Incorporating incoming procedures (ISO9001:2008) with ISO 13485:2003

T

theva

Involved In Discussions
Dear Covers,

How do we incorporate incoming procedures (ISO9001:2008) with ISO 13485:2003, many thanks.
 
Marc

Marc

Fully vaccinated are you?
Leader
A quick "Bump". My Thanks in advance to anyone who can help with this one.
 
G

Gert Sorensen

There are a few differences between ISO 9001 and ISO 13485. These are listed in Annex B of ISO 13485:2003. Use the table to identify the additional procedures that you need to have in place - there are not that many, so it should be a reasonable task.
 
somashekar

somashekar

Leader
Admin
theva said:
Dear Covers,

How do we incorporate incoming procedures (ISO9001:2008) with ISO 13485:2003, many thanks.
Click to expand...
Hi Theva.
Pretty much same. Pay attention to traceability as medical device risk management will bank a lot on proper traceability for complaint matters.
Where you have no resource for inspection, identify the same and ensure supplier provides evidence of inspecting the supplied parts meeting your specification.
At certain places safety marks on components purchased is a requirement where you mark your medical device with safety mark of test labs like UL / CSA / ETL / TUV or such other. Refer to the product file given by your test lab and incorporate such requirements into your incoming procedures
 
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