Independence Matters

Sam Lazzara
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 Did you ever notice that in most judicial systems, the Judge is independent from the Plaintiff and Defendant? And in most sporting events there are (presumably) impartial judges and referees?

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.

RESPONSIBILITY

ISO 13485:2003 clause 5.5.1
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Top management shall ensure that responsibilities and authorities are defined, documented and communicated within the organization. Top management shall establish the interrelation of all personnel who manage, perform and verify work affecting quality, and shall ensure the independence and authority necessary to perform these tasks.

US FDA 21 CFR 820.20 Management responsibility.
(b) Organization. (1) Responsibility and authority.
Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks. 


QUALITY AUDITS





ISO 9000:2005


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. 
 


DESIGN REVIEW




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. 
 





DESIGN VALIDATION





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.

 





USABILITY VALIDATION 



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.
















































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