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QMS for Beginners – A quick guide on where to Start, and what to do first

Whether you are freshly minted into the QMS position or you are a founder of a Startup, or a product manager with a new project, you’re reading this because your strategy requires QMS oversight and your first question is likely “where to start” and “what to do”. 

 

This page will cover the aspects of:

  • Compliance (ISO 13485:2016, CE Mark, U.S.QSR (21CFR 820) for 510(K))
    • Step by step guide – explained in 13 points
  • Checklist summary
    • Steps of Implementing ISO 9001-2015 Quality Management System
    • Checklist for implementing a QMS for ISO 13485-2016

1. Figure out what QMS you need

What is it you need? FDA QSR, ISO 13485: 2003, ISO 13485: 2016, or ISO 9001: 2015.

Secure a copy of whatever Standard you intend to be compliant with, and get at least a bit familiar with it… you need a general idea of what is expected, why and very importantly get a feel for the technical language they use. If you are a real keener you can learn all the details. Otherwise read on… there are easier ways.

Care should be taken as more than one ISO can apply or be connected. For example; if you are following FDA QSR or ISO 13485: 2016, they are based on principals of Risk Management, so you also need to secure a copy of ISO 14971 Risk Management. 

2. Designate a QMS Manager (unless that’s you)

Designate someone as the QMS Manager. Likely you are a founder and you don’t want to do it yourself – really, you do have higher priorities. Find someone who enjoys administration and documentation -- yes, they do exist! They can then start to make your QMS a reality. But don’t think you can escape this. You’re going to have to stay involved, especially in the initial phases to ensure QMS is “seen” as a priority, and you need to keep it front and center -- everyone else will want to lock the QMS Manager in the closet… because QMS is not their priority, Sales are. But compliance and either your 510(k) or ISO certification depends on it…

So, plan ahead now, when it’s easy, not later, when it’s much harder. 

3. You will need a QMS manual (a.k.a Quality Manual, Quality DNA)

Various ISO standards and FDA QSR’s require that you have a QMS manual. In the QMS manual you will outline the various policies and procedures your company and teams will follow to produce quality outcomes. This will include how you will measure quality, Define Risk, make and define how to correct mistakes and prevent them with what actions (CAPA or Corrective Actions, Preventative Actions), etc...

The QMS manual will also define the various roles that are needed within the company such as who will do what and how. For example, QMS Manager, but also what role unit managers will play.

The QMS manual, then becomes your “go-to” book on what to do. You’ll also need to keep it up to date. Without help it's not an easy task.

qmsWrapper can simplify the process of establishing a Quality Manual. Learn more here.

The GAP Analysis

Here’s the critical element. You should also realize that the QMS Manual drives the GAP Analysis. It will point out the differences between what you said you would do to ensure Quality outcomes, and the processes that you execute on and what you have done to ensure Quality outcomes. The GAP is what you are missing!

qmsWrapper GAP Analysis has 2 advantage:

  • When you subscribe for qmsWrapper you can choose optional add-ons, like the QMS Manual and the GAP Analysis Module (checklist). Not only does this represent a huge saving in costs, they can be very pricy to buy directly, the real cost however is in time – yours and your teams.
  • The second big benefit with using the QMS Manual from qmsWrapper, is that it is integrated into and throughout the qmsWrapper software. What you document in the QMS Manual is reflected in the qmsWrapper application, in particular through the QMS Workflow processes. So, what’s in the manual is executed in the Workflow processes. 
  • Both the Manual and QMS Workflow processes, are integrated into the GAP analysis Module.

4. Organizing the work

Next you will need to define the flow of how work gets done within your organization, i.e. the workflows. Why, because you need to understand where compliance issues will fit in. Workflows can show you the path tasks take through your organization… i.e. how things work, task by task.

A workflow process is a series of predefined tasks organized in steps, automatically initiated, and to be sequentially followed. Such workflows processes, help reduce work related errors and provide documented trails or records of what was done, by whom and when – ideal for compliance.

Most ISO’s are organised through workflow processes, and most Enterprise based QMS systems are workflow based systems.

What is important for you, is that Workflows and processes can include QMS rules and requirements defined as QMS events or issues or tasks.

In qmsWrapper, they are specifically called QMS Workflow-Processes and represent the easiest way of achieving Compliance.

In qmsWrapper, QMS Workflow Processes for ISO 13485 (2003), ISO 13485 (2016) and FDA QSR, are included.  

Also, the Wrapper Workflow Process Editor allows you to create your own or edit/modify the existing ones to suit your particular needs.

This gives you the flexibility and power of an enterprise level system, ideally packaged for any small to medium sized company including Startups. 

5. Software or paper based system

A recent survey in the USA determined that approximately 50% of the companies that had a QMS system, were still on a paper based system. The reasons were simple, they were initiated and installed at a time when paper was king and a change to an automated or computerized system would represent a major disruption – because change is hard. Still, the main reason for companies to migrate to a computerized system is usually related to either the increasing cost of personnel or lack of trained personnel. Startups and small companies understand the HR problem clearly.

