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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.

Safety and Quality policy

The growth of Comecer SpA within such complex and delicate limits as those of the design and construction of high-tech dispensing and containment systems in the Radiopharma, Pharma and ATMP areas requires all staff to be fully responsible, mature and professional ethics in order to never forget the first objective: safety for the operator, for the patient and for the product as well as safety for workers, even before success and profit.

“Safety First” is the philosophy that distinguishes and identifies all the policies and actions of Comecer SpA, which has implemented a Quality, Health and Safety Management System, inspired by risk-based thinking principles, which takes into account risks and opportunities in order to increase the probability of achieving the objectives and meeting the expectations of the interested parties, within the context in which the organization carries out its activities.

Furthermore, social and environmental sustainability are two other priorities for Comecer: thinking about Quality, Safety and the Environment means responding to a fundamental ethical criteria that places the human being at the center of problems and of every solution search.

Therefore, Comecer SpA makes the utmost commitment to the prevention of any possible risk, guaranteeing constant supervision of processes and activities carried out, including those entrusted to suppliers, third party contractors, contractors and people of the community in which it operates to guarantee health protection and the safety of workers and the civil community as well as respect for the environment.

Based on this, the company is committed to pursuing the following objectives:

• Promote Quality, with the utmost respect for stakeholders, as a strategy for achieving excellence;
• Prevention of the Health and Safety of workers, ensuring supervision and prevention against the risks present in the workplace, following the control hierarchy approach, according to UNI EN ISO 45001:2018;
• Define and maintain a quality management system compliant to UNI EN ISO 9001:2015 and UNI CEI EN ISO 13485:2016;
• Respect the quality requirements of product and service according with what has been agreed with customers and in compliance with the applicable standards;
• Improve over time the combination of cost and quality by processing within a sustainable growth path;
• Continuously direct the company in order to fully satisfy customers’ needs and anticipate their future expectations;
• Apply research, monitoring, cultural and qualitative development to the supplier base, a necessary resource to pursue continuous improvement;
• Keep the professional level of employees up to the tasks assigned, promoting their continuous improvement in terms of skills, processes and performance;
• Involve and consult workers and their Representatives, on the development, planning, implementatio and evaluation of performances and actions for the improvement of the OHSMS;
• Spread and make this policy available to all collaborators and interested parties with the main purpose of encouraging and boost, both internally and towards its suppliers, sensitivity to the prevention of accidents and occupational diseases, through training and communication, also in order to prevent the offenses evisaged by provided for by D.lgs 231/01.

Comecer SpA also undertakes:

• to ensure that this policy is understood, implemented and supported by all involved people, ensuring adequate human, technical and financial resources with capabilities to ensure the achievement of the Objectives
• to keep this policy in line with the company scenario and with the technical – structural – organizational development, through the periodic review of this document;
• to plan, implement, review, maintain and continually improve its Quality, Health and Safety Management System to address these objectives while remaining faithful to its mission: Safety First.