A good Quality Management System (QMS) is essential for any business aiming to deliver high-quality products and services consistently and compliantly.
In the UK, industries like healthcare, pharmaceuticals, and manufacturing rely on QMS frameworks to ensure operational excellence and pinpoint opportunities for continual improvement.
But the management of quality assurance processes is no mean feat. Traditionally, the process involves a lot of manual workflows within siloed systems. The risk of non-compliance in this scenario (alongside productivity hindrances) can impact both productivity and customer satisfaction.
That’s where the Document Management System (DMS) comes in. Digital solutions like the DMS make sure quality workflows are streamlined and automated, for better accuracy and faster processing.
- What Is A Quality Management System?
- Types of Quality Management Systems
- Benefits of Implementing a Quality Management System
- Challenges in Traditional Quality Management
- How a DMS Supports Quality Management Systems
- Transform Your Quality Management System with a DMS Solution
What Is A Quality Management System?
A Quality Management System (QMS) is a structured framework that enables an organisation to consistently meet customer expectations and regulatory requirements in the production and delivery of products and services. It includes processes, policies, and procedures for employees to follow and document with the aim of high-quality outcomes and the minimisation of risks and errors.
The goal of implementing a QMS is to refine operations by driving towards continuous improvement in regards to identifying inefficiencies, risks, and bottlenecks.
Types of Quality Management Systems
There are several standard QMS methodologies that are recognised worldwide. Some cater to specific industries and some fall into a more general purpose category. Here’s a quick overview of the most well-known and implemented QMS’s:
ISO 9001 Quality Management System
ISO 9001 is one of many standards researched, defined and certified by the International Organization for Standardization. At the beginning of 2024, ISO had published over 25,000 international standards. ISO 9001 specifically addresses a systematic approach to quality management.
The ISO 9001 certification enables organisations to take a look at their leadership, employee/stakeholder engagement, processes, relationship management throughout the value chain, and assess them through a customer-centric approach. These quality management principles aim to improve customer satisfaction, improve operational efficiency and risk management, and create a competitive market advantage.
ISO 9001 is a relatively generic model, and is used by organisations of all sizes and industries.Total
Quality Management (TQM)
Total Quality Management (or TQM) focuses on involving the entire company, from executive management to frontline workers, in quality improvement efforts. In the UK, it’s mostly used in healthcare, manufacturing and service sectors.
There is a strong focus on education and training for employees in TQM. It also leverages multiple quality management tools such as PDCA (Plan, Do, Check, Act) Cycles, fishbone or ishikawa diagrams to identify root issues, and control charts to monitor process variations.
Six Sigma
Six Sigma takes a more data-driven approach. It’s a QMS that’s primarily used in manufacturing, healthcare and finance, but could be applied to supply chains in almost any industry. Notable users of Six Sigma include General Electric and Amazon.
Six Sigma focuses on continuous improvement in processes with structured methodologies including DMAIC (Define, Measure, Analyse, Improve, Control) and DMADV (Define, Measure, Analyse, Design, Verify).
Organisations can use Six Sigma to identify and rectify defects, monitor the stability of processes and track performance using statistical analysis.
Lean Quality Management
You may have heard of Lean methodologies before. Lean methodologies focus on minimising waste and maximising efficiency. Lean Quality Management combines core Lean principles with traditional quality management practices so businesses can focus on delivering high-quality products.
Lean Quality Management uses value stream mapping, just-in-time (JIT) production, error-proofing and root cause analysis, among other tools, to help companies reduce waste all the way through the value chain.
This QMS is frequently paired with Six Sigma and is often used in UK industries like manufacturing and logistics.
Compliance-Based QMS
Quality is an important consideration for any industry, and so is the speed of production. But, for some industries, heavy levels of regulation make that a more complex situation.
Industries in the UK such as pharmaceuticals, medical device production and good production are strictly regulated by bodies and rules such as the Medicines and Healthcare products Regulatory Agency (HMRA) and Good Manufacturing Practice (GMP).
For companies in these industries, many QMS’s focus on establishing clear quality policies that are strictly aligned with compliance regulations. Standard Operating Procedures (SOPs) and competency training are focal points, as well as clear document control and the establishment of audit trails.
Benefits of Implementing a Quality Management System
Implementing a QMS has the ability to transform organisations through operational efficiency, reduced costs, and the development of a culture of innovation.
Improved efficiency and reduced operational costs
A QMS helps to standardise workflows, eliminating redundancies and streamlining operations. The introduction of increased automation further reduces error rates and saves time and resources throughout the value chain.
Better compliance with regulatory standards
Almost all businesses in the UK are subject to varying levels of regulation. In the UK, the pharmaceutical, healthcare, and financial services industries must comply with particularly high standards.
Regulation naturally slows down production cycles. It can involve extra physical checks and processes throughout production and requires a lot more paperwork to be produced along the way.
The cost of ignoring compliance within production processes can also be extremely costly. For example, in 2023, Drax Group was fined £25 million in the UK by Ofgem for failing to provide sufficient documentation on their imports of biomass materials. Another case involved MS Amlin Underwriting Limited, who were fined £9.7 million by the Prudential Regulation Authority for multiple issues related to risk management and data governance in its underwriting processes.
