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I work for a medical device company that is ISO 13485 registered. Being a smaller company, we outsource most of our manufacturing. We do cleaning and sterile barrier packaging in house. The equipment that is used has been in place for about 8 years or so, which predates my employment here by about 6 years.
During our yearly ISO audit last year, the auditor made a couple of observations regarding us not having procedures for IQ, OQ, and PQ. Also, an observation was made regarding us not having a Validation Master List.
Does anyone have samples or a template for developing these procedures? Also, I can't seem to find out exactly what a Validation Master List is. I have searched here and other places. Since the validations have taken place years ago, how does an IQ, OQ, PQ philosophy apply to me now?
Thanks in advance for any help.
During our yearly ISO audit last year, the auditor made a couple of observations regarding us not having procedures for IQ, OQ, and PQ. Also, an observation was made regarding us not having a Validation Master List.
Does anyone have samples or a template for developing these procedures? Also, I can't seem to find out exactly what a Validation Master List is. I have searched here and other places. Since the validations have taken place years ago, how does an IQ, OQ, PQ philosophy apply to me now?
Thanks in advance for any help.