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Creating a digital landscape to manage all the moving parts of your organization is no easy task, simply due to the fact that nobody can do everything you need, exactly the way you need it. Organizations are forced to implement several software systems that allow them to manage their digital workflows to achieve their objectives.  Since one of those systems will be your quality management system and the QMS software you use to manage it, it is important to know which are the most important components of quality management software.

To achieve results, companies need to satisfy three essential prerequisites of any QMS Software implementation project:

  1.  Ensure Workflow needs can be met with the available data fields and functionality.
  2.  Ensure the level of detail in appropriate. (Too much is a waste of time, too little will risk process failure)
  3.  Ensure there is the capacity for change, as knowing all of your workflow needs (see No 1) is next to impossible prior to implementation.

A quality management system is fundamentally a risk management tool that helps a company meet customer expectations.  As such, it is important to keep in mind that its effectiveness is directly proportional to the flexibility it has to address risk with the least amount of effort or resources.

These Are the Most Important Components of Quality Management Software

However, once the prerequisites of your QMS Software implementation project are understood, there are also four important components you will need to address to ensure the implementation and maintenance of your QMS software-based quality management system is successful right out of the gate, and for the years to follow.

These are the four most important components of quality management software:

  1. Organizational strategy is essential
  2. The processes mark the route to follow
  3. Human talent is a key factor
  4. Information systems and technology

If we step back and take a look at this list, we can see some deeper principles at play.  This is due to the fact that your quality management system and QMS software can only provide the structure that then lives or dies based on how it is used by the people it needs to be connected to in order to provide the controls needed to achieve its indented purpose.  You can tell which QMS software has been designed to tap into these deeper principles by the inclusion of features that allow you to establish and support the relationships between different areas of the software that should work synergistically with each other.

Organizational Strategy Is Essential

The Strategic Branding module in TLM can help an organization organize the various elements that go into the strategy to satisfy your customers and gain market share.

Regardless of whether strategy planning is performed in your QMS software or not, ensuring adequate responsibility is assigned, communicated and monitored is key to any QMS software implementation project and TLM has several features that support this requirement found in all ISO based quality management standards, such as ISO 13485 section 5.5.1 Responsibility and Authority.  For example, job descriptions are controlled documents, and you can link your employees to more than one as needed.  Likewise, referencing responsibilities in your documents by job description or department, allows the flexibility to keep the appropriate people connect to the procedures they need to follow, and doesn’t force document revision changes when you have staffing changes.

The Processes Mark the Route to Follow

ISO auditors are pushing organizations more and more to structure their internal audit program based on the audit of processes, instead of simply auditing the various sections and requirements of the ISO standard.  To support this, the audit module in your QMS software will need to be capable of supporting both types of audits.  Ideally, since your controlled documentation controls the various processes throughout your organization, your QMS software will let you set up process audits by the selection of the documents that collectively provide the needed control over that process.   Makes perfect sense, right?

Taking a process approach to building a world class organization and using your quality management system as the project management tool to accomplish this also makes perfect sense as your QMS Software should have all the tools you need to address each stage of the implementation, as well as the risk management when processes change due to your continuous improvement efforts.

Human Talent Is a Key Factor

If we look at the ADKAR model of change, we find one of the key requirements in successful change management is Knowledge.  TLM supports your training needs with training features for both document specific training as well as other training events.   To ensure there is assigned responsibility for evaluating the need for training, system settings can support either dedicated training coordinators as well as supporting the approach where supervisors are responsible for training assignments.

This ability to adapt to the wide variation in how individual companies approach the structure of their quality management system and the QMS software that manages it, is why TLM is one of the best choices for ensuring your QMS software doesn’t force concessions and work arounds to accomplish key business activities.

Information Systems and Technology

The last component is the simple fact that trying to do all this with a paper-based quality system management system is just going to be a handicap your organization can’t afford and expect to remain competitive.

If you are a medical device manufacture and want to use an electronic QMS software system then, section 4.1.6 of ISO 13485 will be part of what gets audited at your organization.

4.1.6 The organization shall document procedures for the validation of the application of computer software used in the quality management system. Such software applications shall be validated prior to initial use and as appropriate, after changes to such software or its application.

This means you will need to produce documents such as hazard analysis, test protocols, traceability matrix, and testing reports for each module being used.  Luckily for TLM customers they have a very painless option to get them out of the countless hours it would take to create all these documents and test records.   TLM provides all of these documents and allows you to also follow the requirements in the next paragraph for section 4.1.6.

The specific approach and activities associated with software validation and revalidation shall be proportionate to the risk associated with the use of the software.

The TLM Validation Packages follow a methodology that allows testers to follow a risk-based approach to the scope and level of effort used for any given set of validation records.  These documents will allow you to fly past section 4.1.6 with flying colors and will save you enough time to be an approximate 10-fold return on investment.

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