![]() Shareholder interests, types of customers and suppliers.Size and complexity of the organization.A range of approaches are available to manage risk and opportunities.Interested parties (and their requirements) that are relevant to the quality management system.The scope of the standard – “organization needs to demonstrate its ability to consistently provide product or service that meets customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction.”.While verifying risks and opportunities, consider:.Critical areas should be audited annually with frequency based on:Ħ.1 Actions to address risks and opportunities.Within a 3-years period, all should be audited at least once. An audit program should cover all parts of the company and all elements of the management system.The internal audit system needs to be fully operational and effective.Employees should understand the importance of fully investigating the cause and the methodology used.And where appropriate, implement the corrective action at those sites. For multi-site certifications, any nonconformity and Root Cause Analysis should include all sites covered by the certificate.Conduct a Root Cause Analysis and create a plan to eliminate the nonconformity from occurring again.Follow-up to determine if the action was effective.In response to a nonconformity/finding a corrective action should be implemented.Support services like maintenance of production machinery, transportation, etc.Any information technology needed including hardware and software.Maintaining infrastructure like production machinery, measuring equipment, etc.Also consider access to infrastructure – roadways, railroads and airports. ![]()
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