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In today’s fast-paced business environment, companies in the medical device industry face the critical challenge of balancing regulatory compliance with operational efficiency. Regulatory requirements, such as implementing a quality management system (QMS), are not merely checkboxes to tick – they are essential tools designed to achieve a greater purpose: safeguarding patient safety. However, businesses often struggle to reconcile the need for stringent quality control with the need to optimise operational performance.

In this blog post, Bernhard Bichsel, Co-CEO, and Deborah Rossier, Quality Management Representative (QMR) at ISS AG, share their insights on striking a practical balance between regulatory compliance and operational efficiency. Over their morning coffee – a ritual they both consider essential – they explore their perspectives on achieving this balance while keeping patient safety as the central focus. This dual perspective underpins not only how ISS AG manages its own QMS but also how it supports clients. Are you curious to learn about the evolving role of QMS and the importance of leadership in fostering a culture of quality ownership? Read on to discover more.

Practical Quality Management: Aligning Business and Patient Safety Goals

At ISS AG, the quality management system (QMS) is much more than a regulatory requirement – it is a cornerstone of the company’s operations and services. Designed with patient safety as the ultimate goal, quality management is approached through a lens of practicality, balancing compliance with efficiency. As Bernhard, Co-CEO of ISS AG, explains, a QMS must be capable of meeting stringent regulatory and operational requirements without unnecessary complexity or perfectionism. This pragmatic approach ensures that the QMS supports the company’s mission to maintain effectiveness and adaptability in its own operations, while also guiding clients in achieving similar goals. When the QMS is viewed from both the Executive Board and the Quality Management Representative, it reflects a balance of strategic vision and operational focus.

Deborah, Quality Management Representative at ISS AG, underscores that a robust QMS is integral to business success. It provides a framework for consistency across operations, training, documentation, and the reliability of products and services, all of which directly contribute to patient safety. By embedding these principles into both its internal processes and its client-focused services, a quality-driven culture is cultivated where the QMS is not just an abstract ideal, but an actionable and measurable practice.

Acknowledging the dynamic nature of the medical device industry, both Bernhard and Deborah emphasise the need for a QMS that is adaptable and resilient. Bernhard describes it as a system that evolves alongside the business, tailored to specific needs and continuously updated to reflect changing landscapes, noting, "We need a system that supports us through change." Deborah highlights that the quality management system fosters consistency while enabling continuous improvement, always prioritising patient safety. Achieving this requires more than technical compliance. It demands a culture of quality ownership, strong leadership, and a commitment to improvement.

 


The QMS Addresses Internal and External Quality Expectations

As a service provider in the MedTech sector, the QMS is central to ensuring both internal alignment and external credibility. While external drivers – such as customer expectations and regulatory requirements – are critical, Deborah highlights the equally important internal role of the QMS in supporting consistent employee training, standardising processes, and enabling scalable growth without compromising quality. Bernhard emphasises that the QMS is more than a compliance tool; it underpins the organisational culture by promoting consistency, fairness, and transparency in processes. This ensures changes are implemented uniformly and effectively across the company.

ISO 13485 is quite flexible in terms of implementation, offering high-level guidelines that can be adapted to fit specific situations. For me, quality lies in the overall performance and sustainability over the long term to ensure patient safety.

Deborah, in your experience, what adjustments to the QMS ensure scalability and adaptability?

To ensure the viability and adaptability of a QMS, it's crucial to keep it closely aligned with day-to-day business operations. Understanding what is being done, rather than just what the process says, is key. When supporting customers during internal audits, it’s important to ask, "Are you really doing what the process says?" Often, the response is “Not really”. In that case, I explain that updating processes according to what is done is necessary and beneficial. Processes should evolve with the business to reflect ongoing changes. Scalability also requires consistency, but digital tools play a major role. With the help of AI and automated interfaces, collaboration becomes easier and more efficient, enabling the QMS to grow and adapt as the company expands.

