If you want to develop a Quality Management System that meets the regulation and powers your commercial success you’re going to need an eQMS.
What’s a QMS?
A Quality Management System (QMS) is a formalised system that documents processes, procedures, and responsibilities for achieving a company’s quality policies and objectives. A QMS coordinates and directs an organisation’s activities to meet customer and regulatory requirements.
A QMS can be paper-based, but in recent years more organisations are building out eQMS (electronic quality management systems) using digital tools.
A QMS defines the ‘way you do things’
A Quality Management System defines ‘the way you do things’ as an organisation in order to consistently deliver products and services to required standards both now and in the future.
Why do you need a QMS?
Having a documented and auditable quality management system is a regulatory requirement in many sectors. For example, in pharma and medical device development where there is a significant risk to life if standards in design, production and labelling are not rigorously observed.
But other industries also use quality management standards specified in ISO 9001 even though having a QMS and obtaining the standard is not required by law. Companies often use ISO 9001 to ensure they can be guaranteed uniformity of approach and quality outcomes no matter where in the world (or from whom) they are purchasing services, components or equipment.
Compliance vs quality - what’s the difference?
Traditionally, the quality industry has been obsessed with the idea of ‘compliance’. And that's understandable since being able to demonstrate that you understand and implement regulation correctly is essential for avoiding fines and trading legally.
But In the 20th-century quality became a byword for bureaucracy at the expense of efficiency. Think quality, think men with clipboards and hard hats box-ticking against endless lists of requirements. If you could prove that you carried our specific tasks in certain uniform ways you would win your ISO certification and not be required to dust off your QMS documents until you were assessed again.
More recently, though, industry and regulators have realised that ‘compliance culture’ - the unthinking and inflexible imposition of ‘standards’ - is not the best way to build organisations committed to maintaining and improving quality long term.
A QMS is now seen as a more holistic undertaking, as shown in ISO 7’s principles of Quality Management:
- A customer focus in your approach to product development and delivery
- A commitment to quality from the top of your organisation
- The engagement of all employees in the pursuit of quality,
- A process-driven approach to realising quality standards,
- A commitment to evidence-based decision making
- A commitment to continual quality improvement
- Strong relationship management of customers, suppliers and regulators
Why ‘a culture of quality' beats compliance culture
Compliance culture is intransigent and monolithic, it doesn’t think about customer needs and outcomes - only about observing process and box-ticking.
A quality culture is focused on customers needs - it is flexible, responsive and continually improving the way we work to create better and safer products for end users.
We’re in a world where technology is changing fast and businesses need to innovate rapidly with cutting edge tools. Because of this, we need to embed a culture of quality across our organisations, so we can rapidly adopt new ways of working that create products to a higher standard.
Eliminating waste, driving efficiency, improving innovation, increasing customer satisfaction, minimising risks to consumers, - these are objectives of a great QMS which the ISO standards champion. And they dovetail with commercial objectives for sustainable and successful businesses, too.
What’s an eQMS?
An eQMS is a digital quality management solution designed to help modern businesses realise required quality standards more effectively through automation, streamlining and real-time collaboration around process and documentation.
They can be DIY systems (strung together out of shared drives, Google docs etc) or they can be formal, proprietary platforms sold and licensed by a third party.
But what solution is best for a modern business?
A DIY eQMS?
Creating an eQMS on your own without a dedicated tool can be a risky business, it can mean stitching together email, Dropbox and spreadsheet solutions with improvised editing hierarchies. You may struggle to keep protected documents up to date while alerting users to changes as they occur. In these scenarios, mistakes are bound to happen. Without proper workflows processes can fail, information fall through the cracks and auditing will be difficult to manage.
But if you go the other direction and invest in a traditional eQMS you could end up being trapped in a highly restrictive platform that sucks up your time and limits your flexibility.
A traditional eQMS?
Traditional eQMS are heavy-duty solutions used in large, international businesses to try and ensure conformity and accountability across dispersed teams working on lengthy projects. As a result, they can be expensive and pretty clunky. These solutions may take weeks or months of installation by specialist consultants. Once installed, they often need lengthy training and trouble-shooting to integrate into your operations. And when you try to use them they can require you to work in very specific ways, meaning you have to change your SOPs and other processes to use them effectively.
A process-driven eQMS?
But there is an alternative. A cloud-based, process-driven eQMS can give you the tools to help visualise your business as a connected whole while making your quality management robust and intuitive.
This new breed of eQMS can help you define your SOPs in a graphical format while assembling and storing your documentation as securely as the regulation requires.
A graphical eQMS can be a single source of truth about your operations for workers and auditors alike:
- Through Business Process Modeling they allow companies to define the steps of all the tasks that they perform, showing inputs, dependencies and outputs in a recognisable way that is easy to follow and audit
- They can describe the relationships between people and processes in the organisation - showing internal teams and auditors exactly who is responsible for what,
- They can store documents securely with access hierarchies to prevent unauthorised changes, whole governing complex approval processes for change control
- They can let you set up bespoke document workflows that ensure processes are automated but work in the way you need them to
- They can keep your business focused on outcomes - on visualising the relationships and processes that lead to the fulfilment of quality goals.
Using a formal eQMS will mean that you can reap the benefits of governance through a robust, digitised and auditable system. But choosing a flexible and graphical eQMS will help you live out the principles of modern, customer-focused, quality management in everything you do.