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Production and Process Controls

Production and process controls ensure devices are manufactured consistently and meet specifications (ISO 13485:2016 Section 7.5).

Key requirements​

  • Documented production procedures — work instructions at all critical steps
  • Process validation — for processes where output cannot be fully verified by subsequent inspection (e.g., sterilisation, welding, adhesive bonding)
  • In-process inspection and testing — at defined checkpoints during manufacturing
  • Device identification and traceability — each device traceable to its components and manufacturing records
  • Contamination control — particularly for sterile devices and implantables
  • Cleanliness of product — including particulate and bioburden control where relevant
  • Device history records (DHR) — a complete manufacturing record for each batch or unit

Process validation (critical)​

Processes that cannot be fully verified by inspection must be validated before production begins and re-validated after any significant change.