ISO 13485 - Controlling Production and Service Provision - Product Catalogues

[acro14]

Hi there,

the iSO 13485 talks of controlling production and service provision. If you have to set up a product catalogue which is made available to customers to sell goods would that be a service provision or just a means of marketing? Does the process need to be controlled? I will appreciate your help.

acro14

 

[somashekar]

Re: ISO 13485 - production and service provision

Hi there,

the iSO 13485 talks of controlling production and service provision. If you have to set up a product catalogue which is made available to customers to sell goods would that be a service provision or just a means of marketing? Does the process need to be controlled? I will appreciate your help.

acro14

Product catalog is an output of design and development, that serves the marketing. Its a product that your production process may not make, but perhaps out sourced and can be in hard / soft form. As an information supplied to the customer (potential customer) its correctness and completeness is utmost important and can also give you regulatory risks if not correctly represented. You need to control and have a good hold on its volume and distribution.

 

[DEVigil]

Re: ISO 13485 - production and service provision

We control ours as promotional labeling under our labeling controls procedure, if that helps.

 

[regork]

acro14,
ISO 13485:2016 4.2.3 Medical Device File requires documentation and control of product labeling. The product catalog that you describe would be considered "product labeling". I also recommend that you review specific country regulations for product labeling.