Feedback in ISO 13485
Feedback in ISO 13485
Clause 8.2.1
As one of the measurements of the performance of the quality management system, the organization shall monitor information relating to whether the organization has met customer requirements.
The methods for obtaining and using this information shall be determined.
The organization shall establish a documented procedure for a feedback system [see 7.2.3 c)] to provide early warning of quality problems and for input into the corrective and preventive action processes (see 8.5.2 and 8.5.3).
If national or regional regulations require the organization to gain experience from the post-production phase, the review of this experience shall form part of the feedback system (see 8.5.1).
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on Sunday, November 22nd, 2009 at 10:29 am and is filed under ISO 13485 standard.
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