What is a quality management system (QMS) and how does it work?


    Nobody ever asks if they need a sales team, or how a HR team works, when they set up a company. But the question, "what is a quality management system?" is one that businesses have to confront, often unexpectedly, as they set themselves up to scale and get to market.

    When you think about how a business works, the first things that probably come to mind are the typical processes and departments: product development, sales, marketing, HR, and so on.

    But each of these operational areas are driven by an overarching system that is often overlooked, ignored or misunderstood: the quality management system, or QMS.

    We're going to dive into exactly what a QMS is, what it should look like, and - most critically - why your business absolutely needs one.


    Table of Contents

    1. What is a quality management system?
    2. What's in a quality management system?
      1. Documents
      2. Training
      3. Events
      4. Suppliers
    3. Who needs a quality management system?
    4. Why do you need a quality management system?
      1. Lower operating costs
      2. Lower operational risk
      3. Boosted revenue
      4. Stronger team
    5. When do you need a quality management system?
    6. 9 core elements of a quality management system
    7. What is QMS certification?
    8. What does a QMS not do? 3 misconceptions
      1. The QMS makes rules to follow
      2. The QMS is just about regulatory compliance
      3. The QMS is for the quality manager to run
    9. What is QMS software?
    10. Conclusion





    What is a quality management system? QMS meaning


    What does QMS stand for? Quality management system.

    And a quality management system is the bundle of processes and responsibilities that makes your business run how it’s supposed to, and ensures that the products and services that you provide satisfy your customers and your stakeholders.

    In a nutshell, that's it. Your QMS is the formalized system that guides your business to its objectives and ensures the quality of what you do.

    ISO defines quality as the:


    "... degree to which a set of inherent characteristics of an object fulfils requirements."


    The quality management system, then, is the mechanism which maximizes the ability of your 'objects' - products and services - to fulfil the requirements of the people that receive them from you and use them.

    The stronger your quality management system is, and the more you invest in it, the stronger the rest of your business becomes.

    In fact, according to Harvard Business Review:


    Companies with highly developed [quality] spend, on average, $350m less annually fixing mistakes than companies with poorly developed [quality].


    It's worth noting, too, that the strength of your QMS can depend on the tools and platforms you use to manage it.

    More and more quality-centric companies are turning to 'electronic' eQMS software to turn their quality systems into optimized, digital systems that live in the cloud.

    We'll touch on that later.


    What's in a QMS?


    A good QMS is formed of some typical key ingredients as follows:




    Documents structure and organize how information flows around your business, keeping everyone on the same page and working in the way they’re supposed to.

    Key quality documents include your quality manual and policy, work instructions and standard operating procedures (SOPs). Document control is often viewed as the 'core' or 'baseline' of your quality management system, setting out how things should be done.


    Read the 6 most common document blunders that hurt life science companies the most





    An effective training program ensures everyone in your company can do their job properly. This typically happens by issuing documents such as company policies and procedures to employees, and testing if they've read and understood them.


    Event management


    Quality management processes like CAPA and non-conformance management make your products and services stronger, by identifying problems, weaknesses and waste, then fixing them.

    These are often labelled 'event management' processes, since they involve responding to quality 'events' like complaints and defects with corrective action or preventive action to maximize product quality.


    Supplier management


    As businesses rely more and more on interactions with third parties for products and services, supplier management is becoming an increasingly important component of the modern QMS too.

    After all, it's no good being a high-quality business if you're working with an ineffective supply chain that's dragging you down!


    Download our essential guide to life science supplier management



    For certain industries, other niche quality management ingredients besides these core components can come into play. Food companies, for example, need processes such as HACCP in their QMS, while medical device companies need to think about how they manage design controls.


    What is a quality management system?


    The industry you operate in dictates exactly how your quality management will look, and what's in it.

    But the commonalities of documents, training, event and supplier management will always be indispensable for any type of business.


    Who needs a quality management system?


    A functional QMS and quality management principles are important for any company that provides a product or service to customers. If you do any kind of business, some level of quality management is required.

