Understanding the Basics of Quality Management Systems

Understanding the Basics of Quality Management Systems (QMS)

Understanding the Basics of Quality Management Systems (QMS) 750 501 Xcelpros Team

Introduction to QMS

In our last post, we talked about the main principles of TQM, or Total Quality Management, which serve as the groundwork for modern Quality Management Systems (QMS). Today, Quality Management Systems have become the norm, often completely replacing the traditional Total Quality Management approach. The TQM process shares some common goals with QMS, but there are some distinct underlying principles.

Modern organizations have evolving needs, and a modern QMS prioritizes newer principles, such as organizational agility and transparency. QMS content and design also vary based on specific business requirements. While the components of a QMS may vary widely from organization to organization, there are some key elements which remain essential to any effective system.

Simply put, a QMS is a set of policies, procedures, and processes required to plan and execute an area of business. These systems influence an organization’s ability to meet customer needs and regulatory requirements. Therefore, an effective QMS focuses on streamlining processes, reducing errors, and increasing customer satisfaction.

Structures of Quality Management Systems

While the exact structure of a QMS can differ between organizations, certain standards must be met for it to be considered a true QMS. ISO 9001:2015 is the international standard for quality management systems (QMS), and it outlines requirements for organizations to establish, implement, maintain, and continually improve a Quality Management System.

The key requirements for a QMS, according to ISO 9001:2015, include:

  1. 1. Scope
    1. a. Define the scope of the QMS, including the products, services, and processes it covers.
  2. 2. Normative References
    1. a. Identify relevant standards and documents used as references for implementing the QMS.
  3. 3. Terms and Definitions
    1. a. Provide clear definitions of terms used within the QMS.
  4. 4. Context of the Organization
    1. a. Understand the internal and external factors that can impact the organization’s ability to achieve its objectives.
    2. b. Identify interested parties and their requirements.
  5. 5. Leadership
    1. a. Top management’s commitment to the QMS.
    2. b. Establish a quality policy and communicate it.
    3. c. Assign roles and responsibilities within the organization.
  6. 6. Planning
    1. a. Set quality objectives in line with the organization’s goals.
    2. b. Develop plans to achieve those objectives.
  7. 7. Support
    1. a. Provide necessary resources for the QMS.
    2. b. Ensure competent personnel.
    3. c. Establish communication processes.
    4. d. Manage documented information (policies, procedures, records).
  8. 8. Operation
    1. a. Plan and control operational processes.
    2. b. Establish controls for product/service requirements.
    3. c. Determine criteria for monitoring and measurement.
    4. d. Implement processes to address risks and opportunities.
  9. 9. Performance Evaluation
    1. a. Monitor, measure, analyze, and evaluate the QMS.
    2. b. Assess customer satisfaction.
    3. c. Conduct internal audits and management reviews.
  10. 10. Improvement
    1. a. Continually improve the effectiveness of the QMS.
    2. b. Correct nonconformities and take corrective/preventive actions.
    3. c. Enhance processes based on evaluation and analysis.

Figure 1:Key Features of a Quality Management System based on ISO:9001

Key Features of a Quality Management System based on ISO:9001

Revolutionizing Quality Management

Nowadays, advanced software and modern tools continue to saturate every facet of the business world. It should come as no surprise then, that more quality management / quality assurance professionals are pushing for the newest wave of QMS software solutions. Taking this approach enables them to optimize their business processes, elevating their performance to new heights. According to Harvard Business Review, companies with highly developed Quality Management Systems spend, on average, $350m less annually fixing internal mistakes than companies with poorly developed Quality Management Systems.

Implementing a Quality Management System (QMS) requires a strategic approach and commitment from all levels of an organization. An article from McKinsey states, “Quality is a value-added partner and coach that helps integrate compliance into regular operations while enabling speed and effectiveness.” With the right implementation partner, a QMS can significantly contribute to a company’s success- they are essential tools for enhancing customer satisfaction, increasing operational efficiency, and ensuring compliance with regulations.

However, these systems are not a one-size-fits-all solution; ideally, a QMS is tailored to the specific needs and circumstances of the organization it is designed for. By incorporating essential components and features for the specific business, developing an effective solution becomes a more straightforward operation.

Integrated QMS Solutions for Dynamics 365

As a Microsoft Cloud Solution Provider (CSP), XcelPros provides implementations, services, and licensing for Microsoft products. To ensure we continue providing the best possible services for our customers, we regularly review our implementations of Dynamics 365 Finance and Supply Chain Management. Over time, we recognized a trend in the growing need for QMS features which integrate directly with Dynamics, as we found most of our customers were stuck using third-party QMS solutions. This was especially true of clients in highly regulated industries, including pharmaceuticals, chemicals, medical devices, and manufacturing (CMO, CRO).