 


Broadening the Perspective: Quality Management as a Strategic Business Enabler

Deborah and Bernhard broaden the discussion to focus on quality management’s role in balancing operational demands with regulatory compliance, specifically addressing the challenge of implementing a QMS while navigating the tension between strict quality controls and the need for operational efficiency. They highlight how this tension is especially evident in environments where speed, cost control, and adaptability are prioritised – often conflicting with the formal, structured nature of quality management systems.

Building on this, they point to another key challenge: aligning quality objectives with business goals. Bernhard and Deborah both underscore the importance of integrating quality into business strategy to ensure it is viewed as a facilitator rather than a roadblock. Bernhard notes the inherent conflict between today’s demand for speed and the consistency that quality management requires. "In today's world, everything moves fast, but consistency takes time," he remarks, highlighting a key tension for leadership: maintaining high standards while responding to rapid business needs.

Deborah adds, from a QMR standpoint, that adaptability within the QMS is essential to tackling this challenge. For her, the focus lies on identifying and addressing problem areas proactively. "Continuous improvement (CIP) may be complex and costly, but it is essential for a QMS that remains relevant and effective," she explains. With adaptability and a commitment to improvement, a QMS can evolve beyond compliance to become a powerful tool for continuous progress and business alignment.

 


Leadership as a Driving Force Behind Quality Management

For a quality management system to succeed, leadership must champion it from the top down. Bernhard and Deborah agree that quality cannot be left solely to the QMR or quality teams; instead, it must be actively supported and promoted by leadership. Bernhard highlights that without the commitment of leadership, even the most well-designed QMS cannot deliver its full potential. While hurdles and discussions about responsibilities may still arise, they offer valuable opportunities for growth. An active and open exchange between leadership and quality management strengthens the ability to address these challenges collaboratively and shapes a shared understanding of embedding quality into both strategic and operational activities. Bernhard acknowledges that executive boards may still view quality systems as burdensome instead of an investment when they are not fully integrated into daily operations. At ISS AG, we address this challenge by viewing the QMS not as a checklist, but as a dynamic tool that simplifies and supports business processes.

Overcoming challenges between the Executive Board and quality management requires a culture that recognises quality and business operations as complementary, not mutually exclusive. As Bernhard notes, the Executive Board must view the QMS as an enabler. Internal experts, external advisors or consultants can play a vital role in bridging the gap between the structured demands of quality management and the dynamic needs of business operations.

Deborah uses an analogy, the Red Queen Hypothesis from Alice in Wonderland, to describe the situation: "To stay in the same place, you must keep moving forward." This reminds us that quality management is not a fixed goal but needs constant adaptation, particularly in organisations where it is perceived as an obstacle. By fostering cross-functional collaboration and promoting a shared understanding of quality management as a requirement for compliance and patient safety, as well as a strategic advantage, companies can align their operational goals with their quality objectives.

The challenge is finding solutions that benefit both quality management and business, fostering a mindset where everyone works together to identify the most beneficial outcome.

Bernhard, how can the Executive Board foster a quality culture, and what are the key responsibilities in this process?

Providing a clear strategic direction is crucial. Without a defined vision, building the systems needed to achieve organisational goals is impossible. Fostering a quality culture begins with taking clear ownership of its importance and actively supporting it. This means dedicating time, resources, and leadership to quality initiatives while leading by example. Creating an environment of open communication and trust is essential, where employees feel empowered to find solutions and make decisions independently. Quality must be ensured to align with the company's broader objectives and support the business processes. In essence, leaders must recognise the importance of quality and establish a clear path forward to create a sustainable quality culture.

 


Navigating Buzzwords: Strategy, Success, and Implementation

As part of their discussion, Deborah and Bernhard reflected on buzzwords such as "strategy," "success," and "implementation," sharing their thoughts on how these concepts relate to the challenges and opportunities in quality management:

Strategy

Strategy

This is the guiding principle, the North Star, which both must focus on together. It's the direction to follow, the signpost that shows the way, and where you must first and foremost align yourselves.

Strategy

Strategy

At its core, it is about achieving sustainable advantages over competitors in harmony with society and the environment. It is often very abstract but usually highly relevant.

Success

For me, success is both extrinsic and intrinsic. Externally, it's about our customers' success, which we share. Internally, it's about staying true to our values and attracting customers who want what we offer without compromising.

