Obsolete Document Retention Requirements

How long does ISO 9001/13485 obligate a company to retain hard copies of approved/released documents that have become obsolete?
For example, Revisions 01 and 02 of a certain document have been replaced by Rev. 03. How long (if at all) do we need to keep/save obsolete hard copies of Rev. 01 and Rev. 02?

Clause 4.2.3.1 of ISO 14969 says that a company needs to “ensure prompt withdrawal of obsolete copies of controlled documents”. Does this mean that we no longer need to retain hard copies of the approved/released obsolete documents, or is it sufficient to simply remove them; of course, we will retain the soft copies.

Thanks a lot.

Asherlee

Re: Retention of obsolete documents

Hi

ISO 13485 clearly specifies that we need to maintain at least one copy of obsolete control copy (for any future complaint, recalls or MDRs).

Clause 4.2.3 states that "The organization shall define the period for which at least one copy of obsolete controlled documents shall be retained. This period shall ensure that documents to which medical devices have been manufactured and tested are available for at least the lifetime of the medical device as defined by the organization......"

AG Kumar

Medical Device Directive changes (for 2007/47 / EC)
"Records must be retained for 5 + years:
Records must now be maintained for inspection by the Competent Authorities for the useful life of the product or 5 years from date of manufacture, whichever is greater. For implantable devices, records need to be kept for 15 years from the time the last product was manufactured. "

JPAL MHLW 169 (Article 8 (4)) also specifies that obsolete documents to be maintained for at least 5 years from the date of obsolescence.

Great responses so far -

Thanks to all