Medical device audits are vital for ensuring compliance, maintaining quality, and safeguarding patient safety. While technical expertise often takes center stage, the role of soft skills in audits is equally important—but frequently overlooked.

In this blog post, we dive into why soft skills are essential for successful audits in the medical device industry.

Through an insightful interview with seasoned auditor Andy Nichols, we explore how qualities like emotional intelligence, clear communication, and empathy can transform the audit process.

Andy shares his expertise on balancing technical precision with human connection, offering actionable strategies for auditors to enhance their effectiveness and build stronger, more collaborative relationships.

A Career Steeped in Auditing Excellence

Andy Nichols began his auditing career before ISO certification became mainstream in the late 1980s. As one of the first registrar auditors, Andy contributed to the growth of ISO auditing in a rapidly evolving industry. His experience includes conducting some of the first ISO audits for major Fortune 500 companies, such as DuPont, and helping organizations navigate the complexities of quality management.

Throughout his career, Andy has not only led audits but also focused on mentoring and training the next generation of auditors. He has developed and delivered numerous audit courses, ensuring auditors are equipped with the necessary skills to succeed.

Andy is dedicated to reshaping auditor training and addressing critical gaps in audit management, including the often-overlooked importance of soft skills.

Why Soft Skills Matter in Auditing

Auditing is as much about people as it is about processes. Soft skills enable auditors to navigate the complexities of human behavior, build trust, and foster collaboration.

According to Andy, emotional intelligence is foundational He explains, “An auditor needs to understand that everyone has a different personality. It’s not just about reading body language but also about understanding what motivates someone and adapting accordingly.”

Key Soft Skills for Auditors

1. Emotional Intelligence: The ability to “read the room” and adapt to different personalities is critical. Andy explains that understanding someone’s problem-solving style can be useful when addressing nonconformities. By recognizing how an individual approaches challenges, an auditor can tailor their approach to better align with the person’s natural tendencies, making the audit process more effective and less confrontational.

2. Clear Communication: Auditors often speak the language of standards, but this can alienate auditees. Andy advises avoiding jargon, and instead framing findings in terms that resonate with the auditee’s perspective. This approach not only facilitates clearer communication but also reduces resistance, fostering a more cooperative and productive audit process.

3. Empathy and Collaboration: Building rapport and fostering a sense of collaboration, rather than competition, ensures that audits are seen as opportunities for improvement rather than adversarial encounters.

Balancing Technical and Human Elements

According to Andy, the success of an audit hinges on the balance between technical precision and human connection. This begins in the planning phase and extends through the post-audit review.

Effective Audit Planning

A well-planned audit sets the stage for collaboration. Key strategies include:

• Understanding Organizational Context: Focus on uncovering real challenges instead of simply ticking compliance boxes. Tailoring Communication: Pre-audit introductions and clear explanations of the audit’s purpose can mitigate resistance and build trust.

Opening and Closing Meetings

Andy describes the opening meeting as a “courtesy” that formalizes the trust established during planning. Effective opening meetings should emphasize shared goals and de-emphasize rigid formality to create an approachable atmosphere.

The closing meeting is an opportunity to ensure transparency and address nonconformances constructively. Andy advises presenting findings in a way that encourages actionable follow-ups without creating confrontation. “Balance honesty about findings with a collaborative tone,” he says.

Soft Skills in Action: Real-World Applications

Andy’s insights reveal how soft skills impact various aspects of auditing:

Internal Audits

Internal auditors must navigate the fine line between empathy and objectivity. Andy highlights that 80% of internal auditing involves understanding the challenges managers face. By focusing on solutions rather than faults, auditors can drive meaningful improvements.

Supplier Audits

Supplier audits often suffer from adversarial dynamics, driven by misunderstandings or rigid interpretations of standards. Andy encourages a modern approach to supply chain partnerships, focusing on key suppliers and fostering mutual benefits. “Talk to purchasing teams about the total cost of fixing nonconformities,” he advises. “Frame the audit as an opportunity for supplier development.”

Addressing Resistance

Auditees may resist audits for reasons ranging from time constraints to skepticism about the auditor’s intentions. Andy underscores the importance of proactive communication stating, “When did you last do something to show the auditee you’re serious and competent?” This simple question can shift perceptions and build credibility.

Overcoming Challenges in Soft Skills Development

While technical training is widely available, resources for developing soft skills in auditing are less common. Andy identifies several ways to bridge this gap:

1. Training Programs: Developing customized training that emphasizes empathy, communication, and conflict resolution.

2. Mentorship: Pairing new auditors with experienced professionals to model effective soft skills.

3. Continuous Learning: Encouraging auditors to explore resources like the Ladder of Inference (explained in the link), which helps understand how perceptions influence actions.

Soft Skills and Industry Impact

Soft skills contribute to long-term relationships and trust, which are crucial for the medical auditing industry. Andy explains, “Audits aren’t just about compliance, they’re about ensuring quality and safety.”

By fostering strong relationships, auditors can:

• Enhance the quality of medical devices.

• Strengthen partnerships with suppliers and regulatory bodies.

• Drive continuous organizational improvement.

Conclusion: The Human Side of Auditing

Andy Nichols’ career underscores the transformative power of soft skills in auditing. His advice to auditors is simple yet profound:

Technical proficiency is essential, but it’s the human connection that drives true success.

For auditors looking to enhance their effectiveness, Andy offers this advice: “Focus on understanding people as much as processes. The ability to connect, communicate, and collaborate will set you apart.”

For organizations seeking audits that combine technical expertise with a human touch, Medpoint offers the experience and insight needed to facilitate effective and impactful audit processes.

Learn more about how you can leverage Medpoint’s expertise here: https://medpoint.com/request-a-quote/