Product & Process
To be successful in today’s markets, a single product idea is not enough. Nearly all the world’s markets are regulated, meaning governments present strict challenges to producers. HELVETING supports you in the introduction and preservation of quality assurance measures.
Quality is an important foundation for our HELVETING developments as well as for your developments and products. A company must develop and produce safe products which satisfy the customer’s demands and which observe prescribed regulations.
Quality management is a core task of the management. A quality management system is prescribed in industry sectors such as aerospace, automotive, medical engineering, parts of health care, medical rehabilitation or pharmaceutical and food production.
What are HELVETING’s competences in the area of quality assurance and process optimisation?
Our experts are proficient in regulatory affairs at international markets and ensure together with you the quality assurance as well as the bonded risk management through the complete lifecycle. Thereby, HELVETING is on your side to secure your success at the market.
A high quality standard is essential for HELVETING. For this purpose, the standardised HELVETING engineering process (HEP) is the central tool designed by HELVETING. The quality management system of HELVETING is certified by ISO 9001 (QM-System) and ISO 13485 (Quality management system for the design and manufacture of medical products). You as customer benefit from this. We gladly support you with our structured approach for the realisation of your quality management goals.
Our quality team is, besides our own aforementioned certifications, familiar with the following norms: ISO/TS 16949 (Norm for quality management systems in the North American and European automotive industry), ISO 14001 (Norm for international Environmental Management System) and OHSAS 18001 (Occupational Health- and Safety Assessment Series – Occupational health and safety management systems). We gladly consult you to ascertain what quality assurance measures are essential and appropriate for your company.
What is the assistance HELVETING is offering in the setup and realisation of a quality management system?
You develop products for strictly regulated markets and you ask yourself, if you are in need of quality management systems? What are the costs of a quality management system? And what are the costs for the case you do not possess one? HELVETING seconds you in these decisions and the realisation of custom-made strategies for your quality assurance.
HELVETING provides you the modules to establish a quality management system. We support you in adapting these modules to your business needs and we help you answering questions such as: What areas are had to be covered, what are not? And how explicitly are the details described?
When is a risk management in action?
The responsibility for the handling with risks and guarantee of safety of products are generally borne by the producer and they are been liable to statutory provisions. HELVETING supports you to carry the responsibility. We consult you with the choice and implementation of the methods suiting you. HELVETING also assumes for you the complete facilitation and coordination of the risk management as well as the creation and the lead of the documentation.
What is the assistance HELVETING is offering for admissions and registrations in the international environment?
More and more governments regulate their markets with own statutory provisions in order to protect the users. HELVETING is on your side when it comes to international registration and admission. Our specialists in the competence centre regulatory affairs dispose of long-time experience in dealing with authorities and notified bodies in various branches. HELVETING also gladly assumes for you the role of the admission commissioner in your company.
How does HELVETING support the product life-cycle management?
Product lifecycle management means the consequent succession of a product life-cycle and the continuous integration of all information which arise in its course. HELVETING supports you with the product care and maintenance as well as the construction and design. Our experts and our interdisciplinary positioned teams assume particular design and reengineering projects and on demand, even complete management of the technical product life-cycle.
Quality management and regulatory affairs in medical engineering?
HELVETING has itself specialised in the realisation of regulatory requirements and norms in the field of medical engineering and gladly consults you competently in the areas of quality management and regulatory affairs. We consult you before and during the certification or preservation audits and help you optimise your processes focusing on your company’s profitability. Even in questions on quality assurance and validation you can count on HELVETING. Our experts have deep knowledge of international regulations and standards such as the 21 CFR 820 Quality system regulations (USA).
We consult and support you in the conceptual and substantial design of an efficient and standard-compliant technical documentation. Furthermore, HELVETING is familiar with the areas evaluation of usability with documentation according to IEC 62366 as well as system, design and process risk analyses and risk assessments in accord with ISO 14971.
We offer you individual solutions for your document management. Thereby, our quality team is optimally supported by business IT and software specialists.