Certification
ISO 13485

Guarantee the quality of medical devices

La ISO 13485 is a specific quality management system standard for companies of the medical sector, which includes aspects of the standard ISO 9001 and specific requirements for the of medical devices.

The European Directive 93/42 / EEC regulates medical devices which include a very wide range of substances and products: a medical device is in fact any instrument, device, implant, substance or other product, used alone or in combination, including software computer used for correct functioning, intended by the manufacturer to be used in humans for the purpose of:

diagnosis, prevention, control, therapy or mitigation of one disease;
diagnosis, control, therapy, alleviation or compensation of a wound or a handicap;
study, replacement or modification ofanatomy or of an physiological process;
of intervention on conception, which product does not exert the main action, in or on the human body, for which it is intended, by pharmacological or immunological means or by metabolic process but whose function can be assisted by such means.

La Certification ISO 13485: 2016 Medical devices-Quality Management Systems - Requirements for regulatory purposes, is a standard harmonized with the European Directives on Medical Devices. The standard specifies i requirements for a quality management system in cases where an organization has to prove its ability to supply medical devices and related services that meet customer requirements and meet regulatory needs regarding medical devices and related services. The standard was created with the intention of merging the previous ISO 13485 and ISO 13488 together by integrating and updating their contents.

Advantages for the company that certifies itself

The advantages for manufacturers of Medical Devices subject to conformity assessment procedures with the intervention of the Notified Body concern a direct and independent verification preparatory to any market surveillance activities carried out by the Ministry of Health
For companies that distribute or market medical products and for companies that provide services related to devices, the ISO 13485 certification has the advantage of representing a direct and independent verification of the activities, as well as allowing them to participate with greater chances of success in public administration tenders
Finally, for Users, Customers, Patients, the Quality Management System Certification in the medical field testifies to the efforts by the Organization for the supply of products / services in line with the state of the art required by laws and regulations, through the application of tested organizational models aimed at continuous improvement

Certification Process

1) Definition of the contract

> Request for an offer from the customer interested in certification

> Acquisition of all the information necessary for the certification and issue of the offer by AX-REGISTER

> Acceptance of the offer by the customer

2) Preliminary audit (on request not compulsory)

> Analysis of any gaps and assessment of the current compliance of the ISMS with the regulatory requirements

3) Initial Audit

> Verification aimed at evaluating the implementation of the principles and structure of the Management System (applicable legislation and regulations, security policy, risk analysis, Statement of Applicability (SoA), clear and consistent definition of the purpose, risk treatment plan)

4) Certification Audit

> Verification aimed at evaluating the adequate and effective implementation of the Management System, through techniques that involve the analysis of documents, observations, interviews with personnel.

> This verification is aimed at issuing the certificate

5) Surveillance Audit

> Audit carried out annually after certification, to check continuous improvement

6) Certification Renewal Audit

> The Renewal Audit is carried out after three years following a complete verification or continuous evaluation over time.