At Mectalent, quality management is one of the foundations of everything we do. Our quality system is based on the ISO 9001 and ISO 13485 quality management standards. Together, they ensure that our operations are systematic, transparent, and built around customer needs. The result: reliable processes and first-class service for every customer.
What ISO 9001 certification means for us and our customers
ISO 9001 is the world’s most widely used quality management standard. For Mectalent, it provides the framework to strengthen reliability, efficiency, and competitiveness while maintaining consistently high quality in every project.
In practice, ISO 9001 means:
- Processes that are clearly defined and transparent
- Leadership commitment that sets direction across the organization
- Active involvement of our skilled employees
- A culture of continuous improvement and risk-based thinking
For our customers, our commitment to the ISO 9001 quality management system means that we understand their needs and develop our services to meet their expectations.
Mectalent’s strong management commitment to quality management provides a clear direction for the entire organization. Quality is a shared responsibility of all our employees and an essential part of our work. Our processes are carefully documented, ensuring that, for example, the different phases of production proceed systematically and predictably.
The principle of continuous improvement is a fundamental part of the quality system. We are constantly looking for new ways to enhance our operations. ISO 9001 is also based on risk-based thinking, which means that we identify potential risks and proactively prevent them.
ISO 13485 certification – safe, compliant, and reliable medical devices
The quality system based on ISO 13485 specifically covers the manufacturing of medical devices and their components.
Our customers benefit from:
- Comprehensive risk management throughout the entire product lifecycle
- Full traceability and documentation from design to production and delivery
- Strict compliance with international safety and regulatory requirements
- Transparent and systematic handling of deviations
For customers in medical technology, this means complete confidence: every product we design and manufacture is safe for use, fully traceable, and compliant with the strictest industry standards.
>> Learn about our solutions for medical technology
The Benefits of combining ISO 9001 and ISO 13485
Different industries and markets set different requirements. By integrating ISO 9001 and ISO 13485 into one quality management system, Mectalent ensures consistent, efficient, and transparent operations across all projects — from complex medical devices to precision engineering solutions in other high-tech sectors.
For our customers, this means versatility and guaranteed quality. Regardless of project size or complexity, we deliver reliable results that meet both general quality expectations and the most demanding regulatory requirements.
>> Read the blog: Quality assurance for machined parts
How internal and external audits ensure continuous quality
Certification is not a one-time achievement. Maintaining it requires continuous monitoring and improvement. That’s why we conduct both internal audits and external audits on a regular basis.
Internal audits ensure that our processes consistently follow agreed standards and support customer needs.
External audits by independent certification bodies, regulators, and sometimes even our customers, provide impartial confirmation of compliance and transparency.
Systematically documented audits are not just about compliance — they are tools for continuous development, ensuring that our operations remain reliable, transparent, and aligned with customer expectations.
Mectalent – a certified partner for long-term success
By uniting ISO 9001 and ISO 13485 in one integrated quality management system, Mectalent combines technical excellence with a customer-oriented way of working. This ensures not only high-quality product development and manufacturing services and safe products but also strong, long-term partnerships.
If you are looking for a partner who understands demanding quality requirements and meets them systematically and transparently, Mectalent is ready to deliver. Contact our experts, and let’s build product solutions that meet the strictest global standards.