    But in highly regulated industries like life science or aerospace, where effective processes can be the difference between life and death, proving to a regulator that your QMS works is absolutely crucial for getting to market and selling your products.

    Regulators like the FDA, EU or MHRA typically won't allow your regulated products to be marketed or used at all unless you can prove you have a functional QMS in place, and they'll conduct an audit to investigate if your quality management system works how it should.

    That means digging into your document stack, asking you to prove your team are properly trained for their roles, seeing how you respond to quality events, investigating your supplier management processes, and more.


    Read the 5 things every life science QMS needs



    Why do you need a quality management system?


    It makes sense that doing things in an ordered, consistent way that maximizes your customers' happiness is highly beneficial for your organization.

    We've seen already that a quality management system, at its core, is all about making your business work how it's supposed to. Another way of saying this is that your QMS makes your business be the best it can be.

    The benefits of this can be profound, including:


    1. Lower operating costs


    Your QMS is all about identifying wastage, weaknesses and redundancies, then fixing them.

    That means leaner, stronger and more efficient processes that take less effort and cost to run.

    Cutting a redundant process step, identifying a manufacturing improvement or boosting output by 10% can all be transformational moments for your business with five- or six-figure financial impacts.


    2. Lower operational risk


    Risk and quality management often intersect.

    A robust QMS should take your operational risks, like competitors, regulatory change and process weaknesses, into account - then overcome them with proactive, well-planned processes.

    The more highly regulated your company, the greater the risk you face.

    A tiny product risk in the life science industry, for instance, can snowball into patient injury or death, triggering catastrophic recalls, fines, shutdowns and regulatory investigations.

    A good QMS insulates your company from this risk, acting as a protective blanket that keeps you in business.


    3. Boosted revenue


    By minimizing costs and risk, your company's revenue will naturally increase as a result of your quality management activities.

    But that's not the only thing to consider.

    Aligning your colleagues around standardized, high-quality processes that keep your customers happy also boosts customer retention and spend, making them less likely to ditch your services and go elsewhere.

    We can see in this chart that cutting customer churn from 20% to 5% makes your company grow 50% faster and unlock 40% more revenue over a 5-year period:


    What is a QMS customer retention and churn


    Meeting customer needs with your QMS can therefore be a vital operational weapon.


    4. A stronger team


    IDC's whitepaper, 'Counting the Cost of Employee Misunderstanding', found that 89% of life science companies have experienced unplanned downtime from employee misunderstanding.

    85% of those have seen reputational damage as a result - and over a third have lost business.

    Misunderstanding sounds like a murky and nebulous concept to tackle, but it really comes down to whether or not your employees know how to do their jobs to the best of their ability every single day.

    Your quality management system is the key to fixing this problem.

    Carefully documented processes, thoughtful and effective training, and a robust culture of quality all keep your teams aligned and connected - minimizing mistakes and maximizing morale.


    Read more about the benefits of a quality management system



    When do you need a quality management system?


    In short? As soon as humanly possible!

    The QMS is the beating heart of your business and the connecting tissue ensuring all its elements work together - with customer satisfaction as the focal point.

    It can be tempting to focus all your attention on your product in your company's early days, leaving 'admin' like policies and procedures for later.

    This is a mistake. Committing to a quality focus from the very first days of your company, with elements like a quality policy, quality manual and clear operating procedures, will set the tone of what your organization becomes.

    And companies that neglect important quality management elements like standardization and customer focus usually find that they become much harder to instil later:


    "Most enterprises are organized by functions - sales, marketing, operations, maintenance, engineering, finance - that are managed independently.

    Functions are typically islands of competency ruled by jealous kings, populated by antagonistic armies and separated by shark-filled seas.

    These disconnects are a significant weakness."

    - John S. Mitchell, "Operational excellence: journey to creating sustainable value"


    Scary things like the 'deviation spiral' can then take hold, where your teams experiment with alternative ways to do things that 'spiral' further and further away from the original intent.

    Soon, it can become impossible to know what's actually happening in your company each day - and regulatory audits will become a nightmare that block your route to market.