The reality of today is that you should start with an appropriate QMS software, it’s easier than a paper-based system.

qmsWrapper has all the rules and procedures for Compliance already built-in. Just add your own tasks. That means you don’t have to be a highly qualified QMS expert with extensive QMS experience, you don’t need to know all the exact details of FDA QSR or ISO Standards for medical devices or ISO 9001 to stay compliant. qmsWrapper integrated QMS packages the expertise in its validated and verified for use QMS Workflow Processes. All you have to do is follow them.

6. Risk Management (RM) and Risk Analysis (RA)

Risk Management (RM) is the basis of FDA’s QSR and now of ISO 13485 (2016).
Both specifically refer to ISO 14971 for how to determine what is RM and how to do it.

So there is no ignoring RM! Whatever you select has to include RM as part of the solution. A Stand-Alone system can work as it helps you address the problems. But when RM is integrated into the Project Management, then it can create a history of RM issue for a project or sub-project that is Traceable and Trackable.

You seriously need to factor that into the plans.

7. Document Management & Control (DMC)

Many companies initially make the mistake of thinking a Document Management system is all they need to start with. After all, the proof of Compliance is a signed document! Right? Sounds logical and certainly it helps. But don’t kid yourself, it’s far from complete and far from easy. There is more to Compliance than a signed document and version control.

DMC is necessary but it is not enough for achieving compliance:

  • Many enterprise QMS system vendors, want you to believe that DMC is all a small company needs. They are trying to protect their high end and high priced systems. Document Management only systems are just that - Document management, they are not a QMS. The simple DMC does not support the workflows. They do store documents well however.
  • The second problem for DM only solutions is knowledge. As a startup, you don’t know all the details required for Compliance. Sure, you read the ISO Standard, 100 times, but really, did you figure it all out? I’m going to take a wild guess here and say, not really! Your priority after all is the product and sales.

Face it, this is not just details we’re talking about, it’s red tape. You need help not just with DM but also with all the other details that lead to Compliance, including the How-To’s. A system that can guide you through this process, is worth its weight in developer hours… a.k.a. company cash.

  • Another example of a Forms based system is the PDF based system. These types of Compliance systems initiate a “basic workflow” where a PDF form is circulated, usually by email, to designated assignees. These Assignee Users have to know what to do with it and, here’s the hard part, know exactly when to initiate it. Really, asking users to do an admin tasks – willingly! Good Luck with that!

Not being integrated into the real workflows, but bolted on, these types of add on systems depend heavily on outside triggers and user knowledge. Although they do handle documents well, initiating and getting the work and tasks that lead to the completed forms is lacking – let the paper chase begin.

There are many examples where the FDA looked past the “completed” form to the “work” that should have lead to that perfectly executed PDF Form. The problem is that when only the perfectly signed and completed form is found, and there is no supporting proof of the work, tasks, leading to that document. This is the point when the perfectly signed form usually gets shredded (i.e. you get an FDA deficiency letter).

Forms must be supported by completed tasks that show who did what, when, how and approved by whom.

Usually, it is only later that companies realize that besides a DMC, a project management software would be of great help as well.
And rarely are these separate solutions ever compatible with each other, being very vendor specific, and usually very pricy when purchased separately. Now you’re stuck with two systems at twice the price and twice the fun!

Learn more about Document Management & Control with qmsWrapper here.

8. Selecting the right system to support your Compliance

Compliance Solutions are essentially QMS based solutions. They come in all shapes and sizes. Some solutions are nothing more than forms tacked on to a project management workflow. They are missing many of the Compliance elements of a complete QMS system.

Most QMS systems are big enterprise level systems. Sometimes they provide scaled down versions but the usual suspects usually remain expensive and just as difficult to manage as the enterprise systems they are based on.

A Startup has to include various QMS functionalities to properly support Compliance but do it in a way they can handle – i.e. within the context of their personnel limitations and knowledge. Rarely are there more than only 1 x QMS manager in a startup or even a medium sized company (to find QMS managers you usually look in the basement office, a forgotten closet…).

What to do? Don’t be fooled by scaled down systems. They rarely inherit the good genes of their original systems, they are designed not to be too good, so vendors can protect the pricing of the Enterprise Systems. Rather focus on solutions designed for Startups and Small and Medium Sized Company’s. Like in golf, know your handicap.

9. Web based – it’s really an HR issue!

The next issue, is whether you have the human resources to support an in-house network. Stop thinking this is even a possibility. Nowdays, web-based options move network management to the web application provider. The reality is that you simply don’t have the manpower or technical expertise to setup and manage an internal network. Instead, go with a web-based solution and invest in a better internet connection instead – it’s far cheaper, but more importantly, keeps your team focused on their essential tasks.

10. Team communications – how will you communicate with each other?

Right now you’re asking yourself why is team communication important when the issue is a QMS system for Compliance.

Simple, Team messaging is the best and easiest way for teams to communicate, and although there are many Team messaging apps on the market, none are purpose built to help your team support Compliance -- except one.

The problem with the “only” Team Messaging apps is that chat messages and files shared via chat are lost to compliance. Sure, some of them have a Bot function you can program and hope it catches everything, but that’s time-consuming and more work again.

