Clear differences between ISO 13485 and AS 9100D requirements

DuncanGibbons

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#1
I've tried to identify clear differences in requirements between ISO 13485 and AS 9100D. Below are the clauses in AS 9100D that are unique to AS 9100D and have no matching clauses in ISO 13485:

7.1.2 People
8.1.1 Operational risk management
8.1.2 Configuration management
8.1.3 Product safety
8.1.4 Prevention of counterfeit parts
8.5.1.1 Control of equipment, tools and software programs
8.5.1.2 Validation and control of special processes
8.5.1.3 Production process verification

I determined these by critically searching for similar requirements in ISO 13485. Can any confirm that these are unique to AS 9100D, or if they disagree and know of clauses/requirements in ISO 13485 that fulfil these clauses for medical?

My focus is on the "Validation and control of special processes" requirements.
 
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QE1993

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#2
My company is certified to both AS9100/9001 and ISO 13485, so this thread will be very helpful to me. Below are some of my thoughts.

7.1.2 has the same intent as 6.1 13485
8.1.1. Operational risk management is spoken about in 7.1 Product realization risk management (which would encompass operational risk)
8.5.1.1 has similar intent as Monitoring and Measurement of product and processes in 13485 and 7.6 control of M&M equipment
8.5.1.2 is 7.5.6 in 13485, along with some sprinkling of 6.2 in regards to qualified personnel.
 

DuncanGibbons

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#3
I have your ISO 13485 suggestions correlated elsewhere to different requirements of AS 9100D. I was quite "strict" when correlating requirements between the two standards, do the audits follow the standards stringently or to they apply a bit of intuition as well?

An example being, I have 7.5.6 (ISO 13485) correlated to the general requirements stated in 8.1 & 8.5.1 (AS 9100D), these requirements matchup almost word for word. But as for 8.5.1.2 etc. I find these requirements are aerospace specific.
 

QE1993

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#4
We have two different quality manuals for AS and 13485, which isn't the most value added way to go IMO, but it certainly makes it easier, so I have not necessarily done a strict clause to clause correlation, although maybe I should.

I do not find 8.5.1.2. unique to AS9100. Again, you said you're being "strict" with the correlation, so I'm not sure if you're comparing word to word, but 8.5.1.2. AS is all about validating special processes (where the resulting output can not be verified), which is also the requirement of 7.5.6. Can you tell me why you think 8.5.1.2 is unique to AS?
 

DuncanGibbons

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#5
I was under the impression that 8.5.1 relates to normal processes and 8.5.1.2 to special processes, ie requiring separate procedures for each. It seems for 7.5.6 of ISO that only one procedure is needed for processes generally, hence why the correlation is almost word for word between 7.5.6 and 8.5.1 stemming from ISO 9001 I imagine. Of course, this is purely from me just reading the two standards, I could be misinterpreting it.

Are there any clauses/requirements you can think of that are completely unique to AS 9100D of the top of your head?
 
#6
Hello Everyone:

I would like to get some idea about one could address the event where the product is a biochemical, the customer is the DOD, the manufacturing environment is cGMP and the DOD guidance is AS9100 / FAR? It appears that the ISO 13485 would be applicable with some modification for the product being controlled by the FDA. AS9100 would require attention be given to "Counterfeit components", Domestic Sources for Chemicals, Continuous Improvement, and FAI. Your thoughts on the appropriate standard(s) for this application.

George
 

DuncanGibbons

Involved In Discussions
#7
Hello Everyone:

I would like to get some idea about one could address the event where the product is a biochemical, the customer is the DOD, the manufacturing environment is cGMP and the DOD guidance is AS9100 / FAR? It appears that the ISO 13485 would be applicable with some modification for the product being controlled by the FDA. AS9100 would require attention be given to "Counterfeit components", Domestic Sources for Chemicals, Continuous Improvement, and FAI. Your thoughts on the appropriate standard(s) for this application.

George
Does the DoD require you as the supplier to be AS9100 certified for an FDA regulated product?
 
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