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  • dipanpatel replied to the topic Quality Management System Documentation Hierarchy in the forum Device Documentation 7 years, 1 month ago

    The point of a QMS helps coordinate and give instruction to an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency. Keeping that in mind I believe that the organization that utilizes the 5 different steps would be more beneficial. Assuming that this process is used by a larger organization, the extra steps actually lead to more efficiency due to a more clarity in instruction and step that more stages give. The first set of steps might work for a smaller company just because of the smaller size but might only be tailors to said the company. The policy is a directive of the top management with respect to quality and in addition to work, the instructions can help in reducing errors. In short term, it is a long process but it is more practical in long-term efficiency.