ISO 13485:2003 Registration Audit - Management Review of major regulatory standards

[Doug Tropf]

Yesterday our company, an ethylene oxide contract sterilizer, successfully completed our assessment audit for upgrade to 13485:2003. We had one minor NCR that reads, "Although most major regulatory standards were reviewed during management review, a review of EN 550 was not documented".

I wish to express my appreciation for the Cove and those who
provide so much valuable information. I was a frequent visitor while making
preparations for our upgrade audit.

[Aaron Lupo]

Originally Posted by Doug Tropf

We had one minor NCR that reads, "Although most major regulatory standards were reviewed during management review, a review of EN 550 was not documented".

Congrats on your upgrade.

I have to ask, if you could explain the NC you received or if yur auditor provided more detail??

[Doug Tropf]

Aaron

Even though we had addressed "regulatory changes" in our Management Review meeting, the auditor questioned how we were ensuring that the regs cited in our quality manual (ISO 13485, EN 550, 21 CSR 820 and ISO 11135) had not been changed in the time period covered in out meetings. I apparently didn't give him the correct answer on EN 550. Our CAPA was to
add verbage in our Management Review procedure stating that we will verify the effective dates of the above mentioned regs and document same in our meeting minutes.

[Aaron Lupo]

Originally Posted by Doug Tropf

Aaron

Even though we had addressed "regulatory changes" in our Management Review meeting, the auditor questioned how we were ensuring that the regs cited in our quality manual (ISO 13485, EN 550, 21 CSR 820 and ISO 11135) had not been changed in the time period covered in out meetings. I apparently didn't give him the correct answer on EN 550. Our CAPA was to
add verbage in our Management Review procedure stating that we will verify the effective dates of the above mentioned regs and document same in our meeting minutes.

How do you track updates to external standards, most companies use a service for about $500 a year that will track a list of standards for them and let them know if and when any of them change.

[Doug Tropf]

I use a free service provided at www.techstreet.com to track regulatory standard changes. You can choose the standards you wish to have tracked and then be notified via email when changes to those standards occur. I also subscribe to various ezines (all free) to keep up with safety and environmental standard changes.

[bio_subbu]

Ya, absolutely what doug tropf is says is correct..

You can get free service by techstreet to track regulatory standard updates

Subbu