Armandoleos21
Starting to get Involved
Can someone share a excel template/Gantt chart for implementing a QMS for a small start-up medical device manufacturer?
Need assistance to build a QMS for small startup med device manufacturer
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Good day @Armandoleos21 ;
Two considerations...
1- Is your organization simply developing a QMS in order to "pass an audit" (get the cert?), (horse and pony show) or...
2- Is your organization hoping to capture and sustain its intent, therefore developing a QMS that will help monitor and hold accountable (an actual beneficial tool for the organization) ?
Those are important questions for your leadership to answer.
Regardless, there are loads of snakeoil salespersons on line, who will provide exactly what you are asking for. They will not be tailored to the needs of your organization, therefore, not providing the benefit to your organization. I recommend educating yourself/organization or hiring a consultant that has credible testimonials in regard to such services.
Hope this helps.
Be well.
Two considerations...
1- Is your organization simply developing a QMS in order to "pass an audit" (get the cert?), (horse and pony show) or...
2- Is your organization hoping to capture and sustain its intent, therefore developing a QMS that will help monitor and hold accountable (an actual beneficial tool for the organization) ?
Those are important questions for your leadership to answer.
Regardless, there are loads of snakeoil salespersons on line, who will provide exactly what you are asking for. They will not be tailored to the needs of your organization, therefore, not providing the benefit to your organization. I recommend educating yourself/organization or hiring a consultant that has credible testimonials in regard to such services.
Hope this helps.
Be well.
Hi,
I must admit that the wording of the question is a little confusing for me...
Assuming that the goal is to implement a QMS for a medical device manufacturer - this would involve numerous documents in various formats / file types.
Excel template for what?... Normally an Excel file would be used for some calculation or analysis of data, or for holding / managing / presenting elaborate information, or as a fillable form, or similar...? A medical device QMS might include multiple Excel files for various purposes.
A Gantt chart would normally be used as a project management tool. Did you mean a Gantt chart template for managing the project of implementing a new QMS?
This sounds more like a classroom/homework assignment than an actual business issue. As @Ronen E wrote, a Gantt charts is a project management tool. Projects have end-points with arbitrary (or 'project-specific') intermediate goals, but a QMS has to be both 'living' and 'complete' (for the business).
If the startup is particularly small, I don't imagine a typical project planning tool is going to be that valuable for a few reasons:
- The company is less likely to have resources available to move from one project to a QMS project
- A QMS is inter-linked, so there aren't precisely precursor/successor tasks
My experience with large/small/startup MD companies would be that rather than crafting an appropriate plan for the company that some cookie-cutter plan would be pruned of 'not relevant' portions and then ultimately not quite work... mostly because it is easy to rationalize some elements of a QMS as not worth of effort without fully appreciating the interlinks. Project plans (as manifested by Gantt Charts) explicitly don't offer any consideration for elements not in the project plan, which is (in general) not how a QMS for a medical device company manifests.
Im not sure I understand your question but that's never stopped me before...
Step 1) Who in the company would you consider on the side of quality? I require at least the CEO.
Step 2) What do we have currently in place for system controls? Is it close to the ISO requirement or do we need a total rebuild?
Step 3) What expertise is needed to complete our QMS documentation? Will we need consultants?
Step 4) Start building the QMS. For FDA and MDR Post Market Surveillance is important. Id start in complaint handling, CAPA and product V&V. Build out the risk file. Wrap up the QMS with document controls, Training etc. If the FDA showed up one day and I had a choice between a) having solid training and document controls in place vs b) Having complaints, CAPA and product testing, Id prefer a finding in A over B.
Step 1) Who in the company would you consider on the side of quality? I require at least the CEO.
Step 2) What do we have currently in place for system controls? Is it close to the ISO requirement or do we need a total rebuild?
Step 3) What expertise is needed to complete our QMS documentation? Will we need consultants?
Step 4) Start building the QMS. For FDA and MDR Post Market Surveillance is important. Id start in complaint handling, CAPA and product V&V. Build out the risk file. Wrap up the QMS with document controls, Training etc. If the FDA showed up one day and I had a choice between a) having solid training and document controls in place vs b) Having complaints, CAPA and product testing, Id prefer a finding in A over B.
Jane's
Involved In Discussions
The only way to do business is to implement a qms.
You are on the right track, just don’t seek shortcuts, embrace the challenge and treat the QMS like you treat the product or service you sell to your customers - it will bring you money by saving you money and time.
You are on the right track, just don’t seek shortcuts, embrace the challenge and treat the QMS like you treat the product or service you sell to your customers - it will bring you money by saving you money and time.
Enternationalist
Quite Involved in Discussions
Context is important here. Startups are in a totally different situation from an operating manufacturer. If you aren't releasing a product for use, a full quality management is really just for practice (not a bad thing, but not yet returning much value).
If you are at an extremely early prototype stage, I would say implementing a full QMS is a waste of your time and money. Focus on your product's operating principles and market viability so that you can secure the investment you need to keep running. Full quality management is indispensable, but it needs to come at the right time if you aren't pulling profits. Perfecting your document control processes is pointless if you don't have a device that actually works and makes sense.
For a lot of medical devices, it's probably appropriate to just look at the scope of quality management you need to implement to achieve your next milestones - for example, in the US, an investigational device is exempt from many requirements other than basic design controls. You could implement many other practices that are beneficial, but in that situation I wouldn't be forking out a ton of money to get a full QMS certified just yet.
For this reason, and many more, we would need a lot more information about your situation to understand what is really required for your device and what the best practices would be.
If you are at an extremely early prototype stage, I would say implementing a full QMS is a waste of your time and money. Focus on your product's operating principles and market viability so that you can secure the investment you need to keep running. Full quality management is indispensable, but it needs to come at the right time if you aren't pulling profits. Perfecting your document control processes is pointless if you don't have a device that actually works and makes sense.
For a lot of medical devices, it's probably appropriate to just look at the scope of quality management you need to implement to achieve your next milestones - for example, in the US, an investigational device is exempt from many requirements other than basic design controls. You could implement many other practices that are beneficial, but in that situation I wouldn't be forking out a ton of money to get a full QMS certified just yet.
For this reason, and many more, we would need a lot more information about your situation to understand what is really required for your device and what the best practices would be.
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