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ISO 13485 QMS Implementation Training

racglobal

Involved In Discussions
#1
I have a question. For a brand new startup, what is the training required for somebody who put together the QMS? Since the person is the author on 100% of the documents, what is this person's training? How do we document this person's training? Is it sufficient that we show the person's ISO qualification and CV? What certifications are required? I don't think this person's training would involve reading the QMS documents that they wrote. Has anyone encountered this situation, going back to the company's founding days?

Thanks.
 

somashekar

Staff member
Super Moderator
#2
Hi..
More than the author of all documentation, the requirement to know about any QMS is the PDCA approach and the interactions of the processes. Add to this the 8 principles of quality management ...
  • 1 Customer focus. ...
  • 2 Leadership. ...
  • 3 Involvement of people. ...
  • 4 Process approach. ...
  • 5 System approach to management. ...
  • 6 Continuous improvement. ...
  • 7 Factual approach to decision making. ...
  • 8 Mutually beneficial supplier relationships.
Now add to this the specific requirements of the medical device you are getting involved into, as compared to the definitions given in the ISO 13485 as well as specifics mentioned within the standard ISO 13485. This will help in understanding the exclusions and non-applicability.
There are several open training materials on the web (A good web search will get you plenty) as well as Training programs about ISO 13485 introduction are available (again a web search for such training resources)
After being exposed to these, documenting the training is a no big deal, when competency can be demonstrated. You really don't need any certificate to showcase it, but if he gets one it will add.
 

John Broomfield

Staff member
Super Moderator
#3
A brand new start up (without the support of a parent company) has to establish its processes first. Subject matter experts usually do this. This is normal without any ISO standard being considered. So, it will decide on its mission and business model while determining the opportunities, regulations and the risks. It will then design its core process as necessary to fulfill its mission (resulting in a flowchart perhaps). The processes necessary to support and sustain the core process will then be put in place.

Then the system manager (usually another hat worn by one of the subject matter experts) working with the subject matter experts as process owners to establish any necessary documentation (usually software, procedures and/or forms) so the legal entities, people and processes interact as a system fulfilling its purpose (mission).

Sure you can buy someone else's documented procedures and these may be cheap to copy but expensive to implement. It may be best to grow the system, processes and any documentation organically so the unique new offering delivers competitive services and products that fulfill the needs of customers and other stakeholders.
 

yodon

Staff member
Super Moderator
#4
There's no *required* training for anyone on anything. The only requirement is that a person has necessary competency to perform tasks assigned. If a person, through experience, is competent to assemble the QMS, no additional training is required.
 
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