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ISO 13485

The original basis of norm ISO 13485, as declared in the text itself, is ISO 9001. Its standards structure is, in fact, identical in form to ISO 9001 and shows how, when compared to other standards systems such as those of the automotive sector, 13485, there is, effectively in practice, a standard for quality management systems with additional and/or particular specific requirements compared to ISO 9001. 

The requirements are substantially identical to ISO 9001 and are added to only by the strict connection with medical devices, so the requisites with which they comply also require the specific cogent requisites of the medical sector including territorial (national or regional) prescriptions or regulations.

The great degree of flexibility in QualiWare makes it particularly appropriate for the management of the parts to be added required by ISO 13485, such as, for example, the provision of a specific archive of requisites and characteristics of the medical devices.

From what has already been announced it clearly emerges that ISO 13485 requires the management of a quantity of information (documents and registrations) higher than what is normally required for  an ISO 9001 system. The same concept of control and traceability is applied, implicitly, to these documents and registrations that is naturally applied to products.

It is therefore evident that having an IT support which is capable of organizing information and guaranteeing its safe conservation and traceability is an obvious choice for firms which decide to seek certification under ISO 13485.

QualiWare, with its all-round completeness already manages to manage systems (even complex ones) in accordance with ISO 9001: in the case of ISO 13485 the software’s standard modules can be used with only the slightest adaptations to the specific situation of the company in question. Using the Form Designer the specific management tools required for the particular medical devices produced by the firm can be created (traceability modules, field information gathering, recording of operations, etc.).

All managed by a single database and in a controlled manner, something which isn’t possible if you rely  on the traditional Office tools for your information management. As we have seen, ISO 13485 requires a series of procedures much greater than ISO 9001 and a registration system which is just as big.

QualiWare’s powerful document management module lets you look after all these procedures, as well as all the other support documents (operating instructions, manuals, not only of the system but also of the product) also with personalized workflows which are different depending on type.

The need to understand what is registered and the related storing of data, including that of the external commercial structure, can be met using QualiWare web functions which allow you to register and store even via internet, and thus not at your client’s or distributor’s premises. QualiWare’s research and document organization tools are everything you need to manage, in a simple way, also return information (categorizable and easily findable by product, by type, by client, by geographical location, by medical application, etc…).

Also the Planning management module can turn out to be useful for keeping track of project progress, of the various checking stages, revisions and validations, and all connected documentation (internal and external).

Finally, the new Revision management module (and not only the Direction version) can surely be a valuable management support inasmuch as revisions themselves make up a large part of the standard and must therefore be handled dynamically, with decisional generation which can lead to preventive and improving corrective action or which brings and keeps the product/service up to scratch. The standard requires several of these (direction, validation, etc…) thus their correct performance is a considerable strong point.