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Clause ISO 9001 Question in Human English ISO 9001 4.1 Is the procedure [Context of the Org Proc. Title] up to date and being followed? ISO 9001 4.1 Is the COTO Log up to date re: issues of concern? ISO 9001 4.1 Is this reviewed by top management? ISO 9001 4.2 Is the COTO Log up to date re: interested parties (stakeholders)? ISO 9001 4.2 Is this reviewed by top management? ISO 9001 4.3 Is the scope statement in the [Quality Manual Doc Title] still accurate? ISO 9001 4.3 Are all applicable activities covered by the QMS scope? ISO 9001 4.3 Are any exclusions from ISO 9001 documented and properly justified in the [Quality Manual Doc Title]? ISO 9001 4.4.1 Is the [Quality Manual Doc Title] accurate re: the top-level processes are identified and the sequence and interaction chart is accurate? ISO 9001 4.4.1 Are inputs and outputs defined in some manner for each top-level process? ISO 9001 4.4.1 Are processes being measured for effectiveness somehow? ISO 9001 4.4.1 Are process resources (people, facilities and equipment) considered and provided, as necessary? ISO 9001 4.4.1 Does each top-level process have people assigned for responsibility and authority? ISO 9001 4.4.1 Does the COTO work address risks and opportunities related to processes? ISO 9001 4.4.1 If a process doesn ’t meet a goal or measurement, is corrective action taken? ISO 9001 4.4.1 Does management seek to improve the processes over time? ISO 9001 4.4.2 Are there procedures and other documents, as well as records, in place to support the QMS? ISO 9001 5.1.1 Interview top management; do you get the sense that top management takes overall responsibility for the QMS? ISO 9001 5.1.1 Did management develop the quality policy and objectives? ISO 9001 5.1.1
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