The Cove Business Standards Discussion Forums
Having got ISO 13485:2016 are you dropping ISO 9001?
UL - Underwriters Laboratories - Health Sciences
Having got ISO 13485:2016 are you dropping ISO 9001?
Having got ISO 13485:2016 are you dropping ISO 9001?
Having got ISO 13485:2016 are you dropping ISO 9001?
Having got ISO 13485:2016 are you dropping ISO 9001?
Having got ISO 13485:2016 are you dropping ISO 9001?
Having got ISO 13485:2016 are you dropping ISO 9001?
Having got ISO 13485:2016 are you dropping ISO 9001?
Having got ISO 13485:2016 are you dropping ISO 9001?
Having got ISO 13485:2016 are you dropping ISO 9001?
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Having got ISO 13485:2016 are you dropping ISO 9001?


Monitor the Elsmar Forum
Sponsor Links




Courtesy Quick Links


Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services


Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC



International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags
iso 13485:2016, iso 9001:2015, multiple standards in a company
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 8th February 2018, 06:23 AM
Dave-h's Avatar
Dave-h

 
 
Total Posts: 57
Question Having got ISO 13485:2016 are you dropping ISO 9001?

All of our products are medical devices and we sell only into the medical world. With the divergence of the two standards we are planning to drop 9001, although there are some customers around the world who do not yet understand 13485 and still ask for 9001.

Does anyone have any experience of dealing with those customers who seem to think that 9001 is the only game in town?

Thanks.

Sponsored Links
  Post Number #2  
Old 8th February 2018, 11:30 PM
Marc's Avatar
Marc

 
 
Total Posts: 26,502
Re: Having got ISO 13485:2016 are you dropping ISO 9001?

Anyone? Your response is appreciated! My Thanks in advance!
  Post Number #3  
Old 9th February 2018, 10:58 AM
Edward Reesor

 
 
Total Posts: 79
Re: Having got ISO 13485:2016 are you dropping ISO 9001?

We are medical device manufacturers and sell only to medical device distributors and have always had 13485 only. Mind you we also conform to 14971 and a whole bunch of standards that are directly related to the devices that we manufacture. To my knowledge, we have never had anyone balk at the fact that we are not 9001 certified (especially when shown that they are all voluntary anyway).

I was filling out the (newer) Health Canada MDL amendment form and noticed that it had a declarations where you confirmed a) that you had certain certifications, or b) that your products conformed to some other standard with objective evidence or has been tested for safety and effectiveness. (see page 7, section 15 of the Class II MDL Amendment Application Form).
Thank You to Edward Reesor for your informative Post and/or Attachment!
  Post Number #4  
Old 9th February 2018, 08:18 PM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 6,206
Re: Having got ISO 13485:2016 are you dropping ISO 9001?

Quote:
In Reply to Parent Post by Dave-h View Post

All of our products are medical devices and we sell only into the medical world. With the divergence of the two standards we are planning to drop 9001, although there are some customers around the world who do not yet understand 13485 and still ask for 9001.

Does anyone have any experience of dealing with those customers who seem to think that 9001 is the only game in town?

Thanks.
Yes, I have heard of few organizations that have decided to surrender their ISO 9001 which they had just as an added feather in the ISO 13485 cap !

At one of my clients, there was only one client who wanted the ISO 9001 but we convinced them of our continuation of ISO 13485 cert only and an assurance to comply with their requirements.
Thanks to Ajit Basrur for your informative Post and/or Attachment!
  Post Number #5  
Old 10th February 2018, 02:09 AM
John Broomfield's Avatar
John Broomfield

 
 
Total Posts: 2,592
Lightbulb Re: Having got ISO 13485:2016 are you dropping ISO 9001?

Quote:
In Reply to Parent Post by Dave-h View Post

All of our products are medical devices and we sell only into the medical world. With the divergence of the two standards we are planning to drop 9001, although there are some customers around the world who do not yet understand 13485 and still ask for 9001.

Does anyone have any experience of dealing with those customers who seem to think that 9001 is the only game in town?

Thanks.
Dave,

Are you including your sales team in this potentially risky decision?

They may say that retaining evidence that your organizationís management system also conforms to ISO 9001 is still a worthwhile investment.

...how much extra does it cost?

Until your customers are up to speed on ISO 13485, this question may end up being a recurring item on the agenda of management reviews.

Best wishes,

John
Thanks to John Broomfield for your informative Post and/or Attachment!
  Post Number #6  
Old 10th February 2018, 08:54 AM
isolytical

 
 
Total Posts: 24
Re: Having got ISO 13485:2016 are you dropping ISO 9001?

The customer voice and the sales/marketing input are good clues as to how to proceed. When this comes up my answer is usually 'customer education', when the details are not known.
To that end, the explanation, since you are a device manufacturer, is that you are required to follow FDA regulations, namely 21CFR820, and others. Since about 2002-2003 the FDA has harmonized the QSR with ISO13485. With the divergence, the regulations 'favor' using ISO13485.
And if selling into the EU, ISO13485 supports those registrations too.
Thanks to isolytical for your informative Post and/or Attachment!
  Post Number #7  
Old 12th February 2018, 11:41 AM
Cathy McFadden

 
 
Total Posts: 2
Re: Having got ISO 13485:2016 are you dropping ISO 9001?

Dave, we are also dropping 9001, so far we have not had any negative feedback.
Thanks to Cathy McFadden for your informative Post and/or Attachment!
  Post Number #8  
Old 12th February 2018, 03:09 PM
MKS Compliance

 
 
Total Posts: 1
Re: Having got ISO 13485:2016 are you dropping ISO 9001?

We are 100% medical device contract manufacturer and dropped ISO 9001 at our surveillance audit in 2017. No issues from a customer standpoint or notified body perspective. No sense in continuing with ISO 9001 based on our business focus.
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
ISO 13485:2003 vs. ISO 13485:2016 Differences Comparison al40 ISO 13485:2016 - Medical Device Quality Management Systems 4 18th April 2018 11:00 AM
Does anyone have a comparison between ISO 9001:2015 and ISO 13485:2016? al40 ISO 13485:2016 - Medical Device Quality Management Systems 2 2nd March 2017 01:38 PM
EN ISO 13485:2016 vs. ISO 13485:2016 - Unannounced MDD Audit yesterday Shamann2 ISO 13485:2016 - Medical Device Quality Management Systems 4 2nd February 2017 12:13 AM
Need for ISO 9001:2015 if we are ISO 13485:2016 DianaBC EU Medical Device Regulations 4 12th January 2017 03:31 AM
Migration (Transition) to ISO 13485:2016 from ISO 13485:2003 sriramsl ISO 13485:2016 - Medical Device Quality Management Systems 1 27th October 2016 02:46 PM



The time now is 02:23 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"