Are you familiar with the problem of unclear processes, unclear interfaces and frequent errors? You are aware that an organized quality management system is necessary, but you don’t have the time to introduce it? Sternberg Consulting transforms these challenges into a clear path to success.
ISO 9001: A New Chapter In Quality And Expansion
Imagine a future in which your business processes are perfected, sources of error are minimized, customer satisfaction increases, and new markets welcome your products with open arms. ISO 9001 certification not only marks the receipt of a certificate – it is the start of a new chapter of quality and expansion for your company.
Are you familiar with the problem of unclear processes, unclear interfaces and frequent errors? You are aware that an organized quality management system is necessary, but you don’t have the time to introduce it? Sternberg Consulting transforms these challenges into a clear path to success.
ISO 9001: A New Chapter In Quality And Expansion
Imagine a future in which your business processes are perfected, sources of error are minimized, customer satisfaction increases, and new markets welcome your products with open arms. ISO 9001 certification not only marks the receipt of a certificate – it is the start of a new chapter of quality and expansion for your company.
The path to ISO 9001
Certification starts with understanding its impact and ends with recognizing your performance. Let’s find out how we can make this possible.
Sternberg Consulting has extensive experience with quality management systems and brings valuable expertise to your ISO 9001 certification process. The journey through the maze of quality standards revealed a clear vision: to use ISO certification as a catalyst for business improvement. Our references are your guarantee of outstanding performance.
The path to ISO 9001
Certification starts with understanding its impact and ends with recognizing your performance. Let’s find out how we can make this possible.
Sternberg Consulting has extensive experience with quality management systems and brings valuable expertise to your ISO 9001 certification process. The journey through the maze of quality standards revealed a clear vision: to use ISO certification as a catalyst for business improvement. Our references are your guarantee of outstanding performance.
We are suitable for you if…
you are a small or medium-sized company.
you want to expand into new markets with confidence.
you are committed to improving your business processes.
you want to increase the satisfaction and loyalty of your customers.
you value a partnership approach to ISO 9001 certification.
We are suitable for you if…
you are a small or medium-sized company.
you want to expand into new markets with confidence.
you are committed to improving your business processes.
you want to increase the satisfaction and loyalty of your customers.
you value a partnership approach to ISO 9001 certification.
Plans for all
These are the starting prices based on the number of employees. Please make an appointment with us for a personal consultation.
Plans for all
These are the starting prices based on the number of employees. Please make an appointment with us for a personal consultation.
Other services
Internal audit
An internal audit ensures your quality management, efficiency and ISO 9001 conformity. We identify your weak points, offer customized solutions and thus promote quality, customer satisfaction and company strengthening.
External quality management
Interim Management Service
Our interim management service provides rapid expert support for quality management tasks by providing a specialist consultant to lead your quality management consultancy’s initiatives when required.
Other services
Internal audit
An internal audit ensures your quality management, efficiency and ISO 9001 conformity. We identify your weak points, offer customized solutions and thus promote quality, customer satisfaction and company strengthening.
External quality management
Interim Management Service
Our interim management service provides rapid expert support for quality management tasks by providing a specialist consultant to lead your quality management consultancy’s initiatives when required.
QM Blog: Your knowledge advantage
Welcome to our QM blog – the hub for the latest ISO 9001 insights. Stay up to date on standards, optimization advice and industry trends. With Sternberg Consulting you always stay one step ahead.
QM Blog: Your knowledge advantage
Welcome to our QM blog – the hub for the latest ISO 9001 insights. Stay up to date on standards, optimization advice and industry trends. With Sternberg Consulting you always stay one step ahead.
Yes, ISO 13485 is basically mandatory for manufacturers of medical devices and in vitro diagnostic devices in the European Union (EU). While it’s not explicitly mandated by EU regulations, compliance with ISO 13485 is harmonized with the requirements of the Medical Device Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR). Achieving compliance with this standard enables organizations to establish a comprehensive Quality Management System (QMS) that aligns with the demands of MDR and IVDR. This, in turn, allows them to obtain the CE marking, which is obligatory for medical device market access within the EU. Therefore, while not directly mandated, adherence to ISO 13485 is practically essential for manufacturers seeking to operate within the EU market.
Yes, ISO 13485 is primarily intended for organizations in the medical device industry (including suppliers) to ensure the safety and efficacy of medical devices throughout their lifecycle.
ISO 13485 is a standalone standard, separate from ISO 9001. But ISO 9001 is a subset of ISO 13485. So if you comply with ISO 13485, you also comply with ISO 9001.
