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MANAGEMENT SYSTEM

Quality

Accountability, autonomy and expertise to properly manage the business processes

Our

CERTIFICATIONS

Alse Medica was certified UNI EN ISO 9001:2000 in 1999, updated UNI EN ISO 9001:2015 on Oct. 26th, 2017, certificate UNI EN ISO 9001:2015.

IN 2018 IT WAS ALSO CERTIFIED ISO 14001:2015

Alse Medica management system is organized in such a way as to:

 

  • consistently promote policies supporting business quality;
  • ensure the correct retention of all internal and external documents;
  • assess the compliance of documents and product release;
  • guarantee after-sales service according to current legislation.

Alse Medica has defined responsibilities, job descriptions, tasks and mutual relations of all personnel; it checks on the activities impacting the quality of the service offered; it sets out procedures that allow the staff to act with proper autonomy and knowledge in order to:

 

  • promote the necessary actions to prevent cases of non-compliance relevant to service or processes;
  • identify and record every issue related to service and management processes;
  • propose, offer and initiate solutions through clear and appropriate communication channels within the company;
  • check on the implementation of solutions;
  • monitor the non-compliant event until a corrective action is taken.

To this purpose the Organization Chart and relevant job descriptions have been defined (and are updated in case of major internal changes). At customer request, Alse Medica can provide a copy of the company organization chart with both titles and names.

CORRECTIVE AND PREVENTIVE ACTIONS

ALSE MEDICA has defined documented methodologies to prevent or eliminate, should they occur, cases of non-compliance by effectively taking action against their causes through:

  • Identification of the causes of real non-compliance cases.
  • Management of products, processes and services involved in non-compliance events as a consequence of a Non-compliance Report or a Customer Complaint.
  • Development of corrective measures able to eliminate or minimize the causes of non-compliance (including the definition of activities, resources, responsibilities, timescale and checking procedures).
  • Implementation of corrective measures.
  • Review of the effectiveness of corrective measures.
  • Any company function, depending on the site and severity of the non-compliance event, may request a corrective/preventive action. Such request is filed on internal forms.

The person in charge of Quality management reviews the information provided and determines whether to initiate the Corrective/Preventive Action which will then be handled by an appropriate Improvement Group.