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Document and Record Controls

Document and record controls underpin the entire KGMP system (ISO 13485:2016 Sections 4.2.4 and 4.2.5).

Document control requirements​

  • All quality documents (procedures, work instructions, forms) must be reviewed, approved, and version-controlled
  • Current versions must be available at all points of use
  • Obsolete documents must be removed from points of use and identified as obsolete
  • Changes to documents must be reviewed and approved by the original approving function or a designated authority

Record control requirements​

  • Quality records must be legible, identifiable, retrievable, and protected from deterioration
  • Retention periods must be defined — KGMP specifies minimum retention periods
    • Device history records: minimum 5 years from the date of manufacture, or the lifetime of the device plus 1 year, whichever is longer (or per product-specific requirement)
  • Records must be protected from unauthorised modification

Electronic records​

Electronic document and record management systems are acceptable if validated to ensure integrity, security, and accessibility.

For medical devices with indefinite lifetimes (such as implantable devices without known removal dates), retention must be maintained for a minimum of 10 years from the date of manufacture or as specified by MFDS.