ISO 9000:2000修订版及其影响。

Med Device Technol. 2000 May;11(4):45-7.

The planned revision of the ISO 9000 series of standards means that all medical device companies will have to revise their quality systems to align them with the new ISO 9000:2000 standards. This overview outlines the changes and the factors companies need to consider, and highlights future standards activity.

ISO 9000系列标准的修订计划意味着所有医疗设备公司都必须修订其质量体系，使其与新的ISO 9000:2000标准保持一致。本概述概括了这些变化以及公司需要考虑的因素，并着重介绍了未来的标准活动。