Quality Management System

Comecer has held Quality Management System (QMS) certification since 2001. The selected reference standards are UNI EN ISO 9001 and EN ISO 13485.
This target was strongly desired by the company leadership in order to create an ordered, balanced and flexible organization aimed toward the efficient management of company processes and human resources and toward increasing standardised quality client needs.

This certification was issued by certification body TÜV SÜD which is responsible to monitor the conformity status annually by means of inspection.

Integrated Policy for Quality, Health and Safety, Environment and Energy

Social and environmental sustainability are priorities for Comecer S.p.A.: thinking about Quality, Environment, Safety and Energy means responding to a fundamental ethical principle that puts the human being at the centre of problems and any search for a solution.

The context in which Comecer operates, dedicated to the design, manufacture and installation of high-tech dispensing and containment systems in the field of Radiopharma, Pharma and ATMP, requires all personnel the utmost responsibility, maturity and professional ethics order not to forget, at any time, the primary objective: that is safety of operator, patient and product, as well as workers, come before success and profit.

In short, Safety First is the philosophy that distinguishes and identifies all the policies and actions of Comecer Spa, which has implemented a Quality, Environment, Health, Safety and Energy Management System, which takes into account risks and opportunities in order to increase the likelihood of achieving objectives and meeting the expectations of stakeholders, within the environment in which the organisation carries out its activities (principle of risk-based thinking).

Comecer S.p.A. is fully committed to the prevention of any risk, guaranteeing constant supervision of the processes and activities carried out, including those entrusted to suppliers, third-party contractors, contractors and the people in the community where it operates to ensure the safeguarding of the health and safety of workers and the community, as well as respect for and protection of the environment and the territory where it operates with its activities and the fight against climate change, with the clear intention of reducing the costs associated with the use of energy in relation to its needs, thus protecting the environment.

In this sense, the company is committed to pursuing the following objectives to:

• Promote Quality, with the utmost respect for stakeholders, as a strategy to achieve excellence, by establishing and maintaining a Quality Management System compliant with ISO 9001 (as a manufacturer of machinery) and ISO 13485 (as a distributor of Medical Devices);
• Comply with the quality requirements of the product and the service in accordance with what has been agreed with the customers and in compliance with the applicable rules;
• Improve over time the combination of cost and quality, progressing within a path of sustainable growth;
• Focus the company on meeting customers’ needs and anticipating their future expectations;
• Ensure and protect the Health and Safety of workers by guaranteeing healthy working environments and suitable safety conditions, through the prevention of occupational diseases and accidents and the implementation and promotion of a Health and Safety culture, based on the hierarchy of controls approach according to ISO 45001;
• Apply research, monitoring, cultural and qualitative development of the supplier base with whom it works, a resource required to pursue continuous improvement;
• Maintain the professional status of all staff at the level of the assigned tasks, promoting their continuous improvement in terms of skills, processes and performance;
• Encourage Consultation and Participation of workers, including through their Representatives, on the development, planning, implementation, performance assessment and actions for improvement of the Occupational Health and Safety Management System;
• Identify, assess and minimise environmental and safety risks considering the environment and factors inside and outside the company, based on principles of ISO 14001;
• Raise awareness among contractors and subcontractors to adopt the organisation principles by providing them with environmental criteria and requirements for the supply of goods and services;
• Reduce or prevent the environmental impact of products and their packaging, favouring reuse, recycling of materials and correct waste disposal, taking into account the entire life cycle of the machines built, starting from design;
• Monitor, communicate and improve their environmental performance;
• Identify, assess and manage climate change risks both at their site and along the supply chain;
• Increase the use of renewable energy wherever possible, reducing CO2 emissions;
• Comply with the applicable requirements of the current Italian and European legislation on energy use in accordance with standard ISO 50001;
• Support the design and purchase of energy-efficient products and services for improved energy efficiency;
• Improve the plant energy efficiency by constantly monitoring process energy vectors and identifying and implementing appropriate measures to reduce its energy consumption (considering energy consumption as a factor to be taken into account when purchasing new machinery, designing new processes and installations);
• Establish specific responsibilities and tasks aimed at ensuring the continuous improvement of energy efficiency and waste prevention, and the continuous updating of all the workers’ professional qualifications, especially those whose activities have a direct impact on the consumption of energy resources and on the EMS;
• Inform and train all personnel on the general performance of the Quality, Environment, Health, Safety and Energy Management System, as well as the Policy and the objectives to be achieved;
• Periodically verify critically and objectively the effectiveness, adequacy, degree of application and progressive improvement of the performance of the Management System for Quality, Environment, Health, Safety and Energy, including the Policy, objectives and targets achieved.

Comecer S.p.A. is also committed to:

• disseminating and make this Policy available to all employees and stakeholders with the main aim of fostering and encouraging, both internally and with regard to its suppliers, awareness for quality, environment, energy and the prevention of accidents and occupational diseases through training and disclosure, also in order to prevent the crimes provided for by Italian Legislative Decree 231/01;
• ensuring that this policy is understood, implemented and supported by all stakeholders, guaranteeing adequate human, technical and financial resources to make the achievement of the Objectives possible;
• keeping this policy in line with the company’s reality and technical-structural-organisational development, by periodically reviewing it;
• planning, implementing, reviewing, maintaining effective and continuously improving its Quality, Environment, Health, Safety and Energy management system while remaining true to its mission.

This policy is disseminated and communicated, through various channels, to all employees within the organisation and made available to all stakeholders working on behalf of the company in order to promote their involvement.