Quality Policy: ISO 13485 vs. ISO 9001 (or AS9100 or..)

Doug Tropf

Quite Involved in Discussions
#11
An update to this post....

During my company's recent ISO 13485 initial registration audit, the auditor didn't bring up the improvement aspect but he did question the quality policy as it did not addresss meeting regulatory requirements.

I did some web surfing and found a couple of quality manuals for ISO 13485 certified companies. None of them had anything about meeting regulatory requirements listed in their quality policy.

Guess it depends on who audits you on any given day.
Under 5.3, 13485 states that the QP includes a commitment to comply with requirements. ISO 14969 adds that the QP establish a commitment to quality and the continuing effectiveness of the QMS to meet customer and regulatory requirements.

FWIW our quality policy does contain a statement about meeting regulatory requirements.
 
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J

Jim-S

#12
Annex B of ISO 13485:2003 states that "Continual improvement of the quality management system is not a current objective of regulations." This is under section 8.5.1 of Annex B.
 

RCW

Quite Involved in Discussions
#13
Update:

I just had a customer audit and the "auditor" jumped on my back for not having "to maintain the effectiveness of the quality management system" in my quality policy. (Once again, we are both ISO9001 & ISO13485 registered.)

I think I will revise my q.p to say:
"We'll do whatever you, the customer, wants.....now get off my back!"

Short, sweet and to the point.
 

howste

Thaumaturge
Super Moderator
#14
Are you allowed to post your policy statement here? I'd be interested to see what it does contain before I rant about how your customer auditor doesn't understand the requirements...
 
Q

Qualqueen

#15
Update:

I just had a customer audit and the "auditor" jumped on my back for not having "to maintain the effectiveness of the quality management system" in my quality policy. (Once again, we are both ISO9001 & ISO13485 registered.)

I think I will revise my q.p to say:
"We'll do whatever you, the customer, wants.....now get off my back!"

Short, sweet and to the point.
Hi RCW,
My shop is also 9001/13485. This is from our QMS:
XXX, Inc. has established, documented, implemented and maintains the effectiveness of its Quality Management System (QMS) in accordance with ISO 13485:2003 while striving to continually improve upon our processes for the betterment of our company and our products. We accomplish this mission in accordance with ISO 13485:2003, ISO9001:2008 and our own internal management guidelines.
Haven't been questioned yet.
 

RCW

Quite Involved in Discussions
#16
Howste - unfortunately I can't post it here.

Qualqueen - Your q.p. nails it perfectly! I can see why nobody has questioned it.


Looks like I need to tweak my q.p. again.
 
D

dullim

#17
Re: Quality Policy:ISO 13485 versus ISO 9001 (or AS9100 or..)

I have doubt whether we can put "Continuous Improvement" under ISO 13485:2003 because we use ISO 9001 as a platform. Some expert in this industries mentioned that as long as we can maintain the product effectiveness even we do continuous improvement, its not big issue
 
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