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+41 (0)61 712 33 33

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ISO
ISO

ISO

ACCREDITED QUALITY MANAGEMENT WITH DIQUALIS

Are you seeking an accreditation or re-accreditation? We ensure your success through a risk-based and business-oriented approach. Keeping your entire process landscape in mind, we provide you with practical advice to achieve your regulatory and economic goals. We support you both strategically and in your day-to-day business.
Communication is the first step to success. Contact us.

YOUR CHALLENGE
– OUR SOLUTIONS

There are many ways to achieve or maintain an accreditation. We work with you to find the path that best suits your day-to-day business and that ensures that the system is maintained with the lowest possible effort. In close collaboration with experienced laboratory facilities, we also support you regarding structural measures to meet the spatial requirements, if necessary. We integrate your QMS into your business processes. Risk assessments are the basis for practical quality processes.

DIQUALIS SUPPORTS YOU
IN VARIOUS FUNCTIONS/ROLES:

Consultant

As your consultant, we answer all of your questions regarding accreditations and support you throughout your system’s entire life cycle.

 

 

 

 

 

 

 

 

 

 

Project Manager

We act as project managers in your company to control quality management processes and establish them in a target-oriented manner.

Auditor

As an auditor, we carry out audits, for example as preparation for the accreditation or a review by the Association of Statutory Health Insurance Physicians in accordance with RiliBÄK.

 

 

 

 

 

 

 

 

 

 

 

 

Trainer

To ensure the long-term success of your QMS, we train your employees individually and company-specifically in quality-related topics.

QA Employee

We act as an external quality management expert/representative to provide practical support and accompany your processes.

 

 

 

 

 

 

 

 

 

 

OUR EXPERTISE

ISO

DIN EN ISO 17025 and
DIN EN ISO 15189

Do you want to build trust in the competence of your operations through an accredited QMS? Do you need external resources for the implementation of the QMS? Would you like to have your existing quality management system reviewed for flaws or possible optimizations? Do you need support regarding the system maintenance and day-to-day business?
Then you have come to the right place – we are your reliable partner for all aspects regarding the accreditation.

GCLP

WOULD YOU LIKE TO ASSESS SAMPLES FROM CLINICAL TRIALS
IN YOUR ACCREDITED LABORATORY?

We support you in meeting the requirements for laboratories that perform assessments for clinical trials (Position Paper EMA for laboratories that perform the analysis or evaluation of clinical trial samples, 2012).
Learn more
Unternehmensstruktur
Unternehmensstruktur

GCLP

Sie möchten in Ihrem akkreditierten Labor Proben
aus klinischen Studien messen?

Wir unterstützen Sie in der Implementierung der Anforderungen an Labore, die Messungen für klinische Studien durchführen (Position Paper EMA for laboratories that perform the analysis or evaluation of clinical trial samples, 2012).
Mehr dazu erfahren

OUR Services

PROJECT MANAGEMENT
At your request, we act as project managers for projects on various topics. That way, you save internal resources and benefit from an effective implementation by our experienced project managers. This also includes taking over management functions ad interim.
QUALITY MANAGEMENT TRAINING FOR EMPLOYEES
A quality management system depends on the employees. To ensure long-term success, we train your employees on the topics that are relevant to your organization. The contents are completely tailored to your needs and take a practical approach. The training also includes a simple and effective performance review.
OPTIMIZING DOCUMENT MANAGEMENT
SOP revision, document structure and the linking of documents are often the cause of unnecessarily complicated processes. We revise your documents as well as the associated roles to simplify document management and reduce the administrative maintenance.
CERTIFYING SITES
We certify your production sites on a risk basis in order to make the validation effort pragmatic. In this context, we make use of the scope that the authorities have been offering for some time and that will have to be increasingly used in the future. Of course, the optimization of the associated QA interfaces is included.
CONDUCTING AUDITS & GAP ANALYSES
We conduct audits at your company and/or your suppliers. That includes examination audits, the qualification of suppliers as well as the respective GAP analysis, among other things. This serves as preparation for inspections by authorities and for customer audits. After our audits, you will know exactly what to do.
QUALITY MANAGEMENT CONSULTING
Our consultants receive regular training to ensure that your QMS meets the current requirements of authorities and customers. Drawing on our many years of experience, we transform this theoretical basis into feasible solutions. We create a smooth interaction of business and compliance processes.

YOUR ADVANTAGES WITH DIQUALIS

We implement a quality assurance system that is tailored to your needs. Thanks to our experienced external perspective, we discover potential in the system and use it in the best way possible.

EXPERIENCE WITH VARIOUS GLP AND GMP QUALITY SYSTEMS
RECOGNIZING POTENTIAL FROM A NEUTRAL EXTERNAL PERSPECTIVE
SAVING INTERNAL HUMAN RESOURCES AND COSTS
EFFICIENT, SUSTAINABLE QUALITY MANAGEMENT SYSTEM
PRAGMATIC DOCUMENTATION
ACCELERATED QM PROCESSES
USING REGULATORY REQUIREMENTS TO YOUR ADVANTAGE
INTEGRATION OF NECESSARY REGULATORY REQUIREMENTS
TURN A COST FACTOR INTO A SUCCESS FACTOR