Do ISO 9001 and ISO 13485 have requirements for Shelf-Life?

[NikkiQSM]

Sorry to ask probably a simple question - but i was unable to find the exact answer in any of the threads.

Is shelf-life a requirement of ISO 9001:2008 or 13485?

I keep re-reading the standards and in 13485 - 7.5.5 - I guess you could technically say that it does depending on how you take what is stated.

Thanks in advance!

 

[AndyN]

Re: Do ISO 9001 and 13485 have Requirements for Shelf-Life?

Not specifically - they can't "require" it - however, there IS a requirement that the organization take care of the product in 7.5.5. - "constituent parts"

 

[Marc]

Re: Do ISO 9001 and 13485 have Requirements for Shelf-Life?

There are two aspects here - One is shelf life of completed "products", and the other is shelf life of "parts" or materials which are used to make the product.

Which one are you referring to?

 

[NikkiQSM]

Re: Do ISO 9001 and 13485 have Requirements for Shelf-Life?

Completed Product.

 

[Mark Meer]

Interesting... I've always just presumed that defining a shelf-life for product is appropriate in most cases. ...but you're right, I can't seem to find an explicit requirement for this anywhere in these QMS standards (ISO 9001, 13485), nor in FDA or European regulations.

The regulations, however, do make use of terms like "useful life", "expected life", or "lifetime of the device as indicated by the manufacturer". ...which seems to imply that these are defined somewhere.

That being said, if you're in the world of electrical medical devices, then likely you'll be applying the IEC 60601-1 standard which does have an explicit requirement: "4.4 The MANUFACTURER shall state the EXPECTED SERVICE LIFE of the ME EQUIPMENT or ME SYSTEM in the RISK MANAGEMENT FILE."

 

[Michael_M]

Re: Do ISO 9001 and 13485 have Requirements for Shelf-Life?

In AS9100C (which is ISO9001:2008 with added specifications), 7.5.5 does referance "Shelf life control and stock rotation". Again, this is specific to AS9100C but is under 7.5.5.

This is slightly off topic, but AS9100C has the following under 7.5.5

A. Cleaning
B. Prevention, detection and removal of foreign objects
C. Special handling for sensitive products
D. Marking and labeling
E. Shelf life control and stock rotation
F. Special handling for hazardous material

I would like to say the AS standard added these because the ISO did not specify it well enough (but I don't know why ISO or AS does anything).

 

[Vthouta]

This is really a good question that has no definite answer available in either of these ISO standards. This is purely customer driven in most cases for a finished product.

But, coming to shelf life of parts or materials are generally addressed in customer blueprints, specifications and sometimes on the purchase order.

 

[Marc]

Design requirements are typically where product shelf life is defined for the end product. Years ago I wrote what were at the time called "Environmental Design Criteria Test Plans".

Note that EDCTPs applied to what we are calling "shelf life" which is not related to "useful life" or such.

Shelf Life is typically defined as how long a product can be stored prior to use. The exception would be medicines and chemicals where "shelf life" often includes an expiration date for opened containers which are typically shorter than for unopened containers.

In the "old days", when I wrote EDCTPs, I had to consider storage aspects such as temperature, humidity, as well as integrity tests such as effects of transportation (typically sine and random superimposed vibration and often shock tests), elevation, etc. Often even susceptibility to fungus growth was included to address tropical environments.

I write this only as "food for thought" about what I think most people think of as "shelf life".