Integrated quality management systems, laws, regulatory requirements, standards, conformity, putting products on the market, interim, assistance, ISO 9001, ISO 13485, ISO 14001
Customize and adapt quality management systems to new and regulatory requirements leading you to success.We support you in achieving your management objectives, KPI and implement the defined actions.
Auditor training according to ISO 19011For a company-specific trainingwith maximum comfort and profit
ISO 9001 : 2015
- New structure
- Pragmatic integration into the existing system
- Audit plan
ISO 13485 : 2016
- requirements for the production of medical devices,
processes and putting on the market
- ISO 13485 vs. ISO 9001
Reach compliance by
- Determination of applicable standards, directives, laws
- Determination of the requirements for placing a product on the market
- Creation of technical documentation, product file
- EC conformity assessment, declaration of conformity
Management responsibilitiesSpecific and supplementary training needed?Information about pragmatic solution needed?What is the benefit of a ISO certification?
.Our long-term experience is your benefit. Whether it is in building of a new ISO-certified company or in the revision of an existing quality management system into a practicable and process-oriented all-in-one system.
A (quality) management should be pragmatic, realistic, simple, logical, process-oriented and easy-to-read for employees, simple handling, with little maintenance.Especially for small businesses it is essential to have working documents that are practical and simply understandable and at the same time they fulfill all regulatory "state of the art", customer expectations and standard requirements.
|Risk / Opportunities||Planning of the management system||Goals|
Search new customer existing market segment
Search new customers for the new product
Generation of new leads at fairs
|+ 10 % of previous year|
Completion of complaints
Performance of actions from external audits
Performance of actions from internal audits
|< 0.8 % of number of delivery pos.|
< 25 days
> 95 % completion
> 90 % completion
Breach of customer requirements
of conditions, laws
Faults detected after delivery
Compliance with requirements
Optimization of processes with external helpPlanning of QMS according to ISO 9001:2015
|< 1 notification|
< 1 critical deviation
> 80 % completion
> 99 % top management
Actions, estimated costs, implementation responsibilities and deadlines are defined.The implementation is monitored
and the progress is documented in reports.
|acceptable||to be considered|
IM Systems Integrated Management-Systems
Many years of practical experiences.
In international companies of medical industries and machine industry for the pharmaceutical industry.In chemical laws and regulations.In various standards, directives, laws for conformity assessment.As Head of the quality management.As Director of ComplianceAs Head of Regulatory AffairsAs Consultant for medical productsAs Safety officer for medical productsAs KOPAS / Security OfficerAs a quality auditor.
By using the latest standards, directives and laws.Certified Quality Systems Manager EOQ (European recognized person certification according to ISO 17024)Dipl. Quality Systems Manager, including Quality AuditorDipl. QM Systems Analyst and OrganizatorGraduate in Business Administration / Management ExpertA network of other experts guarantees an optimal solution for you.