ISO standards

What are ISO standards?

​

ISO standards are built by experts from a wide range of fields, each bringing their own perspective. A standard is not imposed, it is developed collaboratively, from real-world experience and different points of view. ISO management system standards cover different topics, such quality, environment or health and safety, and are all built on a proven practice: the plan-do-check act cycle. This cycle enables continuous improvement, helping organizations grow stronger and more effective over time. It's what sets successful companies apart.

​

What is ISO 9001?

​

Although ISO 9001 is named quality management system, it's not just about delivering the "highest quality" product or service. ISO defines quality as "the degree to which a set of inherent characteristics of a product or service fulfills requirements".

In other words, quality management is about ensuring that your product or service consistently meets stakeholder expectations and aligns with your value proposition - whether that means being fast, low-cost, flexible, reliable, safe, best in class, or authentic. Quality has different meanings for different organizations. 

​

What an ISO 9001 Quality Management System does

​

A well-designed ISO 9001 system helps your organization to:

​

• Understand the requirements and expectations of customers and other stakeholders, and act on them

• Set objectives that align with those requirements and expectations

• Anticipate to changes in the world around your organization and how they may affect your objectives

• Identify risks and seize opportunities

• Translate strategy into clear objectives, and objectives into actionable processes and metrics

• Foster leadership and cultivate a quality-focused culture

• Learn from mistakes by addressing root causes rather than just putting out fires

• Make decisions for continuous improvement based on facts and data, not assumptions

• Ensure that your definition of quality extends downstream to suppliers and other external partners

​

Why ISO 9001 works - and what it's not

ISO 9001 is written generically to apply to any organization, from large enterprises to small non-profits. Its flexibility is a strength, but it can also make the standard feel abstract or difficult to apply. When a small or medium-sized enterprise tries to implement a system designed for a large corporation or implement systems that are based on misinterpretations on the ISO standard, it may end up with excessive paperwork, drained motivation, and limited impact.

​

ISO 9001 was designed to be adapted - to fit your organization, your people, and your goals. My role is to help you make ISO 9001 truly practical and tailored, embedding it into your daily operations rather than layering it on top. This involves breaking down each requirement to its essence, understanding the purpose behind it, and applying it in ways that add real value.

​

Are you a medical device company?

​

For organizations in the biomedical field, ISO 9001 forms the foundation for ISO 13485, a quality management system tailored to medical device manufacturers, designers, distributors, and suppliers who need to comply to MDR. ISO 13485 builds on ISO 9001 and places extra emphasis on patient safety, product performance, risk management, and regulatory compliance. Combining my expertise in ISO 9001 with my biomedical background and medical device QMS experience allows me to guide medical device companies through ISO 13485 implementation.

​

ISO 14001

​

ISO 14001 can be seamlessly integrated into your existing quality management system. I support SMEs, retail and service companies in implementing ISO 14001 in a practical and tailored way, with a focus on:

​

• Identifying relevant environmental risks and opportunities

• Ensuring compliance with environmental regulations – and for more complex or high-risk situations, I collaborate with external specialists

• Setting achievable sustainability objectives

• Embedding environmental awareness into daily operations without adding unnecessary bureaucracy

By aligning an ISO 14001 environmental management system with your strategy and everyday processes, I help you turn environmental responsibility into measurable impact and added value for your business, customers, and stakeholders.

​