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QMS in SharePoint - Is anyone doing this?

#1
Was wondering if any one is building their QMS in SharePoint to house their Document control, audit system, CAPA etc.? if so, how do you have it set up?.. or if not, how would you set it up?

Any advice is welcome. only reason we are going this route is because we are planning to be ISO audited at the end of the year and we needed something quick. don't have time to implement a QMS software system.

If someone could guide me on how to present/execute something like this to IT , that would be great!
 

dsheaffe

Involved In Discussions
#2
While these aren't hard and fast rules, below are some suggestions as to how you can take advantage of standard SharePoint functionality:
  • Document Control: Create a document library(s) for policies, procedures, etc and restrict write permissions to only those authorised to make changes. Configure the libraries with versioning enabled so you can show history - and optionally also enable authorisation so that changes need to be authorised before they become visible to all users. (Alternatively instead of having policies/procedures as word documents, you could use Wiki pages if they meet your needs
  • Audits: Use the 'Calendar' app for creating an audit calendar and add optional data fields that might be required. Audit reports can be attached to the calendar entries once completed.
  • CAPA: You could use either a custom list or "Tasks" for this. Again add whatever fields you need for managing your actions.
I have used (or are currently using) all of the above. Each approach has limitations depending on your needs, but I would suggest testing some options and see how you go.
 

Randy

Super Moderator
#3
Yep, just audited a company today that has their EMS & QMS (TS16949) on SharePoint and I've many other clients that do as well....As with anything, it could be "garbage in, garbage out" if you're not careful.

Oh yeah, no problems today.
 

QATN11

Involved In Discussions
#4
Was wondering if any one is building their QMS in SharePoint to house their Document control, audit system, CAPA etc.? if so, how do you have it set up?.. or if not, how would you set it up?

Any advice is welcome. only reason we are going this route is because we are planning to be ISO audited at the end of the year and we needed something quick. don't have time to implement a QMS software system.

If someone could guide me on how to present/execute something like this to IT , that would be great!
There are several good videos on YouTube for this search on "QMS SharePoint"
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#6
Was wondering if any one is building their QMS in SharePoint to house their Document control, audit system, CAPA etc.? if so, how do you have it set up?.. or if not, how would you set it up?

Any advice is welcome. only reason we are going this route is because we are planning to be ISO audited at the end of the year and we needed something quick. don't have time to implement a QMS software system.

If someone could guide me on how to present/execute something like this to IT , that would be great!
We used SharePoint for all documentation we need. I really don't care for it, but it is how we do it. Just make sure the appropriate people have access to it.
 

Ed Panek

VP QA RA Small Med Dev Company FDA and ISO13485:16
Trusted
#7
Was wondering if any one is building their QMS in SharePoint to house their Document control, audit system, CAPA etc.? if so, how do you have it set up?.. or if not, how would you set it up?

Any advice is welcome. only reason we are going this route is because we are planning to be ISO audited at the end of the year and we needed something quick. don't have time to implement a QMS software system.

If someone could guide me on how to present/execute something like this to IT , that would be great!

I did a stint at the VA Research Lab and a few college Universities in tandem and we used SharePoint for our QMS. Aside from FdA concerns over signatures it was perfect.
 

Tagin

Involved In Discussions
#8
We use Sharepoint for our QMS. We make extensive use of custom lists and webpart connections between lists and libraries. For example, for managing audits, we have a custom list as a master list of audits (fields like audit# (this could be the listID#), dates, status (scheduled, closed, etc.), participants, audit standard, etc.) Below this list is a doc library of audit documents. That library view is filtered by a webpart connection to the master audit list, so when I select a particular audit in the master list, I only see the docs associated with that audit. That doc library has metadata fields specific to audit docs such doc type (audit plan, audit report, etc.).

Custom lists are also used for calibration items, tools, maintenance items, etc. KPI indicators can then be used, for example, to indicate yellow when any calibration items are coming due with X days or red when overdue. A list of these KPI indicators can provide a quick view of health of many QMS activities. CAPAs can be SharePoint tasks or doc libraries with added metadata for type, due dates, status, etc. and again can leverage KPI indicators to show when items are past due, etc. All these lists leverage SharePoint list permissions to prevent unauthorized access or changes.

Pages are created for specific processes or activities. E.g., a page for customer service displays links to all their QMS process docs, their reports, forms, etc. to make it as friendly as possible. You could display process KPIs, quality objectives, etc. as well.
 

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