    Deviation spiral


    On the flip side, a proactive approach to your QMS-building will allow you to plan and feed your customer requirements into your processes early, building a quality focus quite literally into the core of your company that will stay there as you mature.

    So, where should you start?

    Think of the handful of core processes that define your business and what it does. Document them and give serious thought to how your QMS could make them interrelate in a standardized, consistent and customer-centric way.

    Typical places to start include:

    • Product design and development
    • Incident management
    • Risk management
    • Marketing and sales
    • Customer/supplier onboarding
    • Competence management


    Start simple and build your way up to a repeatable and measurable process approach.

    Remember: a few scattered QMS ingredients to build on are better than none at all.


    FURTHER READING: How to develop and implement a quality management system (QMS)



    9 core elements of a quality management system


    A quality management system definition can be summarized like a pyramid. The pinnacle document that simply and elegantly defines the goals of the QMS is the quality policy. From there it cascades down into a quality manual, quality objectives, procedures, processes, work instructions, and more. 

    Before developing and implementing a QMS, your organization must find their quality 'bearings'. A QMS starts with a quality policy, which acts as a guiding principle for building the rest of the system. While the quality policy is just a statement, it is the 'north star' of the QMS and will be important for establishing a culture of quality. 


    1. Quality policy


    A QMS is driven by several top-level documents that guide the development of the rest of the QMS. These documents will act as anchors to ensure consistency as the rest of the QMS is developed. The top level documents for any QMS is the quality policy, quality manual, and quality objectives. When you begin creating a quality management system, the first step should be to draft a quality policy. 

    Before you can do anything meaningful with a new quality management system, you first need to define what quality means within your company by writing a quality policy. A quality policy can also be your company’s mission, values, or statement of principles. Once you’ve crafted this, you’re then able to set expectations across the organization, from executives and upper-level management to supervisors and employees. The quality policy is the first step towards building a culture of quality into your organization.

    A quality policy should be a simple, straightforward statement that makes it clear what the company priorities are. A quality policy can be revised down the road if necessary, but since this is a key anchoring component it is best to take some time to think it through and get it right the first time. 

    Quality policy example


    Let's take a look at the following excerpt as a quality policy example and make some conclusions based on the policy:

    The Widget Company is committed to building quality, compliant widgets to support our customers in their endeavors. This commitment is demonstrated through quality processes that are executed by well-trained personnel to produce consistent results every time. Our management team is dedicated to continually improving and innovating to better meet customer needs.

    Based on this policy, it's assumed that the Widget Company will  have a strong focus on processes that run well and personnel that are trained to know how to do their jobs well. It also identifies that management is responsible for continual improvement and innovation. This policy can then be used to develop quality objectives to ensure that the values outlined in the policy are adhered to.

    Once the policy is established it is critical to publicize throughout the company. This should be publicly posted in the facility and personnel at all levels should be well aware of the policy. If applying for certification, ISO auditors may even quiz personnel to see if they know the policy, or at a minimum if they know where to look for it. 


    2. Quality manual


    A quality manual is an overview of the entire QMS that can be given to a customer or auditor to help them quickly understand how the QMS is structured and which QMS area, if any, the organization is exempt from or otherwise does not apply to their system

    • Describe the scope of the QMS
    • Detail the requirements of the QMS standard or framework
    • List any elements of the QMS which are excluded from the implementation
    • Reference specific quality procedures used within the organization
    • Provide visual documentation of critical processes via flowchart
    • Explain the organization’s quality policies and objectives

    The quality manual should be almost an outline format and should not contain details of the procedures or processes. Flowcharts, tables, and other visual representations of the information are helpful and appropriate for the manual. The manual should also identify the hierarchy of quality documents. For example:

    quality manual


    3.Quality objectives


    These objectives are designed to encourage organizations to define strategic goals and a purpose for the QMS. Objectives translate an organization’s vision into practice by creating a link between customer requirements and specific, measurable, and attainable goals. Well-written objectives lend purpose to a quality management system initiative and establish a customer-centric culture in an organization. They also serve as guideposts to tell the organization what is working well and what areas may need more attention. 

