Quality

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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 notified body TÜV SÜD which is responsible to monitor the conformity status annually by means of inspection.

Corporate Quality, Environment, Occupational Health, Safety Policy, and Energy

The growth of Comecer SpA within such complex and delicate limits as those of the design and manufacture of high-tech dispensing and containment systems in the field of Radiopharma, Pharma and ATMP requires all staff comply with maximum responsibility, maturity and professional ethics so as not to forget at any time the primary goal: that of the operator, patient and product safety as well as that of the workers, 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, inspired by the principle of risk-based thinking and 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.

Social and environmental sustainability are priorities for Comecer SpA: 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.

Therefore, Comecer SpA 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 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:

• Promote Quality, with maximum respect for stakeholders, as a strategy to achieve excellence;
• Protect Workers’ Health and Safety by ensuring vigilance and prevention, mitigating the risks present in workplaces, by following the hierarchy of controls approach according to the standard UNI EN ISO 45001:2018;
• Maintain and continuously improve a Quality Management system in accordance with the current Edition of the standard ISO 9001 and ISO 13485;
• 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;
• Continuously guide the company to fully meet customers’ needs and anticipate their future expectations;
• Apply research, monitoring, cultural and qualitative development of the supplier base, a resource required to pursue continuous improvement;
• Protect the Health and Safety of Workers by ensuring vigilance and prevention against the risks of occupational diseases and accidents, through the implementation and promotion of a Health and Safety policy;
• Maintain the professional status of all staff at the level of the tasks assigned to them, 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, drawing on the principles of UNI EN ISO 14001:2015;
• Raise awareness among contractors to adopt the organisation’s 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 at all stages of production, 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;
• Increase the use of renewable energy wherever possible, reducing CO₂ emissions;
• Comply with the applicable requirements of current Italian and European legislation on energy use in accordance with the principles of ISO 50001:2018;
• Implement appropriate measures to reduce its energy consumption;
• Support the purchase of energy efficient products and services, and to plan for improved energy efficiency;
• Improve the energy efficiency of the plant by constantly monitoring the energy vectors of the processes and by carrying out improvement projects;
• View energy consumption as a fundamental criterion when purchasing machinery, and as a key factor in the design of new processes and installations;
• Establish specific responsibilities and tasks aimed at ensuring the continuous improvement of energy efficiency, 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;
• Educate and train all the personnel working at the production site on matters of energy performance, and the measures envisaged and taken to prevent energy waste;
• Critically and objectively verify the effectiveness, adequacy, and level of application of the EMS, including the Policy itself, on a periodic basis;
• Verify the progressive improvement of the energy performance, the objectives, and the goals achieved.
• Disseminate and make available this policy to all employees and stakeholders with the main aim of fostering and encouraging, both internally and with regard to its suppliers, awareness of the environment, energy and the prevention of accidents and occupational diseases through training and disclosure, also in order to prevent the crimes provided for by Legislative Decree 231/01.

Comecer SpA is also committed to:

• ensuring that this policy is understood, implemented and supported by all stakeholders, guaranteeing adequate human, technical and financial resources to ensure the achievement of the Objectives;
• 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 to address these objectives 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.