CONSULTANCY FOR VARIOUS ECONOMIC SECTORS (FOR EXAMPLE FOR MANUFACTURERS AND DISTRIBUTORS OF MEDICAL DEVICES, PHARMACEUTICAL AND CHEMICAL COMPANIES AND ORGANISATIONS FROM THE MECHANICAL, METAL AND ELECTRICAL ENGINEERING SECTORS)

CONSULTING IN TIMES OF CHANGE

The consulting services of CONSILIO ET OPERA GMBH cover the same departments and management systems already mentioned under the menu “PROJECT AND INTERIM MANAGEMENT”: quality management, environmental management, EMAS, sustainability management, energy management, occupational health and safety management, regulatory affairs, marketing and sales as well as management of strategic business units.

In contrast to the complete operational assumption of a corporate function or support of one or more management systems within an interim management mandate, our services focus on strategy development as well as organizational and process consulting. After profound analysis of our customers’ challenges and consideration of the changing environment, we provide decision-making aids for their mastering. The resulting packages of measures are finally implemented by our customers.

STRATEGY DEVELOPMENT, ORGANISATIONAL AND PROCESS CONSULTING

FOR QUALITY MANAGEMENT

CONSILIO ET OPERA consults your quality management department on the following topics:

Initial setup of a lean QMS according to ISO 9001, ISO 13485, MDR, IVDR, FDA 21 CFR part 820 or Medical Device Single Audit Program (MDSAP)
Development of resource-saving integrated management systems (in conjunction with ISO 14001, EMAS, sustainability management system resulting from CSRD/ESRS)
Further development of a QMS compliant to ISO 9001 towards ISO 13485 compliance
Further development of the quality policy in cooperation with the management board
Optimization of QM-processes towards leanness and efficiency

ON ENVIRONMENTAL MANAGEMENT, EMAS AND SUSTAINABILITY MANAGEMENT

CONSILIO ET OPERA advises you on your environmental management system (EMS) according to ISO 14001 or its extension to the Eco-Management and Audit Scheme “” (EMAS) as well as your sustainability management or your non-financial sustainability reporting according to the “Corporate Sustainability Reporting Directive” (CSRD) Basis of the “European Sustainability Reporting Standards” (ESRS). Our consulting services extend to:

Environmental Management System (EMS) according to ISO 14001

Initial inventory & gap analysis
Definition of environmental objectives and environmental policy in line with the corporate strategy
Development of an action plan for the gradual achievement of environmental goals
Structure of the management system
Planning of communication & training concepts
Conception of internal audits
Development of an Environmental Metrics System (environmental indicators)
Planning of corrective and improvement measures
Development of a concept for regular compliance checks
Extension of the ISO 14001 strategy to new business units or locations
Planning of the link with other management systems (e.g. based on ISO 9001, ISO 13485, sustainability management in the context of CSRD / ESRS)

Extension of the environmental management system to EMAS

Gap analysis between ISO 14001 and EMAS
Consulting on corporate strategy & stakeholder integration
Planning for additional requirements (e.g. internal environmental audit, environmental statement)
Integration of EMAS into existing corporate policies
Planning of an environmental performance measurement system
Harmonisation of EMAS environmental data for efficient use in CSRD / ESRS reporting
Conception of adjustments in finance and controlling
Personnel & training planning
Integration into an overall system with other management systems (e.g. based on ISO 9001, ISO 13485, sustainability management in the context of CSRD / ESRS)

Sustainability management system in the context of CSRD / ESRS and the associated non-financial sustainability reporting

Gap analysis between existing sustainability management and ESRS reporting requirements
Materiality analysis
Stakeholder & risk analysis
Development of ESG targets
Planning of sustainability governance & internal responsibilities
Conception of ESRS reporting & data management
Advice on compliance & lean integration together with other management systems (e.g. according to ISO 9001, ISO 13485, ISO 14001, EMAS, ISO 50001, ISO 45001) into an efficient overall system
Continuous improvement of the sustainability management system (incl. benchmarking and KPI definition)

IN ENERGY MANAGEMENT

Consulting in strategic planning and definition of measures for your energy management system according to ISO 50001 by CONSILIO ET OPERA includes:

Support for the development of energy policy
Participation in the definition of measurable energy targets and action plans
Implementation of energy assessment and identification of significant energy consumers
Planning of responsibilities and powers in the EnMS
Implementation of a risk and opportunity assessment and planning of measures
Definition of energy performance indicators (EnPIs) and methods for monitoring
Preparation of the audit program and definition of the audit methodology
Creation of a plan for training and qualification of employees
Planning of regular management review to ensure the effectiveness of the EnMS
Consulting on the integration of the energy management system (EnMS) together with other management systems (e.g. according to ISO 9001, ISO 13485, ISO 14001) into an efficient overall system

MANAGEMENT OF SAFETY AND HEALTH AT WORK

CONSILIO ET OPERA offers the following consulting services for your occupational health and safety management system according to ISO 45001:

GAP analysis and determination of the actual state
Support of the top management in the development of occupational health and safety policy
Participation in the identification & evaluation of risks & opportunities
Identification of legal & other requirements
Advice on the definition of occupational health and safety targets & measures for target achievement
Structuring of the documented information
Planning of internal & external communication
Training & awareness planning
Support in the definition of operational control processes
Development of an internal audit plan
Planning of management review
Emergency & crisis management planning
Consulting on the integration of the occupational health and safety management system (OH&S-MS) together with other management systems (e.g. according to ISO 9001, ISO 13485, ISO 14001) into a lean overall system

FOR REGULATORY AFFAIRS

The Regulatory Affairs function of medical device manufacturers supports CONSILIO ET OPERA in advising on:

Development of options for action with regards to product registration strategies
Revision of documents required for the conformity assessment / registration of medical devices / in vitro medical devices
Assessment of claims on medical devices / in vitro medical devices and elaboration of recommendations on compliant communication

FOR MARKETING, SALES AND MANAGEMENT OF STRATEGIC BUSINESS UNITS

CONSILIO ET OPERA’s consulting services to companies from the fields of medical technology and in vitro diagnostics on marketing and sales as well as the control of strategic business units include:

Conception of the marketing and sales strategy
Process optimization and performance management in sales
Planning of product launches
Analysis and further development of the overall strategic concept
Development of measures to support the existing medical device portfolio
Planning the new development of medical devices/in vitro diagnostics according to customer needs
Cross-functional process optimization (lean administration and lean production)

CONSILIO ET OPERA GUARANTEES

WARRANTY OF CONFIDENCE

If your company has signed a service contract and is not a 100 % satisfied with our performance, it is free to terminate it with immediate effect.

TELEPHONE SUPPORT

Once your company has given a mandate for consulting or project / interim management it will receive a voucher for 2 hours of telephone consultation in addition to each weekly working contingent (40 hours) ordered. A voucher can be redeemed within one year of issue.

OUR QUALITY MANAGEMENT SYSTEM

PERSONNEL SEARCH

Our strategic alliance partners include independent personnel agencies and freelancers. This offers you the advantage that we can support your personnel search through our network also when you are dealing with large projects. The precondition for this, however, is that our company will be engaged in the same project as these additional external human resources.

YOUR GOALS ARE OUR MISSION

YOUR GOALS ARE OUR MISSION