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ISO 13485:2016 clause 8.2.4

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Stephen Lennon, Feb 16, 2021.

  1. Stephen Lennon

    Stephen Lennon New Member

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    Good Afternoon all,

    This is my first post to the Forum!

    I have a question surrounding ISO13485:2016 Clause 8.2.4, mainly ensuring objectivity and impartiality of the audit process, Auditors shall not audit their own work.

    I am the QA/RA for a small business (15 employees), I have attended a 13485 lead auditors course and have been performing the Internal Audits within the company. I have previously audited my own work, found NCRs, and raised them for CAPA, and sign off by the CEO.

    But how do I demonstrate objectivity and impartiality? Is this going to be a case of bringing in an additional external company/person to audit my work?
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Great question, Stephen and welcome to QFO!

    I believe that there's 2 aspects to demonstrating objectivity and impartiality. Firstly, it comes in the form of planning and preparing for an audit. A methodical gathering of information about the scope of the audit and also the audit criteria and compiling a "checklist" (for want of a better name) shows a degree of objectivity and impartiality. Secondly once the audit is completed, the records generated from your notes as you checked off the criteria and investigated the process which created the information you used in planning, should show impartiality. ISO 19011 might also shed some light, but I hesitate to lead with that. It's about planning and results.
     
  3. Stephen Lennon

    Stephen Lennon New Member

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    Hi Andy, nice to meet you.

    When preparing for an Internal audit I have created a "checklist" by process and department, I understand the rationale behind your point "the records generated from your notes as you checked off the criteria and investigated the process which created the information you used in planning, should show impartiality." But is this enough to satisfy a notified body auditor? Or an auditor scraping the barrel to find an NCR?

    I shall have a look through ISO 19011, thank you.
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    That is an impossible question to answer and, experience shows, best treated by addressing the auditor's behaviours to their NB, and nothing else. Jumping through hoops for a capricious character is wearing and costly. Do the above objective and impartial things, confidently demonstrate how they work and if you get a negative response and a "finding" (however graded) reject it and politely explain that their career as an NB auditor with you as clients is likely to end at the termination of that visit.
     

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