Looking for Case Studies for How to interpret the requirements of ISO 13485

  • Thread starter qualitygoddess - 2010
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Q

qualitygoddess - 2010

#1
Has anyone used a case study to help people see how to interpret the requirements of ISO 13485? Like an audit report with observations, and the people had to determine if the observations were nonconformances? If so, please provide link to the source.........

Thanks.
 
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#2
Re: Looking for Case Studies for 13485

Has anyone used a case study to help people see how to interpret the requirements of ISO 13485? Like an audit report with observations, and the people had to determine if the observations were nonconformances? If so, please provide link to the source.........

Thanks.
With my most recent client seeking registration to ISO 13485, I merely
  1. took a "quick and dirty" tour alone to make my own private gap analysis of the operation without any mention of ISO 13485 to any of the "troops."
  2. then sat down with senior management to describe a gap analysis process
  3. outlined the basic requirements of ISO 13485 (hitting special emphasis on things I had observed) and asked them if they could think of anything (while we were sitting in the Board Room) in their operation which might need tweaking so an outsider could connect that process to the comparable requirement in ISO 13485
  4. wrote down their guesses and went out with them to the processes in question and either confirmed or eliminated the "first guesses" as n/c - a lot more processes were actually conforming than they had guessed
  5. This whole process took less than 2 hours with the senior management
  6. when we finished comparing their guesses with my opinion of the same items, they were surprised to learn they had just done a partial "gap analysis" and, because they were senior management, had the right, power, and authority to change what needed to be changed without going through layers of reports and training employees to perform a "gap analysis"
  7. When they saw how easy the process could be when the decisions to change or leave alone could be made right away, they were eager to go forward with the outside consultant (me) as guide while they went through a full bore gap analysis.
This was a very well-run, established company, a leader in its field and had very few processes to tweak to meet requirements of ISO 13485.

In point of fact, we (senior management and I) did not use the term "ISO" when communicating any changes to employees. The entire emphasis was on "tweaking the business processes."
 
F

freelovefest

#3
Has anyone used a case study to help people see how to interpret the requirements of ISO 13485? Like an audit report with observations, and the people had to determine if the observations were nonconformances? If so, please provide link to the source.........

Thanks.
I have some audit scenarios I use in an auditor training course. These present a scenario and require people to determine if the situation is conforming or not. These are based off of real life scenarios which have occured during an audit.

Not sure if this is what you are looking for, but it might prove useful
 

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