Do you need to manage or implement an ISO 13485 or 9001 Quality System?

Is my Quality System complete? 

How to formalize a new procedure? 

How can I meet the recommendations of the notified body? 

Is my SdQ compliant with the new edition of the standard?

...


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The ISO standards are technical standards developed by international commissions and possibly implemented at continental (EN) and national (UNI) levels. They are basically extremely useful guidelines for any company to obtain services, products and production processes that comply with the objectives set and the purpose for which they were designed. 

In such a complex and standardized sector as that of the biomedical sector, in particular that of medical devices, it is very advantageous to have a UNI CEI EN ISO 9001 and/or UNI CEI EN ISO 13485 certification, both for those who manufacture and for those who distribute medical devices. It is also an often mandatory requirement in customer-supplier relations and is a competitive factor of competitiveness that is appreciated and requested also during public tenders. 

However, it is important to establish a Company Quality System that can be certified by an accredited third party body, which has the task of periodically verifying that the production processes and products meet the requirements of the technical standards, aimed at satisfying and demonstrating the presumption of conformity to the mandatory standards provided for at EU and national level. 

Eumed can help you to develop from scratch a Company Quality System or to improve an already implemented one, possibly allowing internal personnel to develop the skills necessary to manage Quality in complete autonomy. 

ISO 9001 is a standard suitable for any organization that adopts an internal management system based on a standard of international value. It is not only a certificate of compliance with the requirements, but it is the tool that aims at the continuous improvement of the company, through controls and constant monitoring of processes with the primary objective of satisfying customers, partners and stakeholders of your company. The ISO 9001:2015 standard came into force in September 2015. 

The ISO 13485 standard is specifically aimed at companies that deal with the category of medical devices, thus integrating ISO 9001, which is less specific in the medical field. The primary purpose of standard 13485 is to ensure that the production, distribution and service of biomedical products are committed to creating safe, effective and innovative devices for both patients and users. The application of this standard is not compulsory, but it is the most convenient solution because certainly by applying a harmonised technical standard, the requirements are presumed to comply with the mandatory ones.  

On March 1, 2016, the ISO 13485:2016 standard was voted, with numerous modifications, additions and additional requirements in addition to the 2003 version. The relevant factor is that it is no longer aligned with the structure of the ISO 9001:2015 standard: the approach on which the 2015 version of the 9001 standard is based was not considered appropriate for a standard aimed at meeting the regulatory requirements in the field of medical devices in the international arena.  

A special effort is therefore required for manufacturers of DM with a management system certified according to both ISO 9001 and ISO 13485. In fact, for certification according to both standards, it is necessary to adopt the ISO 13485 standard as the primary reference because, as a harmonised standard according to numerous regulatory schemes in the field of medical devices (Europe, Canada, Japan, to name but a few examples), it has priority importance. 

To obtain ISO 9001 / ISO 13485 certification, the organisation must first plan and implement the quality management plan, explaining it and communicating it to all personnel, and then apply it to each sector of its activity. It is also necessary to have the appropriate documentation to be able to consult and present to the certification body at the time of inspection; this documentation must define the process of design, manufacture, distribution, maintenance and testing relevant complete with attached descriptions of the procedures applied, also highlighting their implementation. 

The certification process includes an evaluation of the documents of the quality system (manual and procedures), the degree of preparation of personnel with respect to the system implemented, and some examples of the activities carried out. The objective of the audit is therefore to examine the production system and assess the degree of compliance of the company with ISO 9001 and/or ISO 13485 by drawing up a detailed report, with any reports of non-compliance. At the end of the audit, the certificate of conformity is obtained, which is valid for three years. 

Eumed can lead you to certification by choosing the management system that best suits your organisation, whether it is a lean and flexible system or a more rigorous and vigilant one