November 3, 2016




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


  • With appropriate qualifications, training, background









Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s