Lecture 5: Internal Audits and Compliance

Quality & Standards - Lecture 5: Internal Audits and Compliance - 23 slides

Explore Lecture 5: Internal Audits and Compliance, covering This lecture emphasizes the critical role of internal audits in ensuring compliance with ISO 13485 for medical device.

Topics Covered

  • Introduction to Internal Audits in ISO 13485
  • Importance of Internal Audits for Compliance
  • Understanding ISO 13485 Requirements
  • Key Principles of Internal Auditing
  • Executing the Audit: Step-by-Step Process
  • Interviewing Personnel During Audits
  • Observing Processes and Practices
  • Collecting Evidence: Techniques and Tools
  • Documenting Audit Findings
  • Follow-Up Actions Post-Audit
  • Monitoring Implementation of Actions
  • Example of an Audit Report
  • Lessons Learned from Audit Findings
  • The Role of Management in Audits
  • Audit Planning: Overview and Objectives
  • Setting Audit Scope and Criteria
  • Identifying Audit Team Members
  • Continuous Improvement through Audits
  • Common Challenges in Internal Audits
  • Best Practices for Effective Auditing
  • Preparing for External Audits
  • Summary of Key Takeaways
  • Conclusion and Next Steps

References

  • ISO 13485:2016 (2016) Medical Devices: Quality Management Systems. Geneva: ISO.
  • Tummala, V.M.R. and Schoenherr, T. (2011) Assessing and Managing Risks Using the Supply Chain Risk Management Model. International Journal of Production Research.
  • ISO 13485:2016 and ISO 14971:2019 standards documentation.
  • ISO 19011:2018 (2018) Guidelines for Auditing Management Systems. Geneva: ISO.
  • ISO 13485:2016. Clause 8.2.4 Internal Audit.
  • ISO 13485:2016. Clause 6.2 Human Resources.
  • ISO 13485:2016. Clause 6.3 Infrastructure.
  • ISO/IEC 19011:2018. Guidelines for auditing management systems.
  • Mears, P. (1995) Quality Improvement Tools and Techniques. NY: McGraw-Hill.
  • ISO (2016) ISO 13485: Medical Devices — QMS Requirements for Regulatory Purposes. Geneva: ISO.
  • Maxwell, J. (2012) KPI Handbook: Developing Metrics. Boston: Wiley.
  • ISO (2016) ISO 13485: Medical Devices – Quality management systems – Requirements for regulatory purposes.
  • Drucker, P. (1993) Managing for the Future: The 1990s and Beyond. Boston: Harvard Business Review Press.
  • ISO (2016) ISO 13485: clause 5 (Leadership).
  • ISO 13485:2016, Clause 8.2.2.1 Internal Audits.
  • ISO 19011:2018, Guidelines for Auditing Management Systems.
  • ISO (2016) ISO 13485: Medical devices, 3rd edn. Geneva: ISO.
  • Burtis, C.A. and Bruns, D.E. (2014) Quality and Auditing Strategies. Oxford: Wiley.
  • Brown, L. (2020) Effective Quality Audits for Medical Devices. Boston: McGraw Hill.
  • ISO (2016) ISO 13485:2016. International Organization for Standardization.
  • Russell, J.P. (2013) The Internal Auditing Pocket Guide. ASQ Quality Press.
  • Harrington, H.J. (1991) Business Process Improvement. McGraw-Hill.
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