ISO 13485 QMS Implementation Training

[racglobal]

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]

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]

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]

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.

 

[Startup01]

I'm in a similar situation although our ISO auditor did not question my competency as the SME writing the QMS, there were significant questions on how the rest of the companies competencies were assessed. I'm looking for wording to put into our training procedure on how competencies are assessed at the senior management level. There are a total of 4 employees in the company and each of them is a partner and VP level individual with expertise in their own areas (Business, Sales/Marketing, Engineering, and Quality/Regulatory). Most of what I've seen for assessing competency suggests using a manager to review work and provide the assessment. What do you do when everyone is a senior leader?

 

[John Broomfield]

When you say “writing a QMS” are you writing a work of fiction?

The documented parts of your QMS should reflect what is actually done.

So, determine what your organization actually does to define the competencies required to do the job well. Usually, the person in need of the new resource defines the required attributes, skills and knowledge (ASK).

They recruit for attributes primarily. Candidates with the required attributes may also bring some of the required skills and knowledge. So the hiring decision may be determined by the cost of bringing the new candidate up to speed for that role.

A candidate for a leadership position may bring completely new ASK to take the organization in a new direction. That would be a board level decision an may involve specialist recruiters.

So, stop seeking the right form of words and analyze what actually happens. Exactly as an auditor would do.

 

[Sidney Vianna]

as the SME writing the QMS

Remember one thing: a QMS is NOT a system of documents; it is a documented system.

Huge difference.

 

[Ronen E]

There are a total of 4 employees in the company and each of them is a partner and VP level individual with expertise in their own areas (Business, Sales/Marketing, Engineering, and Quality/Regulatory).

(Emphasis added)
What stands behind this statement? Whatever your answer is, that's your proof of their competence.
Additionally, you state that one of these VPs has expertise in Quality/Regulatory - that person should have adequate knowledge/experience to answer your questions. If not, maybe they need a seasoned assistant.
Other than that, set up your QMS and start running it. If your internal and external audit results show that the system is functioning well, it'll be evidence that whatever competence you (as a group) have, it's sufficient.