Discover the definitive guide to document control for ISO 9001:2015, providing in-depth insights into the key components, implementation strategies, and technological tools to streamline your quality management system.
What is a Quality Management System (QMS) and why is it essential to use one?
If you are contemplating a career as a quality professional, one of your first tasks is to know what a quality management system (QMS) is and why your organisation should use one.
You will find that the field of quality management is brimming with jargon for example phrases such as “total quality management”, continuous improvement and “six sigma” can be confusing and make it difficult to understand precisely exactly what you need to know.
Therefore, the aim of this article is to clearly explain what a QMS is, some of the key terms and why every company should use one in its business operations:
What is a QMS?
Let’s start with what a QMS is. A QMS is a documented set of procedures and processes that help businesses to meet customer needs and expectations by ensuring the effective achievement of organisational objectives.
Why is a QMS important?
A QMS helps to coordinate and direct an organisation’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.
Implemented and maintained quality management systems have the power to affect all aspects of an organisation’s performance.
It will include:
- How you measure and evaluate performance against standards
- Who carries out each task within a process
- What processes are required to produce good quality products or services at all stages of production
- How frequently do you monitor these processes
- What action do you take if improvements are required
ISO 9001:2015 QMS standard
ISO 9001:2015 is the latest version of the ISO 9001 standard. It’s also known as the world’s most widely recognised QMS standard.
The 2015 ISO 9001 standard is simply a revision of its 2009 counterpart. There are no significant changes to the requirements or structure of the standard—it’s still broken down into five parts:
Part 1: Management system requirements
Part 2: Planning quality management system
Part 3: Performance evaluation of the quality management system
Part 4: Documentation requirements
Part 5: Guidelines for conformity assessment
The 2015 version of the ISO 9001 standard is more accessible and easier to understand than previous iterations. It’s also designed to help companies focus on improving processes that are critical to quality—and not just compliance.
In order to outline the basic requirements all quality management systems should possess, ISO/TC 176, the international organisation responsible for maintaining ISO’s quality management standards, developed the seven principles of quality management as the basis for ISO 9001 certification.
The customer is the most important stakeholder of an organisation, and we must keep them at the centre of its activities. All work in an organisation should satisfy customers’ requirements by focusing on their needs, wants, and expectations.
Leadership is essential to any organisation’s success. It is a key factor in how organisations are run, who they hire, what they produce, and how they interact with their customers. In this context, leadership refers to those individuals with power over others’ actions within an organisation (e.g., managers).
Leadership is not just about the people at the top; it’s also about all members of an organisation being leaders as well by setting examples for others to follow through with their behaviour and actions.
Engagement of people
The engagement of people is a key concept in quality management. It’s about having the right people on board, supporting them with training and coaching, and ensuring sure they’re motivated to contribute their best efforts to the organisation.
A process approach to quality management emphasises the importance of identifying and developing processes to achieve the desired outcome.
Processes should be repeatable, measurable, and controllable by those who have authority over them to improve efficiency moving forward (i.e., if something goes wrong).
A good process also helps identify problems quickly so we can solve them before they become more significant issues later on down the line—this is especially true for large projects with many people involved!
This principle is self-explanatory, but it’s important to mention that improvement is a continuous process, not an event or a single point in time. Improvement is based on data and analysis, both of which require careful planning and analysis by those responsible for the quality management system.
It’s also important to note that continual improvement isn’t just a top priority—it’s a shared responsibility between all levels within an organisation (from executives to frontline workers).
Evidence-Based decision making
It is impossible to overstate how vital data is to decision-making. To improve processes and make better decisions about moving forward, you need to collect data from your QMS and perform analyses to provide insights into the current state of the process.
However, evidence-based decision-making is a continuous process that must be built into any QMS; it’s not something you will ever achieve perfectly at once.
Relationships are everything when it comes to quality management in organisations.
- Customers: You can’t build a great product without customers or sell it without them, so it’s important to manage your relationships with them well. The best way to do this is by ensuring you listen and respond quickly when they have issues or questions.
- Suppliers: Similarly, the quality of your products depends on the supplies you get from other businesses—so managing your supply chain well will help ensure that there are no issues with production at any time. This means keeping an eye on costs and being flexible if needed (for example, letting suppliers know early that you need another batch of parts made up as soon as possible).
Achieving ISO 9001 certification
It is essential for organisations seeking ISO 9001 certification to follow the principles outlined above when designing their quality management programmes.
Certification under this standard shows that an organisation has achieved certain levels of performance in areas such as:
- Customer satisfaction
- Productivity improvements
- Inventory control
- Reduction in waste and rework
- Improved employee motivation
To achieve ISO 9001 certification, you will have to prove undoubtedly to auditors that your QMS meets the standard’s key elements and requirements. Having developed and maintained ISO-compliant systems for our clients for more than 25 years, we can assist you if you need help.
Why should you use a QMS?
There are many reasons for having a QMS, which can be divided into two categories: internal and external.
Internal reasons include:
- To comply with regulations (e.g., ISO 9001)
- To improve customer satisfaction
- To improve efficiency (e.g., fewer changes)
- To improve employee engagement (employees feel valued by their company’s actions)
- To improve profitability (e.g., fewer recalls or product returns)
External reasons include:
- To improve reputation (e.g., fewer product recalls)
- To gain competitive advantage (e.g., cost or service advantage)
- To gain customer loyalty
How can you benefit from implementing a QMS?
There are many benefits to implementing a QMS. Some of the major benefits include:
- Increased productivity. Visibility of your processes will make it easier to find and fix problems before they turn into something more serious— which can make your company more productive overall.
- Improved quality. A good QMS ensures that all employees are working toward the same goals for product quality, so every unit produced is as good as it can be in terms of consistency and reliability. This leads to fewer returns, which means more satisfied customers!
- Reduced costs. A well-maintained QMS helps keep costs down by identifying problems earlier rather than later in the production process. Having this information available at all times means no time wasted on unnecessary investigations or fixes later on down the line (or worse yet… after production has already started). It also reduces waste by preventing defects from occurring — saving money directly through reduced materials used per unit produced and less lost labour hours spent making corrections post-production instead of during assembly itself.”
- Improved customer satisfaction. A good QMS helps your customers feel more confident that they are receiving a quality product—and that’s a win for everyone! A satisfied customer is more likely to be willing to spend money on your products again in the future and recommend them to others looking for new solutions.
The next steps
If your company is looking for a way to improve its processes, then it’s clear that you should implement a process-based QMS. It can help you maintain high standards of best practices in your business and keep up with changing customer requirements.
The Agility System software supports the need to be both ISO-compliant and process-based. Our business analysts can help transform the current traditional system into an ISO 9001-compliant quality management system that provides improved operational performance and maintains compliance.
Book your free demo today, and a member of our team will be in touch to discuss your bespoke business needs and help you begin your journey to a process-based approach.
The importance of the process approach to quality management and the steps you can take towards implementation.
The ISO 9001 standard is one part of the group (or “family”) of ISO 9000 standards. This ISO family is focused on Quality Management Systems (QMS) that help organisations “ensure that their products and services consistently meet customer’s requirements and that quality is consistently improved.”
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