    Quality objectives should be realistic; don’t aim for the stars if you haven’t even made it to the moon yet. For example, if non-conformances have been an issue that you are now working on through quality objectives, don’t aim for perfection right out of the gate. Quality objectives should be revisited and revised periodically, so it’s okay to be realistic and then challenge yourself once things are more in control. Some example quality objectives include:

    • 100% of training for new employees completed within 30 days of hire
      • This goal is aligned to the quality policy with its focus on personnel training. This can be measured by looking at training records for new employees and verifying that training has been completed within 30 days. This also puts emphasis on training since management will be looking at this as part of Management Review.

    • 85% of nonconformance reports closed within 45 days
      • This goal makes sense for a company that has struggled with nonconformances, maybe due to a change in leadership, lack of personnel, etc. Additionally, 100% is probably not an appropriate goal for something like nonconformance reports since often you are relying on suppliers for information and there may need to be replacement product manufactured prior to closure of the report.

    • Achieve zero (0) major nonconformances during ISO 13485 recertification audit.

    Quality objectives should provide a clear vision for every member of the organization to understand the company's purpose and the value of a QMS. The objectives should provide a clear metric for measuring progress against strategic goals, including the timeline for achievement and a measurable parameter of improvement.


    4.Organizational structure and responsibilities


    The top level documents provide a basic framework and starting point for the QMS, but they do not contain enough detail to ensure quality. A QMS needs various policies, procedures, processes, documents, and records to maintain consistent quality and document evidence of that quality.

    A QMS should include a clear and current model of the organization's structure and the responsibilities of all individuals within the organization. This is typically accomplished with an organizational chart, which visually shows the roles and the flow of responsibility. This can be embedded in the quality manual, but is typically managed as a stand alone document and referenced within the quality manual. For ISO 13485, this document should identify who is serving as a Management Representative (usually the Quality Manager). 


    5. Document and records control and management


    In a QMS, all documents must be controlled and all records must be retained. Think of documents as procedures, form templates, the quality manual, work instructions, approved supplier lists, and other documents that contribute to making the product in any small way. Document control means that these documents must be revision controlled so that any changes to the documents are correctly approved and evaluated for any potential effect on production or product risk. Further, these document changes must be communicated to all necessary personnel and any copies that have been distributed must be replaced with the new revision. All of these processes must be documented.

    Further, an organization must have processes in place for records control and retention. Records can be thought of more like the evidence of work. So if a document is put through the revision process, all of the evidence that it was properly approved and communicated would be considered records. Key examples of records include: training records, manufacturing batch records, complaint records, nonconformance records, etc.

    Effective record-keeping is crucial to the success of the QMS, the ability to obtain certification with QMS standards, and regulatory compliance. During QMS design, organizations should create specific definitions of records within the organization and policies for document creation, retention, and editing. Document and records control is commonly managed through an electronic QMS and with change control software to ensure access is limited and to automate the document control process where possible.


    6. Processes and procedures


    The entire QMS approach to quality control is to establish standardized, replicable processes throughout the organization. This means processes out on the production floor just as much as the document control process taking place in the corporate offices. Standards for quality management require organizations to identify and define all organizational processes which use any resource to transform inputs into outputs. Virtually every responsibility in the organization can be tied to a process, including purchasing.

    Initial efforts to define processes should create a high-level picture of how processes serve the organization and intersect with resources such as employees, machines, or technology. After identifying processes, organizations can begin to define standards and success metrics:

    • Identify organizational processes
    • Define process standards
    • Establish methods for measuring success
    • Document a standardized approach to ensuring quality output
    • Drive continual improvement

    It may be helpful to develop a process map that identifies how all of the processes are interconnected. This is useful not only for identifying potential bottlenecks that will have significant ripple effects, but also to help personnel see how their role and responsibilities has an effect on everything else in the company. Helping personnel see that their role is important to the bigger picture is helpful in building a culture of quality and personnel that know they are valued members of the team.