A QMS addresses both these aspects of compliance. Firstly, it helps ensure that any regulatory requirements are implemented more seamlessly into production, through improved processes and automation. Secondly, it means that audit trails are clear and accessible and reduces the risk of expensive compliance fines or legal action.
Improved risk management
Any business operation inherently carries some level of risk. But a QMS helps to reduce that risk and, therefore, avoid costly mistakes.
For example, poor processes at a manufacturing plant could result in entire batches of products being unfit for consumption. Lost paperwork in financial services can leave the company open to fines as the result of an audit. Disputes with suppliers can halt production or distribution and affect sales.
With a QMS, every step of the supply chain is monitored for efficiency and accuracy to reduce errors and downtime and enhance trust among partners and customers.
Continuous improvement and innovation
Even when production isn’t causing specific issues, there’s always room for improvement. The identification of inefficiencies can drastically reduce costs and improve profit margins for organisations.
A 2023 study from PwC found that executives across all industries drastically underestimate the impact of quality on customer loyalty. When asked about the moment or experience that generated customers loyalty, only 23% of executives thought product quality was the driving factor. But, when asked the same question, 46% of consumers pointed to product quality as the key reason for their brand loyalty.
The right QMS helps to regularly or continuously identify opportunities for the business to create efficiencies and improve quality, whether it’s reducing duplicate efforts or finding a faster way to move from point A to point B in a process.
Challenges in Traditional Quality Management
Of course, a QMS is just the first step. While these frameworks are essential for putting a structure in place, companies need tools and technologies to implement them effectively. Without this, traditional quality management still faces challenges like:
- Manual Document Handling: Paper-based processes (even digital ones) are slow, error-prone and difficult to scale.
- Siloed Systems: The hand-off from one department to another is typically a hotspot for inefficiency. A lack of integration between systems hampers collaboration.
- Limited Access: Employees struggle to file and retrieve information and documents when they’re needed.
- Compliance Risks: Without automated processes and integrations, sticking to regulatory requirements becomes difficult and seamless audit trails are almost impossible.
When it comes to quality, a Document Management System (DMS) helps to resolve these challenges, regardless of the specific QMS your organisation uses.
How a DMS Supports Quality Management Systems
While the QMS is your overall framework, a DMS supports its implementation by taking the manual document management work off your hands.
Streamlining document control and accessibility
From policies and procedures to record retrieval, document management is one of the most time consuming aspects of a QMS. A DMS becomes a central repository for document digitisation, making them easy to search, retrieve and share in seconds.
For example, a manufacturing company might use a DMS to store SOPs and instantly provide employees with the latest versions to reduce the risk of outdated practices.
Automating document review and approval processes
Many business documents naturally pass through multiple teams and systems on their journey. This often includes review and approval cycles—something that is almost guaranteed to create bottlenecks from one step to the next.
With a DMS, you can leverage predefined approval stages and automatic routing to reduce delays and remove lots of manual work.
For example, an accounts payable team needs to manage multiple approvals and signatures throughout the purchasing process. A DMS can take manual emailing and approvals out of the way, with features like automated notifications ensuring stakeholders take action promptly.
Ensuring data security and confidentiality in QMS
Data breaches (especially in highly regulated industries) can have severe consequences, both financially and reputationally. But without dedicated document management software, it becomes far too easy for sensitive information to:
- Become available to those who don’t need to see it
- Get leaked or distributed
- Become lost or misrouted
With a DMS like DocuWare, you can safeguard these types of breaches through encryption, role-based access, and secure cloud storage. These features ensure compliance with UK GDPR and other standards and reassure your suppliers, partners, employees and customers that you handle data correctly.
Enhancing traceability and document version control
Regulations frequently require accountability in the form of audits. When that happens, it can be a scramble to ensure all documentation is properly filed and retrievable to demonstrate a clear audit trail. Without that audit trail, it’s difficult to prove full compliance and the business can be left open to penalties as a result.
This audit trail can relate to HR documents, accounts payable procedures, health and safety checks and more.
With a DMS, documents are easily retrieved and organised for compliance checks. Plus, all interactions with the document including access, change histories and approvals are stored along with it. This drastically reduces manual work during the audit process and provides peace of mind that your compliance is in order.
Supporting real-time collaboration and communication
Quality management is not only the role of one person or team. Multiple functions interact with the supply chain and production process, and it’s the sum of all those interactions that determine quality. That’s why QMS’s focus on employee training and engagement as a core principle, regardless of industry.
From one step of a process to the next, a DMS ensures that employees are working with the most accurate and up-to-date information. It reduces both duplication of work and errors and streamlines collaboration between team members and departments.
Transform Your Quality Management System with a DMS Solution
Taking your QMS to the next level with a DMS like DocuWare unlocks new levels of efficiency, compliance and growth. With features like workflow automation, centralised document storage, enhanced security and compliance-ready audit trails, a DMS provides consistency and streamlines your processes in businesses of all sizes.
DocuWare’s comprehensive solution is a user-friendly platform with all of these features and more. Use built-in traceability and reporting to stay audit-ready and compliant. Whether you’re a small enterprise or a large corporation, DocuWare empowers your team to focus on quality and innovation. Enhance your QMS today with DocuWare!
