Relationship between ISO 13485 QMS and Operational Performance in Medical Device Industry

Instructions — System Behavior Only

Base all responses on 'observable system behavior' during the last 12 months, NOT individual behaviour.

  • Rate what the system actually did (physically or administratively), not written procedures or personal intent.
  • Evaluate whether the system blocked, deferred, or allowed movement when the stated condition occurred.
  • Items marked [RC] are reverse‑coded to verify response consistency.
Response Scale

Rate how consistently the control was enforced when the condition occurred (NOT how often the event occurred): 

Always: Enforced without exception

Often: Enforced in most cases 

Sometimes: Enforcement inconsistent 

Rarely: Enforced only in exceptional cases 

Never: Control was not enforced


Informed Consent: 

This 10–15 minute survey is for an IGNOU MBA research project (MMPP‑001). Participation is entirely voluntary and involves no foreseeable risk. All responses are anonymous, unlinked to personal identity, and aggregated for academic analysis only. There are no right or wrong answers, only honest observations of how systems function in practice. By proceeding, you consent to participate.

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