![]() This approval corresponds to or leads to the release. ![]() However, in section 4.2.4 on document control, it requires documents to be both evaluated and approved. ISO 13485:2016 does not mention the term release, even when talking about document control. Regulatory requirements for the document release a) ISO 13485:2016 The consequences are time-consuming and costly fixes, delayed approvals or even legal problems. There is a very real risk that this will be a problem during an audit or approval process. ![]() If manufacturers do not review or release documents (or do not do so at the right time), they fail to comply with the regulatory requirements. The creation of the documents is then rightly perceived as a process that is as time-consuming as it is pointless as an excess of QM bureaucracy. The documentation has lost its function as a quality assurance element. ![]() ![]() developing) without the review and release step. Worse still: the team does not wait and simply continues working (e.g. Inefficient document releases can shut down your entire team: it has to wait for overworked experts and supervisors to review and release the documents. Why are efficient document releases important? Unnecessary waiting ![]()
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