Quality Systems Consulting
We specialize in right-sizing your quality management system to meet your goals.
We Offer
Full scope engagements
Project based engagements
Full scope engagements
We start with an assessment of the current state of the QMS to maximize efficient use of time and money, identify valuable next steps and meet regulatory requirements.
Gap Assessment
If your QMS is non-existent or immature, then a gap assessment is the best first step.
OR
Internal Audit
If your QMS is complete, or close to it, then an internal audit is the best place to start.
Project based engagements
We can jump in to help with special projects where your team needs support. Examples of project-based engagements include:
CAPA closure and/or effectiveness checks
Audit preparation or remediation
Management reviews
Launch of a new product or process
Get to Work
We help you prioritize and plan the next steps while taking into account your resources – people, timeline, and budget – to achieve your goals. Sometimes this means all-hands-on-deck to get something done ASAP. Sometimes this means planning a year of projects to meet a future goal. Either way, we support your team with planning, strategy and execution to arrive at your destination.
Frequently Asked Questions
What if I already have a quality system, but it’s not useful?
We see this all the time. The most common reason is that a previous consultant or employee dropped off a QMS that they used at a previous company. More often than not, that QMS was designed for a large mature company and isn’t suitable for a small or early-stage company.
How do you work with our team?
Over years of experience, we have developed multiple approaches that are suitable for different situations. If you have people available to do quality assurance, then we work with them to implement the plan.
If you don’t have a resource available, then Qualomics can work independently to reach your goals. However, you will have the best outcome by involving your team as much as possible. However, it is important to acknowledge that you will have the best outcome by involving your team as much as possible. Contact us to learn why.
Do you provide hands-on support?
Yes. We are proud of what differentiates us from our competitors, many of whom are former executives. With all due respect, a former executive hasn’t done hands-on work in a long time. We haven’t forgotten what it takes to do Quality day-to-day and we always keep an eye on how our plans impact your operations. We can do your document control, corrective action implementation, complaint handling, and all of the other aspects of ISO 13485 and 21 CFR 820, or US FDA requirements.
Do you provide strategic support?
Absolutely. We have expertise at the executive, manager, specialist and associate level.
How do you charge for consulting work?
We charge per hour for work performed. We keep a time tracker and provide you with a monthly report of time and tasks. We do not accept any fixed-price consulting projects. Our experience has taught us that project-based work never works out. There are too many dependencies in a QMS implementation project that put aspects of the timeline out of our control.