Management system guidance
9.1 Monitoring, Measurement, Analysis and Evaluation
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9.1.4 Evaluation of Compliance
With reference to the evaluation of compliance, your organization should set up a process that involves the determination of the frequency of the evaluation, the execution of the evaluation and the actions that need to be taken.
If during a compliance evaluation, a failure to fulfil a compliance obligation is identified, the organization needs to take action to achieve compliance. This may require getting in contact with a regulatory agency to agree the action to be taken. Once that agreement is in place, it becomes another compliance obligation.
The Certification Auditor’s role is not to verify the result of the compliance audit, but to assess the effectiveness of the audit process and taken actions. An understanding of compliance status must be demonstrated.
Therefore, your organization must have the means (inspections, tests, audits) that are frequent and robust enough to ensure that knowledge and understanding of compliance status is maintained.
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