Mastering ISO 9001:2015 Quality Principles - A Guide to Implementation

ISO 9001:2015

ISO 9001:2015 and its related quality standards are all based on the ‘Seven Quality Management Principles’ defined by the organisation in their guidelines. But what’s the best way to embed those standards into the everyday thinking of your company?

How can these principles become second nature to your employees and part of your organisational DNA?

What are ISO 9001:2015’s seven key quality management principles?

  1. Customer focus approach to product development and delivery
  2. Quality leadership 
  3. Engagement with people
  4. Process driven approach to quality standards
  5. Continual improvement
  6. Evidence-based decision making
  7. Strong relationship management of customers, suppliers and regulators 

Quality Management principles

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Who needs ISO 9001:2015?

ISO 9001:2015 applies to every organisation, regardless of a company’s size or the industry in which they operate. Globally, over one million organisations have applied the standard to their quality management systems. The overwhelming response from these companies is that it helps them:

  • Better organise their processes
  • Improve the efficiency of their processes
  • Continually improve as an organisation

Are there Digital Solutions to Quality Compliance?

Companies around the world spend vast amounts of money every year on EQMS solutions to ensure they can prove their adherence to the standards set out in ISO and by industry regulators. These heavyweight and expensive EQMS solutions are purchased as tools to control and manage the implementation of regulatory requirements such as training, storage of procedural documentation and product change approval processes.

In practice, these QMS solutions are often imposed by a Quality Management function that is removed from the teams who are actually charged with complying with their strictures. This approach to quality tends to lead to siloed thinking with systems that are proscriptive, overly bureaucratic in their operation and often unpopular with the teams who must use them.

But there is a new breed of graphical Quality Management System which can place the pursuit of quality at the heart of your approach to product delivery and customer service.

How can a Graphical Quality Management System help?

A gBMS (Graphical Quality Management System)—powered by a ‘process driven intranet’—is a series of interactive and dynamic web pages that can: 

  • Detail your entire operational structure
  • Act as a secure digital repository for your quality and product management documentation
  • Operate as a project management tool in its own right

A gBMS is an accessible web based QMS, PM and training resource to which an entire company can contribute. It can be an efficient and scalable way of achieving the aims of the quality approach outlined by the seven principles: 

What are the benefits of using a graphical Quality Management system to comply with ISO 9001:2015?

Using a graphical Quality Management system can help you embed the 7 Quality Management Principles into your organisational thinking. Here’s how:

1. Customer Focus

A graphical Quality Management system necessarily focuses on the relationship between every part of your organisation and the end products you are delivering. 

  • The project and product management tools a gBMS offers can help you structure development processes in a more collaborative way. 
  • They can help you integrate the customer focused insight of a whole organisation into more iterative designs and agile refinements for new and existing products. 

You can read more about the quality impact of user-centric design in a medical device context here.

2. Leadership

A graphical Quality Management system is intended to sit at the centre of an organisation’s approach and be a constantly updated source of best practice for your company. The leadership team who installs and champion a BMS, are providing: 

  • A mechanism to replicate quality processes across teams 
  • Good governance of documentation 
  • A shared understanding of policy, goals and strategy

3. Engaging your people

A good graphical Quality Management system is a resource for all your teams to pool and refine their knowledge about the tasks they perform every day. These tasks are the lifeblood of your business and ‘ownership of them’ is key to future optimisation. 

A McKinsey study of evolving quality systems points to the centrality of an engaged workforce in delivering innovation and material improvements in quality outcomes.

4. A process driven approach

Achieving consistency in the quality of your end products demands consistency in the processes you follow to deliver them. 

A gBMS allows your business to build permanently available interactive flow diagrams, with deep links to more detailed instructions and specs to help with questions and clarification. It can ensure the proper replication of critical processes even in the face of organisational growth and change.

5. Continual Improvement

When a gBMS becomes the authoritative, collective resource for training and optimisation purposes, it can also become the driver for product innovation and change within an organisation. 

A McKinsey study shows how creating a culture where ‘quality thinking’ is owned and curated by the people who deliver your products leads to a self-sustaining cycle of continuous improvement in efficiency and standards.

6. Evidence-based decision making

A graphical Quality Management system can become a shared resource for everyone in an organisation to make decisions and suggest changes based on the most up-to-date data and an understanding of the wider business context. BMSs are intended to give everyone a holistic view of their role within a business, empowering them to make the best decisions when it comes to maintaining and improving quality.

7. Relationship management

A graphical Quality Management system can make the range of relationships and dependencies that impact upon work visible to every person in a workforce. This, in turn, can lead to better and more informed decision making when it comes to managing third party supplier, client and regulatory relationships.

How is your quality management: Ad hoc, analytical or chaordic?


Understanding the seven principles of Quality Management for ISO 9001:2015 is key to designing systems and ways of working that reflect ISO’s overall requirements and objectives. 

Installing a Graphical Quality Management system as a central quality resource for your entire organisation is one way of embracing the proactive approach to quality improvement that is replacing an outmoded ‘inspect and correct’ paradigm for regulators around the world. 

Editor’s note: This post was originally published in 2019 and has been updated for accuracy and comprehensiveness. 

Cognidox manage business graphically

Tags: ISO 9001:2015, Quality Management System

Joe Byrne

Written by Joe Byrne

Joe Byrne is the CEO of Cognidox. With a career spanning medical device start-ups and fortune 500 companies, Joe has over 25 years of experience in the medical device and high-tech product development industries. With extensive experience in scaling businesses, process improvement, quality, medical devices and product development, Joe is a regular contributor to the Cognidox DMS Insights blog where he shares expertise on scaling and streamlining the entire product development cycle, empowering enterprises to achieve governance, compliance, and rigour.

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