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Controlling the fabrication environment is not an end in itself. Manufacturers who process and assemble their product in controlled environments know that the clean-room or mini-environment must be appropriately designed and must also be maintained clean and contamination free. H...
Read MoreOrganisations may have to align their management systems with the structure of the revised standard. As an example the organization’s quality manual may need to be amended. A risk management processes may need to be developed to determine the level and extent of control for “...
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2019