SS-EN ISO13485 Work Instruction Requirements for Dentures

CK12345 · #1 20th July 2012, 04:15 AM

Hello!

Luckily for me, I found this awesome forum and it already makes my work a lot easier.
Thanks all!

And now to my question...

In ISO 13485, about work instructions:
Can I write "all work is done according to the order (from the dentist), and all material is used according to the instructions from the manufacturer"?
We are a company that creates dentures.
If we have to write more "in-depth" instructions, it will take too much time and effort keeping it updated, since we change materials (and in that case, work instructions) pretty often.

Sorry for my bad English.

Thanks again!

**DannyK** · #2 20th July 2012, 07:02 AM

Hello CK12345,

You could if the order provides all the detailed information required and the manufacturer's instructions are complete and accessible

CK12345 · #3 20th July 2012, 07:24 AM

Thanks for the answer!

I will put the instructions from manufacturers on every department.

	The Deming PDCA Cycle	ISO 9001 QMS Implementation	FMEA Information	APQP Information
Auditing Information	8-D Problem Solving	Statistics	Error Proofing (Poka Yoke)	Brainstorming
Identifying Waste	Pull Systems	Lead Time Reduction	Planned Maintenance	Quick Setup
Discovering Change	Process Capability - Cp vs. Cpk	Histogram Animation	Process Loop Animation	Taguchi Loss Function
		Fishbone / Cause and Effects Animation