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10 Key Steps for Implementing a QMS


Any digital quality management system (QMS) evaluation project should be seen as an opportunity to improve quality within your organization. Like all projects, there are a number of steps needed to ensure that the preparation, implementation, and rollout are a success.

#1 Carry Out an Internal Organization Audit

Taking an inventory of your current system is a vital step before investing in any long-term project. All quality management processes, from document management to concrete processes, need to be analyzed thoroughly. The audit helps you understand your quality system's strengths and weaknesses; it can also help you determine how well it aligns with regulations and standards that your company needs to follow. The results of the audit can be used to draft measures to optimize agility, conformity, and profitability.

#2 Measure ROI

Return on investment (ROI) is a key metric for decision-making and gives an overall idea of the project's performance. There are free online tools that you can use to estimate the short- and medium-term costs of integrating a digital QMS within your company. Calculate your ROI.

#3 Get Stakeholders Onboard

There's no point in having an approach to quality in place unless it's supported by management and implemented throughout the organization. In order to make sure everyone's committed to the project and to avoid cutting corners, key decision-makers need to be informed early on about the new quality system, its advantages, and what pain points it will address. This step requires the management team and quality manager to use all of their professionalism to sell the plan to C-level executives, the board, the IT manager, their teams, and anyone else involved.

#4 Set a Policy and Objectives

An important aspect of a quality approach is to clearly define a policy and articulate it as specific and concrete objectives. Communicate about what you are trying to achieve to help everyone understand the reasons for the change. Potential objectives might include:

Commercial objectives

  • Improve customer satisfaction
  • Increase market access
  • Expand the company footprint
  • Bring new added-value for product effectiveness and safety
  • Increase responsiveness and competitiveness

Internal objectives

  • Optimize operational efficiencies
  • Implement a lean quality management plan
  • Integrate complete traceability
  • Reduce risk
  • Increase visibility into quality processes and the purposes they serve
  • Gain insights from real-time data
  • Improve assessment and quality control
  • Ensure regulatory compliance
  • Reduce costs
  • Enhance the culture of quality within your organization

The quality strategy can be turned into a pitch for the primary stakeholders, serving as a roadmap throughout the implementation. It gets everyone working together toward common goals.

#5 Assemble a Team to Steer the Project

Once the quality goals have been established, the next step is putting a team in place to guide the project to completion. In most cases, the head of the project (typically the individual championing the project) will be from the quality or IT department, making it vital to involve staff from every department impacted by the new goals. Having them participate in the project ensures broad-scale buy-in from those it will affect. Roles and responsibilities of team members will be defined based on each member’s individual expertise.

#6 Assess the Requirements and Draw Up Technical and Functional Specifications

The detailed analysis of the current quality system performed in step one helps you assess your company’s requirements. From there, determine actionable steps toward the implementation of a digital QMS.

A quality software implementation plan implies selecting a solution that is appropriate to your field, which can best fill your organization’s needs. You’re then ready to draft technical and functional specifications, including all project milestones.

#7 Choose the Software

With your company's requirements delineated, it's time to choose the most suitable software solution. Key factors to look for are:

Functionality: By looking at the scope of the solution, you can ascertain whether it meets not only your organization’s current quality needs, but also future ones. It's important that the solution you choose integrates quality processes. For example, you should be able to open a customer complaint as a basis to generate the necessary non-conformance, and then launch a corrective action / preventative action (CAPA) to resolve the issue. The CAPA process needs to create a request to update the document and/or schedule staff training. This only works if your system for nonconformance, CAPA, and document management is digital and integrated. . In sum, the functionality of your QMS should improve productivity, and that needs to be a should be primary factor when selecting software.

The Software's Operational Power: A digital QMS can reduce the time it takes to locate documents, improve access and sharing of documents, and increase data security, just to name a few.

Updates: The software solution provider should offer regular updates to ensure that your system always remains compliant with changing regulations.

Support: When relying on an external partner for services, such as software validation, maintenance, and user training, it's always important to make sure that the supplier also offers expert support from specialists in the field.

Software Validation: Life sciences companies are required to integrate a validation step that complies with regulatory requirements. Medical device companies, for example, are subject to the ISO 13485 standard that calls for the application of a risk-based approach to software validation. Validation is needed throughout the software's life cycle, from the start of the project and throughout implementation. When choosing your digital QMS, make sure that it's designed for trouble-free validation, which includes having an electronic signature and an audit trail with full traceability.. You should also check that the software provider offers validation record and data integrity guarantees. These are all huge plus points.

#8 Select a Licensing Model

You want to ensure each user has the type of access that is required for their role. In some cases, full access is appropriate because they are closely involved with your quality processes and require the ability to create, revise, approve, or otherwise make changes to information within the system. Other times, an individual will need less capabilities, such as only needing to view a document, or complete her training, or initiate a quality process – but not participate in the approval processes for any of those. Most QMS systems provide two levels of access. Having the two different types of user rights – full access or limited – helps you provide access for all stakeholders while making sure only people with appropriate rights can make changes or perform approvals.

#9 Deploy the Software

If necessary, deployment of the software will include integrating with all your existing business systems. At this stage, you should also ensure the software is configured to meet your specific needs. This is also the point where existing data should be collected and migrated to the software's database.

#10 Train the Users

Training is a crucial step, and its duration will depend on the size of your solution as well as the number of employees needing to be trained. A tailored training program is the best way to make sure the software is used correctly; by learning the software one step at a time, good practices can be steadily become ingrained habits and policies. Check the knowledge gained by users through a test training and exams, which ensure that key functions of the software are used properly. Users can be taught how regulations and standards are built into the software, meaning that using the software makes more sense to them and becomes more intuitive.


Philippe Charbon is President of Apsalys, the official distributor of MasterControl for the French-speaking world. The collaboration with MasterControl brings manufacturers the tools they need to streamline compliance. He has more than 30 years of experience in Information Systems, Quality, and Quality in the Life Sciences.

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