In response to these findings, we developed our own line of QMS solutions that integrate fully with Microsoft Dynamics 365, eliminating the need for third-party solutions (not only pricey, but also not very user-friendly). First, Integrated Quality Management, or iQM, makes it easy to manage complaints, CAPA, and deviations centrally within Dynamics. Integrated SOP Management (iSM) offers comprehensive functionality for authoring, maintaining, and distributing Standard Operating Procedures (SOPs). Finally, with chemical and pharmaceutical companies in mind, we created Integrated Chemical Management. iCM offers complete functionality for SDS management, label management, and DEA customer management.

For companies without a system in place for managing complaints, deviations, and/or corrective actions and preventative actions (CAPA), iQM may be the perfect solution for you. Companies who are managing labels or safety data sheets (SDS) manually or need a better system for DEA customer management will find that iCM is just the solution you have been looking for. If you don’t yet have a way to manage internal SOPs digitally, Integrated SOP Management (iSM) offers everything you need. These products work great individually, or you can choose to bundle them all into a convenient package for maximum benefit.

Final Thoughts on Quality Management Systems

Your business may already have a solution in place for managing SOPs, labels and SDS, complaints, deviations, or any of the other features mentioned above. If that’s the case, is your QMS setup for managing those issues digitally and integrated with your organizational software?

Until now, even if you were using Microsoft Dynamics 365 as your ERP, it’s unlikely that your QMS was seamlessly integrated. Chances are, your QMS is a separate system, held together by an aging string of code that’s almost as old as your organization. Or, perhaps you are still using manual processes (which is more common than you may think). Whatever the circumstances may be, XcelPros can help make your processes more efficient. Modernizing products and processes is the best way to stay in compliance with any regulatory standards your business may be held to, and to keep customers coming back for reliable, consistent, and high-quality products.

Stay tuned for our next post, which will provide more detail about XcelPros’ QMS applications and how they can help your company.

If you are ready to put a new QMS into place now, there’s no reason to delay – Schedule Demo

Workflows, Part 2: Creation, Compliance, and Details

Workflows in D365 Part 2: Creation, Compliance, and Details

Workflows in D365 Part 2: Creation, Compliance, and Details 700 500 Xcelpros Team

Custom Workflows in Dynamics 365

In the first part of our workflow series, we discussed workflows in Microsoft Dynamics 365 (D365), the stages involved in workflows, their benefits, and some use cases. This week, we will teach you how to create a workflow in D365. Finally, we will share how this technology’s workflows can help organizations comply with regulatory requirements to avoid quality assurance issues.

Dynamics 365 lets businesses tailor workflows to match unique requirements, ideally making processes faster and more efficient. With workflows in place, you can focus more on delivering exceptional customer experiences. A recent whitepaper by MSDynamicsWorld discusses how workflows give companies 100% control over orders, increasing gross margins significantly.

Creating Workflows in D365

If you are just starting with Dynamics and are unsure where to begin, you’ll want to consider partnering with a Microsoft CSP (Cloud Solution Provider) that can help. Your Microsoft Partner will be able to guide you through the decision-making process, helping you determine what parts of Dynamics 365 your company can utilize in terms of what software, and for what departments, etc.

Creating a workflow in Microsoft Dynamics 365 (D365) is very straightforward. You can easily set up simple workflows in D365 on your own in just a few simple steps. As this series is meant to be more of a summary about how simple workflows can be, not a comprehensive guide to setting them up, we’ll only look at a simple workflow. If you want to go deeper and learn about setting up complex workflows that span multiple departments, your Microsoft CSP will be able to help you get started setting up Workflows in D365.

If you already have Dynamics 365 or are in the implementation process, not to fear- you can set up workflows in D365 in a few simple steps. This is not meant to be a comprehensive guide to setting up workflows, but a summary of the steps involved so you understand how simple workflows can be.

Creating a Workflow in Dynamics 365

  1. 1.Defining the Process: Identify the process you want to automate via workflows and the steps involved.
  2. 2.Creating the Workflow: In Dynamics 365 for Finance and Operations (F&O), go to the “Workflow” module area and select “New Workflow.” Give your workflow a name and define the parameters.
  3. 3.Defining Stages: Identify the stages or steps involved in the process you are creating a workflow for. Then, define the actions that need to be taken at each one of those stages.
  4. 4.Assigning Roles: Assign roles to each workflow stage to ensure that the right people are notified and responsible for completing the tasks.
  5. 5.Testing and Refinements: Test the workflow to ensure it is working as expected, then refine the workflow based on feedback and performance.

Workflows and Compliance

A critical need often overlooked by organizations is ensuring continuous compliance with laws and regulations. Standard Operating Procedures (SOPs) provide a set of guidelines that employees can follow to ensure that every action taken within the business is consistent, reliable, and compliant with relevant laws and regulations. Thankfully, maintaining workflows and standard operating procedures (SOPs) directly in D365 is one of the best ways for businesses to track and maintain consistency, efficiency, and regulatory compliance.