    7. Data management and analysis


    Having access to data to make data-driven decisions will allow the QMS framework to drive continuous improvement and preventative quality control activities. Data analysis should be used to identify processes or systems that are out of control as early as possible instead of waiting until major nonconformance occurs. The organization must have plans in place for collecting this data and performing statistical analysis on the data. This data may then be used to assess if the quality objectives are being met and/or other metrics that the organization has established. It is common to compile this data to create a quality dashboard to give upper management a snapshot view of how the QMS is performing. 

    The types of data required to demonstrate effective QMS performance can vary significantly between organizations. However, at a minimum, it should include the following sources:

    These data points will also feed into an organization’s risk analysis process for products as well as for risk-based decision making pertaining to the QMS. For example, high rates of nonconformance with a specific component from a supplier may necessitate updating the risk analysis documents for any products that use that component to account for the possibility of the nonconformance making it through to finished product. Additionally, that data should be reviewed as part of the supplier review process to determine if another supplier should be sourced or if changes to the supplier evaluation process are required.


    8. Continuous improvement


    A QMS is most valuable to an organization when the tools and processes built into the QMS are being used for continuous improvement. This shift to innovation and improvement instead of putting out fires as they come up is where a QMS can make a huge difference in the overall trajectory of a company. Maintaining quality and process performance at consistent levels is the most basic goal of any QMS, but when fully implemented and mature, that QMS should allow for improvement of quality and processes. 

    For example, continuous improvement can use kanban or similar methods to analyze a process and find ways to streamline it. This may mean reorganizing a packaging area so that production personnel can complete tasks more quickly, while also minimizing the risk for mixups on the line. 

    Auditors like to see corrective and preventive actions (CAPA) that are opened for continuous improvement projects. It signals to them that the systems are in control enough that there are resources being devoted to improvement, but also shows a commitment to quality and improvement. 


    9. Quality instruments


    The control and calibration of tools used to measure quality are integral to the success of a QMS. If machines or equipment are used to validate products or processes, this equipment must be carefully controlled and calibrated according to industry standards. Depending on the instrument, this could involve periodic calibrations or calibration before every measurement.

    The QMS system design within an organization should dictate a clear policy for the maintenance of quality instruments based on nationally or internationally recognized standards for each piece of quality equipment. This documentation should address:

    • Intervals for instrument calibration
    • Recognized standards for instrument calibration
    • Manufacturer instructions for adjustment
    • Procedures for identifying and documenting calibration
    • Controls against tampering or adjustment post-calibration
    • Methods to protect instruments and equipment from damage

    In addition to these requirements, the QMS should address effective documentation of calibration results, including procedures for maintaining complete records of activities and calibration results.


    What is QMS certification?


    Because the quality management system is all about generating outputs that 'fulfil the requirements' of your stakeholders, you can get it certified by a certifying body to prove to the world that your business has a robust and effective operation in place.

    Once your QMS is implemented, your organization may therefore want to become certified to ISO 9001, the international quality management standard. Think of this as the general, one-size-fits-all structure governing modern quality management systems.

    Then there are other, more niche, industry-specific QMS standards too, such as ISO 13485 for medical device quality management. These niche ISO standards take the broad structure of ISO 9001 and layer in more detailed and rigorous requirements, making them more difficult to get certified to.

    The certifications your QMS needs will depend on the industry you operate in, the services and products you provide, and how committed and quality-centric you are. Critically, some regulated industries make QMS certification a mandatory part of doing business.

    The first step towards QMS certification is identifying and qualifying a registrar. A registrar is an organization that certifies compliance with the ISO standard. The certification process can take a while, so look into various registrars at least 6 months in advance to figure out any special requirements they may have and what their process is for certification.

    For an initial certification, there will be a one-or-more-day on-site audit that will look at your entire QMS and ensure that it is compliant with the standard(s). Once certified you will be subject to periodic recertification audits. The frequency and recertification requirements vary by registrar. 


    What does a QMS not do? 3 misconceptions


    As we think about what a QMS meaning is, it's also worth taking some time to consider what it isn't.

    Unfortunately, since the QMS remains a largely hidden and underappreciated element in a lot of businesses, there are a few misconceptions about what it does.


    Misconception #1: The QMS makes rules to follow


    Quality is often conflated with red tape, bureaucracy and finger-pointing compliance managers.

