Establishing clinical QMS for a small NGO

[PetraZr]

Dear all, I work for a small non-profit organisation (around 25 people) who will be in a sponsorship of a few clinical trials. Till now we mainly outsourced QM activities, but now we want to implement our own clinical QMS. Can you tell where exactly to start? Till now we have only some SOPs, training records, risk tools in place.
Is it a good start to develope a broader quality management plan with companies objectives, vision, mission etc. and then break it down into smaller (more concrete) sections? For now we don't plan to use any electronic software.
Thank you.

 

[yodon]

Is the intent to get certified? If so, to what standard?

Is management driving this or are they just saying put a QMS in place but leave us alone?

 

[PetraZr]

Thank you for your reply. To get certified is not our goal yet. But as a sponsor of clinical trials, we'll be inspected by Regulatory Authorities. What constitutes an effective QMS is not well defined for clinical development. Many organizations had been attempting to implement the ICH Q10 for GMP though.

 

[yodon]

That's about what I was thinking.

In that case, you *may* want to start by (getting a copy and) looking at ISO 9001. It provides a basic framework for a QMS (I will say that some of the stuff is a bit not-so-added-value, but still a reasonable structure). ISO 9001 no longer requires a "Quality Manual" and really cut back on documentation requirements.

You might find that the wording tends to be biased towards a physical product. Get in the mindset that your services are your product.

One of your more critical aspects will be document and record control. Getting those properly managed will go a LONG way.

I would suggest you re-calibrate your thinking from (just) training to competency. (That's not to say to get rid of training records, but training is just a part of the competency aspect.)

Things like engaging with customers, managing communications, managing changes, etc. will be important to you.

What should be a goal for establishing a QMS is to enable continuous improvement. That implies some measurements. Don't collect metrics for the sake of collecting metrics. Ensure that any you do collect are meaningful and help you drive for improvement. Too frequently I see elaborate dashboards that nobody can explain what the data means or how it's used for improvement (but boy, do they look nice with all colors and dials and graphs).

Hope that helps some. As you dig in and bump into issues, this site has a TON of discussions and attachments that might help if you search; and of course, you can post questions if a search doesn't turn up anything.

 

[PetraZr]

Thank you very much. That was really helpful for the beginning and gave the project some structure.