Success

Success is when we are able to satisfy customer needs. That’s what makes our work enjoyable — knowing that what you do is genuinely valued.

Implementation

It’s a continuous process, not just a one-time decision. Strategy and implementation are closely linked, requiring regular reflection to ensure we’re on the right track and adjusting as needed.

Implementation

Implementation is the actual work. It is often challenging, but a strategy has no value if you don’t occasionally look at the results.

Strategy

Deborah

This is the guiding principle, the North Star, which both must focus on together. It's the direction to follow, the signpost that shows the way, and where you must first and foremost align yourselves.

Bernhard

At its core, it is about achieving sustainable advantages over competitors in harmony with society and the environment. It is often very abstract but usually highly relevant.



Success

Deborah

For me, success is both extrinsic and intrinsic. Externally, it's about our customers' success, which we share. Internally, it's about staying true to our values and attracting customers who want what we offer without compromising.

Bernhard

Success is when we are able to satisfy customer needs. That’s what makes our work enjoyable — knowing that what you do is genuinely valued.



Implementation

Deborah

It’s a continuous process, not just a one-time decision. Strategy and implementation are closely linked, requiring regular reflection to ensure we’re on the right track and adjusting as needed.

Bernhard

Implementation is the actual work. It is often challenging, but a strategy has no value if you don’t occasionally look at the results.

 


Fictional Allies to Inspire the Foundations of a Strong and Effective QMS

A QMS should be built on principles that are both robust and reliable, as success in quality management depends on systems grounded in truth and integrity. And sometimes, a little help from fictional characters offers a fun way to reimagine support. Deborah selects Shuri, the genius inventor from Marvel’s Black Panther, as she exemplifies the values critical to effective quality management. Shuri's technological expertise, innovative mindset, and ability to foster collaboration across teams highlight the importance of continuous improvement – a cornerstone of any successful QMS.
Interestingly, Shuri’s role in developing advanced technology draws a parallel to Q from the James Bond franchise. Just as Q is the creative force behind 007's innovative tools, Shuri's knack for high-tech solutions embodies the modernisation and optimisation needed to enhance a QMS. Together, these fictional allies illustrate how innovation and a focus on continuous improvement can elevate quality systems to meet both current and future challenges.

For Bernhard, Captain America embodies the core values that underpin an effective QMS. Known for his honesty, integrity, and straightforwardness, Captain America represents the principles Bernhard considers essential for building a system that is not only powerful but also sincere and transparent. He believes that a QMS must operate with unwavering integrity, as honesty and principled action are non-negotiable. Without these attributes, Bernhard argues, a quality system loses its purpose and fails to deliver meaningful results. Captain America serves as a model for maintaining the delicate balance between strength and moral values, ensuring that power is exercised responsibly. In this way, the superhero reflects the same strategic thinking, collaboration, and commitment to excellence that are critical for driving success in quality management.

Regardless of who is recruited, effective collaboration between the executive board and the quality management team is essential for success – whether in a service provider, medical device manufacturer, or distributor. Rooted in the overarching requirement to ensure patient safety, this collaboration fosters a shared commitment to quality and ensures the QMS evolves to meet changing needs. By aligning compliance with business objectives, organisations can drive both operational efficiency and sustainable growth while upholding the highest standards of safety.

 


About The Experts


Deborah, Head of Quality & Engineering and QMR, joined ISS AG in 2020. She has a MSc. in Molecular Life Sciences with Special Qualification in Microbiology & Immunology from the University of Bern as well as a CAS in QM Medical Technology. She is a certified ISO 13485:2016 Lead Auditor and supports clients in the strategic development and targeted enhancement of their quality management systems.
Deborah Rossier
Head of Quality & Engineering, QMR
Bernhard is experienced in management and regulatory and former Head of Medical Device Division at Swissmedic. Since 2022 he is owner of ISS AG and Co-CEO. He is Dipl. El.-Ing. FH/STV and holds an executive MBA HSG as well as a CAS in Strategic Marketing Management.
Bernhard Bichsel
Co-CEO

 


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