Independence Matters

Independence is the basis for judicial systems and sporting matches. And for quality systems, it is generally accepted that personnel who are independent of an activity are more objective (impartial) than persons who are directly responsible for the success of the work. 

This belief has influenced medical device regulation and standards significantly, and the trend continues. Here are some examples of requirements for independence.
ISO 13485:2016 clause 5.5.1:
Top management must ensure their personnel have the independence and authority necessary to perform these tasks.
US FDA 21 CFR 820.20 Management responsibility. (b) Organization. (1) Responsibility and authority.
Personnel who manage, perform, and assess work affecting quality, must have the independence and authority necessary to perform these tasks. 
Audit – systematic, independent and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled. 
US FDA 21 CFR 820.3(t)
Quality audit means a systematic, independent examination of a manufacturer's quality system...
ISO 13485:2003 clause 8.2.2 Internal audit
Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work
US FDA 21 CFR 820.22 Quality audit
Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. 
US FDA 820.30 Design controls (e) Design review. 
The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an 
individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. 

IEC 60601-1:2005, section 11.4 (PEMS = Programmable ElectroMedical Systems)
The person having the overall responsibility for the PEMS validation shall be independent of the design team. The manufacturer shall document the rationale for the level of independence. No member of a design team shall be responsible for the PEMS validation of their own design. All professional relationships of the members of the PEMS validation team with members of the design team shall be documented in the Risk Management File.


IEC 62366:2007 (EN 62366:2008), 5.9 Usability Validation
The manufacturer shall validate usability of the medical device according to the Usability Validation Plan. The results shall be recorded in the Usability Engineering File.

NOTE 4 – Individuals that were not directly responsible for the User Interface design should be involved in the usability validation.

Published by Sam Lazzara

Sam Lazzara is a Biomedical Engineer (MS Case Western, BS Brown University) and Certified Biomedical Auditor with 30+ years medical device experience. Sam’s systems and documents have delighted dozens of regulatory auditors from the United States FDA, the California Department of Health, and a flock of European Notified Bodies. He has guided quality system implementation for over 20 firms, leading to third-party certification and government approvals. A medical device start-up specialist, Sam provides state-of-the-art solutions tailored to the needs of each client. He mentors clients on all aspects of quality assurance and regulatory affairs. Sam gets particularly excited about design control, risk management, and post-market surveillance.

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