Managing and enforcing paper-based SOPs has always been a complex and challenging task. Take advantage of Dynamics’ included workflow capabilities to manage SOPs digitally. This will simplify your business’s SOP (Standard Operating Procedure) compliance with streamlined processes and tasks.

Let us explore how workflows in Dynamics 365 effectively simplify SOP compliance.

Streamline SOP Management

With D365, you can centralize your standard operating procedures (SOPs), enabling easy creation, updates, and storage of SOPs in one place. Workflows are crucial in enforcing SOP usage by guiding employees through the necessary steps and ensuring adherence to established processes. This centralized approach promotes consistency and eliminates the risk of outdated or conflicting SOPs, ensuring your employees can access the most up-to-date procedures.

Simplify SOP Auditing and Reporting

Staying compliant with laws and regulatory standards often requires regular audits and reporting. D365 workflows help simplify collecting and organizing the data required to complete the audit process. By automating data capture and integrating it into the workflow process, your company can generate accurate and comprehensive reports on regulatory compliance and SOPs. These reports provide valuable insights into potential improvement areas, highlight non-compliance patterns, and ensure regulatory procedures are being followed throughout the organization. With workflows in place to simplify auditing and reporting, your organization can identify areas for optimization, strengthening your SOPs and other regulatory compliance processes.

Efficient SOP Approval and Review Processes

D365 workflows automate the SOP management process, reducing manual effort and potential bottlenecks. Whenever a new SOP is created or an existing SOP requires modification, workflows can be configured to automatically route the document to the appropriate department or team member for validation. This workflow-based automation streamlines the process, eliminates delays, and ensures that SOPs undergo thorough validation by the relevant individual(s) or department(s) before implementation. Businesses can maintain a smooth and efficient SOP management process by simplifying the approval and review processes with workflows.

SOP Task Assignment and Tracking Made Easy

SOP compliance involves assigning and tracking tasks related to specific procedures. D365 workflows can help your company automatically assign tasks based on defined roles and responsibilities. Each employee is assigned specific tasks according to their role and permissions within the workflow. This simplifies task management, ensures that individuals understand their responsibilities, and promotes compliance with SOPs. Additionally, workflows provide real-time tracking capabilities, allowing managers to monitor task progress, identify bottlenecks, and take corrective actions promptly.

Proactive SOP Notifications and Reminders

Another key benefit of workflows in D365 is sending automated notifications and reminders related to SOP compliance. For instance, when a task is due or a review is required, employees receive timely notifications. These proactive reminders within workflows help employees stay on top of their responsibilities, ensuring SOPs are followed and due dates are met. By reducing the risk of being out of compliance, workflows can reduce worry and improve overall compliance rates within your company.

Figure 1:Workflows, SOPs, and Compliance

Workflows, SOPs, and Compliance

Simplifying SOP compliance is a critical aspect of maintaining operational efficiency, regulatory adherence, quality control, and risk mitigation. Setting up workflows in D365 can empower your organization to achieve and maintain SOP compliance effortlessly. This helps foster a culture of adherence to regulatory and compliance issues and sets a foundation for long-term success in regulated business environments.


of decision-makers reported that workflows have helped them reduce errors and improve consistency in their business processes, as highlighted in a recent article by SoftwareOne.

Source: SoftwareOne

More About Workflows in Microsoft Dynamics 365

As your business continues to grow and evolve, keeping up with the latest technology and software is essential. Microsoft Dynamics 365 is an excellent solution for efficient operations and improved productivity. Workflows are a critical software component to ensure operations run efficiently and tasks are completed accurately and on time.

As with any technology, there is always more to learn, so many resources are available to learn more about workflows in D365. From online video tutorials and articles to training courses and certification programs, you can use various resources to maximize your software investment (ROI). Learning about workflows will benefit you and your business, whether you are an experienced user or just getting started.

Dynamics 365 F&O Workflows: Conclusion

In today’s digitally driven world, knowing how to use corporate technology tools is essential in maintaining a competitive edge. Workflows in Microsoft Dynamics 365 Finance and Supply Chain are an essential part of this process and are more accessible than ever. From speed to scalability, Microsoft’s flagship Enterprise Resource Planning (ERP) system helps increase efficiency and profitability, enabling users to customize the platform based on their unique business needs.

In the first installment, we explored the basics of workflows, their key benefits, and some use-case examples. This week, we discussed how to create a workflow, how workflows can help keep companies in line with SOPs and compliance, and provided some additional facts and resources about workflows in Dynamics 365.

Take your business’s quality operations into the future with workflows in Dynamics 365. Workflows help businesses improve efficiency and manage compliance standards without expensive hardware or IT support needs.

Get ready for revolutionary results today!

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Also Read: Quality Management and Control – Best Practices