    And while some businesses do treat quality this way, it's not how your QMS should be run.

    Instead of inventing rules and procedures, then forcing everyone to follow them, your QMS should be a collaborative and business-wide connecting system that's supported by everyone.

    That means your laboratory team needs to contribute to your laboratory SOPs.

    Your product engineers need a big say in how your product processes are documented and run.

    And you shouldn't foist an elaborate training management system onto your people team without involving them.

    In short: a good QMS is a living repository for the best way to do things, agreed on and committed to by everyone in your company.

    It's not the company police!


    Misconception #2: The QMS is just a tool for regulatory compliance


    Your quality management system is all about guaranteeing the quality and integrity of the products and services you provide.

    This does serve an important regulatory and compliance role, since it allows you to prove that your drugs or medical devices are safe, effective and compliant for the markets they're entering - in turn, allowing your company to certify to quality standards like ISO 9001 or ISO 13485.

    But treating your QMS purely as a 'certificate maker' and a necessary evil to make regulators like the FDA happy misses the point of what it is.

    A robust, functional QMS can do so much more than give you a baseline of compliance.

    Armed with the right data, your quality system opens the door to continuous quality improvement, constantly lifting your operational maturity beyond the bare minimum of compliance and strengthening your business in relation to its competitors.

    So don't just think 'compliance' - think 'quality'!

    As a 2019 FDA report puts it:


    “Many pharmaceutical manufacturing firms have focused their efforts on compliance with cGMPs, which include standards for material systems, equipment and facilities, production, laboratory, packaging and labeling, and a quality system. 

    These standards, however, are foundational and set a minimum threshold that companies must achieve in order to be allowed to supply the U.S. marketplace. They do not include more advanced levels of quality management…”


    If we consider the quality maturity curve, we can see how the QMS isn't just a binary tool separating compliance from non-compliance.

    Rather, it's a continually evolving weapon in your company's arsenal, that can be scaled up from quality control through quality assurance to total quality management:


    Quality maturity steps


    FURTHER READING: Total quality management (TQM): definition and principles



    Misconception #3: The QMS is for the quality manager to run


    Our 2024 life science quality trends survey found lots of quality managers feeling siloed, cut-off and undervalued by their companies.

    This is symptomatic of a broader image problem experienced by quality: that the QMS is the responsibility of the quality team, and no-one else.

    As we've touched on already, the QMS should never be the remit of a single department. Since it touches the entire business, everyone in the company should be aware of their quality management obligations and commit to supporting the QMS every single day.

    This can, however, be difficult in a manual and paper-based quality management system. Scattered filing cabinets and folders make it difficult for quality to become a visible part of the business culture, while quality essentials like training become frustrating, time-consuming and annoying for everyone else.


    What is QMS software? eQMS meaning


    These challenges are why more and more quality-centric organizations are turning to QMS software (also known as eQMS platforms) to knit quality into the wider company.

    Centralized information and accelerated digital processes make it much simpler for all layers of a company, from laboratory to boardroom, to access and support the QMS.

    The QMS - or, rather, the eQMS - then becomes what it should be: a central cog of the organization, guided but not run by the quality team.

    QMS software also removes the manual admin tasks associated with modern quality work, freeing up more time for continuous improvement and value-add work.

    Users of Qualio's QMS software report, on average:

    • 90% reduction in quality admin
    • 30% faster quality processes
    • Doubled or tripled speed to market
    • 6x faster external audits, with fewer or even 0 non-conformances


    And more.


    Explore the top 5 electronic quality management systems



    Conclusion: quality management system definition


    If you're asking the question, "what is a quality management system?", your company is probably in the earliest stages of its operational maturity.

    That's not a bad thing. Building your QMS from scratch is a golden opportunity to turn a blank canvas into a real driver of continuous business improvement.

    Careful, thoughtful planning of your quality management ingredients, and the tools you'll use to manage them like Qualio's QMS software, will define your business operation and set you up for long-term success. Access our eQMS comparison resources to start your research.

    So, what is a quality management system? It's the key to hitting your operational goals. The best time to start building one is right now!