QUALITY

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.

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