include methods, acceptance criteria and, as appropriate, statistical techniques with rationale for sample size.

组织应当建立确认计划包括方法、接受标准、如果可以，样本大小的统计技术。(新增)。

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The organization shall document verification plans that include methods, acceptance criteria and, as appropriate, statistical techniques with rationale for sample size.

组织应当建立验证计划，包括方法、接受标准、如果可以，样本大小的统计技术。（新增）

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For fixed-point manufacturers supply fluorine plastic -46 material, should be based on supplier quality assurance or inspection report acceptance, and regular outsourcing sample or detection.

对于定点厂家供应的氟塑料- 46料，应依据供方质保书或检测报告验收，并进行定期委外制样或检测。

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