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Japan PAL QMS Audit Experience

B

BarryTaylor

#1
As a UK manufacturer, we have been providing orthopaedic implants to the Japanese market for many years. We now understand from our Japanese subsidiary that our UK manufacturing site will be subject to a PAL (periodic?)QMS audit. We have regular NB ISO 13485 audits with minor/no NCs and our last FDA QSR inspection was 483 free.
....However, I am nervous as I do not know what to expect because have no contacts with experience of a Japanese medical devices QMS audit. I can find little on the internet.

It would be great if somebody who has recently experienced could suggest say, their 5 greatest challenges/surprises/opportunities regarding their audit.

Thanks Barry
 
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rangani_rj

Involved In Discussions
#3
Re: Japan PAL QMS Audit Experience?

Hi Barry,
I could say only, Japanese PAL Ministry Ordinance # 169 is (QMS) is developed based on ISO 13485, so there may be less difference but I don't have real experience with QMS audit so I can?t comment on challenges.

For the difference between these two, type keywords in Google ?Differences Between Japanese QMS and ISO 13485?. You will get PDF. I can?t share PDF here as it may be copyrighted.

Also here in elsmar, follow below pathway or type above same keywords in search box, you will get some knowledge of Japanes QMS
The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Regulations
Japan Medical Device Regulations
Go to page 3 you will find difference between QMS and ISO 13485.

Have a nice day :)
 
B

BarryTaylor

#4
Re: Japan PAL QMS Audit Experience?

Thank you Rangani
I do have Ordinance # 169 and gap analysis. I am hoping there is somebody out there with real experience of hosting a Japanese audit. There are the regulations.......but also interpretation of requirements during the audit. I try to plan well and would like to minimize surprises for both the auditors and ourselves!

Thanks again
 
B

BarryTaylor

#6
Re: Japan PAL QMS Audit Experience?

Just feed back after our Japanese PAL audit
1. The audit was very much a compliance based audit to the requirements of Ordinance 169. Note the Ordinance is being revised with the publication of the new version being imminent. I understand it approximates ISO 13485 even more than the current version.
2. The Japanese auditors/inspectors were very reasonable. There were a number of issues where our evidence and perhaps the translation misrepresented real life, resulting in adverse observations. They were happy to be convinced by the evidence being explained again or further evidence being provided to substantiate compliance.
3. We were surprised by the audit team spending a lot of time in comparing of (very old) submissions by our Japanese subsidiary with current DMR.
4. The audit was managed well, end of day meetings used to resolve any issues, meaning the closing meeting held no surprises. The team left us with 6 draft NCs which they said may be reduced after review. Indeed, they subsequently submitted 1 NC.

Hope this may be of help to anyone subject to their first Japanese QMS audit
 
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