Integrated quality management systems, laws, regulatory requirements, standards, conformity, putting products on the market, interim, assistance, ISO 9001, ISO 13485, ISO 14001

CONSULTING

Integrated Management Systems

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IM Systems supports
you in GMP and in
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coaching and instructing employees, program for internal auditors
Finance support, risk analysis and opportunities
plan management goals and achieve the target
Environmental and economic impacts of an effective quality system
Actions, estimated costs, implementation responsibility
Internal and supplier audits improve the effectiveness
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COMPANY STRATEGY
   
Value contribution to company success


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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.
       
risk based and process oriented quality management system
  
TRAINING PROGRAM
COACHING
   
       
           Company specific training or coaching in case of a personnel shortage?
        

Auditor training according to ISO 19011

For a company-specific training
with maximum comfort and profit
coach and instruct employees according to the new ISO standards, training program for quality auditors
       
ASSISTANCE   
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Are you looking for a short or long time Good Manufacturing Practice interim assistance?

We support you with our know-how professional, efficient, uncomplicated, competent and lean
and
fit in very well in your company.


A company specific training program for
your
quality auditors at your site according to

ISO  9001
ISO 14001
ISO 13485
GMP and other training for top management and quality employees
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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.
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to a ISO certificated company
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.

             
BUSINESS PLAN
PLANNING OF THE (Q) MANAGEMENT
              
Business Analysis
Risk / OpportunitiesPlanning of the management systemGoals
Sales
Marketing
Competitor
Customer care
Orders received
Search new customer existing market segment
Search new customers for the new product
Generation of new leads at fairs
+ 10 % of previous year
> 5
> 4
> 30

Image
Customer notifications
Market risks
Customer risks
Complaints
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
Standards, regulatory
Faults detected after delivery
Compliance with requirements
Optimization of processes with external help
Planning of QMS according to ISO 9001:2015
< 1 notification
< 1 critical deviation
> 80 % completion
> 99 % top management

Goals, actions, estimated costs, responsibilities are to be defined
      
Actions, estimated costs, implementation responsibilities and deadlines are defined.
The implementation is monitored
and the progress is documented in reports.
    
    
PUTTING PRODUCTS ON THE MARKET
          
By putting a product on the market, all ISO standards are to be fulfilled



For each product that is to be marketed, it is necessary to clarify the requirements for placing this product on the market in the country of placing the product on the market.

With a declaration of conformity, the manufacturer confirms the conformity of its product with the legal and normative requirements.



HARMONISED STANDARDS

Harmonised standards Standards are developed by a recognised European Standards Organisation: CEN, CENELEC, or ETSI.

Chemical substances (REACH), Explosives for civil uses, Pyrotechnic articles  
....
Conformity assessment and  management systems   
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Construction
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Consumers and workers protection, Cosmetics products, General product safety, Personal protective equipment (PPE), Toys safety
..     
Energy efficiency, Ecodesign and energy labelling  
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Electric and electronic engineering, electromagnetic compatibility (EMC), Equipment for explosive atmospheres (ATEX), Low Voltage (LVD), Radio and Telecommunications Terminal, Equipment (RED/RTTE), Restriction of the use of certain hazardous substances (RoHS)
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Healthcare engineering, Medical devices (MDD), Active implantable medical devices, In vitro diagnostic medical devices  
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Measuring technology  and instruments (MID), Non-automatic weighing instruments (NAWI)  
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Mechanical engineering and means of transport, Machinery (MD), Cableway installations designed to carry persons, Pressure equipment (PED) Lifts, Equipment for explosive atmospheres (ATEX), Gas appliances (GAD), Inspection of pesticide application equipment, Rail system: interoperability, Recreational craft and personal watercraft, Simple Pressure Vessels (SPVD)
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Services, Community postal services
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Sustainability, Packaging and packaging waste
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ECONOMICAL AND ECOLOCICAL EFFECTS
      
        
We support you in the achievement of your management objectives, KPI and implementation of the defined actions.
        
Assessment or audit show the grade of implementation
Assessments according to ISO 14001 show you the grade of implementation
     
RISK IDENTIFICATION
        

       
Management assessments identify risks and opportunities and as an output they define further actions and objectives.
We do this for you.

      


Probability









         

  Impact


high hazard

risks
activity
acceptable
to be considered

residual risks








insignificantmarginalmoderatecriticalcatastrophic

Identification and assessment of risks and opportunities
with probability of occurrence and degree of damage.
planing of the goals and achievement of the targets
    
About IM-Systems

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 Compliance
As Head of Regulatory Affairs
As Consultant for medical products
As Safety officer for medical products
As KOPAS / Security Officer
As 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 Auditor
Dipl. QM Systems Analyst and Organizator
Graduate in Business Administration / Management Expert

A network of other experts guarantees an optimal solution for you.

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COLLABORATE WITH
 

Re-organization and implementation of a pragmatic and process-oriented, integrated quality management systems
Process optimation, perform on-site audits, audit training, coaching, medical devices, ISO-standards, laws, regulations

Change your view - and things appear different!

Owner
  IM SYSTEMS    
Isabella Moser
Languages: German, English, good basics in French and Italian

Strategy, agile organization and leadership for companies in a digitized world.
Proven transformation process as interim manager or as an agile coach.


Partner
Fraefel & Partner GmbH    
Beat Fraefel
Languages: German, English

Marketing-Consulting, communication, public relatons, strategy, flyer, brochures, websites, produkt lounge
 

Partner

Margit Keller
Languages: German, English


Professional Websites; individual structures according to your wishes
 
Partner
TheSunWeb
Jaroslaw Kozak
Languages: Polish, English
CONTACT FORM
CONTACT

IM Systems
Isabella Moser
Bahnhofstrasse 208
CH-8620 Wetzikon/ZH
Switzerland

Phone 0041 43 928 08 28  *

mailto: info(at)imsystems.ch

* no advertising calls




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IM Systems

Phone 0041 - (0)52 385 50 80  (Switzerland)
Phone 0041 - (0)52 385 50 80  (Switzerland)
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