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The evolution of a Quality Management System

Quality Management System Evolution

A focus on a quality management system shouldn’t just mean a ‘box ticking’ exercise for an organisation. And it shouldn’t be regarded as ‘just another cost’ to a business, either.

Instead, it can be treated as an opportunity for your business to evolve and grow - sometimes with spectacular results.

As this research from McKinsey demonstrates there are common moments in every business journey that can trigger a fresh focus on quality. If these are identified and handled correctly, the research argues, it can lead to whole new levels of efficiency and profitability.

McKinsey identifies five stages of ‘quality maturity’, as well as their triggers - and the changes in operational, quality and cultural practices needed to make them possible.

What are the stages of evolution in a quality management system?

The evolution of a quality management system typically spans 5 states of maturity:

  • Starting out
  • Basic quality
  • Stronger quality
  • Embedded quality
  • Standard settting quality

1. Starting out

McKinsey’s research starts by describing a company which is not yet driven by quality goals. They are delivering products but doing so to an inconsistent standard and without much attention to customer needs. They may be losing money due to wastefulness, lost deals, and even financial penalties from clients or regulators for the mistakes they make.

This may be the position of many startups and their trigger to change may be a large fine, a product recall or a new opportunity with an important client who requires they meet a new set of standards (e.g. ISO 9001:2015).

These businesses have the opportunity to save money, win new clients and increase sales by raising the levels of their compliance and the quality of their end products to at least a basic and consistent standard. 

Where are you on quality management maturity grid?

2. Basic quality

Achieving this basic level of quality maturity requires a repeatable, standardized approach to development and manufacturing within your operations. To achieve this, you may need a dedicated quality champion in your business, who can define and implement quality processes and a consistent way of satisfying compliance requirements.

As efficiency improves and the business becomes less reactive in their approach to quality these businesses can see opportunities to further reduce risk exposures and failures. They can begin to see new ways to increase productivity while boosting savings and profitability.

3. Stronger quality

This second stage of quality maturity is driven by robust development and manufacturing processes enabled by digitised QMS systems which embed accountability for improving quality across the organisation. This approach entails developing company-wide methods to review processes, identifying and solving quality problems as they arise.

Businesses can now see opportunities to further empower their staff to improve customer satisfaction and the level of quality they are delivering.

4. Embedded quality

In this third stage of quality maturity, operations are now subject to a continuous cycle of improvement thanks to a digital quality system which facilitates constant review of process and customer needs. Quality and customer satisfaction drive product design and solutions, as well as strategic decision-making. Quality has become the way of life for the company.

McKinsey reports on a Pharma manufacturer who shifted to just such a cross-functional approach to quality management, increasing collaboration, daily reporting and team-based problem solving - and saw a 15% increase in productivity, as well as a measurable reduction in compliance issues.

On the back of this progress, there is now an opportunity for an organisation to start defining and setting standards for an entire industry.

5. Standard setting quality

This stage of maturity sees the adoption of advanced manufacturing, development and control technologies, underpinned by unique insight and innovation in quality processes. Company culture prizes quality as one of its highest achievements, and there is a focus on developing solutions beyond the company’s traditional boundaries.

Real insights and tangible results - download our QMS case studies

Lessons in the evolution of Quality Systems

This research is striking in the way it shows how focusing on quality leads to return on investment at every stage of a company’s evolution. This focus includes

  • Focusing on customer needs and the way they are met
  • Helping workers define and refine their own SOPs within your QMS
  • Building automated non-conformance and CAPA processes into your QMS
  • Making an eQMS a central part of the ‘way you work’ as a company
  • Setting KPIs and reporting on them to target improvements

Investments in quality create a virtuous circle of improvements beyond their initial impact, identifying new efficiencies and new ways of working that can further increase productivity and save businesses money.

Each stage of development clears the way and prepares the ground for the next. In the end, quality informs strategy and organisational culture so completely that its effects are organic and felt in every area of the business.

The research also shows that while implementing a thoroughgoing culture of quality can require financial investment, it doesn’t have to be prohibitively expensive. Instead, those leaders who think about quality systematically and deploy the right solutions at the right time will be able to realise return on investment quickly and in a self-sustaining way.

Flexibility is key

As McKinsey points out:

“Not every organisation needs to achieve the highest level of quality maturity, and certainly not all in one go. But all organisations should recognise that when a trigger looms, an investment in quality capabilities can often open major new opportunities for competitive advantage” 

For high tech developers introducing more efficient digital quality management tools to replace paper-based solutions, could be one such investment.

A flexible Quality Management System, powered by a process driven intranet can present a scalable solution for implementing each stage of an organisation’s journey to quality maturity.

These kind of systems, recognise (as does McKinsey’s research) the need for flexibility in achieving quality goals.

Trying to go from Level 1 to Level 5 in a single move would be impossible. At the same introducing a new supplier and a new quality management infrastructure every time you needed to introduce new capabilities would be expensive and time-consuming.

See our Quality Management System in action

Choosing the right digital tool kit

The right digital QMS can offer solutions for process mapping, project management and deeper collaboration; all within a digital framework that can match the scale of your operation and your requirements in a robust but non-proscriptive way.

We have observed them acting as a central repository of information for an entire organisation and becoming a focus for process optimisation activity at all levels of a business. In this way, they can be seen helping to embed the kind of ‘culture of quality’ that McKinsey is talking about.

But whatever specific solutions are deployed during this journey, the lesson from McKinsey is that to be successful, a growing business needs a quality strategy and an approach to implementation that can evolve with them.

How to build your Med Tech eQMS

Last updated on 25th October 2022

Tags: quality management system, New Product Development

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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