Can one person be lab director and quality manager at the same time?
I want to let you know that I enjoyed last week’s webinar very much. But I wanted to follow up on a question….We are currently a small organization and I’m currently wearing multiple hats including lab director and quality manager, among other things. As we plan for ISO 7025 accreditation, is that something I will continue to do…can 1 person continue doing both or does the quality manager need to be a different person or report to a different group?
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Glad you found the webinar interesting.
In terms of ISO 17025, the Quality Manager needs to be impartial, but need not, if the risk is accepted, be independent. There may however, for certain sectors be regulatory requirements or other standards; that require independence of the QM. What is important is the functional role in ISO 17025, for example the appointed laboratory manager my function as the QM as well, as long as risk is managed, and impartiality is evident.
There are some activities, where you should appoint an independent person; even a person reporting to you, or a colleague; to review for example, documents you author. Furthermore internal auditing requires independence so you will need to contract an independent third party consultant or an independent competent person from another department or sister company to assist with audits.
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Jan 19, 2021