The Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
Required Documents/Records in ISO 9001:2015
UL - Underwriters Laboratories - Health Sciences
Required Documents/Records in ISO 9001:2015
Required Documents/Records in ISO 9001:2015
Required Documents/Records in ISO 9001:2015
Required Documents/Records in ISO 9001:2015
Required Documents/Records in ISO 9001:2015
Required Documents/Records in ISO 9001:2015
Required Documents/Records in ISO 9001:2015
Required Documents/Records in ISO 9001:2015
Required Documents/Records in ISO 9001:2015
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Required Documents/Records in ISO 9001:2015 - Page 3


Elsmar XML RSS Feed
Elsmar Cove Forum RSS Feed

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

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 9001:2015, required documents, required procedures, required records
Reply
 
Thread Tools Search this Thread Rating: Thread Rating: 1 votes, 5.00 average. Display Modes
  Post Number #17  
Old 8th October 2014, 05:44 AM
pldey42's Avatar
pldey42

 
 
Total Posts: 429
Re: Required Documents/Records in ISO 9001:2015

John,

4.4.f requires the organization to determine "the risks and opportunities in accordance with the requirements of 6.1, and plan and implement the appropriate actions to address them" and the last para of 4.4 requires "documented information to the extent necessary." In many but not all situations there will be something like a risk register and documented mitigation plans. In some cases these will reconcile with risks identified in 10k filings which the management system might address.

Some situations won't have documented plans. For example, if a new product idea risks diluting sales of existing product, the new idea might simply be dumped: no documented risk info, necessarily.

When documented info is used with regard to risk, it might address relevant details of processes that deal with risk under 6.1, as well as 4.4. But this would not be mandatory, the organization has the choice, of course.

9.3.1.d requires management to review the effectiveness of actions taken to address risks and opportunities; this is surely often going to be presented to them in written reports - although yes, there's no mandate for such. And 9.3.2 requires documented information on the results of management reviews which might, or might not, mention risk.

But you're right, John, the organization has huge latitude in what it documents with regard to risk and that could well be nil.

On undocumented procs being ok since 2000, yep, true - but I've lost count of the number of organizations I've audited that still have useless documentation they hope will please auditors, sometimes written for them by consultants who ought to know better - but who play it safe, because they're paid to get the organization certified and perceive less risk of certification failure if they document, document, document. "Do you actually do this?" I have often asked. "No," comes the response, "Our consultant wrote it for us." This is a culture that seems to take forever to change. It's born of fear, I think, fear of auditors (who rarely visit and are unknown quantities), fear of failing certification and increased costs of extra audits, an example of the kind of fear that Deming said should be driven out.

Pat
Thank You to pldey42 for your informative Post and/or Attachment!

Sponsored Links
  Post Number #18  
Old 8th October 2014, 06:49 AM
John Broomfield's Avatar
John Broomfield

 
 
Total Posts: 2,461
Yin Yang Re: Required Documents/Records in ISO 9001:2015

Pat,

Agreed, trying to "second guess" or please the auditor is a huge problem.

Of course, it detracts from accepting, planning, designing, operating and improving processes so they fulfill their objectives and result in services and products that fulfill customer requirements.

9001:2015's lack of specificity may make the problem of unnecessary "documented information" even worse.

John
Sponsored Links

  Post Number #19  
Old 8th October 2014, 07:05 AM
pldey42's Avatar
pldey42

 
 
Total Posts: 429
Re: Required Documents/Records in ISO 9001:2015

Undoubtedly.

Pat
  Post Number #20  
Old 8th October 2014, 07:50 AM
Marc's Avatar
Marc

 
 
Total Posts: 25,951
Yin Yang Re: Required Documents/Records in ISO 9001:2015

Quote:
In Reply to Parent Post by John Broomfield View Post

<snip> Undocumented procedures have been recognized for 14 years now but you have to study the definition of procedure. <snip>
I remember "undocumented procedure" arguments/discussions (definition of what a "procedure" is) with ISO 9001 auditors back in 1990, and I went through the "a flow chart is not a procedure" auditor "interpretation" back in 1994 in a company I worked with where we did the "required documented procedures" (and many other procedures) in a flow chart format. That one was fun...
Thanks to Marc for your informative Post and/or Attachment!
  Post Number #21  
Old 8th October 2014, 09:44 AM
AndyN's Avatar
AndyN

 
 
Total Posts: 8,459
Thumbs up Re: Required Documents/Records in ISO 9001:2015

Very interesting discussion and great comments! I too remember a round table of CB auditors (at a TickIT event) having quite heated arguments about documented procedures and how you audit that! Needless to say, each had their own ideas...

