Search Results for: ISO 13485

Are you a supplier to medical device manufacturers?
Do your customers demand the ISO 13485 quality standard?
Then you should deal with the implementation of this standard. The requirements of ISO 13485 are relevant for suppliers who supply medical device manufacturers with products or services. Through the application of ISO 13485, organizations are able to demonstrate their compliance with regulatory requirements, manage risks and ensure best practice to promote quality and safety and improve processes.

Interested in gaining certification?
Do not hesitate to arrange a meeting with us. On the basis of your information as communicated to us in strict confidence, we will draw up a personalised, clearly formulated offer for you. We offer our services worldwide with the exception of USA and Canada.

	Team Ambimed AG A lot of emphasis is placed on structure in the external audits. The auditor is professionally competent and friendly. His pleasant manner ensures a calm climate.
	Ms. G. Palladino, Head of Quality Management The audits with the auditor are well-founded, objective, constructive and friendly.
	Mr. R. Simecek, QHSE, Validation & Calibration The long-standing cooperation with QS ZÜRICH AG is a plus for us. Audits, whether remote or on-site, even across different locations, are carried out competently, purposefully and flexibly adapted to the customer’s circumstances and employees. Thank you!
Mr. R. Emmerlich, Owner The lean process and communication are very customer-oriented, pragmatically practical in application.
(DETECON SCHWEIZ AG)	Detecon Schweiz AG Thanks to his excellent professional competence, our auditor has given us a lot of helpful hints for a continuous improvement of our system. The cooperation is always professional, goal-oriented and efficient.
	Mr. F. Stähli, CFO The experience so far, especially with the audits, has been very positive. The auditing person had pointed out very good inputs for improvements. Everything is positive, stay as professional as before.
Golden Fruits GmbH Mr. M. Ruckli, Owner We are very satisfied with the extremely professional audits carried out by QS ZÜRICH AG. The competent handling, the structured procedure as well as the constructive and courteous manner meet our expectations and requirements in every respect.
	Mr. S. Winkelhausen, Owner As long-term customer, we are fully satisfied with the services provided by QS ZÜRICH AG.
	Mr. E. Ganz, CEO Efficient and targeted certification days, good service.
Logo-Plastic AG	Mr. J. Lochinger, CEO uncomplicated competently targeted
	Ms. U. Fricker, Head of Quality, Environment and Safety/FvP “Audits (certifications ISO 9001, 13485, 22000, 22716) are risk-based and practice-oriented, thus very pleasant and constructive. Optimal response to specific customer needs in cooperation, quick and uncomplicated feedback.”
	Zollikerberg Hospital We are very satisfied with the services Audit and recertification are carried out professionally Administration and information are good, advice helpful Enquiries are answered immediately
	Herr Daniele Mannarino, LQM Touring Club Schweiz/TCS The audits by QS ZÜRICH AG are very pleasant and constructive, keep up the good work, can recommend you at any time!
	Mr. T. Liebisch, CEO Very well-founded specialist knowledge, factual and practical certification.
	Mr. J. Schnurbusch, Head of AEMP The contacts were characterised by: Professionalism, friendly, polite interaction and competence.
	Ms. C. Huf, LQM CTU Bern The auditing person is excellent, very well organised, structured and experienced. She is able to put herself in our somewhat special environment of clinical research. Queries are always addressed very courteously.
Werkatelier im Stadthaus	Ms. N. Lima, Director competent auditors pleasant and encouraged conversations good and friendly customer service
	Mr. D. Brüngger, Head of Quality Management There are good inputs for improvement in the process optimisations and in the procedures.

 

 

 

accredited standards

ISO 9001
ISO 14001
ISO 22000
ISO 45001
ISO 3834
ISO 50001
ISO 13485

not accredited

ISO/IEC 22716
The international standard ISO 22716 Cosmetics – Good manufacturing practice (GMP) – Guide to good manufacturing practice ISO/IEC 22716 specifies the requirements for good manufacturing practice for cosmetic products. It was developed for use in the cosmetics industry and addresses the special features of this sector.
Codex Alimentarius
(CAC/RCP 1-1969) Guideline on principles of food hygiene, HACCP
HACCP
Hazard Analysis and Critical Control Points
EU 2015/C95/01
Guideline on principles of Good Distribution Practice of active substances for medicinal products for human use
ISO/TS 22002-4
Specifies requirements for establishing, implementing and maintaining prerequisite programmes (PRPs), to assist in controlling food safety hazards in the manufacture of food packaging
ISO 22301
Standard for business continuity management

private Label
Management system/auditing according your specific sector
QM Fromarte
Quality management system from the swiss umbrella association of
swiss cheese specialists
Qualivista
Quality manual for retirement and nursing homes
SODK Ost+
Swiss quality guideline for institutions for invalid people
Quality standard Canton Aargau
Quality management system in accordance with the Department of Education, Culture and Sport, Division of Special Education, Homes and Workshops, Quality and Supervision Concept