The real culprit is that most of those apps are really meant to include the Social in the workplace. Preach as they might, these apps want users to have their social and work contacts together. Can you say, not working on priorities? Can you say, Security Back-door? Keep the team focused -- on work!

Email? Not for internal communications! Chat is faster and far more efficient. Users get to the point immediately. There’s no ping pong. And much like any 3rd party chat app, compliance documents stored in emails are also lost to document management and compliance. Email routing or sorting is not the same. Use Email for communicating with the outside. Use Chat for the Team inside.

qmsWrapper chat is Team based compliance:

  • Purpose built to support compliance
  • Files shared via chat can be connected directly to Projects
  • There is no loosing focus from external social media distractions
  • No more time wasting on email ping-pong
  • What more do you want!

Learn more about team messaging with qmsWrapper here.

11. Validate the QMS system before you use it

Before you can use a QMS system, FDA requires that you validate your QMS system for “Intended Use” and ISO 13485 requires validation “For Use”. They are very similar and differ essentially in level of testing.  

What is critical for you however, is that your validation efforts must be documented, even if the “off-the-shelf” application does not belong to you. This means creating your own requirements, specifications, validation documentation, which will steal valuable time from your team, from your product development.

Validation Documentation is extensive and takes a serious amount of team time.

qmsWrapper can offer you an up to date and full set of QMS compliance documentation so you can prove compliance for either FDA’s Validation for Intended Use or ISO’s Validation for Use. 

This complete set of FDA and ISO compliance documentation represents an estimated 423 hours of your team’s valuable time saved, and this for each software update so your compliance requirements are always current.

12. Customer Support and Life Cycle management

Customer support is not the issue at this time. You need to develop and finish your product first, then get it cleared through FDA and CE Approved. You need a system that’s focused on those issues. Don’t get confused by these future requirements. There is time enough to figure it out. 

Life Cycle management. Again, face it, you’re not there yet. Like customer support, focus on FDA 510(k) or DeNovo approval first, then ISO 13485. Life Cycle management comes after and is really handled differently. For now, focus on building success and don’t be distracted by vendors saying that customer support and life cycle are needed now – they are NOT!

Rather what will help your organization now is an integrated QMS system that combines Project Management, Document Management and Control, QMS, Risk Management and Team Messaging…there is only one such product, qmsWrapper.

It’s not that each individual function is some Editor’s pick, it’s that they are integrated for compliance. That makes each of them best in class and overall award winner in category of Team based QMS.

13. Lastly, cost

Startups are not always flush with cash so costs are always a factor. If costs overrun budget, then project fails before it can get to the finish line, FDA clearance and CE approved.

The real ongoing costs are related to network, network management, HR for more QMS persons, redoing QMS events with a stream of CAPA’s. And how many different software apps do you really need to subscribe to, it adds up.

But before you ask yourself what are the costs of a good QMS software, consider what are the costs of developing a great new device or product and then getting rejected because of compliance reasons. How much will a do-over cost you? How much delay will this add to your product launch and in lost revenues.

A fully integrated QMS app, will make using and supporting it in house much simpler and straightforward – i.e. less expensive. Reducing the QMS paperchase is a huge plus and getting users to understand their workflows which include QMS events based on the selected QMS Workflow Processes will greatly reduce ongoing operating costs.

Compliance is a team issue, not one person’s burden. It’s a shared responsibility.

Checklist Summary  

First understand your team and figure out what you can handle. Then factor in all the above 13 points.

The conclusion is pretty straightforward:
For a startup and small to medium sized company you need a web-based, fully integrated QMS software solution, that marries essential business functionality with Quality Management – not as separate functionality, but interconnected and fully unified, in a supportive manner to foster team based compliance.

qmsWrapper is developed by and for a medical device company, it is a Workflow process driven system that integrates the 5 business essential functionality that makes for a great compliance oriented team. It includes;  

  • Quality Management
  • Project Management
  • Risk Management
  • Document Management & Control
  • Team Messaging 

You can find implementation checklists here:

qmsWrapper, QMS is in its DNA.

Currently, qmsWrapper is focused on ISO 13485 and FDA QSR to support 510(k) and DeNovo applications for Medical Devices.

With the quality workflow process based approach, the system not only fosters a team based compliance but introduces an innovative approach to managing QMS, called Managing Through Quality or MTQ.

MTQ is not purely a QMS, it’s also a more effective and efficient way to manage your QMS.

The QMS Workflow Processes, reduce errors, forgotten paperwork, missed QMS reports by fostering team based approach to compliance, so your team is not guessing what to do next for compliance, it’s defined for them, monitored and managed by management automatically.

MTQ helps to coordinate, control and direct your organization’s tasks and activities, normal or QMS related, to help you not only meet your customer’s quality requirements but also your regulatory and compliance requirements.

MTQ supports a team focused approach to QMS, ensures everyone works together towards desired quality outcomes and fosters a culture of team based compliance. 

Everyone is involved!

There really is nothing like qmsWrapper.  This is Innovation you can benefit from!

Our solution offers a full circle of QMS.

If you’re ready to get serious about your quality management and product development efforts, qmsWrapper is your solution. 

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