November 3, 2016

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MANAGEMENT CONTROLS

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Management is Core – ultimately responsible for entire Quality System (QS)

  • Involved, Engaged and Committed to the QS
  • Senior Employee with executive responsibilities
  • Harmonized with ISO and other global regulations

Implement Management Control Subsystem

  • Adequate resources
  • Ensure adequate and effective QS
  • Monitor QS and make necessary adjustments

Management Responsibilities to Establish & Maintain

  • Quality Policy
  • Effective organization structure
  • Appropriate responsibility and authority
  • Adequate resources
  • Appoint representatives
  • Management reviews
  • Establish Quality Plan
  • Establish QS Procedures

Conduct Internal Audit

  • Appropriate auditor, appropriate steps to address issues
  • Appropriate documentation

Personnel

  • With appropriate qualifications, training, background

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