Ten Steps to Ensure Quality (and more) Audit Readiness
Ten steps to prepare for an ISO Audit and ensure your Quality, Environment, Sustainability, Healthcare GDP, or Health & Safety programs are compliant and continually improving.
- ISO or GDP Standard – identify the standard detailing the requirements.
- Management System – in ISO lingo you may have a “Quantity Management System” or an “Integrated Management System” – this is the document that describes how your company will meet the ISO requirements.
- Operational Documents – gather the additional documents that describe operational processes impacted by the requirements – these could be procedures from Human Resources, Procurement, Maintenance, the Employee Handbook, and processes within the Office or Warehouse.
- Previous Audit Report – review the most recent audit report and your response to any nonconformances.
- Audit Plan – define the scope and objectives, create an audit schedule, identify resources; use an audit checklist to ensure all requirements are reviewed.
- Document Audit & Gap Analysis – compare the requirements with your Management System, policies, procedures, and other documents to identify any areas not fully covered.
- Action Items – identify tasks that will fill the documentation gaps identified, and the department who owns implementing the solution; update applicable documents and the Management System.
- Operational Audit – gather evidence to confirm your employees are following the procedures and meeting the requirements; interview employees and observe operations.
- Audit Report – report your findings; document the audit process, methods, recommendations, and nonconformance.
- Corrective & Preventative Actions – complete root cause analysis, identify actions that will correct and prevent nonconformances; monitor to verify implementation and effectiveness.
Be sure to train employees about your Quality, Environment, Sustainability, Healthcare GDP, or Health & Safety programs and their role in achieving the goals. Discussions of customer service performance and KPI achievement should occur frequently. Training should be periodically updated as your program continually improves.
Need help or fresh eyes to get this done? Downsized your audit team and need to have internal audits to maintain your certification? Have an audit scheduled by your customer and feel you would benefit from a pre-audit review to help you to prepare? Unsure how to respond to recent nonconformances? Engage Sobottka Consulting; message, call, or e-mail today to discuss.
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