I believe that there's a dichotomy in the industry where on one hand people follow the mantra "Say what you do, do what you say" which tends to make them over document on the "say what you do" portion - which affects everyone from the "ISO in a Can" purveyors to auditors who somehow learned (in lead auditor courses etc) that the standard (apparently) requires lots of documentation!

I don't see the lack of specificity to be too much of an issue. I believe that since "ISO" has been around for 25 years, only a few will go down an uncharted route, most preferring to do what everyone else has done - create documents. They did before even when ISO 9001:2000 didn't require it.

Those who are going to transition their QMS aren't going to throw documents in the trash and those coming new to QMS are going to take the least line of resistance and not get too creative!

I also don't see a repeat of the "interpretations" of such things as flow charts etc. That kind of thing happened 10 - 15 years ago (or more, typically) and since there's a lot of grey hair in the industry and not a lot of new(er) auditors coming into the industry, most have learned to live with the impacts on how documentation is now created, I'd suggest.
Thank You to AndyN for your informative Post and/or Attachment!
  Post Number #22  
Old 8th October 2014, 01:49 PM
Marc's Avatar
Marc

 
 
Total Posts: 25,951
I Say... Re: Required Documents/Records in ISO 9001:2015

Typically, when I do a "gap analysis", we look at what they have, what is already documented, and what isn't. Usually there is no added documentation because in most cases if documentation wasn't already present they didn't need any to begin with. Over-documentation was a Dilbert cartoon years ago, but I can't find the one I'm thinking of off hand.

There are threads here from way back on over-documentation. Example: ISO 9001: Avoiding Over Documentation
From: http://Elsmar.com/level2/accolades.html


--> Subject: Results?
--> Date: Thu, 24 Jun 1999 16:29:21 -0500
--> From: Anaren Microwave
--> To: Marc Smith
-->
--> Well, as you anticipated, we "passed" with relatively few problems.
--> We had only 7 isolated non-conformities across 5 elements. Details
--> are in the attached file. The auditor said that this was a very
--> good result when compared to other registration audits he has
--> performed. All I can say is I am glad it was successful and Marty
--> said that she was happy to finally win! Once again, thanks for the
--> help. You're advice was extremely important. Especially important,
--> at least in my opinion, was your help in determining where we did
--> not need to document every last thing (by using training, etc.). I
--> think that without this input, we would have spent a lot more time
--> writing things that we did not need and wasted a lot of peoples'
--> time.
We were able to get the audit done in a year while we are
--> achieving record sales and profits. Who can argue with that?

Over-documentation in this day and age is (or should be) well in our past with respect to ISO 9001 requirements.
Thanks to Marc for your informative Post and/or Attachment!
  Post Number #23  
Old 8th October 2014, 02:10 PM
qpled

 
 
Total Posts: 85
Re: Required Documents/Records in ISO 9001:2015

Quote:
In Reply to Parent Post by Marc View Post

Typically, when I do a "gap analysis", we look at what they have, what is already documented, and what isn't. Usually there is no added documentation because in most cases if documentation wasn't already present they didn't need any to begin with. Over-documentation was a Dilbert cartoon years ago, but I can't find the one I'm thinking of off hand.
Now I am trying to find that Dilbert cartoon!
I did find the one about the Records Retention Department throwing documents away since no one ever asked for them back...
  Post Number #24  
Old 8th October 2014, 02:18 PM
Marc's Avatar
Marc

 
 
Total Posts: 25,951
Re: Required Documents/Records in ISO 9001:2015

I think these still work. Credit an old post by Scott Catron:

Using the search function on the Dilbert website, one can search by keywords:

ISO 9000

Quality management

Powerpoint

Dogbert wag


And:

http://Elsmar.com/Forums/fileslist.p...iteria=dilbert

http://www.google.com/cse?cx=partner...ert&gsc.page=1
Thank You to Marc for your informative Post and/or Attachment!
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 9001:2015 Clause 7.5.2 - Is Review and Approval applicable to Records? wywy2020 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 30 14th August 2017 10:57 PM
Control of Records - Is a List of Records Required by ISO 9001? Pat McGhie ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23 11th July 2014 05:48 PM
Is "Master Documents and Records list" required per ISO 9001 ? Haddad9921 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4 5th February 2014 12:25 AM
Control of Records limited to ISO 9001 Required Records - ISO 9001 Clause 4.2.4 D.Salman Records and Data - Quality, Legal and Other Evidence 1 2nd March 2008 12:12 AM
What are typical records of different documents required by ISO9001? osiris Records and Data - Quality, Legal and Other Evidence 2 21st October 2005 10:39 AM



The time now is 03:02 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


 
 
 


NOTE: This forum uses "Cookies"