ISO 13485 audit checklist about planning
ISO 13485 audit checklist about planning
Clause 5.4
5.4.1 Quality objectives
• Has top management established quality objectives (including those needed to meet requirements for product) at relevant functions and levels within the organization?
• Are the quality objectives consistent with the quality policy? What are the measurements?
5.4.2 Quality management system planning
• How do you ensure that the planning of the QMS is carried out in order to meet the requirements given in ISO 9001:2000 section 4.1, as well as the quality objectives?
• How do you ensure that the integrity of the QMS is maintained when changes to the QMS are planned and implemented?
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